A study to evaluate efficacy and safety of obexelimab in patients with IgG4-related disease

Phase 3

• Conditions: Haematological Disorders; IgG4-Related Disease

• Registration Number: ISRCTN18188034
• Lead Sponsor: Zenas BioPharma LLC (USA)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-04-02
• Last Update Posted: 13 May 2024
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

1. Males and females =18 years of age
2. Clinical diagnosis of IgG4-RD
3. Patients must meet the 2019 ACR/EULAR Classification Criteria for IgG4-RD
4. Patients must have active IgG4-RD signs/symptoms (i.e., flare) that require the initiation of GC therapy or the increase in background long-term GC therapy
5. Other inclusion criteria apply

Exclusion Criteria

1. Has disease in only one organ system whose primary manifestation is fibrosis
2. Has received prednisone equivalent given orally at a dose greater than 60 mg/day within the 4 weeks prior to screening or during screening
3. Has received a non-biologic, disease-modifying anti-rheumatological drug or immunosuppressive agent other than GCs within the 4 weeks prior to screening
4. Has received an investigational treatment or direct medical intervention on another clinical study within 12 weeks or < 5 half-lives of the investigational treatment, whichever is shorter, prior to screening
5. Has received live vaccine or live therapeutic infectious agent within the 2 weeks prior to screening
6. Active tuberculosis or high risk for tuberculosis; hepatitis C infection in absence of curative treatment; evidence of hepatitis B infection
7. Use of B cell depleting or targeting agents within 6 months of randomization
8. Other exclusion criteria apply

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Time to first IgG4-RD flare, defined as the reappearance of previous signs/symptoms or appearance of new signs/symptoms of IgG4-RD that requires initiation of rescue therapy in the opinion of the investigator and the Adjudication Committee (AC), from randomization to Week 52.

Secondary Outcome Measures

Name	Time	Method
There are no secondary outcome measures