Tibulizumab Systemic Sclerosis Understanding and Response Evaluation (TibuSURE)

Description

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

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Study Overview

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Study Details

Study overview

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)

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

Tibulizumab Systemic Sclerosis Understanding and Response Evaluation (TibuSURE)

Condition
Systemic Sclerosis (SSc)
Intervention / Treatment

-

Contacts and Locations

Arlington

Rheumatology Associates, Arlington, Texas, United States, 76012

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * Male or female, 18 to 70 years of age
  • * Body mass index between 18.0 and 35.0 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 ≤5 years
  • * Meets at least 1 of the following based on duration since SSc onset:
  • * \<2 years from SSc onset (first non-RP symptom or sign attributed to SSc): mRSS ≥15 and ≤45 at screening
  • * ≥2 years from SSc onset (first non-RP symptom or sign attributed to SSc): mRSS ≥20 and ≤45 at screening, and either:
  • * RNA polymerase III negative, or
  • * Evidence of recent disease progression as defined in the protocol
  • * FVC \>50% predicted
  • * Diffusing capacity of the lungs for carbon monoxide (DLCO) ≥40% predicted (corrected for hemoglobin)
  • * 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

Ages Eligible for Study

18 Years to 70 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Zura Bio Inc,

Study Record Dates

2027-05