Tibulizumab Systemic Sclerosis Understanding and Response Evaluation (TibuSURE)

About

Brief Summary

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)

Primary Purpose

Treatment

Study Type

Interventional

Phase

Phase 2

Eligibility

Gender

All

Healthy Volunteers

No

Minimum Age

18 Years

Maximum Age

75 Years

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