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Monoclonal Antibodies

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
No Placebo-Only Group

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.
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.
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 weeks
Treatment ~ Varies
Follow Up ~assessed for duration of treatment up to 48 weeks, and up to 1 month post-treatment
This trial's timeline: 3 weeks for screening, Varies for treatment, and assessed for duration of treatment up to 48 weeks, and up to 1 month post-treatment for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change in skin thickness measured by modified Rodnan Skin Score
Secondary study objectives
Change in Forced Vital Capacity (pulmonary function)
Change in Scleroderma Health Assessment Questionnaire (SHAQ)
Change in patient global assessment of health status
+8 more
Other study objectives
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 more

Side effects data

From 2017 Phase 2 trial • 10 Patients • NCT01807598
40%
Fatigue
30%
Neutropenia
20%
Abdominal Pain
20%
Constipation
20%
Cough
20%
Anorexia
20%
Anemia
20%
Depression
20%
Diarrhea
20%
Dyspnea
20%
Infusion Related Reaction
20%
Rash
20%
Vomiting
10%
Intracranial hemorrhage
10%
Hyperhidrosis
10%
Respiratory, thoracic and mediastinal disorders - Other, Epiglottitis
10%
Thrombocytopenia
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%
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

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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 4
~210

Find a Location

Who is running the clinical trial?

Seattle Genetics (now a wholly owned subsidiary of Pfizer)UNKNOWN
PfizerIndustry Sponsor
4,660 Previous Clinical Trials
17,877,316 Total Patients Enrolled
1 Trials studying Scleroderma
15 Patients Enrolled for Scleroderma
Lawson Health Research InstituteLead Sponsor
680 Previous Clinical Trials
421,922 Total Patients Enrolled
1 Trials studying Scleroderma
10 Patients Enrolled for Scleroderma
~6 spots leftby Feb 2026
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