Brentuximab Vedotin for Systemic Sclerosis
(BRAVOS Trial)

Recruiting in Palo Alto (17 mi)

+7 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1 & 2

Waitlist Available

Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)

Breakthrough Therapy

Approved in 2 Jurisdictions

Trial Summary

What is the purpose of this trial?

This trial tests the safety of brentuximab vedotin in adults with Diffuse Cutaneous Systemic Sclerosis (dcSSc). The medicine targets specific immune cells to help control the disease. Participants will receive varying doses to determine the safest and most effective amount.

Research Team

Dinesh Khanna, MD, MSc

Principal Investigator

University of Michigan Health System: Department of Internal Medicine, Division of Rheumatology

David Fox, MD

Principal Investigator

University of Michigan Health System: Department of Internal Medicine, Division of Rheumatology

Eligibility Criteria

Inclusion Criteria

You have a specific type of autoimmune disease called Systemic Sclerosis, which is determined by a set of guidelines established in 2013 by the American College of Rheumatology and the European Union League Against Rheumatism.

You have a specific type of systemic sclerosis called Diffuse Cutaneous Systemic Sclerosis (dcSSc), which is diagnosed using specific criteria.

You have had the disease for no longer than 5 years (counting from the first symptom that was not just Raynaud's phenomenon).

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Exclusion Criteria

Certain laboratory abnormalities

Evidence of infection

You have experienced moderate to severe lower digestive problems in the three months before joining the study.

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Treatment Details

Interventions

Brentuximab Vedotin (Antibody-drug Conjugate)

Participant Groups

6Treatment groups

Experimental Treatment

Placebo Group

Group I: Cohort 3: 1.8 mg/kg brentuximab vedotinExperimental Treatment1 Intervention

This is the third/last of three ascending dose cohorts. Participants in this cohort will receive 1.8 mg/kg brentuximab vedotin (to a maximum dose 60 mg) every 3 weeks from week 0 (initial dose) to week 21, a total of 8 treatments. Brentuximab vedotin will be administered as an intravenous infusion over 30 minutes. Cohort 3 Randomization schedule: N=6 assigned to brentuximab vedotin: N=2 assigned to placebo.

Group II: Cohort 2: 1.2 mg/kg brentuximab vedotinExperimental Treatment1 Intervention

This is the second of three ascending dose cohorts. Participants in this cohort will receive 1.2 mg/kg brentuximab vedotin (to a maximum dose 60 mg) every 3 weeks from week 0 (initial dose) to week 21, a total of 8 treatments. Brentuximab vedotin will be administered as an intravenous infusion over 30 minutes. Cohort 2 Randomization schedule: N=6 assigned to brentuximab vedotin: N=2 assigned to placebo.

Group III: Cohort 1: 0.6 mg/kg brentuximab vedotinExperimental Treatment1 Intervention

This is the first of three ascending dose cohorts. Participants in this cohort will receive 0.6 mg/kg brentuximab vedotin (to a maximum dose 60 mg) every 3 weeks from week 0 (initial dose) to week 21, a total of 8 treatments. Brentuximab vedotin will be administered as an intravenous infusion over 30 minutes. Cohort 1 Randomization schedule: N=6 assigned to brentuximab vedotin: N=2 assigned to placebo.

Group IV: Cohort 3: placeboPlacebo Group1 Intervention

1.8 mg/kg placebo (to a maximum dose 60 mg). Participants in this cohort will receive 1.8 mg/kg placebo every 3 weeks from week 0 (initial dose) to week 21, a total of 8 treatments. Placebo will be administered as an intravenous infusion over 30 minutes. Cohort 3 Randomization schedule: N=6 assigned to brentuximab vedotin: N=2 assigned to placebo.

Group V: Cohort 2: placeboPlacebo Group1 Intervention

1.2 mg/kg placebo (to a maximum dose 60 mg). Participants in this cohort will receive 1.2 mg/kg placebo every 3 weeks from week 0 (initial dose) to week 21, a total of 8 treatments. Placebo will be administered as an intravenous infusion over 30 minutes. Cohort 2 Randomization schedule: N=6 assigned to brentuximab vedotin: N=2 assigned to placebo.

Group VI: Cohort 1: placeboPlacebo Group1 Intervention

0.6 mg/kg placebo (to a maximum dose 60 mg). Participants in this cohort will receive 0.6 mg/kg placebo every 3 weeks from week 0 (initial dose) to week 21, a total of 8 treatments. Placebo will be administered as an intravenous infusion over 30 minutes. Cohort 1 Randomization schedule: N=6 assigned to brentuximab vedotin: N=2 assigned to placebo.