Depemokimab for Churg-Strauss Syndrome

Phase-Based Progress Estimates
2
Effectiveness
3
Safety
Churg-Strauss SyndromeDepemokimab - Biological
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial will compare the effectiveness and safety of two different drugs in treating a rare autoimmune disease.

Eligible Conditions
  • Churg-Strauss Syndrome

Treatment Effectiveness

Effectiveness Progress

2 of 3
This is further along than 85% of similar trials

Study Objectives

3 Primary · 12 Secondary · Reporting Duration: Weeks 49 to 52

Week 36
Collagen Diseases
Number of participants achieving remission using the European League against Rheumatism (EULAR) definition (BVAS=0 and OCS <=7.5 mg/day) at Weeks 36 and 52
Up to Week 52
Number of participants achieving remission (BVAS = 0 and OCS <= 4mg/day) within the first 24 weeks with continued remission until Week 52
Number of participants achieving remission (BVAS=0 and OCS <=4mg/day) within the first 24 weeks with continued remission until Week 52
Number of participants in each category of accrued duration of remission
Number of participants in each category of accrued duration of remission according to the EULAR definition of remission (BVAS = 0 plus OCS <=7.5 mg/day) over 52-week intervention period
Number of participants in each category of accrued duration of remission according to the EULAR definition of remission (BVAS=0 plus OCS <=7.5 mg/day) over 52-week intervention period
Number of participants with remission (BVAS=0 and OCS <=7.5 mg/day) within the first 24 weeks with continued remission until Week 52
Number of participants with remission (Birmingham Vasculitis Activity Score [BVAS] =0 and a dose of oral corticosteroid [OCS] less than or equal to [<=] 4 milligram [mg] per day)
Number of participants with remission (Birmingham Vasculitis Activity Score [BVAS]=0 and a dose of oral corticosteroid [OCS] less than or equal to [<=] 4 milligram [mg] per day)
Number of participants with remission (Birmingham Vasculitis Activity Score [BVAS]=0 and a dose of oral corticosteroid [OCS] less than or equal to [<=]4 milligram [mg] per day)
Number of participants with total accrued duration of remission
Number of participants with total accrued duration of remission according to the EULAR definition of remission
Time to first EGPA relapse
Weeks 49 to 52
Number of participants receiving in each category of mean OCS dose during the last 4 weeks of study treatment period (Weeks 49 to 52)

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Trial Design

2 Treatment Groups

Participants receiving mepolizumab+placebo matching depemokimab
1 of 2
Participants receiving depemokimab+placebo matching mepolizumab
1 of 2

Active Control

Experimental Treatment

160 Total Participants · 2 Treatment Groups

Primary Treatment: Depemokimab · Has Placebo Group · Phase 3

Participants receiving depemokimab+placebo matching mepolizumabExperimental Group · 2 Interventions: Placebo matching mepolizumab, Depemokimab · Intervention Types: Drug, Biological
Participants receiving mepolizumab+placebo matching depemokimabActiveComparator Group · 2 Interventions: Placebo matching depemokimab, Mepolizumab · Intervention Types: Drug, Biological
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Placebo matching mepolizumab
2017
Completed Phase 3
~110

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: weeks 49 to 52

Who is running the clinical trial?

GlaxoSmithKlineLead Sponsor
4,650 Previous Clinical Trials
7,949,906 Total Patients Enrolled
7 Trials studying Churg-Strauss Syndrome
1,180 Patients Enrolled for Churg-Strauss Syndrome
GSK Clinical TrialsStudy DirectorGlaxoSmithKline
3,561 Previous Clinical Trials
6,133,368 Total Patients Enrolled
4 Trials studying Churg-Strauss Syndrome
660 Patients Enrolled for Churg-Strauss Syndrome

Eligibility Criteria

Age 18+ · All Participants · 8 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You must be at least 18 years of age to participate in this study.
You are receiving immunosuppressive therapy (excluding cyclophosphamide) and your dosage must be stable for the 4 weeks prior to Baseline (Visit 2) and during the study.