Your session is about to expire
← Back to Search
Monoclonal Antibodies
Administration of Brentuximab vedotin for Systemic Sclerosis
Phase 2
Recruiting
Led By Janet E Pope, PhD
Research Sponsored by Lawson Health Research Institute
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 assessed for duration of treatment up to 48 weeks, and up to 1 month post-treatment
Awards & highlights
Study Summary
This trial aims to test the safety and effectiveness of Brentuximab vedotin in patients with a certain type of skin disease called diffuse cutaneous systemic sclerosis who have not responded well to previous treatment
Who is the study for?
This trial is for patients with a severe form of scleroderma called diffuse cutaneous systemic sclerosis (dcSSc) who have previously been treated with Brentuximab vedotin but experienced a relapse. Participants must show worsening skin symptoms and be able to give informed consent.Check my eligibility
What is being tested?
The study is testing the safety and effectiveness of Brentuximab vedotin, an antibody-drug conjugate targeting CD30, in those who've had dcSSc worsen after stopping previous treatment with the same drug.See study design
What are the potential side effects?
Potential side effects include reactions at the injection site, fever, nausea, fatigue, rash or itching. There may also be risks related to low blood cell counts leading to infections or bleeding problems.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ assessed for duration of treatment up to 48 weeks, and up to 1 month post-treatment
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~assessed for duration of treatment up to 48 weeks, and up to 1 month post-treatment
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in skin thickness measured by modified Rodnan Skin Score
Secondary outcome measures
Change in Forced Vital Capacity (pulmonary function)
Change in Scleroderma Health Assessment Questionnaire (SHAQ)
Change in patient global assessment of health status
+8 moreOther outcome measures
Biopsy
Change in peripheral levels of T-cell activation marker - sIL-2R
Change in peripheral levels of fibrillogenesis - amino terminal propeptide of type III collagen
+2 moreSide effects data
From 2017 Phase 2 trial • 10 Patients • NCT0180759840%
Fatigue
30%
Neutropenia
20%
Anorexia
20%
Constipation
20%
Cough
20%
Abdominal Pain
20%
Anemia
20%
Depression
20%
Diarrhea
20%
Dyspnea
20%
Infusion Related Reaction
20%
Rash
20%
Vomiting
10%
Intracranial hemorrhage
10%
Thrombocytopenia
10%
Respiratory, thoracic and mediastinal disorders - Other, Epiglottitis
10%
Sinusitis
10%
Oral pain
10%
Edema limbs
10%
Portal vein thrombosis
10%
Pleural effusion
10%
Fever
10%
Nausea
10%
Alopecia
10%
Dry skin
10%
Hyperhidrosis
10%
Pruritus
10%
Upper respiratory infection
10%
Vaginal infection
10%
Sore throat
10%
Hypoalbuminemia
10%
Ascites
10%
Dysphagia
10%
Wound infection
10%
Postnasal drip
10%
Dehydration
10%
Insomnia
10%
Ear pain
10%
Watering eyes
10%
Pain in extremity
10%
Urinary frequency
100%
80%
60%
40%
20%
0%
Study treatment Arm
Brentuximab Vedotin
Trial Design
1Treatment groups
Experimental Treatment
Group I: Administration of Brentuximab vedotinExperimental Treatment1 Intervention
Maximum duration of treatment: 48 weeks Maximum dose allowed: 0.6 mg/kg Route of administration: intravenous
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Brentuximab vedotin
2012
Completed Phase 2
~200
Find a Location
Who is running the clinical trial?
Lawson Health Research InstituteLead Sponsor
659 Previous Clinical Trials
413,721 Total Patients Enrolled
Seagen Inc.Industry Sponsor
208 Previous Clinical Trials
74,217 Total Patients Enrolled
Janet E Pope, PhDPrincipal InvestigatorUniversity of Western Ontario, Division of Rheumatology, St. Joseph's Health Care, London, Ontario, Canada
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the current enrollment size of participants for this research?
"Indeed, as per information available on clinicaltrials.gov, this investigation is actively pursuing eligible participants. The trial was first made public on February 14th, 2024 and underwent its most recent revision on February 23rd of the same year. Enrollment targets for this study include recruiting 11 patients at one single research site."
Answered by AI
What risks are associated with the use of Brentuximab vedotin in patients?
"The safety evaluation of administering Brentuximab vedotin by our team at Power rates a 2 on the scale, as this trial is in Phase 2 where some safety data exists but efficacy data is lacking."
Answered by AI
Recent research and studies
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger