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

NCT ID: NCT03160248

Last Updated: 2021-10-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 31 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-07-05
• Study Completion Date: 2021-09-15

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

Study Design

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

Study Groups

Apremilast

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).

Group Type: EXPERIMENTAL

Apremilast

Intervention Type: DRUG

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

Placebo + Apremilast

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.

Group Type: EXPERIMENTAL

Apremilast

Intervention Type: DRUG

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

Placebo Oral Tablet

Intervention Type: DRUG

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

Interventions

Apremilast

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

Intervention Type: DRUG

Placebo Oral Tablet

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

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Clinically confirmed diagnosis of nummular eczema

2. Biopsy-proven, meaning histology consistent with eczema (including PAS-staining)

3. PGA ≥ 3 on a 5 point scale

4. History of continuous use of topical steroids for the last 8 weeks

5. Age 18-85 years of age, body weight ≥ 40 kg and ≤ 160 kg

6. Signed informed consent from patient

Exclusion Criteria

1. Permanent severe diseases, especially those affecting the immune system

2. Pregnancy or breast feeding

3. History or presence of epilepsy, significant neurological disorders, depression, suicidal ideation and behaviour, cerebrovascular attacks or ischemia

4. History or presence of myocardial infarction or cardiac arrhythmia which requires drug therapy

5. Evidence of severe renal dysfunction defined as:

• eGFR < 30 ml/min/1,73 m2 (calculated using the MDRD formula) at screening (Visit 1)

6. 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)

7. History of lymphoproliferative disorders

8. Patients who are considered potentially unreliable or where it is envisaged the patient may not consistently attend scheduled study visits

9. 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.

10. Inability or unwillingness to undergo repeated venipuncture (e.g., because of poor tolerability or lack of access to veins)

11. Inability or unwillingness to undergo repeated punch biopsies

12. History of allergy to any component of the study medication

13. Current use of strong cytochrome P450 enzyme inducers (eg, rifampicin, phenobarbital, carbamazepine, phenytoin and St John's wort)

14. Patients with rare hereditary problems of galactose intolerance, lapp lactase deficiency or glucose-galactose malabsorption

15. Evidence of acute contact dermatitis at screening

16. Evidence of underweight, defined as BMI < 18,5 kg/m2

17. Evidence of Zink deficiency defined as Zink level < 20 µg/dL in serum

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Celgene Corporation

INDUSTRY

Sponsor Role: collaborator

Technical University of Munich

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kilian Eyerich

Role: PRINCIPAL_INVESTIGATOR

Technical University Munich

Locations

Technical University Munich - Department of Dermatology

Munich, Bavaria, Germany

Countries

Germany

Other Identifiers

AP-CL-ECZ-PI-006539

Identifier Type: -

Identifier Source: org_study_id