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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 from week 0 (≥first dose of assigned treatment) to week 12, week 24, week 36, and week 48 post-randomization
Awards & highlights

BRAVOS Trial Summary

This trial is testing a drug, brentuximab vedotin, to see if it is safe and effective for treating Diffuse Cutaneous Systemic Sclerosis (dcSSc), a disease with few treatment options.

Eligible Conditions
  • Systemic Sclerosis
  • Scleroderma

BRAVOS Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from week 0 (≥first dose of assigned treatment) to week 12, week 24, week 36, and week 48 post-randomization
This trial's timeline: 3 weeks for screening, Varies for treatment, and from week 0 (≥first dose of assigned treatment) to week 12, week 24, week 36, and week 48 post-randomization for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Secondary outcome measures
Proportion of participants who experience at least one Grade 2 or higher adverse event
Proportion of participants who experience at least one Grade 3 or higher adverse event
Proportion of participants with Grade 2 or higher peripheral neuropathy
+2 more
Other outcome measures
EXPLORATORY: Change from Baseline in Modified Rodnan Skin Score

Side effects data

From 2020 Phase 4 trial • 60 Patients • NCT01990534
18%
Pyrexia
12%
Peripheral sensory neuropathy
10%
Neuropathy peripheral
10%
Neutropenia
10%
Diarrhoea
8%
Polyneuropathy
8%
Anaemia
8%
Nausea
8%
Upper respiratory tract infection
7%
Vomiting
7%
Decreased appetite
7%
Arthralgia
5%
Hypomagnesaemia
5%
Paraesthesia
5%
Asthenia
5%
Hypokalaemia
5%
Bronchitis
5%
Cough
5%
Alopecia
3%
Nasopharyngitis
3%
Neutrophil count decreased
3%
Back pain
3%
Bone pain
3%
Headache
3%
Depression
3%
Oral herpes
3%
Thrombocytopenia
3%
Tachycardia
3%
Abdominal pain
3%
Constipation
3%
Subcutaneous abscess
3%
Alanine aminotransferase increased
3%
Aspartate aminotransferase increased
3%
Pruritus
3%
Rash
2%
Upper respiratory tract inflammation
2%
General physical health deterioration
2%
Hodgkin's disease
2%
Anaphylactic reaction
2%
Lymphoedema
2%
Renal tubular disorder
2%
Genital haemorrhage
2%
Catheter site inflammation
2%
Chest pain
2%
Chills
2%
Malaise
2%
Oedema
2%
Oedema peripheral
2%
Soft tissue inflammation
2%
Temperature regulation disorder
2%
Vaccination site pain
2%
Liver disorder
2%
Breast cellulitis
2%
Blood lactate dehydrogenase increased
2%
Blood thyroid stimulating hormone increased
2%
Gamma-glutamyltransferase increased
2%
Lymphocyte count decreased
2%
Platelet count decreased
2%
Weight decreased
2%
Hyperglycaemia
2%
Hyperuricaemia
2%
Pain in extremity
2%
Autonomic neuropathy
2%
Dysgeusia
2%
Facial nerve disorder
2%
Somnolence
2%
Insomnia
2%
Device related infection
2%
Herpes zoster
2%
Hordeolum
2%
Extravasation
2%
Fatigue
2%
Conjunctivitis
2%
Coxsackie viral infection
2%
Dengue fever
2%
Influenza
2%
Klebsiella infection
2%
Toothache
2%
Leukocytosis
2%
Leukopenia
2%
Ear pain
2%
Autoimmune thyroiditis
2%
Diplopia
2%
Pseudomonas infection
2%
Sinusitis
2%
Viral infection
2%
Contusion
2%
Ligament sprain
2%
Procedural pain
2%
Blood alkaline phosphatase increased
2%
Haemoglobin decreased
2%
Pneumonia
2%
Device related sepsis
2%
Septic shock
2%
Urinary tract infection
2%
Serum sickness-like reaction
2%
Cerebrovascular accident
2%
Anxiety
2%
Pleural effusion
2%
Vena cava thrombosis
2%
Dyspnoea
2%
Dyspnoea exertional
2%
Nasal congestion
2%
Dermatitis
2%
Dermatitis acneiform
2%
Dermatitis allergic
2%
Dermatitis contact
2%
Erythema
2%
Pruritus generalised
2%
Rash macular
2%
Rash maculo-papular
2%
Rash papular
2%
Rash pruritic
2%
Urticaria
2%
Haematoma
100%
80%
60%
40%
20%
0%
Study treatment Arm
Brentuximab Vedotin 1.8 mg/kg

BRAVOS 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 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 V: 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 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 4
~1100

Find a Location

Who is running the clinical trial?

National Institute of Allergy and Infectious Diseases (NIAID)Lead Sponsor
3,261 Previous Clinical Trials
5,482,989 Total Patients Enrolled
Immune Tolerance Network (ITN)NETWORK
67 Previous Clinical Trials
7,901 Total Patients Enrolled
Seagen Inc.Industry Sponsor
206 Previous Clinical Trials
69,322 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any opportunities to enroll in this clinical experiment at the moment?

"According to the records found on clinicaltrials.gov, this research endeavour is currently accepting participants. The trial was first uploaded on September 20th 2017 and its details were last modified on May 12th 2022."

Answered by AI

In how many different locations can patients access this experiment?

"The University of Michigan Health System: Department of Internal Medicine, Division of Rheumatology in Ann Arbor, the Medical University of South carolina: Division of Rheumatology & Immunology in Charleston and Georgetown University Medical Center: Division od Rheumatology located in Washington D.C are only some out 8 other medical facilities associated with this clinical trial."

Answered by AI

Is this research endeavor open to seniors aged 65 or above?

"According to the prerequisites for this clinical experiment, participants must be aged 18 or above and no older than 70."

Answered by AI

Is it possible to partake in this clinical experiment?

"This trial seeks to enrol 24 patients suffering from scleroderma, aged 18-70. Necessary requirements include a 2013 American College of Rheumatology/European Union League Against Rheumatism classification for systemic sclerosis; LeRoy and Medsger criteria for the diagnosis of diffuse cutaneous systemic sclerosis; disease duration not exceeding 60 months, mild or moderate skin thickening in the forearm with minimal rash severity score system rating (mRSS); Methotrexate dosage limited to 25 mg per week, Mycophenolate mofetil consumed at 3 grams daily or mycophenolate sodium no greater than 2."

Answered by AI

For what therapeutic purpose is Brentuximab Vedotin typically deployed?

"Brentuximab Vedotin has the potential to help treat various forms of cancer, such as Hodgkin Disease and Systemic Anaplastic Large Cell Lymphoma. It may also be employed for those suffering from previously untreated Peripheral T-Cell Lymphoma."

Answered by AI

Is this medical experiment pioneering in its field?

"Since 2011, Seagen Inc. has been researching Brentuximab Vedotin with the earliest study involving 79 patients. This led to Phase 2 approval in the same year. Currently, there are 59 ongoing studies on this medication occurring across 630 towns and cities within 31 nations."

Answered by AI

What precedent is there for the use of Brentuximab Vedotin in clinical research?

"Currently, 59 studies involving Brentuximab Vedotin are ongoing. 6 of these trials are in the late-stage phase 3 testing category. The majority of research is based out of Montvale, New jersey; however there exists 1851 separate sites conducting this clinical trial at present."

Answered by AI

What is the current enrollment count for this clinical research project?

"To operate the trial, 24 qualified individuals are required. The sponsor - PPD - is administrating this medical experiment from two locations: University of Michigan Health System's Department of Internal Medicine Division of Rheumatology in Ann Arbor and Medical University of South carolina's Division of Rheumatology & Immunology in Charleston."

Answered by AI

Who else is applying?

What state do they live in?
California
How old are they?
18 - 65
What site did they apply to?
UCLA Medical Center: Division of Rheumatology
What portion of applicants met pre-screening criteria?
Met criteria
~2 spots leftby Mar 2025