An Open-Label Extension Study of GSK3511294 (Depemokimab) in Participants Who Were Previously Enrolled in 206713 (NCT04719832) or 213744 (NCT04718103)
NCT05243680 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 641
Last updated 2026-01-15
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
Interventions
- BIOLOGICAL
-
GSK3511294 (Depemokimab)
GSK3511294 (Depemokimab) will be administered using a pre-filled safety syringe.
Sponsors & Collaborators
-
Iqvia Pty Ltd
collaborator INDUSTRY - lead INDUSTRY
Principal Investigators
-
GSK Clinical Trials · GlaxoSmithKline
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 12 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2022-03-01
- Primary Completion
- 2025-05-19
- Completion
- 2025-05-19
- FDA Drug
- Yes
Countries
- United States
- Australia
- Canada
- China
- Czechia
- France
- Germany
- Hungary
- Italy
- Japan
- Poland
- Spain
- Taiwan
- United Kingdom
Study Locations
More Related Trials
-
Open-Label Extension Study of Reslizumab in Pediatric Subjects With Eosinophilic Esophagitis
NCT00635089 ·Status: COMPLETED ·Phase: PHASE3
-
Safety and Efficacy Study of Omalizumab Given Prior to Immunotherapy
NCT00329381 ·Status: COMPLETED ·Phase: PHASE4
-
A Study to Assess Subcutaneous AK002 in Eosinophilic Gastritis and/or Eosinophilic Duodenitis
NCT05152563 ·Status: WITHDRAWN ·Phase: PHASE3
-
A FIH Study of YH35324 in Atopic Healthy Subjects or Subjects with Mild Allergic Diseases
NCT05061524 ·Status: COMPLETED ·Phase: PHASE1
-
Predicting the Clinical Response to Omalizumab With Anti-Immunoglobulin E (IgE) Ab Response or Syk Expression in Basophils
NCT02023151 ·Status: COMPLETED ·Phase: PHASE4
-
A Clinical Trial Evaluating the Safety and Effectiveness of Golimumab in Patients With Severe, Persistent Asthma
NCT00675649 ·Status: WITHDRAWN ·Phase: PHASE2
-
Study to Evaluate the Effect of Xolair(Omalizumab) on Improving the Tolerability of Specific Immunotherapy in Patients With at Least Moderate Persistent Allergic Asthma Inadequately Controlled With Inhaled Corticosteroids
NCT00691873 ·Status: COMPLETED ·Phase: PHASE4
-
An Extension Study of AK002 in Patients With Eosinophilic Gastritis and/or Eosinophilic Duodenitis
NCT03664960 ·Status: COMPLETED ·Phase: PHASE2
-
A Study to Assess the Efficacy, Safety and Tolerability of IRL201104 in Adults With Active Eosinophilic Esophagitis
NCT05084963 ·Status: COMPLETED ·Phase: PHASE2
-
A Study of CDX-0159 in Patients With Eosinophilic Esophagitis
NCT05774184 ·Status: COMPLETED ·Phase: PHASE2
-
A Study to Evaluate the Safety and Tolerability, Pharmacokinetics (PK) and Pharmacodynamics (PD) of Melrilimab (GSK3772847) in Healthy Participants
NCT04366349 ·Status: COMPLETED ·Phase: PHASE1
-
A Study to Assess AK002 in Eosinophilic Gastritis and/or Eosinophilic Duodenitis (Formerly Referred to as Eosinophilic Gastroenteritis)
NCT04322604 ·Status: COMPLETED ·Phase: PHASE3
-
A Study of Lirentelimab (AK002) in Patients With Active Eosinophilic Esophagitis
NCT04322708 ·Status: COMPLETED ·Phase: PHASE2/PHASE3
-
Use Of A Response-Adapted Ruxolitinib-Containing Regimen For The Treatment Of Hemophagocytic Lymphohistiocytosis
NCT04551131 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE1/PHASE2
-
A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Axatilimab Monotherapy in Japanese Participants With Recurrent or Refractory Active Chronic Graft-Versus-Host Disease
NCT06263478 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE3
-
Study of Dupilumab in Adult Participants With Active Eosinophilic Esophagitis (EoE)
NCT02379052 ·Status: COMPLETED ·Phase: PHASE2
-
A Study to Evaluate Axatilimab and Corticosteroids as Initial Treatment for Chronic Graft-Versus-Host Disease
NCT06585774 ·Status: RECRUITING ·Phase: PHASE3
-
An Open-label, Nonrandomized Study to Evaluate the Safety and Immunogenicity of Raxibacumab With Reinjection
NCT02016963 ·Status: COMPLETED ·Phase: PHASE2/PHASE3
-
Study to Determine the Efficacy and Safety of Dupilumab in Adult and Adolescent Patients With Eosinophilic Esophagitis (EoE)
NCT03633617 ·Status: COMPLETED ·Phase: PHASE3
-
Safety, Tolerability and Pharmacokinetic of Recombinant Anti-IL-5 Humanized Monoclonal Antibody Injection
NCT04445038 ·Status: UNKNOWN ·Phase: PHASE1
-
Efficacy and Safety Study of Mepolizumab 100 Milligram (mg) Subcutaneous (SC) in Indian Participants Aged Greater Than or Equal to (>=) 18 Years With Severe Eosinophilic Asthma
NCT04276233 ·Status: COMPLETED ·Phase: PHASE4
-
A Study to Assess Immune Response in Pediatric Kidney Transplant Recipients Treated With Daclizumab (Zenapax)
NCT02576145 ·Status: COMPLETED ·Phase: PHASE4
-
Study of the ITK Inhibitor Soquelitinib to Reduce Lymphoproliferation and Improve Cytopenias in Autoimmune Lymphoproliferative Syndrome (ALPS)-FAS Patients
NCT06730126 ·Status: RECRUITING ·Phase: PHASE2
-
A Study to Compare the Pharmacokinetics of Mepolizumab as a Liquid Drug in a Safety Syringe or an Autoinjector Versus Lyophilised Drug
NCT03014674 ·Status: COMPLETED ·Phase: PHASE3
-
A Ph1b/2 Study of Axatilimab Monotherapy in Chinese Participants With Recurrent or Refractory cGVHD
NCT06843408 ·Status: RECRUITING ·Phase: PHASE1/PHASE2