Zenas BioPharma Announces Data from the Registrational Phase 3 INDIGO Trial of Obexelimab in Immunoglobulin G4-Related Disease (IgG4-RD), Simultaneously Presented at the EULAR 2026 Congress and Published in the New England Journal of Medicine
Zenas BioPharma announced positive Phase 3 INDIGO trial data for obexelimab in IgG4-RD, published in the New England Journal of Medicine and presented at EULAR 2026. The study met its primary endpoint, showing a 56% reduction in flare risk (HR 0.44, p=0.0005) and all four key secondary endpoints, including a 65% reduction in glucocorticoid use and improved safety profile compared to placebo.
Key figures
- Drug Name
- obexelimab
- Phase Of Trial
- Phase 3
- Deaths placebo
- 1
- Dosing regimen
- 250 mg subcutaneously weekly for 52 weeks
- Total patients
- 194
- Sae placebo pct
- 18.6%
- Deaths treatment
- 0
- Teae placebo pct
- 95.9%
- Sae treatment pct
- 10.3%
- Teae treatment pct
- 97.9%
- Primary endpoint hr
- 0.44
- Flare risk reduction
- 56%
- Flare free rate placebo
- 45.4%
- Grade3 teae placebo pct
- 23.7%
- Primary endpoint p value
- 0.0005
- Flare free rate treatment
- 73.2%
- Grade3 teae treatment pct
- 11.3%
- Gti worsening placebo pct
- 61.2%
- Complete remission placebo
- 19.6%
- Infection rate placebo pct
- 62.9%
- Gti worsening treatment pct
- 42.2%
- Complete remission treatment
- 37.1%
- Glucocorticoid reduction pct
- 65%
- Infection rate treatment pct
- 53.6%
- Glucocorticoid use placebo mg
- 929.8
- Rescue therapy risk reduction
- 59%
- Glucocorticoid use treatment mg
- 329.5
- Adjudicated flare rate reduction
- 52%
- Injection site reaction placebo pct
- 2.3%
- Injection site reaction treatment pct
- 3.5%
- Hypersensitivity grade2plus placebo pct
- 11.3%
- Hypersensitivity grade2plus treatment pct
- 16.5%
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