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New asthma drug shows promise in Long-Term safety check

NCT ID NCT05243680

Disease control Sponsor: GlaxoSmithKline Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study looked at the long-term safety of a drug called depemokimab in 641 adults and teenagers with severe asthma caused by a type of white blood cell called eosinophils. Participants had already completed earlier studies and received the drug for another 12 months. The main goal was to track side effects and whether the body made antibodies against the drug. This is a disease-control treatment, not a cure, as asthma requires ongoing management.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

641 people

The number who actually took part.

Started

Mar 2022

Finished

May 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

12 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion criteria: * Participants who completed the double-blind study intervention treatment during Study 206713 or Study 213744. * Participants capable of giving signed informed consent/assent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol. In France, a participant will be eligible for inclusion in this study only if either affiliated to or a beneficiary of a social security category. Exclusion criteria: * 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: 1. Alanine aminotransferase (ALT) greater than (\>)2 times upper limit of normal (ULN). 2. 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 \[%\]). 3. 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: 1. Participants who have received treatment with an investigational agent (biologic or non-biologic) within the past 30 days or 5 drug half-lives whichever is longer, prior to the first dose, other than Study 206713/213744 study treatment. The term "investigational" applies to any drug not approved for sale for the disease/indication to treat in the country in which it is being used or investigational formulations of marketed products. 2. Participants who are currently participating in any other interventional clinical study.

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Conditions

The condition(s) this trial relates to.

asthma T2-high asthma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Asthma

Contacts and locations

Locations

  • GSK Investigational Site

    Mobile, Alabama, 36608, United States

  • GSK Investigational Site

    Lancaster, California, 93534, United States

  • GSK Investigational Site

    Colorado Springs, Colorado, 80923, United States

  • GSK Investigational Site

    Lafayette, Colorado, 80026, United States

  • GSK Investigational Site

    Coral Gables, Florida, 33134, United States

  • GSK Investigational Site

    Hialeah, Florida, 33013, United States

  • GSK Investigational Site

    Loxahatchee Groves, Florida, 33470, United States

  • GSK Investigational Site

    Miami, Florida, 33144, United States

  • GSK Investigational Site

    Miami, Florida, 33173, United States

  • GSK Investigational Site

    Miami, Florida, 33186, United States

  • GSK Investigational Site

    Orlando, Florida, 32806, United States

  • GSK Investigational Site

    Savannah, Georgia, 31406, United States

  • GSK Investigational Site

    Normal, Illinois, 61761, United States

  • GSK Investigational Site

    Lexington, Kentucky, 40509, United States

  • GSK Investigational Site

    Ypsilanti, Michigan, 48197, United States

  • GSK Investigational Site

    Northfield, New Jersey, 08225, United States

  • GSK Investigational Site

    Toms River, New Jersey, 08755, United States

  • GSK Investigational Site

    The Bronx, New York, 10461, United States

  • GSK Investigational Site

    Gastonia, North Carolina, 28054, United States

  • GSK Investigational Site

    Huntersville, North Carolina, 28078, United States

  • GSK Investigational Site

    Winston-Salem, North Carolina, 27103, United States

  • GSK Investigational Site

    DuBois, Pennsylvania, 15801, United States

  • GSK Investigational Site

    Allen, Texas, 75013, United States

  • GSK Investigational Site

    Boerne, Texas, 78006, United States

  • GSK Investigational Site

    Dallas, Texas, 75225, United States

  • GSK Investigational Site

    Kerrville, Texas, 78028, United States

  • GSK Investigational Site

    San Antonio, Texas, 78207, United States

  • GSK Investigational Site

    San Antonio, Texas, 78229, United States

  • GSK Investigational Site

    Bellingham, Washington, 98225, United States

  • GSK Investigational Site

    Coffs Harbour, New South Wales, 2450, Australia

  • GSK Investigational Site

    South Brisbane, Queensland, 4101, Australia

  • GSK Investigational Site

    Sherwood Park, Alberta, T8H 0N2, Canada

  • GSK Investigational Site

    Kamloops, British Columbia, V2C 5T1, Canada

  • GSK Investigational Site

    Ajax, Ontario, L1S 2J5, Canada

  • GSK Investigational Site

    Ottawa, Ontario, K1G 6C6, Canada

  • GSK Investigational Site

    Changsha, Hunan, 410013, China

  • GSK Investigational Site

    Changchun, 130021, China

  • GSK Investigational Site

    Changchun, 132011, China

  • GSK Investigational Site

    Chengdu, 610041, China

  • GSK Investigational Site

    Guangzhou, 510080, China

  • GSK Investigational Site

    Guangzhou, 510120, China

  • GSK Investigational Site

    Guangzhou, 510150, China

  • GSK Investigational Site

    Guangzhou, 510180, China

  • GSK Investigational Site

    Haikou, 570311, China

  • GSK Investigational Site

    Hangzhou, 310009, China

  • GSK Investigational Site

    Hefei, 230001, China

  • GSK Investigational Site

    Hohhot, 10017, China

  • GSK Investigational Site

    Jinan, 250014, China

  • GSK Investigational Site

    Shanghai, 200040, China

  • GSK Investigational Site

    Shanghai, 200090, China

  • GSK Investigational Site

    Shenyang, 110004, China

  • GSK Investigational Site

    Shenyang, 110016, China

  • GSK Investigational Site

    Ürümqi, 830054, China

  • GSK Investigational Site

    Wenzhou, 323027, China

  • GSK Investigational Site

    Wuhan, 430030, China

  • GSK Investigational Site

    Xuzhou, 221006, China

  • GSK Investigational Site

    Brno, 625 00, Czechia

  • GSK Investigational Site

    Hradec Králové, 500 05, Czechia

  • GSK Investigational Site

    Jindřichův Hradec, 377 01, Czechia

  • GSK Investigational Site

    Strakonice, 38601, Czechia

  • GSK Investigational Site

    Tábor, 390 02, Czechia

  • GSK Investigational Site

    Teplice, 415 01, Czechia

  • GSK Investigational Site

    Caen, 14033, France

  • GSK Investigational Site

    Cholet, 49300, France

  • GSK Investigational Site

    Marseille, 13015, France

  • GSK Investigational Site

    Strasbourg, 67091, France

  • GSK Investigational Site

    Berlin, 10367, Germany

  • GSK Investigational Site

    Frankfurt, 60389, Germany

  • GSK Investigational Site

    Hamburg, 22299, Germany

  • GSK Investigational Site

    Koblenz, 56068, Germany

  • GSK Investigational Site

    Leipzig, 04275, Germany

  • GSK Investigational Site

    Magdeburg, 39120, Germany

  • GSK Investigational Site

    Neu-Isenburg, 63263, Germany

  • GSK Investigational Site

    Gödöllő, 2100, Hungary

  • GSK Investigational Site

    Mosonmagyaróvár, 9200, Hungary

  • GSK Investigational Site

    Szigetvár, 7900, Hungary

  • GSK Investigational Site

    Brescia, 25123, Italy

  • GSK Investigational Site

    Foggia, 71122, Italy

  • GSK Investigational Site

    Messina, 98158, Italy

  • GSK Investigational Site

    Milan, 20122, Italy

  • GSK Investigational Site

    Monserrato CA, 09042, Italy

  • GSK Investigational Site

    Palermo, 90127, Italy

  • GSK Investigational Site

    Pavia, 27100, Italy

  • GSK Investigational Site

    Roma, 168, Italy

  • GSK Investigational Site

    Rozzano MI, 20089, Italy

  • GSK Investigational Site

    Siena, 53100, Italy

  • GSK Investigational Site

    Varese, 21049, Italy

  • GSK Investigational Site

    Aichi, 470-1192, Japan

  • GSK Investigational Site

    Aichi, 489-8642, Japan

  • GSK Investigational Site

    Chiba, 275-8580, Japan

  • GSK Investigational Site

    Fukuoka, 802-0052, Japan

  • GSK Investigational Site

    Fukuoka, 811-1394, Japan

  • GSK Investigational Site

    Fukuoka, 813-0017, Japan

  • GSK Investigational Site

    Fukushima, 960-1295, Japan

  • GSK Investigational Site

    Hiroshima, 734-8530, Japan

  • GSK Investigational Site

    Hokkaido, 053-8506, Japan

  • GSK Investigational Site

    Hokkaido, 064-0804, Japan

  • GSK Investigational Site

    Kagawa, 761-8073, Japan

  • GSK Investigational Site

    Kagawa, 762-8550, Japan

  • GSK Investigational Site

    Kagoshima, 890-8520, Japan

  • GSK Investigational Site

    Kanagawa, 231-8682, Japan

  • GSK Investigational Site

    Kanagawa, 232-0024, Japan

  • GSK Investigational Site

    Niigata, 951-8520, Japan

  • GSK Investigational Site

    Okayama, 702-8055, Japan

  • GSK Investigational Site

    Saga, 843-0393, Japan

  • GSK Investigational Site

    Tokyo, 103-0027, Japan

  • GSK Investigational Site

    Tokyo, 141-8625, Japan

  • GSK Investigational Site

    Tokyo, 158-0097, Japan

  • GSK Investigational Site

    Tokyo, 185-0014, Japan

  • GSK Investigational Site

    Tokyo, 204-8585, Japan

  • GSK Investigational Site

    Gdansk, 80-214, Poland

  • GSK Investigational Site

    Kielce, 25-355, Poland

  • GSK Investigational Site

    Krakow, 30-033, Poland

  • GSK Investigational Site

    Krakow, 31-624, Poland

  • GSK Investigational Site

    Lodz, 90-242, Poland

  • GSK Investigational Site

    Lublin, 20-552, Poland

  • GSK Investigational Site

    Ostrowiec Świętokrzyski, 27-400, Poland

  • GSK Investigational Site

    Rzeszów, 35-051, Poland

  • GSK Investigational Site

    Strzelce Opolskie, 47-120, Poland

  • GSK Investigational Site

    Barcelona, 08006, Spain

  • GSK Investigational Site

    Benalmádena, 29631, Spain

  • GSK Investigational Site

    Girona, 17005, Spain

  • GSK Investigational Site

    Granada, 18014, Spain

  • GSK Investigational Site

    Madrid, 28031, Spain

  • GSK Investigational Site

    Madrid, CP 28041, Spain

  • GSK Investigational Site

    Palma de Mallorca, 07010, Spain

  • GSK Investigational Site

    Pozuelo de AlarcOn Madr, 28223, Spain

  • GSK Investigational Site

    Santiago de Compostela, 15706, Spain

  • GSK Investigational Site

    Valencia, 46015, Spain

  • GSK Investigational Site

    Zaragoza, 50009, Spain

  • GSK Investigational Site

    Kaohsiung City, 807, Taiwan

  • GSK Investigational Site

    Taichung, 40705, Taiwan

  • GSK Investigational Site

    Bradford, BD9 6RJ, United Kingdom

  • GSK Investigational Site

    Chertsey, KT16 0PZ, United Kingdom

  • GSK Investigational Site

    London, EC1M 6BQ, United Kingdom

  • GSK Investigational Site

    Manchester, M8 5RB, United Kingdom

  • GSK Investigational Site

    Nottingham, NG5 1PB, United Kingdom

More trials for these conditions

Other studies related to the condition(s) this trial covers.