Brentuximab Vedotin for Systemic Sclerosis (BRAVOS)

  • STATUS
    Recruiting
  • End date
    Oct 26, 2023
  • participants needed
    24
  • sponsor
    National Institute of Allergy and Infectious Diseases (NIAID)
Updated on 26 May 2022
methotrexate
immunosuppressive agents
immunosuppression
azathioprine
rheumatism
progressive systemic sclerosis
mycophenolate
raynaud's phenomenon
raynaud's syndrome
diffuse cutaneous systemic sclerosis
MRSS

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.

Description

This is a multicenter prospective double blind placebo controlled dose escalation safety clinical trial with brentuximab vedotin and stable background immunosuppressive therapy in adult individuals with Diffuse Cutaneous Systemic Sclerosis (dcSSc). Adult male and female participants with dcSSc will be recruited by a collaborative group of clinical sites in the United States. Participants who meet the eligibility criteria will be enrolled without regard to gender, race, or ethnicity.

Eligible participants will be randomly assigned to study treatment, either brentuximab vedotin or placebo equivalent in a 6:2 ratio favoring brentuximab vedotin. Three dose cohorts are planned with 8 participants in each cohort, for a total of 24 participants who receive sufficient doses of the investigational medication to assess safety.

The doses planned for each ascending dose cohort include 0.6mg/kg, 1.2 mg/kg, and 1.8 mg/kg brentuximab vedotin or placebo equivalent. All cohorts will receive intravenous administration of study medication every 3 weeks for 21 weeks, for a total of eight doses. Following completion of treatment, participants will undergo follow-up visits at weeks 24, 28, 36 and 48.

Details
Condition Diffuse Cutaneous Systemic Sclerosis, Scleroderma, dcSSc
Treatment Placebo, brentuximab vedotin
Clinical Study IdentifierNCT03222492
SponsorNational Institute of Allergy and Infectious Diseases (NIAID)
Last Modified on26 May 2022

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