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Antibody-drug Conjugate

Brentuximab Vedotin for Systemic Sclerosis (BRAVOS Trial)

Phase 1 & 2
Waitlist Available
Research Sponsored by National Institute of Allergy and Infectious Diseases (NIAID)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline thru week 12 visit or 12 weeks on study if visit was missed/thru week 24 visit or 24 weeks on study if visit was missed/thru week 36 visit or 36 weeks on study if visit was missed/thru week 48 visit or 48 weeks on study if visit was missed

Summary

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.

Eligible Conditions
  • Systemic sclerosis
  • Scleroderma

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline thru week 12 visit or 12 weeks on study if visit was missed/thru week 24 visit or 24 weeks on study if visit was missed/thru week 36 visit or 36 weeks on study if visit was missed/thru week 48 visit or 48 weeks on study if visit was missed
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline thru week 12 visit or 12 weeks on study if visit was missed/thru week 24 visit or 24 weeks on study if visit was missed/thru week 36 visit or 36 weeks on study if visit was missed/thru week 48 visit or 48 weeks on study if visit was missed for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Proportion of Participants That Experience at Least One Grade 3 or Higher Adverse Event at or Before Week 48.
Secondary study objectives
Proportion of Participants That Experience at Least One Grade 2 or Higher Adverse Event at or Before Weeks 12
Proportion of Participants That Experience at Least One Grade 2 or Higher Adverse Event at or Before Weeks 12, 24, 36, and 48.
Proportion of Participants That Experience at Least One Grade 2 or Higher Adverse Event at or Before Weeks 24.
+17 more
Other study objectives
EXPLORATORY: Change from Baseline in Modified Rodnan Skin Score

Side effects data

From 2018 Phase 3 trial • 131 Patients • NCT01578499
47%
Peripheral sensory neuropathy
36%
Nausea
27%
Diarrhoea
27%
Fatigue
17%
Vomiting
17%
Pruritus
15%
Alopecia
15%
Decreased appetite
14%
Pyrexia
12%
Myalgia
12%
Arthralgia
11%
Asthenia
11%
Oedema peripheral
11%
Rash maculo-papular
11%
Dyspnoea
11%
Pruritus generalised
9%
Paraesthesia
9%
Pain in extremity
9%
Weight decreased
9%
Hypertension
8%
Dysgeusia
8%
Headache
8%
Urticaria
8%
Neutropenia
8%
Hyperglycaemia
6%
Peripheral motor neuropathy
6%
Dizziness
6%
Chills
6%
Upper respiratory tract infection
6%
Hyperuricaemia
6%
Urinary tract infection
6%
Muscle spasms
5%
Anaemia
5%
Constipation
5%
Alanine aminotransferase increased
3%
Skin infection
3%
Insomnia
3%
Cough
3%
Cellulitis
2%
Multiple organ dysfunction syndrome
2%
Neuropathy peripheral
2%
Drug eruption
2%
Cancer pain
2%
Diverticulitis
2%
Sepsis
2%
Impetigo
2%
Sinusitis
2%
Extravasation
2%
General physical health deterioration
2%
Musculoskeletal chest pain
2%
Hypotension
2%
Dry skin
2%
Peripheral swelling
2%
Hypertriglyceridaemia
2%
Lower respiratory tract infection
2%
Fracture
2%
Lymphoma
2%
Neck pain
2%
Hepatocellular injury
2%
Intestinal perforation
2%
Haemolytic uraemic syndrome
2%
Pancreatitis
2%
Pulmonary embolism
2%
Urinary retention
2%
Stress
2%
Aspartate aminotransferase increased
2%
Staphylococcal skin infection
100%
80%
60%
40%
20%
0%
Study treatment Arm
Brentuximab Vedotin
Methotrexate or Bexarotene

Trial Design

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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Brentuximab Vedotin
2015
Completed Phase 3
~1080

Find a Location

Who is running the clinical trial?

Immune Tolerance Network (ITN)NETWORK
67 Previous Clinical Trials
7,841 Total Patients Enrolled
National Institute of Allergy and Infectious Diseases (NIAID)Lead Sponsor
3,327 Previous Clinical Trials
5,366,175 Total Patients Enrolled
Rho Federal Systems Division, Inc.Industry Sponsor
43 Previous Clinical Trials
14,946 Total Patients Enrolled
PPD DEVELOPMENT, LPIndustry Sponsor
163 Previous Clinical Trials
37,298 Total Patients Enrolled
Seagen Inc.Industry Sponsor
210 Previous Clinical Trials
74,321 Total Patients Enrolled
PPDIndustry Sponsor
161 Previous Clinical Trials
36,374 Total Patients Enrolled
Dinesh Khanna, MD, MScStudy ChairUniversity of Michigan Health System: Department of Internal Medicine, Division of Rheumatology
1 Previous Clinical Trials
110 Total Patients Enrolled
David Fox, MDStudy ChairUniversity of Michigan Health System: Department of Internal Medicine, Division of Rheumatology
1 Previous Clinical Trials
36 Total Patients Enrolled
~2 spots leftby Dec 2025
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