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Evaluating tibulizumab for systemic sclerosis treatment

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

Phase 2 Interventional Zura Bio Inc · NCT06843239

This study is testing a new treatment called tibulizumab to see if it can help adults with systemic sclerosis feel better over a 24-week period.

Quick facts

PhasePhase 2
Study typeInterventional
Enrollment80 (estimated)
Ages18 Years to 75 Years
SexAll
SponsorZura Bio Inc Industry-sponsored
Drugs / interventionstibulizumab
Locations51 sites (La Jolla, California and 50 other locations)
Trial IDNCT06843239 on ClinicalTrials.gov

What this trial studies

This Phase 2 clinical trial investigates the effects of tibulizumab in adults with systemic sclerosis over a 24-week period, followed by an open-label extension where all participants receive the treatment for an additional 28 weeks. The study is randomized and double-blind, comparing tibulizumab to a placebo to assess its efficacy and safety. Participants must meet specific criteria related to the severity and duration of their condition, ensuring a focused evaluation of the drug's impact on systemic sclerosis symptoms.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 70 with diffuse cutaneous systemic sclerosis diagnosed within the last five years.

Not a fit: Patients with systemic sclerosis symptoms for more than five years or those with other severe comorbidities may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve the management of systemic sclerosis symptoms and enhance patients' quality of life.

How similar studies have performed: While this approach is novel for tibulizumab, similar studies targeting systemic sclerosis have shown promise in evaluating new treatments.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

* Male or female, 18 to 75 years of age
* Body mass index between 18.0 and 38.0 kg/m²
* Fulfills classification criteria for SSc according to ACR/EULAR 2013 criteria
* Has diffuse cutaneous SSc, defined as mRSS \>0 over at least one skin area proximal to the elbows and/or knees, in addition to acral fibrosis
* Has had SSc (defined as the first non-Raynaud's phenomenon (RP) symptom or sign attributed to SSc) for ≤7 years
* mRSS ≥15 and ≤45 at screening. Additional requirements for participants ≥2 years to ≤7 years from SSc onset and RNA Polymerase III antibody positive
* FVC \>50% predicted
* Diffusing capacity of the lungs for carbon monoxide (DLCO) ≥40% predicted (corrected for hemoglobin)

Exclusion Criteria:

* Has any of the following complications:

  * Left ventricular failure
  * Pulmonary arterial hypertension
  * Renal crisis within previous 6 months
  * Gastrointestinal dysmotility within previous 3 months
  * Digital ischemia with gangrene, amputation, or unscheduled hospitalization within previous 3 months
* Current rheumatic disease other than SSc that could interfere with assessment of SSc
* Lung disease requiring continuous oxygen therapy
* Evidence or suspicion of active or latent tuberculosis
* Active Crohn's Disease or ulcerative colitis

Where this trial is running

La Jolla, California and 50 other locations

+1 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Systemic SclerosisSclerodermaTibulizumabCutaneousInterstitial lung diseaseAutoimmune diseasesImmune system diseasesSystemic Sclerosis interstitial lung disease
Last reviewed 2026-06-09 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.