A Study to Assess the Effect of Dexpramipexole in Adolescents and Adults With Severe Eosinophilic Asthma (EXHALE-3)

NCT05813288 | Terminated Phase 3 DMC FDA Drug

• 2 other identifiers: AR-DEX-22-022023-503693-20
• Study Type: interventional
• Target: 654
• Locations: 26 countries
• Sites: 282

Brief Summary

The objective of this clinical study is to investigate the safety, tolerability, and efficacy of dexpramipexole in participants with inadequately controlled severe eosinophilic asthma.

Conditions

Eosinophilic Asthma; Asthma; Eosinophilic; Asthma

Keywords

Exacerbations; Severe Asthma; Dexpramipexole; EXHALE; Areteia; EXHALE-3; Uncontrolled Asthma; Asthma Attack

Outcome Measures

Primary Outcomes (1)

• Annualized rate of severe asthma exacerbations over 52 weeks.

  A severe exacerbation was defined as a deterioration of asthma requiring: use of systemic corticosteroids for \>=3 days; or hospitalization or emergency room visit because of asthma, requiring systemic corticosteroids; or death due to asthma.

  Day 1 (baseline, pre-dose) through Week 52

Secondary Outcomes (12)

• Absolute Change in pre-bronchodilator forced expiratory volume (Pre-BD FEV₁) from Baseline

  Day 1 (baseline, pre-dose), Weeks 36, 44, 52

• Mean Change From Baseline at Week 52 in Asthma Control Questionnaire-6 (ACQ-6) (Key Secondary Endpoint)

  From randomization to Study Week 52

• Mean Change From Baseline at Week 52 in Standardized Asthma Quality of Life Questionnaire for 12 Years and Older (AQLQ+12) Total Score (Key Secondary Endpoint)

  From randomization to Study Week 52

• Annualized rate of severe exacerbations requiring an emergency over 52 weeks department visit or hospitalization

  Day 1 (baseline, pre-dose), Week 52

• Annualized rate of severe exacerbations (AAER) from Week 4 to Week 52.

  Week 4 through Week 52

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

Oral administration of dexpramipexole tablet

150 mg BID; 75 mg BID

Placebo DRUG

Oral 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.
• Asthma-related criteria
• Documented physician diagnosis of asthma for ≥12 months prior to Screening Visit 1.
• 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).
• Treatment of asthma, participants must satisfy all the below (items a to c):
• Participants who have received asthma controller medication with medium or high dose inhaled corticosteroids (ICS ≥500 μg/day fluticasone propionate dry powder formulation daily or clinically comparable, per GINA 2021) on a regular basis for at least 12 months prior to Screening Visit 1.
• Documented treatment with a stable dose of either medium or high dose ICS for at least 3 months prior to Visit 1. The ICS may be contained within an ICS/long-acting β2 agonist (LABA) combination product. Daily oral corticosteroids are an allowed concomitant medication; participants on daily oral corticosteroids must be on a stable dose for 3 months before Screening Visit 1.
• Use of one of more additional daily maintenance asthma controller medications according to standard practice of care is required. Use of a stable dose of any additional asthma controller medications must be documented for at least 3 months 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.
• Variable airflow obstruction documented with at least one of the following criteria:
• Bronchodilator reversibility, using the criteria above, documented in the past 24 months prior to Screening Visit 1 or during Screening.
• Peak flow variation of ≥20% over a 2-week period, documented in the past 24 months prior to Screening Visit 1 or during Screening.
• Airflow variability in clinic FEV₁ ≥20% between two consecutive clinic visits, documented in the past 24 months prior to Screening Visit 1.
• Airway hyperresponsiveness (provocative concentration causing a 20% fall in FEV₁ of methacholine \<8 mg/mL or other clinically relevant bronchoprovocation testing) documented in the past 24 months prior to Screening Visit 1 or during Screening.

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 due to asthma, or treatment with systemic corticosteroids) at any time from 4 weeks prior to Screening Visit 1.
• 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, 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-IL-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 coming year.
• General medical history
• Weight \<40 kg at Screening Visit 1.
• Current smoking within 12 months prior to Screening Visit 1 or a smoking history of \>10 pack-years. Smoking includes tobacco, vaping, and/or marijuana use.
• Known or suspected alcohol or drug abuse

Sponsors & Collaborators

• Areteia Therapeutics: lead

Study Sites (282)

Research Site 30001-287

Mobile, Alabama, 36608, United States

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Research Site 30001-487

Chandler, Arizona, 85224, United States

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Research Site 30001-462

Peoria, Arizona, 85381, United States

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Research Site 30001-322

Surprise, Arizona, 85378, United States

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Research Site 30001-458

Tucson, Arizona, 85724, United States

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Research Site 30001-010

Little Rock, Arkansas, 72212, United States

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Research Site 30001-502

Canoga Park, California, 91303, United States

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Research Site 30001-485

Inglewood, California, 96410, United States

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Research Site 30001-362

Laguna Niguel, California, 92677, United States

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Research Site 30001-497

Los Angeles, California, 90017, United States

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Research Site 30001-500

Northridge, California, 91324, United States

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Research Site 30001-489

Pasadena, California, 91105, United States

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Research Site 30001-501

San Diego, California, 92120, United States

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Research Site 30001-434

San Diego, California, 92123, United States

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Research Site 30001-484

Santa Monica, California, 90424, United States

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Research Site 30001-304

Valencia, California, 91355, United States

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Research Site 30001-305

Valencia, California, 97355, United States

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Research Site 30001-291

Jacksonville, Florida, 32216, United States

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Research Site 30001-318

Maitland, Florida, 32751, United States

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Research Site 30001-311

Miami, Florida, 33144, United States

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Research Site 30001-288

Miami, Florida, 33165, United States

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Research Site 30001-310

Miami, Florida, 33165, United States

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Research Site 30001-329

Miami, Florida, 33165, United States

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Research Site 30001-082

Miami, Florida, 33179, United States

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Research Site 30001-301

Naples, Florida, 34103, United States

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Research Site 30001-348

Ocala, Florida, 34471, United States

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Research Site 30001-331

Orlando, Florida, 32807, United States

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Research Site 30001-293

Orlando, Florida, 32819, United States

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Research Site 30001-312

Pembroke Pines, Florida, 33026, United States

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Research Site 30001-429

Plantation, Florida, 33317, United States

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Research Site 30001-319

Viera, Florida, 32940, United States

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Research Site 30001-452

Dunwoody, Georgia, 30350, United States

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Research Site 30001-483

East Point, Georgia, 30344, United States

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Research Site 30001-366

Lilburn, Georgia, 30047, United States

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Research Site 30001-328

Maywood, Illinois, 60153, United States

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Research Site 30001-535

Westchester, Illinois, 60154, United States

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Research Site 30001-347

Louisville, Kentucky, 40202, United States

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Research Site 30001-437

Alexandria, Louisiana, 71303, United States

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Research Site 30001-286

Lafayette, Louisiana, 70508, United States

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Research Site 30001-313

Marrero, Louisiana, 70072, United States

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Research Site 30001-352

Zachary, Louisiana, 70791, United States

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Research Site 30001-414

Annapolis, Maryland, 37067, United States

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Research Site 30001-472

Farmington Hills, Michigan, 48336, United States

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Research Site 30001-442

Southfield, Michigan, 48034, United States

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Research Site 30001-372

Warren, Michigan, 48088, United States

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Research Site 30001-421

Mankato, Minnesota, 56001, United States

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Research Site 30001-406

Rochester, Minnesota, 55905, United States

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Research Site 30001-522

North Las Vegas, Nevada, 89030, United States

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Research Site 30001-363

Edison, New Jersey, 08817, United States

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Research Site 30001-499

Hamilton, New Jersey, 08619, United States

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Research Site 30001-474

Massena, New York, 13662, United States

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Research Site 30001-455

New York, New York, 10016, United States

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Research Site US-30001-369

New York, New York, 10029, United States

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Research Site 30001-300

Schenectady, New York, 12304, United States

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Research Site 30001-398

Charlotte, North Carolina, 28277, United States

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Research Site 30001-439

Rocky Mount, North Carolina, 27804, United States

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Research Site 30001-413

Cleveland, Ohio, 44106, United States

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Research Site 30001-495

Columbus, Ohio, 43235, United States

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Research Site 30001-327

Philadelphia, Pennsylvania, 19140, United States

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Research Site 30001-414

Franklin, Tennessee, 37067, United States

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Research Site 30001-364

Memphis, Tennessee, 38105, United States

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Research Site 30001-334

Allen, Texas, 60607, United States

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Research Site 30001-090

Austin, Texas, 78726, United States

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Research Site 30001-415

Dallas, Texas, 75246, United States

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Research Site US-30001-418

Frisco, Texas, 75034, United States

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Research Site 30001-299

Houston, Texas, 77063, United States

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Research Site 30001-315

Katy, Texas, 77494, United States

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Research Site 30001-295

McKinney, Texas, 75069, United States

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Research Site 30001-373

Mesquite, Texas, 75150, United States

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Research Site 30001-481

Nederland, Texas, 71627, United States

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Research Site 30001-297

Pearland, Texas, 77584, United States

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Research Site 30001-238

San Antonio, Texas, 78258, United States

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Research Site 30001-377

San Antonio, Texas, 78258, United States

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Research Site 30001-335

Sugar Land, Texas, 77479, United States

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Research Site 30001-333

Pleasant View, Utah, 84404, United States

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Research Site 30001-515

West Valley City, Utah, 84120, United States

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Research Site 30054-035

Buenos Aires, 30054-035, Argentina

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Research Site 30054-031

Buenos Aires, 4190, Argentina

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Research Site 30054-048

Buenos Aires, 8000, Argentina

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Research Site 30054-045

Buenos Aires, B1646EBJ, Argentina

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Research Site 30054-026

Buenos Aires, B1824KAJ, Argentina

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Research Site 30054-049

Buenos Aires, B1842, Argentina

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Research Site 30054-050

Buenos Aires, B1842, Argentina

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Research Site 30054-044

Buenos Aires, B1878FNR, Argentina

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Research Site 30054-012

Buenos Aires, B1900BNN, Argentina

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Research Site 30054-021

Buenos Aires, B7600FYK, Argentina

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Research Site 30054-034

Buenos Aires, B8000JRB, Argentina

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Research Site 30054-015

Buenos Aires, C1121ABE, Argentina

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Research Site 30054-024

Buenos Aires, C1425BEN, Argentina

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Research Site 30054-008

Buenos Aires, C1426ABP, Argentina

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Research Site -30054-043

Buenos Aires, Cl426ABP, Argentina

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Research Site 30054-054

Concepción del Uruguay, E3260EPD, Argentina

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Research Site 30054-051

Córdoba, 5000, Argentina

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Research Site 30054-052

Córdoba, 5000, Argentina

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Research Site 30054-047

Mendoza, 5509, Argentina

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Research Site 30054-010

Mendoza, M5500CCG, Argentina

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Research Site 30054-032

Mendoza, M5501GCA, Argentina

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Research Site 30054-028

Mendoza, M550JIAAJ, Argentina

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Research Site 30054-042

Santa Fe, 2128, Argentina

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Research Site 30043-013

Salzburg, 5020, Austria

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Research Site 30043-012

Vienna, 1130, Austria

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Research Site 30043-001

Weiz, 1090, Austria

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Research Site 30055-036

Curitiba, 808101-00, Brazil

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Research Site 30055-021

Porto Alegre, 90410-000, Brazil

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Research Site 30055-035

Rio de Janeiro, 22061-080, Brazil

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Research Site 30055-025

Salvador, 40060-325, Brazil

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Research Site 30055-025

São Paulo, 03164-000, Brazil

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Research Site 30056-013

Santiago, Providencia, 7501126, Chile

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Research Site 30056-009

Curicó, 3341643, Chile

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Research Site 30056-007

Santiago, 7500657, Chile

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Research Site 30056-013

Santiago, 7501126, Chile

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Research Site 30056-011

Santiago, 7510000, Chile

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Research Site 30056-010

Santiago, 7630226, Chile

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Research Site 30056-006

Santiago, 8330034, Chile

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Research Site 30056-012

Santiago, 8389001, Chile

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Research Site 30056-005

Temuco, 4781151, Chile

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Research Site 30056-014

Viña del Mar, 2520598, Chile

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Research Site 30086-021

Shanghai, 201299, China

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Research Site 30385-008

Zadar, 23000, Croatia

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Research Site 30385-002

Zagreb, 10000, Croatia

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Research Site 30385-007

Zagreb, 10000, Croatia

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Research Site 30420-018

Brno, 61 800, Czechia

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Research Site 30420-012

Brno, 62 500, Czechia

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Research Site 30420-003

Jindřichův Hradec, 37 701, Czechia

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Research Site 30420-007

Lovosice, 41 002, Czechia

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Research Site 30420-014

Olomouc, 77 900, Czechia

Location

Research Site 30420-010

Strakonice, 38 601, Czechia

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Research Site 30420-009

Teplice, 41 501, Czechia

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Research Site 30033-012

Cholet, 49300, France

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Research Site 30033-005

Grenoble, 38043, France

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Research Site 30033-013

Libourne, 33500, France

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Research Site 30033-014

Lille, 59037, France

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Research Site 30033-002

Lyon, 69317, France

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Research Site 30033-001

Marseille, 13003, France

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Research Site 30033-006

Marseille, 13015, France

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Research Site 30033-007

Montpellier, 34295, France

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Research Site 30033-003

Paris, 75018, France

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Research Site 30033-015

Reims, 51100, France

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Research Site 30033-004

Saint-Herblain, 44800, France

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Research Site 30033-018

Strasbourg, 67091, France

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Research Site 30049-081

Augsburg, 86150, Germany

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Research Site 30049-060

Berlin, 10717, Germany

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Research Site 30049-005

Berlin, 10961, Germany

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Research Site 30049-004

Cottbus, 03050, Germany

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Research Site 30049-082

Delitzsch, 04509, Germany

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Research Site 30049-059

Frankfurt, 63089, Germany

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Research Site 30049-019

Frankfurt, 95606, Germany

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Research Site 30049-006

Fürstenwalde, 15517, Germany

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Research Site 30049-035

Hanover, 30625, Germany

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Research Site 30049-073

Homburg, 66421, Germany

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Research Site 30049-061

Leipzig, 04275, Germany

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Research Site 30049-056

Leipzig, 04357, Germany

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Research Site 30049-038

Magdeburg, 39120, Germany

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Research Site 30049-051

Munich, 80539, Germany

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Research Site 30049-028

Munich, 81241, Germany

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Research Site 30049-029

Witten, 58456, Germany

Location

Research Site 30036-005

Balassagyarmat, 2660, Hungary

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Research Site 30036-001

Budapest, 1122, Hungary

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Research Site 30036-014

Debrecen, 4027, Hungary

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Research Site 30036-017

Edelény, 3780, Hungary

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Research Site 30036-013

Gödöllő, 2100, Hungary

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Research Site 30036-006

Szeged, 6720, Hungary

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Research Site 30036-018

Szigetvár, 7900, Hungary

Location

Research Site 30091-006

Ahmedabad, Gujarat, 382345, India

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Research Site 30091-010

Ahmedabad, Gujarat, 382350, India

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Research Site 30091-011

Himmatnagar, Gujarat, 383001, India

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Research Site 30091-001

Surat, Gujarat, 395006, India

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Research Site 30091-024

Rohtak, Haryana, 124001, India

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Research Site 30091-043

Aurangabad, Maharashta, 431001, India

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Research Site 30091-004

Nagpur, Maharashta, 440010, India

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Research Site 30091-023

Nagpur, Maharashta, 440010, India

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Research Site 30091-033

Pune, Maharashta, 411057, India

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Research Site 30091-018

Jaipur, Rajasthan, 302039, India

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Research Site 30091-021

Kanpur, 208002, India

Location

Research Site 30972-008

Beersheba, Israel

Location

Research Site 30972-001

Jerusalem, 9112026851, Israel

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Research Site 30972-009

Kfar Saba, 4428164, Israel

Location

Research Site 30972-011

Ramat Gan, 5262000, Israel

Location

Research Site 30972-012

Rehovot, 7661041, Israel

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Research Site 30972-005

Sha‘ar Ha‘Aliya, 3109601, Israel

Location

Research Site 30039-004

Bergamo, 24127, Italy

Location

Research Site 30039-012

Ferrara, 44124, Italy

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Research Site 30039-020

Genova, 16132, Italy

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Research Site 30039-013

Naples, 80131, Italy

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Research Site 30039-002

Padua, 35128, Italy

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Research Site 30039-017

Reggio Emilia, 42123, Italy

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Research Site 30039-011

Roma, 00168, Italy

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Research Site 20081-010

Kanazawa, 920-8650, Japan

Location

Research Site 30370-016

Kaunas, 50161, Lithuania

Location

Research Site 30370-017

Klaipėda, 92231, Lithuania

Location

Research Site 30370-002

Vilnius, 06256, Lithuania

Location

Research Site 30052-024

Guadalajara, Jalisco, 44100, Mexico

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Research Site 30052-025

Morelia, Michoacon, 58260, Mexico

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Research Site 30052-026

Chihuahua City, 31203, Mexico

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Research Site 30052-030

Durango, 34080, Mexico

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Research Site 30052-033

León, 37160, Mexico

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Research Site 30052-028

Mexico City, 6700, Mexico

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Research Site 30052-023

Monterrey, 64718, Mexico

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Research Site -30051-023

Arequipa, 04017, Peru

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Research Site 30051-022

Lima, 15023, Peru

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Research Site 30051-026

Lima, 15023, Peru

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Research Site 30051-020

Lima, 15046, Peru

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Research Site -30051-028

Lima, 15072, Peru

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Research Site 30051-017

Lima, 15072, Peru

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Research Site 30051-021

Lima, 15801, Peru

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Research Site 30787-388

Rio Piedras, 00918, Puerto Rico

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Research Site 30001-383

San Juan, 00918, Puerto Rico

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Research Site 30787-405

San Juan, 00918, Puerto Rico

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Research Site 30001-345

Vega Baja, 00694, Puerto Rico

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Research Site 30027-013

Benoni, 1501, South Africa

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Research Site 30027-009

Cape Town, 7530, South Africa

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Research Site 30027-011

Cape Town, 7570, South Africa

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Research Site 30027-012

Cape Town, 7700, South Africa

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Research Site 30027-021

Cape Town, 7700, South Africa

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Research Site 30027-007

Durban, 3630, South Africa

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Research Site 30027-001

Durban, 4000, South Africa

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Research Site 30027-014

Durban, 4091, South Africa

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Research Site 30027-023

Durban, 4301, South Africa

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Research Site 30027-010

Durban, 4450, South Africa

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Research Site 30027-030

Johannesburg, 1827, South Africa

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Research Site 30027-026

Johannesburg, 2193, South Africa

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Research Site 30027-031

Krugersdorp, 1739, South Africa

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Research Site 30027-008

KwaZulu, 4092, South Africa

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Research Site 30027-032

Plettenberg Bay, 6600, South Africa

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Research Site 30027-029

Polokwane, 0699, South Africa

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Research Site 30027-004

Pretoria, 0002, South Africa

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Research Site 30027-019

Pretoria, 0204, South Africa

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Research Site 30027-015

Thabazimbi, 0380, South Africa

Location

Research Site 30027-018

Vereeniging, 1935, South Africa

Location

Research Site 30027-017

Welkom, 9460, South Africa

Location

Research Site 30082-019

Gwangju, 61469, South Korea

Location

Research Site 30082-022

Seoul, 02841, South Korea

Location

Research Site 30082-018

Seoul, 03312, South Korea

Location

Research Site 20082-028

Seoul, 05278, South Korea

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Research Site 30082-010

Suwon, 16499, South Korea

Location

Research Site 30082-017

Wŏnju, 26426, South Korea

Location

Research Site 30034-046

A Coruña, 15006, Spain

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Research Site 30034-052

A Coruña, 15706, Spain

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Research Site 30034-011

Barcelona, 08017, Spain

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Research Site 30034-049

Barcelona, 08025, Spain

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Research Site 30034-013

Barcelona, 08036, Spain

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Research Site 30034-021

Lugo, 27003, Spain

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Research Site 30034-053

Madrid, 28040, Spain

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Research Site 30034-037

Madrid, 28046, Spain

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Research Site 30034-045

Madrid, 28046, Spain

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Research Site 30034-050

Santander, 39008, Spain

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Research Site 30034-043

Valencia, 46017, Spain

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Research Site 30034-041

Vigo, 36211, Spain

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Research Site 30886-013

Douliu, 640, Taiwan

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Research Site 30886-004

New Taipei City, 220, Taiwan

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Research Site 30886-006

New Taipei City, 23561, Taiwan

Location

Research Site 30886-005

Taichung, 404327, Taiwan

Location

Research Site 30886-007

Taichung, 40705, Taiwan

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Research Site 30886-011

Tainan, Taiwan

Location

Research Site 30886-010

Taipei, 100, Taiwan

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Research Site 30886-008

Taipei, 11031, Taiwan

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Research Site 30886-003

Taipei, 112, Taiwan

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Research Site 30886-009

Taipei, 112, Taiwan

Location

Research Site 30090-017

Alanya, 07400, Turkey (Türkiye)

Location

Research Site 30090-018

Ankara, 06230, Turkey (Türkiye)

Location

Research Site 30090-021

Ankara, 06230, Turkey (Türkiye)

Location

Research Site 30090-008

Ankara, 06620, Turkey (Türkiye)

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Research Site 30090-009

Ankara, 06930, Turkey (Türkiye)

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Research Site 30090-029

Antalya, 07070, Turkey (Türkiye)

Location

Research Site 30090-019

Bornova, 35100, Turkey (Türkiye)

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Research Site 30090-016

Çanakkale, 17020, Turkey (Türkiye)

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Research Site 30090-027

Gaziantep, 27410, Turkey (Türkiye)

Location

Research Site 30030-024

Istanbul, 34020, Turkey (Türkiye)

Location

Research Site 30090-020

Istanbul, 34020, Turkey (Türkiye)

Location

Research Site 30090-026

Istanbul, 34750, Turkey (Türkiye)

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Research Site 30090-011

Istanbul, 34844, Turkey (Türkiye)

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Research Site 30090-012

Izmir, 35170, Turkey (Türkiye)

Location

Research Site 30090-013

Mersin, 33110, Turkey (Türkiye)

Location

Research Site 30090-010

Nilufer, 16059, Turkey (Türkiye)

Location

Research Site 30090-022

Tekirdağ, 59100, Turkey (Türkiye)

Location

Research Site 30090-002

Yüreğir, 01240, Turkey (Türkiye)

Location

Research Site 30380-002

Chernivtsi, 58001, Ukraine

Location

Research Site 30380-011

Kyiv, 03057, Ukraine

Location

Research Site 30044-027

Glasgow, G20 7BE, United Kingdom

Location

Research Site 30044-059

High Wycombe, HP11 2QW, United Kingdom

Location

Research Site 30044-039

Leicester, LE3 9QP, United Kingdom

Location

Research Site 30044-025

Sheffield, S25FX, 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

• Michael E. Wechsler, MD

  National Jewish Health

  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: March 27, 2023
• First Posted: April 14, 2023
• Study Start: March 27, 2023
• Primary Completion: December 8, 2025
• Study Completion: December 8, 2025
• Last Updated: December 15, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

ZA (21); CL (10); CN (1); TU (18); HU (7); AU (3); CR (3); IL (6); PE (7); IN (11); KR (6); UA (2); ES (12); PR (4); AR (23); JP (1); IT (7); LI (3); DE (16); GB (4); US (76); FR (12); TW (10); BR (5); ME (7); CZ (7)