A Study to Assess the Effect of Dexpramipexole in Adolescents and Adults With Eosinophilic Asthma

NCT05748600 | Active Not Recruiting Phase 3 DMC FDA Drug

• 2 other identifiers: AR-DEX-22-032022-003005-30
• Study Type: interventional
• Target: 600
• Locations: 18 countries
• Sites: 335

Brief Summary

The purpose of this study is to evaluate dexpramipexole as an add-on oral therapy in participants with inadequately controlled eosinophilic asthma to evaluate improvements in lung function, asthma control, and quality of life. In addition, the study will further evaluate the safety and tolerability of dexpramipexole in participants with eosinophilic asthma.

Conditions

Eosinophilic Asthma; Asthma; Eosinophilic; Asthma Attack

Keywords

FEV1; Asthma; Dexpramipexole; EXHALE; EXHALE-4; Areteia; Uncontrolled Asthma; Asthma Attack; forced expiratory volume

Outcome Measures

Primary Outcomes (1)

• Change in pre-BD FEV₁ from baseline

  Pre-bronchodilator forced expiratory volume (pre-BD) FEV₁, absolute change from baseline, averaged over Weeks 20 and 24.

  Day 1 (baseline, pre-dose), Weeks 20, 24

Secondary Outcomes (7)

• Change from baseline in Asthma Control Questionnaire-6 (ACQ-6)

  Day 1 (baseline, pre-dose), Weeks 20, 24

• Change in Standardized version of the Asthma Quality of Life Questionnaire for 12 years and older (AQLQ+12) from baseline to Week 24.

  Day 1 (baseline, pre-dose) through Week 24

• Change from baseline absolute eosinophil count (AEC) averaged across Weeks 20 and 24.

  Day 1 (baseline, pre-dose) through Week 24

• Change from baseline forced vital capacity (FVC) averaged over Weeks 20 and 24.

  Day 1 (baseline, pre-dose), Weeks 20, 24

• Change from baseline forced vital capacity (FVC) at Weeks 4, 8, 12, 16, 20, and 24.

  Day 1 (baseline, pre-dose), Weeks 4, 8, 12, 16, 20, and 24

Study Arms (3)

150 mg BID

EXPERIMENTAL

Dexpramipexole 150 mg oral tablet taken twice a day

Drug: Dexpramipexole Dihydrochloride

75 mg BID

EXPERIMENTAL

Dexpramipexole 75 mg oral tablet taken twice a day

Drug: Dexpramipexole Dihydrochloride

Placebo

PLACEBO COMPARATOR

Placebo oral tablet taken twice a day

Drug: Placebo

Interventions

Dexpramipexole Dihydrochloride DRUG

administration of dexpramipexole tablet

150 mg BID; 75 mg BID

Placebo DRUG

administration of placebo tablet

Placebo

Eligibility Criteria

• Age: 12 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Signed informed consent form and assent form, as appropriate.
• Male or female ≥12 years of age at Screening Visit 1. Sites in Poland will only include participants aged ≥18 years.
• Asthma-related criteria
• Documented physician diagnosis of asthma for ≥12 months prior to Screening Visit 1.
• Participants requiring at a minimum daily low dose inhaled corticosteroids (ICS; ≥100 μg/day fluticasone propionate dry powder formulation daily or clinically comparable, per GINA 2021), plus one or more additional daily maintenance asthma controller medications, eg, long-acting β2 agonist (LABA), leukotriene antagonist, theophylline, long-acting muscarinic antagonists, cromolyn/nedocromil. Note: In Poland, this will instead include participants requiring a minimum daily medium dose ICS (≥500 μg/day fluticasone propionate dry powder formulation daily or clinically comparable, per GINA 2021). Use of daily ICS must be for at least 12 weeks prior to Screening Visit 1 and the doses of all controller medications must be stable for at least 4 weeks prior to Screening Visit 1.
• Pre-BD FEV1 ≥40% and \<80% (\<90% for participants 12 to 17 years of age) of predicted at Screening Visit 2.
• ACQ-6 ≥1.5 at Screening Visit 2.
• Eosinophil count of ≥0.30x10⁹/L at Screening Visit 1. If the initial value is between 0.250x10⁹/L to 0.299x10⁹/L, then this may be repeated once at an unscheduled visit (prior to Screening Visit 2).
• General medical history
• Negative urine pregnancy test for women of childbearing potential (WOCBP; after menarche) at the Screening and Baseline visits.
• WOCBP must use either of the following methods of birth control, from Screening Visit 1 through the End of Study Visit:
• A highly effective form of birth control (confirmed by the investigator). Highly effective forms of birth control include: true sexual abstinence, a vasectomized sexual partner, Implanon, female sterilization by tubal occlusion, any effective intrauterine device (IUD), IUD/intrauterine system (IUS), Levonorgestrel Intrauterine system, or oral contraceptive.
• Two protocol acceptable methods of contraception in tandem.
• Women not of childbearing potential are defined as women who are either permanently sterilized (hysterectomy, bilateral oophorectomy, or bilateral salpingectomy), or who are postmenopausal. Women will be considered postmenopausal if they have been amenorrheic for 12 months prior to the planned date of the Baseline Visit without an alternative medical cause. The following age specific requirements apply:
• Women \<50 years old will be considered postmenopausal if they have been amenorrheic for 12 months or more following cessation of exogenous hormonal treatment and follicle stimulating hormone levels in the postmenopausal range.

You may not qualify if:

• Asthma-related criteria
• A participant who experiences a severe asthma exacerbation (defined as a deterioration of asthma that results in emergency treatment, hospitalization prior to the Screening Visit 1 up to and including the Baseline Visit.
• Participants who experience an asthma exacerbation during the Screening/Run-in Period may remain in screening and proceed with study visits 14 days after they have completed their course of oral steroids or returned to their pre-Screening visit maintenance dose of oral steroids and the investigator considers participant has returned to baseline status.
• Current diagnosis of diseases which may confound interpretation of this study's findings such as allergic bronchopulmonary aspergillosis, eosinophilic granulomatosis with polyangiitis, eosinophilic gastrointestinal diseases, or hypereosinophilic syndrome, or lung diseases (eg, chronic obstructive pulmonary disease, idiopathic pulmonary fibrosis).
• Respiratory infection: Upper or lower respiratory tract, sinus, or middle ear infection within the 4 weeks before Screening Visit 1.
• Prohibited medications/procedures
• Treatment with a biologic investigational drug in the last 5 months prior to Screening Visit 1. Treatment with non-biologic investigational drugs in the previous 30 days or five-half-lives prior to Screening Visit 1, whichever is longer. Treatment with GSK3511294 (long acting anti-interleukin-5) in the past 12 months.
• Treatment with any of the following monoclonal antibody therapies within 120 days prior to Baseline: benralizumab, dupilumab, mepolizumab, reslizumab, omalizumab, tezepelumab, or tralokinumab.
• Treatment with pramipexole (Mirapex®) within 30 days of Baseline.
• Treatment with selected drugs known to have a substantial risk of neutropenia in the past 30 days prior to Screening Visit 1.
• Bronchial thermoplasty procedure in the past 12 months prior to Screening Visit 1 or planned during the study period.
• General medical history
• Weight \<40 kg at Screening Visit 2.
• Current smoking within 12 months prior to Screening Visit 1 or a smoking history of \>10 packyears. Smoking includes tobacco, vaping, and/or marijuana use.
• Known or suspected alcohol or drug abuse.

Sponsors & Collaborators

• Areteia Therapeutics: lead

Study Sites (335)

Research Site 40001-487

Chandler, Arizona, 85224, United States

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Research Site 40001-462

Peoria, Arizona, 85381, United States

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Research Site 40001-322

Surprise, Arizona, 85378, United States

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Research Site 40001-374

Bakersfield, California, 93301, United States

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Research Site 40001-227

Encinitas, California, 92024, United States

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Research Site 40001-349

Huntington Beach, California, 92647, United States

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Research Site 40001-485

Inglewood, California, 06410, United States

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Research Site 40001-440

La Palma, California, 90623, United States

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Research Site 40001-357

Lancaster, California, 93534, United States

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Research Site 40001-089

Los Angeles, California, 90048, United States

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Research Site 40001-362

Mission Viejo, California, 92691, United States

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Research Site 40001-449

Napa, California, 94558, United States

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Research Site 40001-062

Newport Beach, California, 92660, United States

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Research Site 40001-043

Newport Beach, California, 92663, United States

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Research Site 40001-380

Redding, California, 96001, United States

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Research Site 40001-434

San Diego, California, 92123, United States

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Research Site 40001-088

San Jose, California, 95117, United States

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Research Site 40001-359

Upland, California, 91756, United States

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Research Site 40001-003

West Covina, California, 91790, United States

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Research Site 40001-419

Westminster, California, 92683, United States

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Research Site 40001-425

Aurora, Colorado, 80014, United States

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Research Site 40001-353

Colorado Springs, Colorado, 80907, United States

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Research Site 40001-385

Wheat Ridge, Colorado, 80033, United States

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Research Site 40001-048

Aventura, Florida, 33180, United States

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Research Site 40001-005

Brandon, Florida, 33511, United States

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Research Site 40001-051

Brandon, Florida, 33511, United States

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Research Site 40001-029

Coral Gables, Florida, 33134, United States

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Research Site 40001-350

Gainesville, Florida, 32607, United States

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Research Site 40001-014

Greenacres City, Florida, 33467, United States

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Research Site 40001-054

Hialeah, Florida, 33012, United States

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Research Site 40001-067

Hialeah, Florida, 33016, United States

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Research Site 40001-020

Homestead, Florida, 33030, United States

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Research Site 40001-015

Kissimmee, Florida, 34744, United States

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Research Site 40001-002

Kissimmee, Florida, 34746, United States

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Research Site 40001-086

Loxahatchee Groves, Florida, 33470, United States

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Research Site 40001-318

Maitland, Florida, 32751, United States

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Research Site 40001-066

Miami, Florida, 33126, United States

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Research Site 40001-001

Miami, Florida, 33135, United States

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Research Site 40001-059

Miami, Florida, 33144, United States

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Research Site 40001-026

Miami, Florida, 33155, United States

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Research Site 40001-288

Miami, Florida, 33165, United States

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Research Site 40001-065

Miami, Florida, 33173, United States

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Research Site 40001-024

Miami, Florida, 33184, United States

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Research Site 40001-338

Miami Beach, Florida, 33169, United States

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Research Site 40001-348

Ocala, Florida, 34471, United States

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Research Site 40001-293

Orlando, Florida, 32819, United States

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Research Site 40001-429

Plantation, Florida, 33317, United States

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Research Site 40001-351

Sarasota, Florida, 34239, United States

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Research Site 40001-069

St. Petersburg, Florida, 33713, United States

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Research Site 40001-370

Tallahassee, Florida, 32308, United States

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Research Site 40001-004

Tampa, Florida, 33607, United States

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Research Site 40001-319

Viera, Florida, 32940, United States

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Research Site 40001-142

Adairsville, Georgia, 30103, United States

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Research Site 40001-075

Augusta, Georgia, 30909, United States

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Research Site 40001-018

Columbus, Georgia, 31904, United States

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Research Site 40001-452

Dunwoody, Georgia, 30350, United States

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Research Site 40001-483

East Point, Georgia, 30344, United States

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Research Site 40001-366

Lilburn, Georgia, 30047, United States

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Research Site 40001-423

Savannah, Georgia, 31406, United States

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Research Site 40001-090

Berwyn, Illinois, 60402, United States

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Research Site 40001-343

Chicago, Illinois, 60607, United States

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Research Site 40001-358

Normal, Illinois, 61761, United States

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Research Site 40001-135

River Forest, Illinois, 60305, United States

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Research Site 40001-403

Skokie, Illinois, 60077, United States

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Research Site 40001-036

Elwood, Indiana, 46036, United States

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Research Site 40001-347

Louisville, Kentucky, 40202, United States

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Research Site 40001-019

Owensboro, Kentucky, 42301, United States

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Research Site 40001-437

Alexandria, Louisiana, 71303, United States

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Research Site 40001-313

Marrero, Louisiana, 70072, United States

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Research Site 40001-352

Zachary, Louisiana, 70791, United States

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Research Site 40001-417

Annapolis, Maryland, 21401, United States

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Research Site 40001-466

Baltimore, Maryland, 21237, United States

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Research Site 40001-456

Takoma Park, Maryland, 20912, United States

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Research Site 40001-055

White Marsh, Maryland, 21162, United States

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Research Site 40001-468

Fall River, Massachusetts, 02723, United States

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Research Site 40001-427

Dearborn, Michigan, 48126, United States

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Research Site 40001-006

Flint, Michigan, 48504, United States

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Research Site 40001-148

Flint, Michigan, 48507, United States

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Research Site 40001-463

Rochester Hills, Michigan, 48307, United States

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Research Site 40001-442

Southfield, Michigan, 48034, United States

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Research Site 40001-372

Warren, Michigan, 48088, United States

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Research Site 40001-421

Mankato, Minnesota, 56001, United States

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Research Site 40001-083

Columbia, Missouri, 65203, United States

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Research Site 40001-074

Saint Charles, Missouri, 63301, United States

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Research Site 40001-046

St Louis, Missouri, 63110, United States

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Research Site 40001-409

Missoula, Montana, 59808, United States

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Research Site 40001-448

Lincoln, Nebraska, 68510, United States

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Research Site 40001-404

Omaha, Nebraska, 68798, United States

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Research Site 40001-473

Las Vegas, Nevada, 89109, United States

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Research Site 40001-387

Brick, New Jersey, 08724, United States

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Research Site 40001-363

Edison, New Jersey, 08817, United States

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Research Site 40001-457

Jersey City, New Jersey, 07304, United States

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Research Site 40001-355

Toms River, New Jersey, 08755, United States

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Research Site 40001-050

East Amherst, New York, 14051, United States

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Research Site 40001-412

Great Neck, New York, 11021, United States

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Research Site 40001-047

Hawthorne, New York, 10532, United States

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Research Site 40001-455

New York, New York, 10016, United States

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Research Site 40001-369

New York, New York, 10029, United States

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Research Site 40001-408

Charlotte, North Carolina, 28273, United States

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Research Site 40001-398

Charlotte, North Carolina, 28277, United States

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Research Site 40001-039

Gastonia, North Carolina, 28054, United States

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Research Site 40001-435

Greenville, North Carolina, 17834, United States

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Research Site 40001-111

Huntersville, North Carolina, 28078, United States

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Research Site 40001-382

Raleigh, North Carolina, 27610, United States

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Research Site 40001-439

Rocky Mount, North Carolina, 27804, United States

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Research Site 40001-283

Winston-Salem, North Carolina, 21704, United States

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Research Site 40001-034

Cincinnati, Ohio, 45215, United States

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Research Site 40001-013

Cincinnati, Ohio, 45219, United States

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Research Site 40001-010

Cincinnati, Ohio, 45236, United States

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Research Site 40001-413

Cleveland, Ohio, 44106, United States

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Research Site 40001-017

Dayton, Ohio, 45424, United States

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Research Site 40001-063

Toledo, Ohio, 43617, United States

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Research Site US-40001-038

Edmond, Oklahoma, 73034, United States

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Research Site 40001-386

Oklahoma City, Oklahoma, 73102, United States

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Research Site 40001-079

Oklahoma City, Oklahoma, 73120, United States

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Research Site 40001-027

Grants Pass, Oregon, 97527, United States

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Research Site 40001-337

Portland, Oregon, 97202, United States

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Research Site 40001-395

Hershey, Pennsylvania, 17033, United States

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Research Site 40001-327

Philadelphia, Pennsylvania, 19140, United States

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Research Site 40001-032

Columbia, South Carolina, 29204, United States

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Research Site 40001-025

Greenville, South Carolina, 29651, United States

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Research Site 40001-430

Rock Hill, South Carolina, 29732, United States

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Research Site 40001-073

Spartanburg, South Carolina, 29303, United States

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Research Site 40001-438

Dickson, Tennessee, 37055, United States

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Research Site 40001-414

Franklin, Tennessee, 37067, United States

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Research Site 40001-334

Allen, Texas, 75013, United States

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Research Site 40001-068

Amarillo, Texas, 79124, United States

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Research Site 40001-023

Dallas, Texas, 75230, United States

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Research Site 40001-028

Dallas, Texas, 75235, United States

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Research Site 40001-415

Dallas, Texas, 75246, United States

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Research Site 40001-304

DeSoto, Texas, 75115, United States

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Research Site 40001-418

Frisco, Texas, 75034, United States

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Research Site 40001-064

Houston, Texas, 77074, United States

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Research Site 40001-085

Houston, Texas, 77099, United States

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Research Site 40001-424

Kerrville, Texas, 78028, United States

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Research Site 40001-295

McKinney, Texas, 75069, United States

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Research Site 40001-304

Red Oak, Texas, 75154, United States

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Research Site 40001-377

San Antonio, Texas, 78258, United States

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Research Site 40001-335

Sugar Land, Texas, 77479, United States

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Research Site 40001-258

Murray, Utah, 84107, United States

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Research Site 40001-333

Pleasant View, Utah, 84404, United States

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Research Site 40001-340

Burke, Virginia, 22015, United States

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Research Site 40001-394

Williamsburg, Virginia, 23188, United States

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Research Site 40001-339

Greenfield, Wisconsin, 53228, United States

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Research Site 40001-433

La Crosse, Wisconsin, 54601, United States

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Research Site 40001-443

La Crosse, Wisconsin, 54601, United States

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Research Site 40054-035

Buenos Aires, B1878FNR, Argentina

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Research Site 40054-044

Buenos Aires, B1878FNR, Argentina

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Research Site 40054-034

Buenos Aires, B8000JRB, Argentina

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Research Site 40054-017

Buenos Aires, C1027AAP, Argentina

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Research Site 40054-008

Buenos Aires, C1426ABP, Argentina

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Research Site 40054-043

Buenos Aires, C14426ABP, Argentina

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Research Site 40054-015

Caba, C1121ABE, Argentina

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Research Site 40054-019

Mendoza, M5500AXR, Argentina

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Research Site 40054-016

Mendoza, M5500CBA, Argentina

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Research Site 40054-010

Mendoza, M5500CCG, Argentina

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Research Site 40054-028

Mendoza, M5501AAJ, Argentina

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Research Site 40054-032

Mendoza, M5501GCA, Argentina

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Research Site 40054-057

Mendoza, M5506BBH, Argentina

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Research Site 40054-024

San Miguel de Tucumán, C1425BEN, Argentina

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Research Site 40054-002

San Miguel de Tucumán, T4000CBC, Argentina

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Research Site 40054-020

San Miguel de Tucumán, T4000IAJ, Argentina

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Research Site 30043-013

Salzburg, 5020, Austria

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Research Site 40055-015

Belo Horizonte, Brazil

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Research Site 40055-007

Blumenau, 89030-101, Brazil

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Research Site 40055-011

Campo Largo, 83606-177, Brazil

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Research Site 40055-043

Curitiba, 80060-900, Brazil

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Research Site 40055-036

Curitiba, 80810-100, Brazil

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Research Site 40055-012

Porto Alegre, 90035-074, Brazil

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Research Site 40055-004

Porto Alegre, 90610-000, Brazil

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Research Site 40055-010

Porto Alegre, 91010-006, Brazil

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Research Site 40055-035

Rio de Janeiro, 22061-080, Brazil

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Research Site 40055-025

Salvador, 40060-325, Brazil

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Research Site 40055-005

Santo André, 09060-870, Brazil

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Research Site 40055-009

Santos, 11075-900, Brazil

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Research Site 40055-001

São Bernardo do Campo, 09715-090, Brazil

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Research Site 40011-004

Ajax, Ontario, L1S 2J5, Canada

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Research Site 40011-016

Ajax, Ontario, L1Z 0M1, Canada

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Research Site 40011-010

Burlington, Ontario, L7N, Canada

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Research Site 40011-014

Ottawa, Ontario, K1H 1E4, Canada

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Research Site 40011-005

Windsor, Ontario, N8X 2G1, Canada

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Research Site 40011-001

Windsor, Ontario, N8X 5A6, Canada

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Research Site 40011-018

Montreal, Quebec, H4A 3J1, Canada

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Research Site 40011-022

Québec, Quebec, G1G 3Y8, Canada

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Research Site 40011-020

Trois-Rivières, Quebec, G9A 4P3, Canada

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Research Site 40011-011

Vancouver, V5Z 1M9, Canada

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Research Site 40972-010

Ashkelon, 7830604, Israel

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Research Site 40972-008

Beersheba, 8410101, Israel

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Research Site 40972-005

Haifa, 3109601, Israel

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Research Site 40972-004

Haifa, 3436212, Israel

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Research Site 40972-001

Jerusalem, Israel

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Research Site 40972-009

Kfar Saba, 4428164, Israel

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Research Site 40972-002

Petah Tikva, 4941492, Israel

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Research Site 40972-011

Ramat Gan, 5262000, Israel

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Research Site 30060-006

Kampung Kelantan, Malaysia

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Research Site 40052-026

Chihuahua City, 31203, Mexico

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Research Site 40052-007

Guadalajara, 044100, Mexico

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Research Site 40052-028

Mexico City, 06700, Mexico

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Research Site 40052-012

San Juan del Río, 76800, Mexico

Location

Research Site 40048-001

Będzin, 42-500, Poland

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Research Site 40048-018

Bialystok, 15-044, Poland

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Research Site 40048-032

Bialystok, 15-430, Poland

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Research Site 40048-023

Gdansk, 80-214, Poland

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Research Site 40048-006

Giżycko, 11-500, Poland

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Research Site 40048-021

Katowice, 40-081, Poland

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Research Site 40048-002

Katowice, 40-365, Poland

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Research Site 40048-027

Krakow, 30-033, Poland

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Research Site 40048-033

Krakow, 31-011, Poland

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Research Site 40048-008

Krakow, 31-159, Poland

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Research Site 40048-040

Krakow, 31-864, Poland

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Research Site 40048-015

Lodz, 90-141, Poland

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Research Site 40048-009

Lodz, 90-302, Poland

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Research Site 40048-005

Lodz, 90-549, Poland

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Research Site 40048-022

Lublin, 20-089, Poland

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Research Site 40048-024

Maków Podhalański, 34-220, Poland

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Research Site 40048-031

Ostrowiec Świętokrzyski, 27-400, Poland

Location

Research Site 40048-010

Piaseczno, 05-500, Poland

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Research Site 40048-016

Poznan, 61-578, Poland

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Research Site 40048-039

Rzeszów, 35-205, Poland

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Research Site 40048-014

Skierniewice, 96-100, Poland

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Research Site 40048-012

Trzebnica, 55-100, Poland

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Research Site 40048-019

Wroclaw, 51-162, Poland

Location

Research Site 40787-365

Guaynabo, 00968, Puerto Rico

Location

Research Site 40787-390

Ponce, 00717, Puerto Rico

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Research Site 40787-388

San Juan, 00907, Puerto Rico

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Research Site 40787-383

San Juan, 00918, Puerto Rico

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Research Site 40787-405

San Juan, 00918, Puerto Rico

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Research Site 40787-360

San Juan, 00927, Puerto Rico

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Research Site 40787-345

Vega Baja, 00694, Puerto Rico

Location

Research Site 40040-004

Brasov, Brașov County, 50366, Romania

Location

Research Site 40040-006

Cluj-Napoca, Cluj, 400371, Romania

Location

Research Site 40040-002

Brasov, 500051, Romania

Location

Research Site 40040-009

Cluj-Napoca, 400162, Romania

Location

Research Site 40040-007

Cluj-Napoca, 400371, Romania

Location

Research Site 40040-001

Constanța, 900002, Romania

Location

Research Site 40040-010

Sângeorgiu de Mureş, 547365, Romania

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Research Site 40040-003

Timișoara, 300310, Romania

Location

Research Site 40027-013

Benoni, 1500, South Africa

Location

Research Site 40027-025

Cape Town, 7505, South Africa

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Research Site 40027-009

Cape Town, 7530, South Africa

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Research Site 40027-011

Cape Town, 7570, South Africa

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Research Site 40027-021

Cape Town, 7700, South Africa

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Research Site 30090-020

Durban, 4001, South Africa

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Research Site 40027-007

Durban, 7570, South Africa

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Research Site 40027-026

Johannesburg, 2193, South Africa

Location

Research Site 40027-005

KwaZulu, 4001, South Africa

Location

Research Site 40027-008

KwaZulu, 4092, South Africa

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Research Site 40027-020

KwaZulu, 4170, South Africa

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Research Site 40027-023

KwaZulu, 4301, South Africa

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Research Site 40027-027

KwaZulu, 4301, South Africa

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Research Site 40027-010

KwaZulu, 4450, South Africa

Location

Research Site 40027-006

Mpumalanga, 1050, South Africa

Location

Research Site 40027-004

Pretoria, 0002, South Africa

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Research Site 40027-019

Pretoria, 0204, South Africa

Location

Research Site 40027-018

Vereeniging, 1935, South Africa

Location

Research Site 40027-017

Welkom, 9460, South Africa

Location

Research Site 40082-003

Anyang-si, 14068, South Korea

Location

Research Site 30082-024

Bucheon-si, 14584, South Korea

Location

Research Site 40082-007

Busan, 48108, South Korea

Location

Research Site 40082-021

Gwangju, 61469, South Korea

Location

Research Site 40082-020

Incheon, 21565, South Korea

Location

Research Site 40082-006

Jeonju, 54907, South Korea

Location

Research Site 40082-019

Seoul, 04763, South Korea

Location

Research Site 40082-012

Seoul, 05030, South Korea

Location

Research Site 40082-008

Seoul, 06591, South Korea

Location

Research Site 40082-004

Seoul, 07061, South Korea

Location

Research Site 40082-011

Seoul, 08308, South Korea

Location

Research Site 40082-010

Suwon, 16499, South Korea

Location

Research Site 40886-001

Kaohsiung City, 807, Taiwan

Location

Research Site 40886-004

New Taipei City, 220, Taiwan

Location

Research Site 40886-006

New Taipei City, 23561, Taiwan

Location

Research Site 40886-005

Taichung, 40403, Taiwan

Location

Research Site 40886-007

Taichung, 40705, Taiwan

Location

Research Site 40886-010

Taipei, 100, Taiwan

Location

Research Site 40886-008

Taipei, 110, Taiwan

Location

Research Site 40866-003

Taipei, 11217, Taiwan

Location

Research Site 40886-009

Taipei, 11240, Taiwan

Location

Research Site 30066-004

Pathum Thani, 12120, Thailand

Location

Research Site 40090-002

Adana, 01240, Turkey (Türkiye)

Location

Research Site 40090-018

Ankara, 06230, Turkey (Türkiye)

Location

Research Site 40090-021

Ankara, 06230, Turkey (Türkiye)

Location

Research Site 40090-024

Ankara, 06230, Turkey (Türkiye)

Location

Research Site 40090-003

Ankara, 06560, Turkey (Türkiye)

Location

Research Site 40090-025

Ankara, 06560, Turkey (Türkiye)

Location

Research Site 40090-008

Ankara, 06620, Turkey (Türkiye)

Location

Research Site 40090-009

Ankara, 06930, Turkey (Türkiye)

Location

Research Site 40090-017

Antalya, 07400, Turkey (Türkiye)

Location

Research Site 40090-019

Bornova, 35100, Turkey (Türkiye)

Location

Research Site 40090-020

Istanbul, 34020, Turkey (Türkiye)

Location

Research Site 40090-026

Istanbul, 34750, Turkey (Türkiye)

Location

Research Site 40090-011

Istanbul, 34844, Turkey (Türkiye)

Location

Research Site 40090-012

Konak, 35110, Turkey (Türkiye)

Location

Research Site 40090-016

Merkez, 17020, Turkey (Türkiye)

Location

Research Site 40090-013

Mersin, 33110, Turkey (Türkiye)

Location

Research Site 40090-024

Pendik, Turkey (Türkiye)

Location

Research Site 40090-022

Tekirdağ, 59100, Turkey (Türkiye)

Location

Research Site 40380-002

Chernivtsi, 58001, Ukraine

Location

Research Site 40380-021

Chernivtsi, 58022, Ukraine

Location

Research Site 40380-009

Ivano-Frankivsk, 76008, Ukraine

Location

Research Site 40380-004

Ivano-Frankivsk, 76018, Ukraine

Location

Research Site 40380-017

Ivano-Frankivsk, 76018, Ukraine

Location

Research Site 40380-014

Ivano-Frankivsk, 76019, Ukraine

Location

Research Site 40380-019

Kyiv, 02002, Ukraine

Location

Research Site 40380-018

Kyiv, 03037, Ukraine

Location

Research Site 40380-007

Kyiv, 03038, Ukraine

Location

Research Site 40380-010

Kyiv, 03038, Ukraine

Location

Research Site 40380-012

Kyiv, 03038, Ukraine

Location

Research Site 40380-015

Kyiv, 03049, Ukraine

Location

Research Site 40380-011

Kyiv, 03057, Ukraine

Location

Research Site 40380-013

Kyiv, 03115, Ukraine

Location

Research Site 40380-016

Lutsk, 45634, Ukraine

Location

Research Site 40380-001

Ternopil, 46023, Ukraine

Location

Research Site 40380-003

Vinnytsia, 21001, Ukraine

Location

Research Site 40380-020

Vinnytsia, 21018, Ukraine

Location

Research Site 40380-008

Vinnytsia, 21029, Ukraine

Location

Research Site 40380-022

Vinnytsia, 21029, Ukraine

Location

Research Site 40380-005

Zhytomyr, 10002, Ukraine

Location

Research Site 40044-018

Bellshill, ML4 3NJ, United Kingdom

Location

Research Site 40044-021

Birmingham, B15 2SQ, United Kingdom

Location

Research Site 40044-077

Bollington, SK10 5JH, United Kingdom

Location

Research Site 40044-017

Chorley, PR7 7NA, United Kingdom

Location

Research Site 40044-022

Enfield, EN3 4GS, United Kingdom

Location

Research Site 40044-019

Liverpool, L22 0LG, United Kingdom

Location

Research Site 40044-084

London, E1 1 EQ, United Kingdom

Location

Research Site 40044-001

Manchester, BL9 0NJ, United Kingdom

Location

Research Site 40044-020

Manchester, M15 6SE, United Kingdom

Location

Research Site 40044-013

Manchester, M22 4DH, United Kingdom

Location

Research Site 40044-009

Manchester, M24 4DZ, United Kingdom

Location

Research Site 40044-036

Manchester, M27 0EW, United Kingdom

Location

Research Site 40044-006

Manchester, M33 4BR, United Kingdom

Location

Research Site 40044-024

Preston, PR2 9RB, United Kingdom

Location

Research Site 40044-026

Rochdale, OL11 4AU, United Kingdom

Location

Research Site 40044-008

Salford, M6 5WW, United Kingdom

Location

Research Site 40044-034

Stockport, SK8 5LL, United Kingdom

Location

Research Site 40044-078

Wythenshawe, M23 9QZ, United Kingdom

Location

MeSH Terms

Conditions

Pulmonary Eosinophilia; Asthma

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Hypereosinophilic Syndrome; Eosinophilia; Leukocyte Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Mona Bafadhel, MD

  Guy's and St Thomas' NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 20, 2023
• First Posted: February 28, 2023
• Study Start: January 30, 2023
• Primary Completion: September 1, 2025
• Study Completion: December 1, 2025
• Last Updated: September 5, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

PL (23); BR (13); ME (4); US (146); TH (1); KR (12); TU (18); GB (18); PR (7); MY (1); AU (1); RO (8); ZA (19); AR (16); IL (8); CA (10); UA (21); TW (9)