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Monoclonal Antibodies
Molecular Characteristics of Brodalumab in Hidradenitis Suppurativa
Phase < 1
Waitlist Available
Led By Yael Renert-Yuval, MD
Research Sponsored by Rockefeller University
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 12 weeks
Awards & highlights
All Individual Drugs Already Approved
No Placebo-Only Group
Summary
This trial is testing Brodalumab, a medication for treating hidradenitis suppurativa. It aims to help patients with this painful skin condition by reducing swelling and pain through blocking inflammation signals.
Eligible Conditions
- Hidradenitis suppurativa
- Hidradenitis Suppurativa
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 weeks
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Interleukin-17 receptor A (IL-17RA) saturation during brodalumab administration at week 12 vs baseline
Secondary study objectives
Change in levels of IL-17A, IL-17C, IL-17, CXCL1, and CXCL8
Correlate IL-17R saturation (measured by the frequencies of immune cells positive to IL-17RA by flow cytometry) with clinical measures, such as pain or the Hidradenitis Suppurativa Severity Score System (IHS4)
Side effects data
From 2019 Phase 4 trial • 210 Patients • NCT0333183534%
Viral upper respiratory tract infection
13%
Headache
9%
Arthralgia
8%
Overdose
6%
Back pain
6%
Nausea
6%
Oropharyngeal pain
6%
Pruritus
5%
Fatigue
5%
Depressive symptom
4%
Diarrhoea
2%
Abdominal pain
2%
Abdominal pain upper
2%
Lymphopenia
1%
Reactive gastropathy
1%
Pancreatic carcinoma metastatic
1%
Stasis dermatitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Brodalumab 210 mg
Fumaric Acid Ester
Awards & Highlights
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
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: Brodalumab treated moderate-to-severe HS patientsExperimental Treatment1 Intervention
Weekly Brodalumab treatment 210mg/1.5ml, given subcutaneously for 12 weeks.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Brodalumab
FDA approved
Find a Location
Who is running the clinical trial?
Rockefeller UniversityLead Sponsor
160 Previous Clinical Trials
16,522 Total Patients Enrolled
3 Trials studying Hidradenitis Suppurativa
10 Patients Enrolled for Hidradenitis Suppurativa
Yael Renert-Yuval, MDPrincipal Investigator - The Rockefeller University
Rockefeller University