Clinical Trial Finder

Tibulizumab Systemic Sclerosis Understanding and Response Evaluation (TibuSURE)

Study Purpose

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)

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

 No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

 Interventional
Eligible Ages 18 Years - 70 Years
Gender All
More Inclusion & Exclusion 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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

 NCT06843239
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

 Phase 2
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

 Zura Bio Inc
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

 Study Director
Principal Investigator Affiliation Zura Bio Inc
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

 Industry
Overall Status Recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

 Systemic Sclerosis (SSc), Scleroderma
Arms & Interventions

Arms

Experimental: Tibulizumab

Subcutaneous injection

Placebo Comparator: Placebo

Subcutaneous injection

Interventions

Biological: - Tibulizumab

Anti BAFF/IL-17 antibody

Other: - Placebo

Placebo (inactive)

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Rheumatology Associates, Arlington, Texas

Status

Recruiting

Address

Rheumatology Associates

Arlington, Texas, 76012

Site Contact

Principal Investigator

[email protected]

702-825-9872

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