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New treatment option for Diffuse Cutaneous Systemic Sclerosis
Official title Open Label Extension Study of Brentuximab Vedotin in Early dcSSc
ClinicalTrials.gov ID: NCT05149768
What this study is testing
What is Brentuximab vedotin?
Brentuximab vedotin is an investigational medicine, being studied as a potential treatment for diffuse cutaneous systemic sclerosis.
Also referred to as ADCETRIS, SGN-35.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The purpose of this study is to assess safety and efficacy of Brentuximab vedotin, a CD30-directed antibody-drug conjugate, in patients with active diffuse cutaneous systemic sclerosis (dcSSc) who relapsed after discontinuation of Brentuximab vedotin.
- Phase 2: a mid-size study of how well it works
- Time commitment: about 48 weeks
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Patients with diffuse cutaneous systemic sclerosis enrolled in the Phase II Adcetris study (BV201708) at St. Joseph's Health centre, aged 18 years or...
- Worsening mRSS of ≥ 4 points as compared to mRSS score at the end of treatment visit (week 48) in the initial study (BV201708).
- Able to give informed consent.
You likely can't join if
- Poor pulmonary function (FVC\<40% and/or DLCO\<30%).
- Pregnancy, breast feeding or child bearing potential without practicing highly effective contraception (and partners for men in the study).
- Clinically significant pulmonary hypertension requiring drug therapy.
- Clinically significant cardiac disease.
- Chronic or ongoing active infectious disease requiring systemic treatment.
- Seropositivity for human immunodeficiency virus (HIV).
See the full eligibility criteria
- Patients with diffuse cutaneous systemic sclerosis enrolled in the Phase II Adcetris study (BV201708) at St. Joseph's Health centre, aged 18 years or older, and:
- Worsening mRSS of ≥ 4 points as compared to mRSS score at the end of treatment visit (week 48) in the initial study (BV201708).
- Able to give informed consent.
- Poor pulmonary function (FVC\<40% and/or DLCO\<30%).
- Pregnancy, breast feeding or child bearing potential without practicing highly effective contraception (and partners for men in the study).
- Clinically significant pulmonary hypertension requiring drug therapy.
- Clinically significant cardiac disease.
- Chronic or ongoing active infectious disease requiring systemic treatment.
- Seropositivity for human immunodeficiency virus (HIV).
- Active tuberculosis (TB) infection.
- Active viral infection with viral replication of hepatitis B or C virus.
- Significant concurrent, uncontrolled medical condition including, but not limited to, renal, hepatic, pancreatic, hematological, gastrointestinal, endocrine, pulmonary, neurological, cerebral or psychiatric disease; and...
- Peripheral neuropathy at screening Grade 2 or higher.
- Known or suspected hypersensitivity to components of the treatment
- Patients known or suspected of not being able to comply with a study protocol (e.g. due to alcoholism, drug dependency or psychological disorder)
- Any of the following laboratory abnormalities at screening:
- Absolute neutrophils count \<2.0 x 109/L
- Hemoglobin \<85 g/L
- Platelet count \< 100 x 109/L
- AST/SGOT or ALT/SGPT \>2.0 UNL
- Participation in another clinical trial within six weeks before randomization in this study, with the exception of continuation from the initial study BV201708.
- Use of rituximab within the previous 4 months.
- Immunization with a live/ attenuated vaccine less than 4 weeks prior to the baseline visit.
- Current or history of progressive multifocal leukoencephalopathy (PML).
The study team makes the final eligibility decision.
Where it's taking place
- London, Ontario, Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 48 weeks per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include London, Ontario, Canada. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.