CompletedPhase 3

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

United States641 participantsStarted 2022-03-01

Plain-language 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.

Who can participate

Age range12 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Exclusion criteria

✕. 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 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.
✕. Participants who are currently participating in any other interventional clinical study.

What they're measuring

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

Timeframe: Up to Week 56

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

Timeframe: Up to Week 52

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

Timeframe: Up to Week 52

Trial details

NCT IDNCT05243680

SponsorGlaxoSmithKline

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-05-19

Results submitted2025-11-18

View on ClinicalTrials.gov More Asthma trials

Who can participate

Age range12 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Exclusion criteria

✕. 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 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.
✕. Participants who are currently participating in any other interventional clinical study.

What they're measuring

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

Timeframe: Up to Week 56

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

Timeframe: Up to Week 52

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

Timeframe: Up to Week 52