Tibulizumab Systemic Sclerosis Understanding and Response Evaluation (TibuSURE)

Part of paid clinical trials in La Jolla, California.

Sponsor
Zura Bio Inc
Study ID
NCT06843239
Phase
PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Tibulizumab — BIOLOGICAL
    Anti BAFF/IL-17 antibody
  • Placebo — OTHER
    Placebo (inactive)

Study Details

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)

Key Dates

Start date
Feb 6, 2025
Status verified
Feb 2026
Primary completion
May 31, 2027
Completion
Jan 31, 2028

Study Design

Enrollment
80 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Tibulizumab
    Subcutaneous injection
  • Placebo Comparator: Placebo
    Subcutaneous injection

Primary Outcome Measure

[Period 1] Change from baseline in modified Rodnan Skin Score (mRSS) at 24 weeks [ Time Frame: Week 24 ]

Central Contacts

Locations (6)

FacilityCityStateZIPSite coordinators
UCSD Altman Clinical and Translational Research Institute Center for Clinical ResearchLa JollaCalifornia92037
Principal Investigator
[email protected]
702-825-9872
IRIS Research and Development LLCPlantationFlorida33324
Principal Investigator
[email protected]
702-825-9872
University of IowaIowa CityIowa52242
Principal Investigator
[email protected]
Massachusetts General HospitalBostonMassachusetts02114
Principal Investigator
[email protected]
702-825-9872
University of Michigan HospitalAnn ArborMichigan48109
Principal Investigator
[email protected]
702-825-9872
Rheumatology AssociatesArlingtonTexas76012
Principal Investigator
[email protected]
702-825-9872

Find similar trials in La Jolla, CA

By research site
UCSD Altman Clinical and Translational Research Institute Center for Clinical Research· La Jolla, CAIRIS Research and Development LLC· Plantation, FLUniversity of Iowa· Iowa City, IAMassachusetts General Hospital· Boston, MAUniversity of Michigan Hospital· Ann Arbor, MIRheumatology Associates· Arlington, TX

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