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Antibody-drug Conjugate

Brentuximab Vedotin for Scleroderma (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 weeks3 visits

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

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

Paraesthesia

Pain in extremity

Weight decreased

Hypertension

Dysgeusia

Headache

Urticaria

Neutropenia

Hyperglycaemia

Peripheral motor neuropathy

Dizziness

Chills

Upper respiratory tract infection

Hyperuricaemia

Urinary tract infection

Muscle spasms

Anaemia

Constipation

Alanine aminotransferase increased

Skin infection

Insomnia

Cough

Cellulitis

Neuropathy peripheral

Multiple organ dysfunction syndrome

Drug eruption

Cancer pain

Diverticulitis

Sepsis

Impetigo

Sinusitis

Extravasation

General physical health deterioration

Musculoskeletal chest pain

Hypotension

Dry skin

Peripheral swelling

Hypertriglyceridaemia

Lower respiratory tract infection

Fracture

Lymphoma

Neck pain

Hepatocellular injury

Intestinal perforation

Haemolytic uraemic syndrome

Pancreatitis

Pulmonary embolism

Urinary retention

Stress

Aspartate aminotransferase increased

Staphylococcal skin infection

100%

80%

60%

40%

20%

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

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