At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 11 enrolled
Drug / intervention
Brentuximab Vedotindrug
Likely dose
Brentuximab Vedotin 0.6 mg/kgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Pilot Study of Adcetris Treatment in Active Diffuse Cutaneous Systemic Sclerosis (Diffuse Scleroderma)
London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's·interventional·Posted Jun 26, 2017·Updated Oct 4, 2023
In Brief
A Phase 2 clinical trial evaluating Brentuximab Vedotin for Diffuse Cutaneous Systemic Sclerosis. Completed, enrolled 11 participants across 1 site.
Detailed Summary
The purpose of this study is to assess feasibility, safety and preliminary efficacy of Brentuximab vedotin (Adcetris), a CD30-directed antibody-drug conjugate, in the treatment of active diffuse cutaneous systemic sclerosis (dcSSc).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDiffuse Cutaneous Systemic Sclerosis
CountriesCanada
CollaboratorsSeagen Inc.
Timeline
Phase 2CompletedFinished
201820192020202120222023202420252026
First PostedJun 2017
Enrollment StartMay 2019
Primary CompletionJun 2023
Study CompletionAug 2023
TodayJul 2026
First PostedJun 26, 2017
Enrollment StartMay 7, 2019
Primary CompletionJun 7, 2023
Study CompletionAug 28, 2023
TodayJul 2, 2026
Enrollment to primary: 4.1 yearsPosted 9.0 years ago
Interventions
Brentuximab Vedotindrug
Dose 0.6 mg/kg i.v. will be given every 3 weeks for 16 cycles (48 weeks) in addition to standard of care medications for SSc that may include cyclophosphamide, methotrexate, azathioprine, mycophenylate mofetil (MMF, cellcept) and mycophenolic acid (myfortic).