An Investigator-initiated Study of Apremilast to Demonstrate Efficacy Nummular Eczema

NCT03160248 | Completed Phase 2 DMC

• 1 other identifier: AP-CL-ECZ-PI-006539
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

Brief Summary

This is an investigator-initiated, single-center, prospective, randomized, double-blind, interventional phase IIb study. Forty patients with clinically and histologically confirmed nummular eczema will be enrolled according to inclusion and exclusion criteria. Patients will be included after written informed consent is obtained. Prior to randomization, average application rate of class II topical steroids per day will be measured for 4 weeks. Subsequently, patients will be randomized in a 1:1 ratio into one arm to receive Apremilast 30 mg BID (following titration phase) for 16 weeks or a second arm receiving identically matching placebo for 16 weeks. From beginning of week 17, all patients will start an open-label treatment with Apremilast 30 mg BID until week 32. Concomitant use of topical steroids (class II) is allowed during the study. During the treatment period both placebo and Apremilast will be applied p.o. from week 0 until week 32.

Conditions

Nummular Eczema; Eczema; Dermatitis Eczema; Nummular Dermatitis

Outcome Measures

Primary Outcomes (1)

• PGA

  Number of Patients Achieving an Improvement (Decrease) in PGA (Physician Global Assessment) by two or more points at week 16 as compared to week 0 or achieving an absolute PGA of 0 or 1 at Week 16

  week 16

Secondary Outcomes (9)

• EASI

  week 16 and 32

• Transepidermal Waterloss (TEWL)

  week 16 and 32

• Histology

  week 16

• Use of topical steroids

  week 16 and 32

• PGA score Arm 2

  week 32

Other Outcomes (5)

• Exploratory endpoint: Change From Baseline in metabolic functions at Week 16 and 32 - weight

  week 16 and 32

• Exploratory endpoint: Change From Baseline in metabolic functions at Week 16 and 32 - BMI

  week 16 and 32

• Exploratory endpoint: Change From Baseline in metabolic functions at Week 16 and 32 - abdominal girth

  week 16 and 32

Study Arms (2)

Apremilast

EXPERIMENTAL

Patients randomized to this arm will start Apremilast with a titration phase of 5 days, followed by 30 mg Apremilast tablets twice daily (BID) by mouth (PO) for a total of 32 weeks (including titration phase).

Drug: Apremilast

Placebo + Apremilast

EXPERIMENTAL

Patients randomized to this arm will receive identically matching placebo (including the titration phase) by mouth for first 16 weeks. Placebo participants will be switched to receive Apremilast 30 mg BID from beginning of Week 17 for another 16 weeks. In this arm Apremilast will be started without titration.

Drug: Apremilast; Drug: Placebo Oral Tablet

Interventions

Apremilast DRUG

This study aims on investigating the efficacy of Apremilast in nummular eczema patients.

Apremilast; Placebo + Apremilast

Placebo Oral Tablet DRUG

This study aims on investigating the efficacy of Apremilast in nummular eczema patients - placebo controlled

Placebo + Apremilast

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Clinically confirmed diagnosis of nummular eczema
• Biopsy-proven, meaning histology consistent with eczema (including PAS-staining)
• PGA ≥ 3 on a 5 point scale
• History of continuous use of topical steroids for the last 8 weeks
• Age 18-85 years of age, body weight ≥ 40 kg and ≤ 160 kg
• Signed informed consent from patient

You may not qualify if:

• Permanent severe diseases, especially those affecting the immune system
• Pregnancy or breast feeding
• History or presence of epilepsy, significant neurological disorders, depression, suicidal ideation and behaviour, cerebrovascular attacks or ischemia
• History or presence of myocardial infarction or cardiac arrhythmia which requires drug therapy
• Evidence of severe renal dysfunction defined as:
• eGFR \< 30 ml/min/1,73 m2 (calculated using the MDRD formula) at screening (Visit 1)
• Evidence of significant hepatic disease defined as:
• At screening (Visit 1):
• Alkaline phosphatase \>3x upper limit of normal (ULN) or alkaline phosphatase \>2,5x ULN and total bilirubin \> 2xULN or
• Aspartate transaminase (AST, SGOT\]) and alanine transaminase (ALT, SGPT\]) \> 2.5x upper limit of normal (ULN)
• History of lymphoproliferative disorders
• Patients who are considered potentially unreliable or where it is envisaged the patient may not consistently attend scheduled study visits
• Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant unless they use effective contraception during the study and for 4 weeks after study completion or discontinuation. The chosen form of birth control must be effective by the time the patient receives her first dose of study drug.
• Inability or unwillingness to undergo repeated venipuncture (e.g., because of poor tolerability or lack of access to veins)
• Inability or unwillingness to undergo repeated punch biopsies

Sponsors & Collaborators

• Technical University of Munich: lead
• Celgene Corporation: collaborator

Study Sites (1)

Technical University Munich - Department of Dermatology

Munich, Bavaria, 80805, Germany

Location

MeSH Terms

Conditions

Eczema

Interventions

apremilast

Condition Hierarchy (Ancestors)

Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous

Study Officials

• Kilian Eyerich

  Technical University Munich

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 17, 2017
• First Posted: May 19, 2017
• Study Start: July 5, 2017
• Primary Completion: September 15, 2021
• Study Completion: September 15, 2021
• Last Updated: October 8, 2021

Record last verified: 2020-10

Locations

DE (1)