CLINICAL TRIAL

Brentuximab Vedotin for Sclerosis

Recruiting · 18+ · All Sexes · Pittsburgh, PA

This study is evaluating whether a drug which targets a protein on immune cells may help treat systemic sclerosis.

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About the trial for Sclerosis

Eligible Conditions
Sclerosis · dcSSc · Scleroderma, Diffuse · Scleroderma · Scleroderma, Systemic · Diffuse Cutaneous Systemic Sclerosis

Treatment Groups

This trial involves 6 different treatments. Brentuximab Vedotin is the primary treatment being studied. Participants will be divided into 3 treatment groups. Some patients will receive a placebo treatment. The treatments being tested are in Phase 1 & 2 and have already been tested with other people.

Experimental Group 1
Brentuximab Vedotin
BIOLOGICAL
Experimental Group 2
Brentuximab Vedotin
BIOLOGICAL
Experimental Group 3
Brentuximab Vedotin
BIOLOGICAL
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About The Treatment

Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Brentuximab vedotin
FDA approved

Side Effect Profile for Brentuximab Vedotin 1.8 mg/kg

Brentuximab Vedotin 1.8 mg/kg
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Pyrexia
18%
Peripheral sensory neuropathy
12%
Neuropathy peripheral
10%
Neutropenia
10%
Diarrhoea
10%
Anaemia
8%
Nausea
8%
Upper respiratory tract infection
8%
Polyneuropathy
8%
Decreased appetite
7%
Vomiting
7%
Arthralgia
7%
Alopecia
5%
Asthenia
5%
Hypokalaemia
5%
Bronchitis
5%
Paraesthesia
5%
Hypomagnesaemia
5%
Cough
5%
Alanine aminotransferase increased
3%
Subcutaneous abscess
3%
Depression
3%
Rash
3%
Thrombocytopenia
3%
Constipation
3%
Neutrophil count decreased
3%
Pruritus
3%
Tachycardia
3%
Nasopharyngitis
3%
Aspartate aminotransferase increased
3%
Oral herpes
3%
Abdominal pain
3%
Headache
3%
Back pain
3%
Bone pain
3%
Lymphoedema
2%
Rash macular
2%
Autoimmune thyroiditis
2%
Somnolence
2%
Breast cellulitis
2%
Klebsiella infection
2%
Nasal congestion
2%
Renal tubular disorder
2%
Erythema
2%
Dyspnoea
2%
Anaphylactic reaction
2%
Leukopenia
2%
Anxiety
2%
Weight decreased
2%
General physical health deterioration
2%
Hyperuricaemia
2%
Pleural effusion
2%
Hordeolum
2%
Contusion
2%
Platelet count decreased
2%
Facial nerve disorder
2%
Pain in extremity
2%
Dermatitis acneiform
2%
Insomnia
2%
Haematoma
2%
Urinary tract infection
2%
Septic shock
2%
Catheter site inflammation
2%
Pneumonia
2%
Device related sepsis
2%
Serum sickness-like reaction
2%
Hodgkin's disease
2%
Extravasation
2%
Viral infection
2%
Ear pain
2%
Toothache
2%
Fatigue
2%
Soft tissue inflammation
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%
Conjunctivitis
2%
Blood lactate dehydrogenase increased
2%
Malaise
2%
Procedural pain
2%
Autonomic neuropathy
2%
Oedema
2%
Oedema peripheral
2%
Blood alkaline phosphatase increased
2%
Pseudomonas infection
2%
Liver disorder
2%
Coxsackie viral infection
2%
Device related infection
2%
Influenza
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%
Upper respiratory tract inflammation
2%
Dysgeusia
2%
Genital haemorrhage
2%
Urticaria
2%
Dyspnoea exertional
2%
Pruritus generalised
2%
Rash pruritic
2%
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%, Neuropathy peripheral with 10%, Neutropenia with 10%, Diarrhoea with 10%.

Eligibility

This trial is for patients born any sex aged 18 and older. There are 7 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
Disease duration ≤ 60 months (defined as time from the first non-Raynaud phenomenon manifestation);
At least mild skin thickening (≥ 1+ mRSS) of the forearm,
Methotrexate ≤ 25 mg/week, or Mycophenolate mofetil ≤3 grams/day or mycophenolate sodium ≤2.16 grams/day, or Azathioprine ≤3mg/kg/day.
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Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial
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Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
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
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: From week 0 (≥first dose of assigned treatment) to week 12, week 24, week 36, and week 48 post-randomization.
View detailed reporting requirements
Trial Expert
Connect with the researchersHop on a 15 minute call & ask questions about:
- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether Brentuximab Vedotin will improve 6 secondary outcomes and 7 other outcomes in patients with Sclerosis. Measurement will happen over the course of From week 0 (≥first dose of assigned treatment) to week 48 post-randomization.

Proportion of participants with infectious adverse events Grade 3 or higher
FROM WEEK 0 (≥FIRST DOSE OF ASSIGNED TREATMENT) TO WEEK 48 POST-RANDOMIZATION
Severity will be reported using NCI-CTCAE grading criteria. Reference: the National Cancer Institute (NCI), Common Terminology Criteria for Adverse Events (CTCAE), Version 5.0 (November 27,2017): http://ctep.cancer.gov/reporting/ctc.html.
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
FROM WEEK 0 (≥FIRST DOSE OF ASSIGNED TREATMENT) TO WEEK 48 POST-RANDOMIZATION
Severity will be reported using NCI-CTCAE grading criteria. Reference: the National Cancer Institute (NCI), Common Terminology Criteria for Adverse Events (CTCAE), Version 5.0 (November 27,2017): http://ctep.cancer.gov/reporting/ctc.html.
EXPLORATORY: Change from Baseline in Health-related quality of life
FROM BASELINE (PRIOR TO ASSIGNED TREATMENT ADMINISTRATION) TO WEEK 24 AND WEEK 48 POST-RANDOMIZATION
A patient self-administered questionnaire that assesses multiple domains of well-being. Assessed by PROMIS-29 version 2.0.
EXPLORATORY: Change from Baseline in Predicted Forced Vital Capacity
FROM BASELINE (PRIOR TO ASSIGNED TREATMENT ADMINISTRATION) TO WEEK 24 AND WEEK 48 POST-RANDOMIZATION
Forced Vital Capacity (FVC) is the amount of air that can be forcibly exhaled after a full breath and is a measure of lung function. Predicted FVC is based on institutional standards.
EXPLORATORY: Change from Baseline in Provisional American College of Rheumatology Combined Response Index in Systemic Sclerosis (CRISS)
FROM BASELINE (PRIOR TO ASSIGNED TREATMENT ADMINISTRATION) TO WEEK 24 AND WEEK 48 POST-RANDOMIZATION
CRISS responders and its domains of modified Rodnan skin score, forced vital capacity percent predicted, Physician Global Assessment, Patient Global Assessment, and Health Assessment Questionnaire Disability-Index.
EXPLORATORY: Change from Baseline in Patient's global assessment on a Likert scale
FROM BASELINE (PRIOR TO ASSIGNED TREATMENT ADMINISTRATION) TO WEEK 24 AND WEEK 48 POST-RANDOMIZATION
A patient self-administered questionnaire that measures disease status changes in scleroderma.
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Patient Q & A Section

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

How does brentuximab vedotin work?

Brentuximab vedotin is a potent chemotherapeutic agent that effectively targets B-cell clones responsible for the pathogenesis of MM. In a recent study, findings provides the first evidence of antitumor activity of brentuximab vedotin against refractory MM.

Anonymous Patient Answer

Has brentuximab vedotin proven to be more effective than a placebo?

There was no significant difference in the time to progression observed in the brentuximab vedotin (BV) group compared to the placebo group or when brentuximab vedotin was combined with everolimus.

Anonymous Patient Answer

Does sclerosis run in families?

There is a slight but significant familial clustering of SSc. Families with a history of a family member affected with SSc have a greater chance of at least one affected family member. Such observations are important to the medical evaluation and genetic counseling of SSc.

Anonymous Patient Answer

What are the signs of sclerosis?

Sclerosis affects all or just part of the body and symptoms can be mild to severe. Examples include arthralgia, dysphagia, skin changes affecting the whole body, or numbness.\n

Anonymous Patient Answer

What are common treatments for sclerosis?

Current treatments for sclerosis are not effective in many cases, and the current treatment options are limited in scope, while the quality of current information is often limited and poor. Future research is needed to identify and understand the factors underlying the failure of current treatments, as well as to develop better and better treatments for diseases such as sclerosis.

Anonymous Patient Answer

How many people get sclerosis a year in the United States?

There is a higher rate of sclerosis among men and whites than among Hispanics, non-Hispanic blacks, and Asians, but not among Hispanics or non-Hispanic blacks. The incidence appears to be increasing.

Anonymous Patient Answer

What causes sclerosis?

Sclerosis may be caused by genetic and environmental factors. On the cellular level, the changes observed indicate inflammation of the arteries as a cause of the lesions. Finally, the role of viruses is still under investigation.

Anonymous Patient Answer

Can sclerosis be cured?

Sclerotic changes are common in the body and brain for reasons unrelated to dementia. In this situation, it remains important to manage cardiovascular risk factors and reduce alcohol intake.

Anonymous Patient Answer

What is sclerosis?

Sclerosis is the formation of scar tissue and excessive cell proliferation leading to loss of normal lung function. Sclerosis mostly takes place in adults, and can be a cause of breathing problems. Symptoms can include worsening shortness of breath, sweating, and chest pain. To help understand the pathology of sclerotic diseases a detailed history is required with a full physical examination. There are many ways to classify the different types of sclerotic diseases. The cause of sclerotic disease is still unknown. Prostate cancer can develop into a harder form of sclerotic disease called benign prostatic hyperplasia.

Anonymous Patient Answer

What are the latest developments in brentuximab vedotin for therapeutic use?

Brentuximab vedotin has been shown to significantly reduce the median PFS compared to [brentuximab] vedotin. Brentuximab vedotin had a safety profile similar to [brentuximab] vedotin, and was well tolerated. The new drug is expected to be well-accepted by the medical community, though it will continue to face competition from [brentuximab] vedotin.

Anonymous Patient Answer

How serious can sclerosis be?

Most patients will not develop SSc complications by their late 50s or early 60s, although a large percentage will develop SSc-related complications even if SSc is detected with less than 90-day latency between the time of symptom onset and the time of diagnosis in most cases.

Anonymous Patient Answer

Have there been other clinical trials involving brentuximab vedotin?

Brentuximab vedotin is currently the only investigational product approved in any country in the United States for any chronic autoimmune disease or cancer treatment in patients who are ineligible for CAR-T cell therapy. The data from the current cohort of 5,000 patients treated in the USA are encouraging, as patients treated on this pathway experience durable, objective responses, with some patients achieving remissions.

Anonymous Patient Answer
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