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NCT Number: NCT06843239

Tibulizumab Systemic Sclerosis Understanding and Response Evaluation (TibuSURE)

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)

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Systemic Sclerosis (SSc) Autoimmune Diseases Connective Tissue Diseases Immune System Diseases Lung Diseases Lung Diseases, Interstitial Respiratory Tract Diseases Scleroderma Scleroderma, Diffuse Scleroderma, Systemic Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

STAT Research S.A., Buenos Aires, Argentina

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Tibulizumab

Biological

Anti BAFF/IL-17 antibody

Other names: ZB-106

Placebo

Other

Placebo (inactive)

Other names: ZB-106 placebo

Primary outcomes

  1. [Period 1] Change from baseline in modified Rodnan Skin Score (mRSS) at 24 weeks

    Time frame: Week 24

    The mRSS assesses skin thickness at 17 different cutaneous sites across the body using a scale from 0 (normal skin) to 3 (severe thickening), with a total score ranging from 0 (no thickening) to 51 (severe thickening in all 17 areas)

  2. [Period 2] Safety and tolerability of tibulizumab

    Time frame: Week 52

    Assessed by the incidence of all treatment-emergent adverse events (TEAEs), as well as changes from baseline in vital signs, electrocardiogram (ECG) parameters, and laboratory results

Secondary outcomes

  1. [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)

    Time frame: Week 24

    HRCT measures the extent of interstitial lung disease by quantifying the amount of lung fibrosis, ground-glass opacity, and honeycomb lung, which are used to calculate the QILD score (scores can range from 0 to 100%, with higher scores indicating greater disease extent)

  2. [Period 1] Change from baseline in forced vital capacity (FVC) in participants with SSc-ILD

    Time frame: Week 24

    FVC is the amount of air that can be forcibly exhaled after the deepest possible breath

  3. [Period 1] Change from baseline in Health Assessment Questionnaire Disability Index (HAQ-DI)

    Time frame: Week 24

    HAQ-DI evaluates patients' self-assessed degree of disability across eight categories, with scores ranging from 0 to 3, where 3 indicates the worst degree of disability

  4. [Period 1] Safety and tolerability of tibulizumab

    Time frame: Week 24

    Assessed by the incidence of all TEAEs, as well as changes from baseline in vital signs, ECG parameters, and laboratory results

  5. [Period 2] Change from baseline in mRSS

    Time frame: Week 52

    The mRSS assesses skin thickness at 17 different cutaneous sites across the body using a scale from 0 (normal skin) to 3 (severe thickening), with a total score ranging from 0 (no thickening) to 51 (severe thickening in all 17 areas)

  6. [Period 2] Change from baseline in QILD obtained with HRCT in the whole lung in participants with SSc-ILD

    Time frame: Week 52

    HRCT measures the extent of interstitial lung disease by quantifying the amount of lung fibrosis, ground-glass opacity, and honeycomb lung, which are used to calculate the QILD score (scores can range from 0 to 100%, with higher scores indicating greater disease extent)

Sponsors and collaborators

Lead sponsor

Zura Bio Inc

Industry

Registry information

Official study 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

Important dates

Study start
2025
Primary completion
2027
Study completion
2028
First posted
Feb 24, 2025
Registry last updated
Jul 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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