MedTrace Logo

Tibulizumab Systemic Sclerosis Understanding and Response Evaluation (TibuSURE)

NCT06843239 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2026-07-20

No results posted yet for this study

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

BIOLOGICAL

Tibulizumab

Anti BAFF/IL-17 antibody

OTHER

Placebo

Placebo (inactive)

Sponsors & Collaborators

  • Zura Bio Inc

    lead INDUSTRY

Principal Investigators

  • Study Director · Zura Bio Inc

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-02-06
Primary Completion
2027-05-31
Completion
2028-01-31
FDA Drug
Yes

Countries

  • United States
  • Argentina
  • Chile
  • Hungary
  • Mexico
  • Poland
  • Romania
  • Serbia
  • Spain
  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06843239 on ClinicalTrials.gov