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 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 11 participants in total. It began in 2024-02-14 with a primary completion date of 2026-02-14.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 including, but not limited to, renal, hepatic, pancreatic, hematological, gastrointestinal, endocrine, pulmonary, neurological, cerebral or psychiatric disease; and cancer. 10. Peripheral neuropathy at screening Grade 2 or higher. 11. Known or suspected hypersensitivity to components of the treatment 12. Patients known or suspected of not being able to comply with a study protocol (e.g. due to alcoholism, drug dependency or psychological disorder) 13. Any of the following laboratory abnormalities at screening: * Absolute neutrophils count \<2.0 x 109/L * Hemoglobin \<85 g/L * Platelet count \< 100 x 109/L * AST/SGOT or ALT/SGPT \>2.0 UNL 14. Participation in another clinical trial within six weeks before randomization in this study, with the exception of continuation from the initial study BV201708. 15. Use of rituximab within the previous 4 months. 16. Immunization with a live/ attenuated vaccine less than 4 weeks prior to the baseline visit. 17. Current or history of progressive multifocal leukoencephalopathy (PML).
Contact & Investigator
Janet E Pope, PhD
PRINCIPAL INVESTIGATOR
University of Western Ontario, Division of Rheumatology, St. Joseph's Health Care, London, Ontario, Canada
Frequently Asked Questions
Who can join the NCT05149768 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Diffuse Cutaneous Systemic Sclerosis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05149768 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT05149768 currently recruiting?
Yes, NCT05149768 is actively recruiting participants. Contact the research team at Janet.Pope@sjhc.london.on.ca for enrollment information.
Where is the NCT05149768 trial being conducted?
This trial is being conducted at London, Canada.
Who is sponsoring the NCT05149768 clinical trial?
NCT05149768 is sponsored by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's. The principal investigator is Janet E Pope, PhD at University of Western Ontario, Division of Rheumatology, St. Joseph's Health Care, London, Ontario, Canada. The trial plans to enroll 11 participants.