NCT05149768CompletedPhase 2
Open Label Extension Study of Brentuximab Vedotin in Early dcSSc
An Open Label Extension Study of Brentuximab Vedotin Treatment in Active Diffuse Cutaneous Systemic Sclerosis (Diffuse Scleroderma)
Source: ClinicalTrials.gov · Last updated 30 Sept 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 3 (actual)
- First submitted
- 24 Nov 2021
- Start date
- 14 Feb 2024
- Primary completion date
- 23 Jul 2025
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Diseases
- Systemic sclerosis (scleroderma)
- NCT number
- NCT05149768
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 3
- From 14 Feb 2024 to the primary completion date, 23 Jul 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Significant concurrent, uncontrolled medical condition including, but not limited to, renal, hepatic, pancreatic, hematological, gastrointestinal, endocrine, pulmonary, neurological, cerebral or psychiatric disease; and cancer.
- Participation in another clinical trial within six weeks before randomization in this study, with the exception of continuation from the initial study BV201708.
- Use of rituximab within the previous 4 months.
- Immunization with a live/ attenuated vaccine less than 4 weeks prior to the baseline visit.
Other illness
- Clinically significant pulmonary hypertension requiring drug therapy.
- Clinically significant cardiac disease.
- Chronic or ongoing active infectious disease requiring systemic treatment.
- Seropositivity for human immunodeficiency virus (HIV).
- Active tuberculosis (TB) infection.
- Active viral infection with viral replication of hepatitis B or C virus.
- Known or suspected hypersensitivity to components of the treatment
- Patients known or suspected of not being able to comply with a study protocol (e.g. due to alcoholism, drug dependency or psychological disorder)
- Current or history of progressive multifocal leukoencephalopathy (PML).
Lab values
- 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
Other
- Poor pulmonary function (FVC\<40% and/or DLCO\<30%).
- Pregnancy, breast feeding or child bearing potential without practicing highly effective contraception (and partners for men in the study).
- Peripheral neuropathy at screening Grade 2 or higher.
Who the study is looking for
- 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:
- Worsening mRSS of ≥ 4 points as compared to mRSS score at the end of treatment visit (week 48) in the initial study (BV201708).
- Able to give informed consent.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Rheumatology Clinic, St. Joseph's Health Care Coordinator of this site? Confirm its status | London | Canada | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.