RECRUITING

Tibulizumab Systemic Sclerosis Understanding and Response Evaluation (TibuSURE)

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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)

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

Quick Facts

Study Start:2025-02-06
Study Completion:2027-05
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06843239

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 70 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Male or female, 18 to 70 years of age
  2. * Body mass index between 18.0 and 35.0 kg/m²
  3. * Fulfills classification criteria for SSc according to ACR/EULAR 2013 criteria
  4. * 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
  5. * Has had SSc (defined as the first non-Raynaud's phenomenon (RP) symptom or sign attributed to SSc) for ≤5 years
  6. * Meets at least 1 of the following based on duration since SSc onset:
  7. * \<2 years from SSc onset (first non-RP symptom or sign attributed to SSc): mRSS ≥15 and ≤45 at screening
  8. * ≥2 years from SSc onset (first non-RP symptom or sign attributed to SSc): mRSS ≥20 and ≤45 at screening, and either:
  9. * RNA polymerase III negative, or
  10. * Evidence of recent disease progression as defined in the protocol
  11. * FVC \>50% predicted
  12. * Diffusing capacity of the lungs for carbon monoxide (DLCO) ≥40% predicted (corrected for hemoglobin)
  1. * Has any of the following complications:
  2. * Left ventricular failure
  3. * Pulmonary arterial hypertension
  4. * Renal crisis within previous 6 months
  5. * Gastrointestinal dysmotility within previous 3 months
  6. * Digital ischemia with gangrene, amputation, or unscheduled hospitalization within previous 3 months
  7. * Current rheumatic disease other than SSc that could interfere with assessment of SSc
  8. * Lung disease requiring continuous oxygen therapy
  9. * Evidence or suspicion of active or latent tuberculosis
  10. * Active Crohn's Disease or ulcerative colitis

Contacts and Locations

Study Contact

Chief Medical Officer
CONTACT
702-825-9872
clinicaltrial@zurabio.com

Study Locations (Sites)

Rheumatology Associates
Arlington, Texas, 76012
United States

Collaborators and Investigators

Sponsor: Zura Bio Inc

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-02-06
Study Completion Date2027-05

Study Record Updates

Study Start Date2025-02-06
Study Completion Date2027-05

Terms related to this study

Keywords Provided by Researchers

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

Additional Relevant MeSH Terms

  • Systemic Sclerosis (SSc)
  • Scleroderma