A study to assess the efficacy, safety, and tolerability of tibulizumab in systemic sclerosis
Research type
Research Study
Full title
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
IRAS ID
1011337
Contact name
Lola San
Contact email
Sponsor organisation
Zura Bio Inc.
Clinicaltrials.gov Identifier
Research summary
This Phase 2 research study evaluates the efficacy, safety, and tolerability of tibulizumab in adults with systemic sclerosis (SSc). The study has two parts. In Part A, participants will randomly receive either tibulizumab (one half of the participants) or a placebo (the other half of the participants) in a double-blind manner, meaning neither participants nor doctors will know which treatment they are receiving. Participants completing treatment in Part A may join Part B, which will be an open-label period (all participants will know they are receiving tibulizumab). Treatments are administered every two weeks for the first four weeks, and then every four weeks.
Eligible participants are 18–70 years old, have been diagnosed with diffuse cutaneous SSc, have had their first non-Raynaud’s symptom of SSc appear within the past 5 years, and show significant skin thickening. Exclusion criteria include prior tibulizumab use or other conditions, medications, physical findings, or laboratory findings that have the potential to interfere with the study.
The study’s main goal is to examine how tibulizumab impacts skin thickening in SSc. Researchers will also evaluate its effects on the lung by assessing scans of participants’ lungs and the participants’ ability to blow air out of their lungs and transfer oxygen into the blood. Additionally, the study will assess impact on quality of life and monitor the safety of tibulizumab by observing side effects.
Zura Bio Inc. (the company running this study) hopes that tibulizumab will be helpful for participants with SSc. The information collected in this study will help the Sponsor learn more about this new medicine and may help future patients with SSc.REC name
East Midlands - Nottingham 2 Research Ethics Committee
REC reference
25/EM/0040
Date of REC Opinion
2 Apr 2025
REC opinion
Further Information Favourable Opinion