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Tibulizumab Systemic Sclerosis Understanding and Response Evaluation (TibuSURE)

NCT ID: NCT06843239

Last Updated: 2025-11-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-02-06

Study Completion Date

2027-05-31

Brief Summary

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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)

Detailed Description

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Conditions

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Systemic Sclerosis (SSc) Scleroderma

Keywords

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Scleroderma Systemic Sclerosis (SSc) Tibulizumab Cutaneous Interstitial lung disease (ILD) Autoimmune diseases Immune system diseases Systemic Sclerosis interstitial lung disease (SSC-ILD) Skin Diseases

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Tibulizumab

Subcutaneous injection

Group Type EXPERIMENTAL

Tibulizumab

Intervention Type BIOLOGICAL

Anti BAFF/IL-17 antibody

Placebo

Subcutaneous injection

Group Type PLACEBO_COMPARATOR

Tibulizumab

Intervention Type BIOLOGICAL

Anti BAFF/IL-17 antibody

Placebo

Intervention Type OTHER

Placebo (inactive)

Interventions

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Tibulizumab

Anti BAFF/IL-17 antibody

Intervention Type BIOLOGICAL

Placebo

Placebo (inactive)

Intervention Type OTHER

Other Intervention Names

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ZB-106 ZB-106 placebo

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Zura Bio Inc

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Study Director

Role: STUDY_DIRECTOR

Zura Bio Inc

Locations

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UCSD Altman Clinical and Translational Research Institute Center for Clinical Research

La Jolla, California, United States

Site Status RECRUITING

IRIS Research and Development LLC

Plantation, Florida, United States

Site Status RECRUITING

University of Iowa

Iowa City, Iowa, United States

Site Status RECRUITING

University of Michigan Hospital

Ann Arbor, Michigan, United States

Site Status RECRUITING

Rheumatology Associates

Arlington, Texas, United States

Site Status RECRUITING

STAT Research S.A.

Buenos Aires, Buenos Aires, Argentina

Site Status RECRUITING

Centro de Investigaciones Médicas Tucumán

San Miguel de Tucumán, Tucumán Province, Argentina

Site Status RECRUITING

Organización Médica de Investigación

Buenos Aires, , Argentina

Site Status RECRUITING

Centro de Investigación y Prevención Cardiovascular-Arenales

Buenos Aires, , Argentina

Site Status RECRUITING

Instituto de Investigación Clínica TyT

Buenos Aires, , Argentina

Site Status RECRUITING

Centro Medico de Estudios Clinicos y Farmacovigilancia (CECYF)

Buenos Aires, , Argentina

Site Status RECRUITING

Consultorios Médicos Dr. Doreski

Buenos Aires, , Argentina

Site Status RECRUITING

Consultora Integral de Salud Centro Médico Privado

Córdoba, , Argentina

Site Status RECRUITING

AES - AS - Clinica Mayo de Urgencias

San Miguel de Tucumán, , Argentina

Site Status RECRUITING

Institute of Rheumatology - PPDS

Belgrade, , Serbia

Site Status RECRUITING

Aberdeen Royal Infirmary

Aberdeen, , United Kingdom

Site Status RECRUITING

Royal National Hospital for Rheumatic Diseases

Bath, , United Kingdom

Site Status RECRUITING

Ninewells Hospital

Dundee, , United Kingdom

Site Status RECRUITING

Chapel Allerton Hospital

Leeds, , United Kingdom

Site Status RECRUITING

Aintree University Hospital

Liverpool, , United Kingdom

Site Status RECRUITING

Royal Free Hospital

London, , United Kingdom

Site Status RECRUITING

Haywood Community Hospital

Stoke-on-Trent, , United Kingdom

Site Status RECRUITING

Countries

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United States Argentina Serbia United Kingdom

Central Contacts

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Chief Medical Officer

Role: CONTACT

Phone: 702-825-9872

Email: [email protected]

Facility Contacts

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Principal Investigator

Role: primary

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Prinicipal Investigator

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Prinicpal Investigator

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Related Links

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https://tibusure.patientwing.com/?campaignId=1796

Related Info

Other Identifiers

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2024-519335-42-00

Identifier Type: CTIS

Identifier Source: secondary_id

ZB-106-SS-201

Identifier Type: -

Identifier Source: org_study_id