Open Label Extension Study of Brentuximab Vedotin in Early dcSSc

• Status: Not yet recruiting
• Trial end date: 2024-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Lawson Health Research Institute
• Collaborator: Seagen Inc.
• Treatments: Brentuximab Vedotin

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).