Single Center Study of Apremilast for the Treatment of Hidradenitis Suppurativa

Part of paid clinical trials in Coral Gables, Florida.

Sponsor
Florida Academic Dermatology Centers
Study ID
NCT02695212
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Apremilast — DRUG
    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

Study Details

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

Key Dates

First listed
Mar 1, 2016
Start date
Jul 31, 2016
Status verified
Mar 2019
Primary completion
Aug 31, 2017
Completion
Aug 31, 2017

Study Design

Enrollment
20 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER

Arms

  • Experimental: Apremilast ( open label)
    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

Primary Outcome Measure

The Proportion of subjects achieving Hidradenitis Suppurativa Clinical Response (HiSCR) [ Time Frame: Week 16 ]

Locations (1)

FacilityCityStateZIPSite coordinators
Florida Academic Dermatology CentersCoral GablesFlorida33134-

Find similar trials in Coral Gables, FL

By condition
Hidradenitis suppurativa
By specialty
DermatologyRheumatologyAutoimmune disease
By research site
Florida Academic Dermatology Centers· Coral Gables, FL

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