Overview
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)
Principal investigator
Eligibility 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
* 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
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