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Monoclonal Antibodies

Brodalumab - Open Label for Hidradenitis Suppurativa

Phase 2
Waitlist Available
Research Sponsored by Florida Academic Dermatology Centers
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 study assessments occurr at baseline and at weeks 4, 8, 12, 16, 20, 24, and 28"
Awards & highlights

Study Summary

The study will be conducted over 24 weeks on active therapy followed by a four-week observational visit. The total length of the study will be 28 weeks. Study visits will occur at Screening, Baseline (Week 0), Weeks 4, 8, 12, 16, 20, 24 followed by an observational visit. Additionally, all subjects will be contacted by phone 1 week following the Baseline visit to ensure daily pain assessments are being recorded. If any signs or symptoms are reported at the time of the call, an unscheduled study visit will be conducted to assess whether an infection is present. Adverse events will be collected throughout the study.

Eligible Conditions
  • Hidradenitis Suppurativa

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~study assessments occurr at baseline and at weeks 4, 8, 12, 16, 20, 24, and 28"
This trial's timeline: 3 weeks for screening, Varies for treatment, and study assessments occurr at baseline and at weeks 4, 8, 12, 16, 20, 24, and 28" for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Hidradenitis Suppurativa Clinical Response (HiSCR)
Hidradenitis
Hidradenitis Suppurativa Clinical Response (HiSCR50)
Secondary outcome measures
Dermatology Life Quality Index or DLQI
Modified Sartorius
Physician s Global Assessment ( PGA)
+1 more

Side effects data

From 2019 Phase 4 trial • 210 Patients • NCT03331835
34%
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 upper
2%
Abdominal pain
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

Trial Design

1Treatment groups
Experimental Treatment
Group I: Brodalumab - Open LabelExperimental Treatment1 Intervention
Randomized subjects will be receiving Brodalumab (210 mg) administered by subcutaneous injection at the following visits: Baseline, week 1, week 2 and every two weeks thereafter, until Week 24. Investigational Product not to be administer into areas where the skin is tender, bruised, red, hard, thick, scaly, or affected by Hidradenitis Suppurativa.
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?

Florida Academic Dermatology CentersLead Sponsor
6 Previous Clinical Trials
118 Total Patients Enrolled
3 Trials studying Hidradenitis Suppurativa
68 Patients Enrolled for Hidradenitis Suppurativa
Ortho DermatologicsIndustry Sponsor
4 Previous Clinical Trials
1,201 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Treatment of Moderate Hidradenitis Suppurativa
Francisco A. Kerdel, MD 2019. "Treatment of Moderate Hidradenitis Suppurativa". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03910803.
All > Hidradenitis Suppurativa
~3 spots leftby May 2025
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