CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 17 enrolled
Drug / intervention
Brentuximab Vedotin +1 morebiological
Likely dose
Not stated in 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.

Search/NCT03222492
NCT03222492Phase 2Completed
CompareCT.gov

Evaluation of Brentuximab Vedotin for Diffuse Cutaneous Systemic Sclerosis BRAVOS: A Phase 1/2 Multicenter Randomized, Double Blinded, Safety Study (ITN075AI)

National Institute of Allergy and Infectious Diseases (NIAID)·interventional·Posted Jul 19, 2017·Updated May 5, 2026

In Brief

A Phase 2 clinical trial evaluating Brentuximab Vedotin and Placebo for Diffuse Cutaneous Systemic Sclerosis and 2 related conditions. Completed, enrolled 17 participants across 8 sites.

Detailed Summary

There is significant unmet need for effective treatment options for Diffuse Cutaneous Systemic Sclerosis (dcSSc). The present study will be a dose-escalation safety trial of brentuximab vedotin, a drug-antibody conjugate approved for the treatment of lymphoma and targeted to the protein CD30 molecule expressed on activated immune cells There is evidence for CD30 involvement in SSc. This study represents the first step in determining safety and tolerability of brentuximab vedotin in SSc.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDiffuse Cutaneous Systemic Sclerosis, Scleroderma, dcSSc
CountriesUnited States
CollaboratorsImmune Tolerance Network (ITN), Seagen Inc., PPD Development, LP, Rho Federal Systems Division, Inc.

Timeline

Phase 2CompletedFinished
201820192020202120222023202420252026
First PostedJul 19, 2017
Enrollment StartSep 20, 2017
Primary CompletionApr 10, 2023
TodayJul 2, 2026
Enrollment to primary: 5.6 yearsPosted 9.0 years ago

Interventions

Brentuximab Vedotinbiological

Ascending dose cohorts. All cohorts will receive intravenous administration of study medication every 3 weeks for 21 weeks, for a total of eight doses.

Placebobiological

Placebo control for blinding (masking), 0.95% normal saline.