All > Amyotrophic Lateral Sclerosis > Scleroderma

Brentuximab Vedotin for Systemic Sclerosis

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
University of Pittsburgh Medical Center: Division of Rheumatology and Clinical, Pittsburgh, PASystemic Sclerosis+2 MoreBrentuximab Vedotin - Biological
Eligibility
18 - 70
All Sexes
What conditions do you have?
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Study 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
  • Diffuse Cutaneous Systemic Sclerosis

Treatment Effectiveness

Effectiveness Progress

1 of 3

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Study Objectives

0 Primary · 6 Secondary · Reporting Duration: From week 0 (≥first dose of assigned treatment) to week 12, week 24, week 36, and week 48 post-randomization

Week 48
EXPLORATORY: Change from Baseline in Modified Rodnan Skin Score
Week 48
EXPLORATORY: Change from Baseline in Health-related quality of life
EXPLORATORY: Change from Baseline in Patient's global assessment on a Likert scale
EXPLORATORY: Change from Baseline in Physical function assessed by the Scleroderma Health Assessment Questionnaire-Disability Index
EXPLORATORY: Change from Baseline in Physician's global assessment on a Likert scale
EXPLORATORY: Change from Baseline in Predicted Forced Vital Capacity
EXPLORATORY: Change from Baseline in Provisional American College of Rheumatology Combined Response Index in Systemic Sclerosis (CRISS)
Week 36
Proportion of participants who experience at least one Grade 3 or higher adverse event
Week 48
Proportion of participants who experience at least one Grade 2 or higher adverse event
Proportion of participants with Grade 2 or higher peripheral neuropathy
Proportion of participants with Grade 3 or higher neutropenia
Week 48
Proportion of participants with any of the following Grade 3 or higher adverse events by week 48: peripheral neuropathy, neutropenia, infectious, infusion reactions and/or progressive multifocal leukoencephalopathy
Proportion of participants with infectious adverse events Grade 3 or higher

Trial Safety

Safety Progress

1 of 3

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1
Romidepsin
1
RIC- alloBMT with high PTCy in SSc
2
ARGX-117

Side Effects for

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

Trial Design

6 Treatment Groups

Cohort 1: 0.6 mg/kg brentuximab vedotin
1 of 6
Cohort 2: 1.2 mg/kg brentuximab vedotin
1 of 6
Cohort 3: 1.8 mg/kg brentuximab vedotin
1 of 6
Cohort 2: placebo
1 of 6
Cohort 3: placebo
1 of 6
Cohort 1: placebo
1 of 6

Experimental Treatment

Non-Treatment Group

17 Total Participants · 6 Treatment Groups

Primary Treatment: Brentuximab Vedotin · Has Placebo Group · Phase 1 & 2

Cohort 1: 0.6 mg/kg brentuximab vedotin
Biological
Experimental Group · 1 Intervention: Brentuximab Vedotin · Intervention Types: Biological
Cohort 2: 1.2 mg/kg brentuximab vedotin
Biological
Experimental Group · 1 Intervention: Brentuximab Vedotin · Intervention Types: Biological
Cohort 3: 1.8 mg/kg brentuximab vedotin
Biological
Experimental Group · 1 Intervention: Brentuximab Vedotin · Intervention Types: Biological
Cohort 2: placebo
Biological
PlaceboComparator Group · 1 Intervention: Placebo · Intervention Types: Biological
Cohort 3: placebo
Biological
PlaceboComparator Group · 1 Intervention: Placebo · Intervention Types: Biological
Cohort 1: placebo
Biological
PlaceboComparator Group · 1 Intervention: Placebo · Intervention Types: Biological
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Brentuximab vedotin
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: from week 0 (≥first dose of assigned treatment) to week 12, week 24, week 36, and week 48 post-randomization

Who is running the clinical trial?

National Institute of Allergy and Infectious Diseases (NIAID)Lead Sponsor
3,165 Previous Clinical Trials
4,937,004 Total Patients Enrolled
Immune Tolerance Network (ITN)NETWORK
67 Previous Clinical Trials
7,877 Total Patients Enrolled
Seagen Inc.Industry Sponsor
187 Previous Clinical Trials
61,234 Total Patients Enrolled
Rho Federal Systems Division, Inc.Industry Sponsor
39 Previous Clinical Trials
15,231 Total Patients Enrolled
PPDIndustry Sponsor
149 Previous Clinical Trials
32,071 Total Patients Enrolled
Dinesh Khanna, MD, MScStudy ChairUniversity of Michigan Health System: Department of Internal Medicine, Division of Rheumatology
1 Previous Clinical Trials
500 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

Eligibility Criteria

Age 18 - 70 · All Participants · 7 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
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).
You have some thickening of the skin on your forearm, at least equal to a level of 1+.
You are taking certain medications, including methotrexate, mycophenolate mofetil or sodium, or azathioprine, but only if you are taking them in specific doses.
You have thickened skin at the site where the skin biopsy will be taken.
You understand what the study is about and agree to participate.

Who else is applying?

What state do they live in?
California100.0%
How old are they?
18 - 65100.0%
What site did they apply to?
UCLA Medical Center: Division of Rheumatology100.0%
What portion of applicants met pre-screening criteria?
Met criteria100.0%
References

Frequently Asked Questions

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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