Treatment with Brentuximab Vedotin for Patients with Early Diffuse Scleroderma
An Open Label Extension Study of Brentuximab Vedotin Treatment in Active Diffuse Cutaneous Systemic Sclerosis (Diffuse Scleroderma)
This study is testing if Brentuximab vedotin can help people with early diffuse scleroderma who got worse after stopping treatment and had previously improved with it.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 11 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's Academic / other |
| Drugs / interventions | rituximab, Brentuximab |
| Locations | 1 site (London, Ontario) |
| Trial ID | NCT05149768 on ClinicalTrials.gov |
What this trial studies
This study evaluates the safety and effectiveness of Brentuximab vedotin, a targeted therapy for patients with active diffuse cutaneous systemic sclerosis (dcSSc) who have experienced a relapse after stopping the treatment. It aims to provide continued access to this therapy for patients who showed improvement during an earlier Phase II study but have since worsened. The study will monitor various health outcomes, including disability indices and inflammatory markers, over an extended treatment period of up to 48 weeks. Participants will be closely observed for changes in their condition and response to the medication.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with diffuse cutaneous systemic sclerosis who have previously participated in the Phase II Adcetris study and experienced a worsening of their condition.
Not a fit: Patients with severe pulmonary or cardiac conditions, active infections, or those who are pregnant or breastfeeding may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve the management of early diffuse scleroderma, potentially reversing immune inflammation and reducing fibrosis.
How similar studies have performed: Preliminary results from similar studies have shown short-term safety and benefits of Brentuximab vedotin in treating systemic sclerosis, indicating potential for success in this extension study.
Eligibility criteria
Show full inclusion / exclusion 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).
Where this trial is running
London, Ontario
- Rheumatology Clinic, St. Joseph's Health Care — London, Ontario, Canada (Recruiting)
Study contacts
- Principal investigator: Janet E Pope, PhD — University of Western Ontario, Division of Rheumatology, St. Joseph's Health Care, London, Ontario, Canada
- Study coordinator: Janet E Pope, PhD
- Email: Janet.Pope@sjhc.london.on.ca
- Phone: 519-646-6332
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.