Clinical trial NCT06843239: Tibulizumab Systemic Sclerosis Understanding and Response Evaluation (TibuSURE)
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Systemic Sclerosis (SSc)
Scleroderma
Keywords: Scleroderma
Systemic Sclerosis (SSc)
Tibulizumab
Cutaneous
Interstitial lung disease (ILD)
Autoimmune diseases
Immune system diseases
Systemic Sclerosis interstitial lung disease (SSC-ILD)
Skin Diseases
Lead sponsor: Zura Bio Inc
Sponsor class: INDUSTRY
First posted: 2025-02-24
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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)


Eligibility criteria: Inclusion 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)

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

Primary outcomes:
measure: [Period 1] Change from baseline in modified Rodnan Skin Score (mRSS) at 24 weeks
timeFrame: Week 24
measure: [Period 2] Safety and tolerability of tibulizumab
timeFrame: Week 52
Secondary outcomes:
measure: [Period 1] Change from baseline in quantitative interstitial lung disease (QILD) obtained with high-resolution quantitative tomography (HRCT) in the whole lung in participants with SSc-interstitial lung disease (ILD)
timeFrame: Week 24
measure: [Period 1] Change from baseline in forced vital capacity (FVC)
timeFrame: Week 24
measure: [Period 1] Change from baseline in Health Assessment Questionnaire Disability Index (HAQ-DI)
timeFrame: Week 24
measure: [Period 1] Safety and tolerability of tibulizumab
timeFrame: Week 24
measure: [Period 2] Change from baseline in mRSS
timeFrame: Week 52
measure: [Period 2] Change from baseline in QILD obtained with HRCT in the whole lung in participants with SSc-ILD
timeFrame: Week 52
Other outcomes:
Locations:
city: Arlington
country: United States
facility: Rheumatology Associates
state: Texas
Study officials:
affiliation: Zura Bio Inc
name: Study Director
role: STUDY_DIRECTOR
References: