Trials / Recruiting
RecruitingNCT06843239
Tibulizumab Systemic Sclerosis Understanding and Response Evaluation (TibuSURE)
A Phase 2, Multi-Center Study Consisting of a Randomized, Double-Blind, Placebo-Controlled Period, Followed by an Open-Label Extension Period, to Assess the Efficacy, Safety, and Tolerability of Tibulizumab in Adults With Systemic Sclerosis
- Status
- Recruiting
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 80 (estimated)
- Sponsor
- Zura Bio Inc · Industry
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
Summary
The study is a Phase 2, multi-center, randomized, double-blind, placebo-controlled study to evaluate the effects of tibulizumab over 24 weeks (Period 1) in adult participants with systemic sclerosis, followed by an open-label extension period where all active participants will receive tibulizumab and will be evaluated for an additional 28 weeks (Period 2)
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Tibulizumab | Anti BAFF/IL-17 antibody |
| OTHER | Placebo | Placebo (inactive) |
Timeline
- Start date
- 2025-02-06
- Primary completion
- 2027-05-01
- Completion
- 2028-01-01
- First posted
- 2025-02-24
- Last updated
- 2026-02-12
Locations
51 sites across 10 countries: United States, Argentina, Chile, Hungary, Mexico, Poland, Romania, Serbia, Spain, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT06843239. Inclusion in this directory is not an endorsement.