Active — Not RecruitingPhase 3

A Phase 3 Study of Obexelimab in Patients With IgG4-Related Disease

United States194 participantsStarted 2023-01-09

Plain-language summary

This study aims to examine the efficacy and safety of obexelimab for the prevention of flare of IgG4-related disease (IgG4-RD)

Age range18 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.

✓. Males and females, ≥ 18 years of age
✓. Clinical diagnosis of IgG4-RD
✓. Patients must meet the 2019 ACR/EULAR Classification Criteria for IgG4-RD
✓. 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
✓. Other inclusion criteria apply

✕. Has disease in only 1 organ system whose primary manifestation is fibrosis
✕. Has received prednisone equivalent given orally at a dose greater than 60 mg/day within the 4 weeks prior to screening or during screening
✕. Has received a non-biologic, disease-modifying anti-rheumatological drug or immunosuppressive agent other than GCs within the 2 weeks prior to screening
✕. 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
✕. Has received live vaccine or live therapeutic infectious agent within the 2 weeks prior to screening
✕. Active tuberculosis or high risk for tuberculosis; hepatitis C infection in absence of curative treatment; evidence of hepatitis B infection
✕. Use of B cell depleting or targeting agents within 6 months of randomization
✕. Other exclusion criteria apply

Primary outcome measure

Timeframe: Randomization to Week 52

NCT IDNCT05662241

SponsorZenas BioPharma (USA), LLC

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-11-13

Who can participate

Age range18 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.

✓. Males and females, ≥ 18 years of age
✓. Clinical diagnosis of IgG4-RD
✓. Patients must meet the 2019 ACR/EULAR Classification Criteria for IgG4-RD
✓. 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
✓. Other inclusion criteria apply

✕. Has disease in only 1 organ system whose primary manifestation is fibrosis
✕. Has received prednisone equivalent given orally at a dose greater than 60 mg/day within the 4 weeks prior to screening or during screening
✕. Has received a non-biologic, disease-modifying anti-rheumatological drug or immunosuppressive agent other than GCs within the 2 weeks prior to screening
✕. 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
✕. Has received live vaccine or live therapeutic infectious agent within the 2 weeks prior to screening
✕. Active tuberculosis or high risk for tuberculosis; hepatitis C infection in absence of curative treatment; evidence of hepatitis B infection
✕. Use of B cell depleting or targeting agents within 6 months of randomization
✕. Other exclusion criteria apply