Efficacy and mode of action of apremilast (Otezla) in moderate hidradenitis suppurativa. An exploratory pilot study.

Phase 1

• Conditions: Hidradenitis suppurativa, acne inversa, ectopic acne; Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]

• Registration Number: EUCTR2016-000859-27-NL
• Lead Sponsor: Erasmus University Medical Center

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2016-06-27
• Last Update Posted: 31 January 2017

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Key inclusion criteria: adult (= 18 years of age) male or female patients with moderate HS according to a PGA of 3 on the 5-point HS-Physician Global Assessment (HS-PGA); HS of more than 6 months duration; have lesions in at least two anatomical locations.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 10
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Key exclusion criteria: contraindication for apremilast; previous use of apremilast; have any current and/or recurrent clinically significant skin condition in the treatment area other than HS; presence of other uncontrolled major disease; pregnant or lactating women.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified