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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

All Individual Drugs Already Approved

No Placebo-Only Group

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ study assessments occurr at baseline and at weeks 4, 8, 12, 16, 20, 24, and 28"

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Hidradenitis Suppurativa Clinical Response (HiSCR)

Hidradenitis

Hidradenitis Suppurativa Clinical Response (HiSCR50)

Secondary study objectives

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

Arthralgia

Overdose

Back pain

Nausea

Oropharyngeal pain

Pruritus

Fatigue

Depressive symptom

Diarrhoea

Abdominal pain

Abdominal pain upper

Lymphopenia

Reactive gastropathy

Pancreatic carcinoma metastatic

Stasis dermatitis

100%

80%

60%

40%

20%

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 - 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

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