Short-term Safety, Efficacy and Mode of Action of Apremilast in Moderate Suppurative Hidradenitis

NCT ID: NCT03049267

Last Updated: 2018-07-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-02-02
• Study Completion Date: 2018-06-28

Brief Summary

Study design: A double-blind randomised placebo-controlled trial

Intervention: Randomized placebo controlled treatment of 20 HS patients of which fifteen patients will be randomized to apremilast and five patients to placebo. The total duration of the treatment period per subject is 16 weeks.

Primary objectives: To evaluate the expression profile of inflammatory cytokines in HS lesional skin at week four (t=4) and week sixteen (t=16):

• of patients receiving apremilast compared to placebo;
• within both groups relative to baseline (t=0).

Secondary objectives:

• To prospectively evaluate the clinical efficacy of apremilast.
• To assess the effect of apremilast on patient reported outcomes measures.
• To assess the short-term safety and tolerability of apremilast in patients with hidradenitis suppurativa.

Detailed Description

Rationale:

Hidradenitis suppurativa (HS) is a chronic, inflammatory, recurrent, debilitating skin disease. It is characterized by painful, deep-seated, inflamed boils in the inverse areas of the body, most commonly the axillae, inguinal and anogenital regions.

Systemic therapy with immunosuppressive agents (systemic corticosteroids, dapsone, cyclosporin) has been investigated in the past decades and has shown limited efficacy. The use of the selective immunosuppressant apremilast has not yet been evaluated in HS. The investigators hypothesize a beneficial effect of apremilast in HS patients, similar to the efficacy of apremilast in psoriasis patients. Namely, it has been shown that the immune dysregulation in the pathogenesis of HS shows many similarities with that of psoriasis. Moreover, the TNF-α blocker adalimumab was registered for HS after approval for the treatment in patients with psoriasis.

Conditions

Hidradenitis Suppurativa

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Apremilast

N=15

Group Type: EXPERIMENTAL

Apremilast

Intervention Type: DRUG

Fifteen patients will be supplied of apremilast for daily oral use; 16 weeks.

Placebo Oral Tablet

N=5

Group Type: PLACEBO_COMPARATOR

Placebo Oral Tablet

Intervention Type: DRUG

Five patients will be supplied with placebo tablets with identical labeling as apremilast for daily use; 16 weeks.

Interventions

Apremilast

Fifteen patients will be supplied of apremilast for daily oral use; 16 weeks.

Intervention Type: DRUG

Placebo Oral Tablet

Five patients will be supplied with placebo tablets with identical labeling as apremilast for daily use; 16 weeks.

Intervention Type: DRUG

Other Intervention Names

Otezla, CC-10004; Placebo comparator

Eligibility Criteria

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.

Exclusion Criteria

• Contra-indication 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Celgene

INDUSTRY

Sponsor Role: collaborator

M.B.A. van Doorn

OTHER

Sponsor Role: lead

Responsible Party

M.B.A. van Doorn

MD, PhD

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Errol Prens

Role: PRINCIPAL_INVESTIGATOR

Erasmus Medical Center

Locations

Erasmus University Medical Center

Rotterdam, , Netherlands

Countries

Netherlands

Other Identifiers

SMASH trial

Identifier Type: -

Identifier Source: org_study_id