NCT02695212

Single Center Study of Apremilast for the Treatment of Hidradenitis Suppurativa

A Phase 2 Open-label Single Center Study to Evaluate the Efficacy of Apremilast for the Treatment of Moderate Hidradenitis Suppurativa

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Florida Academic Dermatology Centers · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The primary objective of this study is to evaluate the safety and efficacy of Apremilast in subjects with moderate Hidradenitis Suppurativa (HS).

Detailed description

This study is an open-label 28-week trial. All Subjects will receive Apremilast with the initial titrating dose as per package insert (10mg per day on day #1, escalating to 30mg twice daily at day #6 and continuation at this dose). The primary efficacy endpoint is: The Proportion of subjects achieving Hidradenitis Suppurativa Clinical Response (HiSCR) at week 16, defined as a 30% reduction in the total number of abscess and inflammatory nodule count with a 50% reduction as an exploratory endpoint.. The Secondary endpoints are: 1. The number of patients achieving a one point reduction in the Physician's Global Assessment (PGA) score at week 16 2. Changes in Modified Sartorius scale from Baseline to Week 16 3. The number of patients achieving a two point reduction (required from baseline score) in the Visual Analog Scale (VAS) pain score at week 16 4. Dermatology Life Quality Index or DLQI, 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 Baseline (Week 0), Weeks 4, 8, 12, 16, 20, 24, and then a observational follow up 4 weeks afterwards. 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.

Conditions

• Hidradenitis Suppurativa

Interventions

Type	Name	Description
DRUG	Apremilast	Investigational Product: Apremilast Doses: Period A: 10mg Per day, day #1, 10mg Twice Per day, day #2 10mg qAM, 20mg qHS day #3 20mg Twice per day, day #4 20mg qAM, 30 mg qHS day #5 30mg Twice per day, day #6 Period B: 30mg Twice per day, day #7 through week #24 Period C: Week 28 (4 weeks off therapy), for final evaluation Mode of Administration: Oral

Timeline

• Start date: 2016-07-01
• Primary completion: 2017-08-01
• Completion: 2017-08-01
• First posted: 2016-03-01
• Last updated: 2019-04-02

Locations

1 site across 1 country: United States