A Dose Finding Study With an Anti-TSLP Antibody (GSK5784283) in Adults Aged 18 to 75 Years of Age With Uncontrolled Asthma

NCT06748053 | Active Not Recruiting Phase 2 FDA Drug

• 2 other identifiers: 2231252024-518321-15
• Study Type: interventional
• Target: 307
• Locations: 9 countries
• Sites: 133

Brief Summary

This study is trying to find the right dose of a long-lasting medicine called GSK5784283 for people with asthma that remains uncontrolled even though they are using regular asthma treatments. GSK5784283 blocks the action of an inflammatory protein called TSLP that may be contributing to your asthma. The study will be conducted in two parts - Part A (dose finding phase) and Part B (extended dosing phase). Part A will assess the lung function, asthma control, participant safety and certain markers of asthma inflammation in the air you breath out and in your blood. Part B will assess the safety and long-term effects of the repeated or single doses of GSK5784283.

Conditions

Asthma

Keywords

Asthma; GSK5784283; Anti-TSLP antibody

Outcome Measures

Primary Outcomes (1)

• Part A: Change from baseline in the fraction of exhaled nitric oxide (FeNo)

  Baseline (Day 1) and at 2, 4, 8,12, 20 and 26 weeks

Secondary Outcomes (21)

• Part A: Change from baseline in blood eosinophil counts

  Baseline (Day 1) and at 2, 4, 8,12, 20 and 26 weeks

• Part A: Change from baseline in the forced expiratory volume (FEV1) [pre-and post-bronchodilator

  Baseline (Day 1) and at 2, 4, 8,12, 20 and 26 weeks

• Part A: Change from baseline in the forced vital capacity (FVC) [pre-and post-bronchodilator

  Baseline (Day 1) and at 2, 4, 8,12, 20 and 26 weeks

• Part A: Change from baseline in the 5-item Asthma Control Questionnaire (ACQ-5)

  Baseline (Day 1) and at 2, 4, 8,12, 20 and 26 weeks

• Part A: Maximum Observed Plasma Concentration (Cmax) of GSK5784283

  Up to 26 weeks

Study Arms (4)

Part A: Dose Finding - GSK5784283

EXPERIMENTAL

Drug: GSK5784283

Part A: Dose Finding - Placebo

EXPERIMENTAL

Drug: Placebo

Part B: Extended Dosing - GSK5784283

EXPERIMENTAL

Drug: GSK5784283

Part B: Extended Dosing - Placebo

EXPERIMENTAL

Drug: Placebo

Interventions

GSK5784283 DRUG

GSK5784283 will be administered.

Also known as: AIO-001, SHR-1905

Part A: Dose Finding - GSK5784283; Part B: Extended Dosing - GSK5784283

Placebo DRUG

Placebo will be administered.

Part A: Dose Finding - Placebo; Part B: Extended Dosing - Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants are eligible to be included in the study only if all of the following criteria apply:
• Informed Consent: Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and this protocol. The participant must be willing and able to comply with trial and follow-up procedures.
• Age: Participants must be 18 to 75 years of age inclusive, at the time of signing the informed consent.
• Documented physician-diagnosed asthma for \>= 2 years that meets the National Heart, Lung, and Blood Institute guidelines
• Evidence of variable airflow obstruction consistent with asthma.
• Documented history of asthma exacerbation within 12 months prior to Visit 1.
• An asthma exacerbation defined as a worsening of asthma symptoms.
• A well- documented requirement for regular treatment with medium or high-dose ICS for at least 6 months prior to screening.
• At least one additional maintenance asthma controller medication is required according to standard practice of care (e.g., long-acting beta 2 agonist (LABA), leukotriene receptors antagonists (LTRA), theophylline, long-acting muscarinic antagonist (LAMA), chromones, etc.). Use of additional asthma controller medications must be documented for at least 3 months prior to Visit 1.
• Weight \>=40 kg.
• Male or eligible Female.
• Female participants: A female participant is eligible to participate if she is not pregnant, not breastfeeding, and at least one of the following conditions applies:
• Not a woman of childbearing potential (WONCBP) OR
• Is a WOCBP and using a contraceptive method that is highly effective, with a failure rate of \<1%, 28 days prior to the 1st dose of the study drug and during the study intervention period and follow-up period. The investigator should evaluate potential for contraceptive method failure (e.g. non-compliance, recently initiated) in relationship to the first dose of study intervention.
• A WOCBP must have a negative serum pregnancy test at screening and a highly sensitive pregnancy test (\[urine or serum\] as required by local regulations) within 24 hours before each dose of study intervention.

You may not qualify if:

• Participants are excluded from the study if any of the following criteria apply:
• Any concomitant respiratory disease that in the opinion of the investigator and/or medical monitor will interfere with the evaluation of the investigational product or interpretation of subject safety or study results (e.g., current upper or lower respiratory tract infection, chronic obstructive pulmonary disease, cystic fibrosis, pulmonary fibrosis, bronchiectasis, allergic bronchopulmonary aspergillosis, Churg-Strauss syndrome, primary ciliary dyskinesia).
• Helminth parasitic infection diagnosed within 6 months prior to Visit 1 that has not been treated with, or has failed to respond to, standard of care therapy.
• Active or latent tuberculosis:
• Participants with a diagnosis or evidence of active or latent tuberculosis are excluded from the study.
• Diagnosis of vocal cord dysfunction, dysfunctional breathing, or pseudo steroid resistant asthma.
• Malignancy: A current malignancy or previous history of cancer in remission for less than 5 years prior to screening (Participants that had localized carcinoma of the skin which was resected for cure will not be excluded).
• History of an unresolved clinically significant infection within 30 days prior to Visit 1.
• A known immunodeficiency (e.g. human immunodeficiency virus - HIV), other than that explained by the use of corticosteroids taken as therapy for asthma.
• Participants who have known, pre-existing, clinically significant cardiac, endocrine, autoimmune, rheumatologic, metabolic, neurological, renal, gastrointestinal, hepatic, hematological or any other system abnormalities that are uncontrolled with standard treatment including eosinophilic conditions such as hyper-eosinophilic syndrome (HES) and eosinophilic granulomatosis with polyangiitis (EGPA).
• Any clinically relevant abnormal findings in physical examination, hematology, clinical chemistry, urinalysis, vital signs at Visit 2 which in the opinion of the investigator, may put the subject at risk because of his/her participation in the study, or may influence the results of the study, or the subject's ability to participate in the study.
• Receipt of any marketed or investigational biologic agent within 4 months or 5 half-lives prior to Visit 1, whichever is longer and up until the end of study.
• Receipt of any investigational non-biologic agent within 30 days or 5 half-lives prior to screening, whichever is longer and up until the end of study.
• Experimental vaccines are not permitted within 30 days prior to randomization and up until the end of the study.
• Use of immunosuppressive medication (e.g., methotrexate, troleandomycin, oral gold, cyclosporine, azathioprine, intramuscular long-acting depot corticosteroid, systemic (oral) corticosteroids) within 3 months prior to Visit 1 and up until the end of study.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (133)

GSK Investigational Site

Little Rock, Arkansas, 72205, United States

Location

GSK Investigational Site

Long Beach, California, 90815, United States

Location

GSK Investigational Site

Los Angeles, California, 90025, United States

Location

GSK Investigational Site

Redding, California, 96001, United States

Location

GSK Investigational Site

Riverside, California, 92506, United States

Location

GSK Investigational Site

Sacramento, California, 95817, United States

Location

GSK Investigational Site

San Jose, California, 95117, United States

Location

GSK Investigational Site

Colorado Springs, Colorado, 80923, United States

Location

GSK Investigational Site

Lakewood, Colorado, 80228-1813, United States

Location

GSK Investigational Site

Wheat Ridge, Colorado, 80033, United States

Location

GSK Investigational Site

New Haven, Connecticut, 06511, United States

Location

GSK Investigational Site

Aventura, Florida, 33180, United States

Location

GSK Investigational Site

Hialeah, Florida, 33012, United States

Location

GSK Investigational Site

Lake Worth, Florida, 33460, United States

Location

GSK Investigational Site

Leesburg, Florida, 34748, United States

Location

GSK Investigational Site

Miami, Florida, 33144, United States

Location

GSK Investigational Site

Miami, Florida, 33166, United States

Location

GSK Investigational Site

Miami, Florida, 33172, United States

Location

GSK Investigational Site

Miami, Florida, 33173, United States

Location

GSK Investigational Site

Plantation, Florida, 33324, United States

Location

GSK Investigational Site

Tampa, Florida, 33607, United States

Location

GSK Investigational Site

Skokie, Illinois, 60077, United States

Location

GSK Investigational Site

Shreveport, Louisiana, 71105, United States

Location

GSK Investigational Site

Lathrup Village, Michigan, 48076, United States

Location

GSK Investigational Site

Warren, Michigan, 48088, United States

Location

GSK Investigational Site

Omaha, Nebraska, 68198, United States

Location

GSK Investigational Site

The Bronx, New York, 10461, United States

Location

GSK Investigational Site

Cincinnati, Ohio, 45236, United States

Location

GSK Investigational Site

DuBois, Pennsylvania, 15801, United States

Location

GSK Investigational Site

Philadelphia, Pennsylvania, 19140, United States

Location

GSK Investigational Site

Pittsburgh, Pennsylvania, 15241, United States

Location

GSK Investigational Site

Wyomissing, Pennsylvania, 19610, United States

Location

GSK Investigational Site

Warwick, Rhode Island, 02886, United States

Location

GSK Investigational Site

Greenville, South Carolina, 29607, United States

Location

GSK Investigational Site

Spartanburg, South Carolina, 29303, United States

Location

GSK Investigational Site

Knoxville, Tennessee, 37909, United States

Location

GSK Investigational Site

Boerne, Texas, 78006, United States

Location

GSK Investigational Site

Cypress, Texas, 77429, United States

Location

GSK Investigational Site

Dallas, Texas, 75225, United States

Location

GSK Investigational Site

Houston, Texas, 77058, United States

Location

GSK Investigational Site

Kerrville, Texas, 78028, United States

Location

GSK Investigational Site

McKinney, Texas, 75069, United States

Location

GSK Investigational Site

San Antonio, Texas, 78212, United States

Location

GSK Investigational Site

San Antonio, Texas, 78229, United States

Location

GSK Investigational Site

Sherman, Texas, 75092, United States

Location

GSK Investigational Site

American Fork, Utah, 84003, United States

Location

GSK Investigational Site

Pleasant View, Utah, 84404, United States

Location

GSK Investigational Site

Salt Lake City, Utah, 84117, United States

Location

GSK Investigational Site

South Ogden, Utah, 84405, United States

Location

GSK Investigational Site

Bellingham, Washington, 98225, United States

Location

GSK Investigational Site

Blagoevgrad, 2700, Bulgaria

Location

GSK Investigational Site

Gorna Oryahovitsa, 5100, Bulgaria

Location

GSK Investigational Site

Lovech, 5500, Bulgaria

Location

GSK Investigational Site

Pazardzhik, 4400, Bulgaria

Location

GSK Investigational Site

Plovdiv, 4002, Bulgaria

Location

GSK Investigational Site

Rousse, 7000, Bulgaria

Location

GSK Investigational Site

Rousse, 7002, Bulgaria

Location

GSK Investigational Site

Sofia, 1000, Bulgaria

Location

GSK Investigational Site

Sofia, 1142, Bulgaria

Location

GSK Investigational Site

Sofia, 1233, Bulgaria

Location

GSK Investigational Site

Sofia, 1431, Bulgaria

Location

GSK Investigational Site

Sofia, 1680, Bulgaria

Location

GSK Investigational Site

Stara Zagora, Bulgaria

Location

GSK Investigational Site

Varna, 9000, Bulgaria

Location

GSK Investigational Site

Vratsa, 3000, Bulgaria

Location

GSK Investigational Site

Kelowna, British Columbia, V1Y 4N7, Canada

Location

GSK Investigational Site

Ajax, Ontario, L1S 2J5, Canada

Location

GSK Investigational Site

London, Ontario, N6A 4V2, Canada

Location

GSK Investigational Site

Toronto, Ontario, M5G 1E2, Canada

Location

GSK Investigational Site

Windsor, Ontario, N8X 1T3, Canada

Location

GSK Investigational Site

Trois-Rivières, Quebec, G8T 7A1, Canada

Location

GSK Investigational Site

Brandýs nad Labem, 25001, Czechia

Location

GSK Investigational Site

Mladá Boleslav, 293 01, Czechia

Location

GSK Investigational Site

Teplice, 415 01, Czechia

Location

GSK Investigational Site

Bendorf, 56170, Germany

Location

GSK Investigational Site

Berlin, 10961, Germany

Location

GSK Investigational Site

Berlin, 12203, Germany

Location

GSK Investigational Site

Darmstadt, 64283, Germany

Location

GSK Investigational Site

Frankfurt, 60596, Germany

Location

GSK Investigational Site

Fürstenwalde, 15517, Germany

Location

GSK Investigational Site

Leipzig, 04347, Germany

Location

GSK Investigational Site

Magdeburg, 39120, Germany

Location

GSK Investigational Site

Mainz, 55128, Germany

Location

GSK Investigational Site

München, 81241, Germany

Location

GSK Investigational Site

Neu-Isenburg, 63263, Germany

Location

GSK Investigational Site

Schleswig, 24837, Germany

Location

GSK Investigational Site

Chiba, 275-8580, Japan

Location

GSK Investigational Site

Fukui, 910-8526, Japan

Location

GSK Investigational Site

Fukuoka, 806-8501, Japan

Location

GSK Investigational Site

Fukuoka, 811-1394, Japan

Location

GSK Investigational Site

Fukushima, 960-1295, Japan

Location

GSK Investigational Site

Gifu, 509-6134, Japan

Location

GSK Investigational Site

Hiroshima, 734-8530, Japan

Location

GSK Investigational Site

Hokkaido, 064-0804, Japan

Location

GSK Investigational Site

Hyōgo, 653-0013, Japan

Location

GSK Investigational Site

Kagawa, 762-0043, Japan

Location

GSK Investigational Site

Kanagawa, 236-0051, Japan

Location

GSK Investigational Site

Mie, 515-8544, Japan

Location

GSK Investigational Site

Nagasaki, 852-8501, Japan

Location

GSK Investigational Site

Okayama, 702-8055, Japan

Location

GSK Investigational Site

Osaka, 596-8501, Japan

Location

GSK Investigational Site

Shizuoka, 420-8527, Japan

Location

GSK Investigational Site

Tokyo, 141-8625, Japan

Location

GSK Investigational Site

Tokyo, 162-8655, Japan

Location

GSK Investigational Site

Tokyo, 204-8585, Japan

Location

GSK Investigational Site

Yokohama, 232-0024, Japan

Location

GSK Investigational Site

Bacau, 600252, Romania

Location

GSK Investigational Site

Brasov, 500283, Romania

Location

GSK Investigational Site

Brasov, 500366, Romania

Location

GSK Investigational Site

Bucharest, 050159, Romania

Location

GSK Investigational Site

Cluj-Napoca, 400139, Romania

Location

GSK Investigational Site

Craiova Dolj, 200515, Romania

Location

GSK Investigational Site

Timișoara, 300310, Romania

Location

GSK Investigational Site

Alcorcon Madrid, 28922, Spain

Location

GSK Investigational Site

Barcelona, 08035, Spain

Location

GSK Investigational Site

Barcelona, Spain

Location

GSK Investigational Site

Benalmádena, 29631, Spain

Location

GSK Investigational Site

Jerez de la Frontera, 11407, Spain

Location

GSK Investigational Site

Madrid, 28003, Spain

Location

GSK Investigational Site

Madrid, 28007, Spain

Location

GSK Investigational Site

Madrid, 28031, Spain

Location

GSK Investigational Site

Madrid, 28040, Spain

Location

GSK Investigational Site

Madrid, 28223, Spain

Location

GSK Investigational Site

Málaga, 29010, Spain

Location

GSK Investigational Site

Santander, 39008, Spain

Location

GSK Investigational Site

Seville, 41012, Spain

Location

GSK Investigational Site

Valencia, 46015, Spain

Location

GSK Investigational Site

Valencia, 46017, Spain

Location

GSK Investigational Site

Zaragoza, 50009, Spain

Location

GSK Investigational Site

Bradford, BD9 6RJ, United Kingdom

Location

GSK Investigational Site

London, EC1M 6BQ, United Kingdom

Location

GSK Investigational Site

London, SE1 9RT, United Kingdom

Location

GSK Investigational Site

Newcastle upon Tyne, NE1 4LP, United Kingdom

Location

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 19, 2024
• First Posted: December 24, 2024
• Study Start: February 10, 2025
• Primary Completion (Estimated): July 17, 2026
• Study Completion (Estimated): September 9, 2027
• Last Updated: May 22, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Anonymized IPD will be made available within 6 months of publication of primary, key secondary and safety results for studies in product with approved indication(s) or terminated asset(s) across all indications.
• Access Criteria: Anonymized IPD is shared with researchers whose proposals are approved by an Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension may be granted, when justified, for up to 6 months.

Locations

US (50); BU (15); JP (20); CZ (3); DE (12); RO (7); GB (4); CA (6); ES (16)