NCT05149768 Open Label Extension Study of Brentuximab Vedotin in Early dcSSc
| NCT ID | NCT05149768 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's |
| Condition | Diffuse Cutaneous Systemic Sclerosis |
| Study Type | INTERVENTIONAL |
| Enrollment | 11 participants |
| Start Date | 2024-02-14 |
| Primary Completion | 2026-02-14 |
Trial Parameters
Eligibility Fast-Check
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Brief Summary
The purpose of this study is to assess safety and efficacy of Brentuximab vedotin, a CD30-directed antibody-drug conjugate, in patients with active diffuse cutaneous systemic sclerosis (dcSSc) who relapsed after discontinuation of Brentuximab vedotin.
Eligibility Criteria
Inclusion Criteria: 1. Patients with diffuse cutaneous systemic sclerosis enrolled in the Phase II Adcetris study (BV201708) at St. Joseph's Health centre, aged 18 years or older, and: 2. Worsening mRSS of ≥ 4 points as compared to mRSS score at the end of treatment visit (week 48) in the initial study (BV201708). 3. Able to give informed consent. Exclusion Criteria: 1. Poor pulmonary function (FVC\<40% and/or DLCO\<30%). 2. Pregnancy, breast feeding or child bearing potential without practicing highly effective contraception (and partners for men in the study). 3. Clinically significant pulmonary hypertension requiring drug therapy. 4. Clinically significant cardiac disease. 5. Chronic or ongoing active infectious disease requiring systemic treatment. 6. Seropositivity for human immunodeficiency virus (HIV). 7. Active tuberculosis (TB) infection. 8. Active viral infection with viral replication of hepatitis B or C virus. 9. Significant concurrent, uncontrolled medical condition includ