Health TrialsbyHealthPanel

Tibulizumab Systemic Sclerosis Understanding and Response Evaluation (TibuSURE)

ConditionsSystemic Sclerosis (SSc)Scleroderma
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorZura Bio Inc

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Left ventricular failure

Pulmonary arterial hypertension

Renal crisis within previous 6 months

Gastrointestinal dysmotility within previous 3 months

Trial design

Design model

Parallel

Treatments tested in this trial

  • Tibulizumab

    Biological/Vaccine

    Anti BAFF/IL-17 antibody

  • Placebo

    Other intervention

    Placebo (inactive)

Treatment groups

80 Participants
are divided into 2 treatment groups
Group A: TibulizumabExperimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 2 interventions

Trial outcomes

Primary outcomes

1

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

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)

Time frame
Week 24
2

[Period 2] Safety and tolerability of tibulizumab

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

Time frame
Week 52

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)

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)

Time frame
Week 24
2

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

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

Time frame
Week 24
3

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

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

Time frame
Week 24
4

[Period 1] Safety and tolerability of tibulizumab

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

Time frame
Week 24

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Zura Bio Inc

Lead sponsor

Source ClinicalTrials.gov
Apply now