Open Label Extension Study of Brentuximab Vedotin in Early dcSSc

Launched by LONDON HEALTH SCIENCES CENTRE RESEARCH INSTITUTE OR LAWSON RESEARCH INSTITUTE OF ST. JOSEPH'S · Nov 24, 2021

Keywords

ClinConnect Summary

This clinical trial is studying the safety and effectiveness of a medication called Brentuximab vedotin for patients with active diffuse cutaneous systemic sclerosis (dcSSc), a serious skin condition that can affect various parts of the body. The trial is designed for people who have previously participated in another study and experienced a worsening of their skin symptoms after stopping the treatment. Participants must be at least 18 years old and show a significant increase in their skin score, which measures the severity of their condition.

If you or someone you know is considering joining this trial, it's important to be aware of the eligibility criteria. Participants should not have serious lung or heart problems, certain infections, or significant other health issues. Those who are pregnant, breastfeeding, or unable to use effective birth control may also be excluded. Throughout the trial, participants will receive Brentuximab vedotin, and researchers will monitor their health closely to understand how well the treatment works and to ensure their safety. This study is currently recruiting participants, and it's a chance to contribute to valuable research in treating this condition.

Gender

ALL

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).