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

NCT03049267 | Completed Phase 2 FDA Drug

• 1 other identifier: SMASH trial
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Hidradenitis Suppurativa

Keywords

acne inversa

Outcome Measures

Primary Outcomes (2)

• Change of expression levels of inflammatory cytokine mRNA in HS lesional skin.

  measurement by qPCR

  t=16 weeks

• Change of expression levels of inflammatory cytokine protein in HS lesional skin.

  measurement by ELISA

  t=16 weeks

Secondary Outcomes (8)

• Abscesses count

  t=0 weeks, t=4 weeks, t=16 weeks

• Nodule count

  t=0 weeks, t=4 weeks, t=16 weeks

• Fistula count

  t=0 weeks, t=4 weeks, t=16 weeks

• Hidradenitis Suppurativa Physician's Global Assessment (HS-PGA) score

  t=0 weeks, t=4 weeks, t=16 weeks

• Hidradenitis Suppurativa Clinical Response (HiSCR)

  t=0 weeks, t=16 weeks

Study Arms (2)

Apremilast

EXPERIMENTAL

N=15

Drug: Apremilast

Placebo Oral Tablet

PLACEBO COMPARATOR

N=5

Drug: Placebo Oral Tablet

Interventions

Apremilast DRUG

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

Also known as: Otezla, CC-10004

Apremilast

Placebo Oral Tablet DRUG

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

Also known as: Placebo comparator

Placebo Oral Tablet

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• M.B.A. van Doorn: lead
• Celgene: collaborator

Study Sites (1)

Erasmus University Medical Center

Rotterdam, Netherlands

Location

MeSH Terms

Conditions

Hidradenitis Suppurativa

Interventions

apremilast

Condition Hierarchy (Ancestors)

Skin Diseases, Bacterial; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Skin Diseases, Infectious; Suppuration; Skin Diseases; Skin and Connective Tissue Diseases; Hidradenitis; Sweat Gland Diseases

Study Officials

• Errol Prens

  Erasmus Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: October 25, 2016
• First Posted: February 10, 2017
• Study Start: February 2, 2017
• Primary Completion: December 6, 2017
• Study Completion: June 28, 2018
• Last Updated: July 24, 2018

Record last verified: 2018-07

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)