An Open-Label Extension Study of GSK3511294 (Depemokimab) in Participants Who Were Previously Enrolled in 206713 (NCT04719832) or 213744 (NCT04718103)

NCT05243680 | Completed Phase 3 Results FDA Drug

• 2 other identifiers: 2128952023-505203-23-01
• Study Type: interventional
• Target: 641
• Locations: 14 countries
• Sites: 137

Brief Summary

The purpose of this open-label 12-month extension study is to continue to characterize the long-term safety, efficacy and immunogenic profile of GSK3511294 (Depemokimab) in participants with severe asthma with an eosinophilic phenotype following completion of clinical studies 206713 or 213744.

Conditions

Asthma

Keywords

GSK3511294; Depemokimab; Asthma; Long-term safety; Open-label

Outcome Measures

Primary Outcomes (3)

• Number of Participants With Any Adverse Events (AEs) and Serious AEs (SAEs)

  An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. An SAE is any untoward medical occurrence that, at any dose: results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or any other situation according to medical or scientific judgment.

  Up to Week 56

• Number of Participants With Worst Case Post-Baseline Positive Anti-GSK3511294 Antibodies (ADA)

  Serum samples were collected for the determination of anti-GSK3511294 antibodies (ADA) using a validated electro-chemiluminescent immunoassay. The assay involved screening, confirmation and titration assays. If serum samples tested positive in the screening assay, they were considered 'potentially positive' and were further analyzed for specificity using the confirmation assay. Samples that confirmed positive in the confirmation assay were reported as 'positive'. Confirmed positive ADA samples were further characterized in the titration assay to quasi-quantitate the amount of ADA in the sample and were also further characterized in the Neutralizing antibody (Nab) assay. A participant was considered positive ADA if they had at least one positive worst case post-Baseline ADA result. Number of participants with worst case post-Baseline positive anti-GSK3511294 antibodies are presented.

  Up to Week 52

• Number of Participants With Worst Case Post-Baseline Positive Neutralizing Antibodies

  Blood samples were collected for the determination of positive neutralizing antibodies. Neutralizing antibody (NAb) test was only carried out on samples that were positive in the confirmatory binding antibody assay. A participant was considered positive for NAb if they had at least one positive worst case post-Baseline neutralizing antibody result. Number of participants with worst case post-Baseline positive neutralizing antibodies are presented.

  Up to Week 52

Secondary Outcomes (4)

• Annualized Rate of Clinically Significant Exacerbations

  Up to Week 52

• Change From Baseline in Asthma Control Questionnaire-5 (ACQ-5) Score

  Baseline (Day 1), Weeks 4, 8, 12, 20, 26, 28, 32, 40 and 52

• Change From Baseline in St. George's Respiratory Questionnaire (SGRQ) Total Score at Weeks 26 and 52

  Baseline (Day 1), Weeks 26 and 52

• Change From Baseline in Pre-Bronchodilator Forced Expiratory Volume in One Second (FEV1) at Weeks 26 and 52

  Baseline (Day 1), Weeks 26 and 52

Study Arms (1)

Participants diagnosed with asthma receiving GSK3511294 (Depemokimab)

EXPERIMENTAL

Biological: GSK3511294 (Depemokimab)

Interventions

GSK3511294 (Depemokimab) BIOLOGICAL

GSK3511294 (Depemokimab) will be administered using a pre-filled safety syringe.

Participants diagnosed with asthma receiving GSK3511294 (Depemokimab)

Eligibility Criteria

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

You may qualify if:

• Participants who completed the double-blind study intervention treatment during Study 206713 or Study 213744.

You may not qualify if:

• Clinically significant change in health status during Study 206713 or Study 213744 which in the opinion of the investigator would make the participant unsuitable for participation in this study.
• A current malignancy or a malignancy that developed during Study 206713 or Study 213744 (participants who had localized carcinoma of the skin that was resected for cure will not be excluded).
• Participants who have other clinically significant medical conditions uncontrolled with Standard of Care (SoC) therapy not associated with Asthma, for example (e.g.), uncontrolled cardiovascular disease or ongoing active infectious disease which in the opinion of the investigator makes them unsuitable for the study.
• Participants with known parasitic (helminth) infections within 6 months prior to Visit 1 will be excluded from the study or required to be adequately treated for helminth infections before initiation of GSK3511294.
• Participants who meet the following based on results of Week 48 assessment from Study 206713 or Study 213744 or from a later result:
• Alanine aminotransferase (ALT) greater than (\>)2 times upper limit of normal (ULN).
• Total bilirubin \>1.5 times ULN (isolated bilirubin \>1.5 times ULN is acceptable if bilirubin is fractionated and direct bilirubin less than \[\<\] 35 percent \[%\]).
• Cirrhosis or current unstable liver or biliary disease per investigator assessment defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminemia, esophageal or gastric varices, persistent jaundice.
• Participants with current diagnosis of vasculitis. Participants with high clinical suspicion of vasculitis at screening will be evaluated and current vasculitis must be excluded prior to enrolment.
• Electrocardiogram (ECG) assessment: QTc corrected by Fridericia's formula (QTcF) greater than or equal to (\>=)450 milliseconds (msec) or QTcF \>=480 msec for participants with Bundle Branch Block at Visit 1.
• Current smokers.
• Participants with allergy/intolerance to the excipients of GSK3511294, a monoclonal antibody, or biologic.
• Participants who are pregnant or breastfeeding. Participants should not be enrolled if they plan to become pregnant during the time of study participation.
• Participants who for any reason permanently discontinued study treatment in the previous study 206713/213744 will be excluded from this study.
• Other investigational product/clinical study:

Sponsors & Collaborators

• GlaxoSmithKline: lead
• Iqvia Pty Ltd: collaborator

Study Sites (137)

GSK Investigational Site

Mobile, Alabama, 36608, United States

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GSK Investigational Site

Lancaster, California, 93534, United States

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GSK Investigational Site

Colorado Springs, Colorado, 80923, United States

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GSK Investigational Site

Lafayette, Colorado, 80026, United States

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GSK Investigational Site

Coral Gables, Florida, 33134, United States

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GSK Investigational Site

Hialeah, Florida, 33013, United States

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GSK Investigational Site

Loxahatchee Groves, Florida, 33470, United States

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GSK Investigational Site

Miami, Florida, 33144, United States

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GSK Investigational Site

Miami, Florida, 33173, United States

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GSK Investigational Site

Miami, Florida, 33186, United States

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GSK Investigational Site

Orlando, Florida, 32806, United States

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GSK Investigational Site

Savannah, Georgia, 31406, United States

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GSK Investigational Site

Normal, Illinois, 61761, United States

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GSK Investigational Site

Lexington, Kentucky, 40509, United States

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GSK Investigational Site

Ypsilanti, Michigan, 48197, United States

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GSK Investigational Site

Northfield, New Jersey, 08225, United States

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GSK Investigational Site

Toms River, New Jersey, 08755, United States

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GSK Investigational Site

The Bronx, New York, 10461, United States

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GSK Investigational Site

Gastonia, North Carolina, 28054, United States

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GSK Investigational Site

Huntersville, North Carolina, 28078, United States

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GSK Investigational Site

Winston-Salem, North Carolina, 27103, United States

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DuBois, Pennsylvania, 15801, United States

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GSK Investigational Site

Allen, Texas, 75013, United States

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GSK Investigational Site

Boerne, Texas, 78006, United States

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GSK Investigational Site

Dallas, Texas, 75225, United States

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GSK Investigational Site

Kerrville, Texas, 78028, United States

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GSK Investigational Site

San Antonio, Texas, 78207, United States

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GSK Investigational Site

San Antonio, Texas, 78229, United States

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GSK Investigational Site

Bellingham, Washington, 98225, United States

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GSK Investigational Site

Coffs Harbour, New South Wales, 2450, Australia

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GSK Investigational Site

South Brisbane, Queensland, 4101, Australia

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Sherwood Park, Alberta, T8H 0N2, Canada

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Kamloops, British Columbia, V2C 5T1, Canada

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GSK Investigational Site

Ajax, Ontario, L1S 2J5, Canada

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Ottawa, Ontario, K1G 6C6, Canada

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Changsha, Hunan, 410013, China

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Changchun, 130021, China

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GSK Investigational Site

Changchun, 132011, China

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GSK Investigational Site

Chengdu, 610041, China

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GSK Investigational Site

Guangzhou, 510080, China

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GSK Investigational Site

Guangzhou, 510120, China

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GSK Investigational Site

Guangzhou, 510150, China

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GSK Investigational Site

Guangzhou, 510180, China

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GSK Investigational Site

Haikou, 570311, China

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GSK Investigational Site

Hangzhou, 310009, China

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GSK Investigational Site

Hefei, 230001, China

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GSK Investigational Site

Hohhot, 10017, China

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GSK Investigational Site

Jinan, 250014, China

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Shanghai, 200040, China

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GSK Investigational Site

Shanghai, 200090, China

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GSK Investigational Site

Shenyang, 110004, China

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GSK Investigational Site

Shenyang, 110016, China

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GSK Investigational Site

Ürümqi, 830054, China

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GSK Investigational Site

Wenzhou, 323027, China

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GSK Investigational Site

Wuhan, 430030, China

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GSK Investigational Site

Xuzhou, 221006, China

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GSK Investigational Site

Brno, 625 00, Czechia

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GSK Investigational Site

Hradec Králové, 500 05, Czechia

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GSK Investigational Site

Jindřichův Hradec, 377 01, Czechia

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GSK Investigational Site

Strakonice, 38601, Czechia

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GSK Investigational Site

Tábor, 390 02, Czechia

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GSK Investigational Site

Teplice, 415 01, Czechia

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GSK Investigational Site

Caen, 14033, France

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Cholet, 49300, France

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Marseille, 13015, France

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Strasbourg, 67091, France

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Berlin, 10367, Germany

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Frankfurt, 60389, Germany

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Hamburg, 22299, Germany

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Koblenz, 56068, Germany

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GSK Investigational Site

Leipzig, 04275, Germany

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Magdeburg, 39120, Germany

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GSK Investigational Site

Neu-Isenburg, 63263, Germany

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GSK Investigational Site

Gödöllő, 2100, Hungary

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GSK Investigational Site

Mosonmagyaróvár, 9200, Hungary

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GSK Investigational Site

Szigetvár, 7900, Hungary

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GSK Investigational Site

Brescia, 25123, Italy

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GSK Investigational Site

Foggia, 71122, Italy

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GSK Investigational Site

Messina, 98158, Italy

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Milan, 20122, Italy

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GSK Investigational Site

Monserrato CA, 09042, Italy

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GSK Investigational Site

Palermo, 90127, Italy

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GSK Investigational Site

Pavia, 27100, Italy

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Roma, 168, Italy

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GSK Investigational Site

Rozzano MI, 20089, Italy

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Siena, 53100, Italy

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GSK Investigational Site

Varese, 21049, Italy

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GSK Investigational Site

Aichi, 470-1192, Japan

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GSK Investigational Site

Aichi, 489-8642, Japan

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GSK Investigational Site

Chiba, 275-8580, Japan

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GSK Investigational Site

Fukuoka, 802-0052, Japan

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GSK Investigational Site

Fukuoka, 811-1394, Japan

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GSK Investigational Site

Fukuoka, 813-0017, Japan

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GSK Investigational Site

Fukushima, 960-1295, Japan

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GSK Investigational Site

Hiroshima, 734-8530, Japan

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Hokkaido, 053-8506, Japan

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Hokkaido, 064-0804, Japan

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GSK Investigational Site

Kagawa, 761-8073, Japan

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GSK Investigational Site

Kagawa, 762-8550, Japan

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GSK Investigational Site

Kagoshima, 890-8520, Japan

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GSK Investigational Site

Kanagawa, 231-8682, Japan

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Kanagawa, 232-0024, Japan

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GSK Investigational Site

Niigata, 951-8520, Japan

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GSK Investigational Site

Okayama, 702-8055, Japan

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GSK Investigational Site

Saga, 843-0393, Japan

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GSK Investigational Site

Tokyo, 103-0027, Japan

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GSK Investigational Site

Tokyo, 141-8625, Japan

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GSK Investigational Site

Tokyo, 158-0097, Japan

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GSK Investigational Site

Tokyo, 185-0014, Japan

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GSK Investigational Site

Tokyo, 204-8585, Japan

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GSK Investigational Site

Gdansk, 80-214, Poland

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Kielce, 25-355, Poland

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Krakow, 30-033, Poland

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Krakow, 31-624, Poland

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Lodz, 90-242, Poland

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Lublin, 20-552, Poland

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GSK Investigational Site

Ostrowiec Świętokrzyski, 27-400, Poland

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GSK Investigational Site

Rzeszów, 35-051, Poland

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GSK Investigational Site

Strzelce Opolskie, 47-120, Poland

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GSK Investigational Site

Barcelona, 08006, Spain

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GSK Investigational Site

Benalmádena, 29631, Spain

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GSK Investigational Site

Girona, 17005, Spain

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GSK Investigational Site

Granada, 18014, Spain

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GSK Investigational Site

Madrid, 28031, Spain

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GSK Investigational Site

Madrid, CP 28041, Spain

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GSK Investigational Site

Palma de Mallorca, 07010, Spain

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GSK Investigational Site

Pozuelo de AlarcOn Madr, 28223, Spain

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GSK Investigational Site

Santiago de Compostela, 15706, Spain

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GSK Investigational Site

Valencia, 46015, Spain

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GSK Investigational Site

Zaragoza, 50009, Spain

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GSK Investigational Site

Kaohsiung City, 807, Taiwan

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GSK Investigational Site

Taichung, 40705, Taiwan

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GSK Investigational Site

Bradford, BD9 6RJ, United Kingdom

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GSK Investigational Site

Chertsey, KT16 0PZ, United Kingdom

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GSK Investigational Site

London, EC1M 6BQ, United Kingdom

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GSK Investigational Site

Manchester, M8 5RB, United Kingdom

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GSK Investigational Site

Nottingham, NG5 1PB, 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

Results Point of Contact

• Title: GSK Response Center
• Organization: GlaxoSmithKline

GSKClinicalSupportHD@gsk.com

866-435-7343

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 8, 2022
• First Posted: February 17, 2022
• Study Start: March 1, 2022
• Primary Completion: May 19, 2025
• Study Completion: May 19, 2025
• Last Updated: January 15, 2026
• Results First Posted: January 15, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: IPD will be made available within 6 months of publishing the results of the primary endpoints, key secondary endpoints and safety data of the study.
• Access Criteria: Access is provided after a research proposal is submitted and has received approval from the 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 can be granted, when justified, for up to another 12 months.

Locations

CN (21); ES (11); TW (2); IT (11); CZ (6); US (29); CA (4); JP (23); FR (4); DE (7); GB (5); PL (9); HU (3); AU (2)