Tibulizumab Systemic Sclerosis Understanding and Response Evaluation (TibuSURE)

Purpose

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

  • Systemic Sclerosis (SSc)
  • Scleroderma

Eligibility

Eligible Ages
Between 18 Years and 75 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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

Study Design

Phase
Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Triple (Participant, Investigator, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Tibulizumab 		Subcutaneous injection
  • Biological: Tibulizumab
    Anti BAFF/IL-17 antibody
    Other names:
    • ZB-106
Placebo Comparator
Placebo 		Subcutaneous injection
  • Biological: Tibulizumab
    Anti BAFF/IL-17 antibody
    Other names:
    • ZB-106
  • Other: Placebo
    Placebo (inactive)
    Other names:
    • ZB-106 placebo

Recruiting Locations

UCSD Altman Clinical and Translational Research Institute Center for Clinical Research
La Jolla, California 92037
Contact:
Principal Investigator
702-825-9872
clinicaltrial@zurabio.com

IRIS Research and Development LLC
Plantation, Florida 33324
Contact:
Principal Investigator
702-825-9872
clincialtrial@zurabio.com

University of Iowa
Iowa City, Iowa 52242
Contact:
Principal Investigator
clinicaltrial@zurabio.com

Massachusetts General Hospital
Boston, Massachusetts 02114
Contact:
Principal Investigator
702-825-9872
clinicaltrial@zurabio.com

University of Michigan Hospital
Ann Arbor, Michigan 48109
Contact:
Principal Investigator
702-825-9872
clincialtrial@zurabio.com

Rheumatology Associates
Arlington, Texas 76012
Contact:
Principal Investigator
702-825-9872
clinicaltrial@zurabio.com

More Details

Status
Recruiting
Sponsor
Zura Bio Inc

Study Contact

Chief Medical Officer
702-825-9872
clinicaltrial@zurabio.com