NCT06843239

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

Recruiting now Phase 2 Last updated 10 February 2026

What this trial tests

Phase 2 trial testing Tibulizumab in Systemic Sclerosis (SSc) in 80 participants. Currently enrolling.

Timeline

6 February 2025

Primary endpoint
1 May 2027

1 January 2028

Quick facts

Lead sponsor	Zura Bio Inc
Phase	Phase 2
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	treatment
Enrollment	80
Start date	6 February 2025
Primary completion	1 May 2027
Estimated completion	1 January 2028
Sites	51 locations across United States, Argentina, Chile, Hungary, Mexico, Poland, Romania, Serbia

Drugs / interventions tested

• Tibulizumab — full drug profile →
• Placebo

Conditions studied

• Systemic Sclerosis (SSc) — all drugs for Systemic Sclerosis (SSc) →
• Scleroderma — all drugs for Scleroderma →

Sponsor

Zura Bio Inc — full company profile →

Who can join

Adults 18 to 75, any sex, with Systemic Sclerosis (SSc) or Scleroderma. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• [Period 1] Change from baseline in modified Rodnan Skin Score (mRSS) at 24 weeks
  Time frame: Week 24
  The mRSS assesses skin thickness at 17 different cutaneous sites across the body using a scale from 0 (normal skin) to 3 (severe thickening), with a total score ranging from 0 (no thickening) to 51 (severe thickening in all 17 areas)
• [Period 2] Safety and tolerability of tibulizumab
  Time frame: Week 52
  Assessed by the incidence of all treatment-emergent adverse events (TEAEs), as well as changes from baseline in vital signs, electrocardiogram (ECG) parameters, and laboratory results

Sponsor's own description

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)

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Innovations in immunotherapy for autoimmune diseases: recent breakthroughs and future directions.
   Alsayb MA. · · 2025 · cited 2× · PMID 41041324 · DOI 10.3389/fimmu.2025.1647066
2. Case-Based Immunology: B Cells and Systemic Sclerosis Interstitial Lung Disease.
   Goldman N, Ong V, Denton CP. · · 2026 · PMID 40685839 · DOI 10.1002/art.43326