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

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ClinicalTrials.gov Identifier: NCT03160248
Recruitment Status : Recruiting
First Posted : May 19, 2017
Last Update Posted : April 13, 2021
Sponsor:
Collaborator:
Celgene Corporation
Information provided by (Responsible Party):
Technische Universität München

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.

Condition or disease Intervention/treatment Phase
Nummular Eczema Eczema Dermatitis Eczema Nummular Dermatitis Drug: Apremilast Drug: Placebo Oral Tablet Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: An Investigator-initiated, Randomized, Double-blind, Placebo Controlled Study of Apremilast to Demonstrate Efficacy in Subjects With Nummular Eczema
Actual Study Start Date : July 5, 2017
Estimated Primary Completion Date : July 1, 2021
Estimated Study Completion Date : October 1, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eczema
Drug Information available for: Apremilast

Arm Intervention/treatment
Experimental: 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).
Drug: Apremilast
This study aims on investigating the efficacy of Apremilast in nummular eczema patients.

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

Drug: Placebo Oral Tablet
This study aims on investigating the efficacy of Apremilast in nummular eczema patients - placebo controlled




Primary Outcome Measures :
  1. PGA [ Time Frame: week 16 ]
    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


Secondary Outcome Measures :
  1. EASI [ Time Frame: week 16 and 32 ]
    EASI 50 score at week 16 and 32 (Eczema Area and Severity Index)

  2. Transepidermal Waterloss (TEWL) [ Time Frame: week 16 and 32 ]
    Change From Baseline in Transepidermal Waterloss (TEWL) at week 16 and 32

  3. Histology [ Time Frame: week 16 ]
    Significant histological improvement at week 16 - Assessed by reduction of epidermal thickness > 30% or reduction of inflammatory infiltrate > 50 % compared to histological findings on baseline.

  4. Use of topical steroids [ Time Frame: week 16 and 32 ]

    Change From Baseline in the Reduction of the Use of Topical Steroids at week 16 and 32

    - Prior to randomization and during the treatment, average application rate of class II topical steroids per day will be calculated. Participants will receive "prednicarbate" from the study centre. On each visit the tube will be weighed to measure usage.


  5. PGA score Arm 2 [ Time Frame: week 32 ]

    Change in PGA score compared to baseline and week 16 for patients in Arm 2 at week 32

    - Comparison of the first and the second 16 weeks of the trial in terms of the change in PGA score from baseline for patients in Arm 2


  6. DLQI [ Time Frame: week 16 and 32 ]
    Change From Baseline in the Dermatology Life Quality Index (DLQI) Total Score at Week 16 and 32

  7. Pruritus Visual Analog Scale (VAS) [ Time Frame: week 16 and 32 ]
    Change From Baseline in Pruritus Visual Analog Scale (VAS) Score at Week 16 and 32

  8. TSQM [ Time Frame: week 16 and 32 ]
    Change From Baseline in the Global Satisfaction Subscale of the Treatment Satisfaction Questionnaire for Medication (TSQM) Score at Week 16 and 32

  9. Safety: Safety of Apremilast will be Assessed by Evaluating Adverse Events (AEs) - Type, frequency, severity, and relationship of the AEs to apremilast [ Time Frame: week 36 ]
    Safety of Apremilast will be Assessed by Evaluating Adverse Events (AEs) - Type, frequency, severity, and relationship of the AEs to apremilast


Other Outcome Measures:
  1. Exploratory endpoint: Change From Baseline in metabolic functions at Week 16 and 32 - weight [ Time Frame: week 16 and 32 ]
    Assessed via physical examination (weight (kg))

  2. Exploratory endpoint: Change From Baseline in metabolic functions at Week 16 and 32 - BMI [ Time Frame: week 16 and 32 ]
    Assessed via physical examination (BMI (kg/m2))

  3. Exploratory endpoint: Change From Baseline in metabolic functions at Week 16 and 32 - abdominal girth [ Time Frame: week 16 and 32 ]
    Assessed via physical examination (abdominal girth (cm)))

  4. Exploratory endpoint: Change From Baseline in metabolic functions at Week 16 and 32 - serum parameters [ Time Frame: week 16 and 32 ]
    Assessed via serum parameters (glucose, HbA1c, cholesterol, HDL, LDL, Lipoprotein (a))

  5. Exploratory endpoint: Change From Baseline in metabolic functions at Week 16 and 32 - characterization of molecular (gene expression profil) [ Time Frame: week 16 and 32 ]
    Changes in metabolic functions during treatment with Apremilast vs. Placebo in the skin (biopsies at week 0 and week 16) as determined by RNA sequencing (RNAseq).



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03160248


Contacts
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Contact: Alexander Böhner +49-89-4140-3195 alexander.boehner@tum.de
Contact: Felix Lauffer +49-89-4140-3195 felix.lauffer@tum.de

Locations
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Germany
Technical University Munich - Department of Dermatology Recruiting
Munich, Bavaria, Germany, 80805
Contact: Alexander Böhner, MD    +49-89-4140-3195    alexander.boehner@tum.de   
Principal Investigator: Kilian Eyerich, MD,Ph.D         
Sponsors and Collaborators
Technische Universität München
Celgene Corporation
Investigators
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Principal Investigator: Kilian Eyerich Technical University Munich
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Responsible Party: Technische Universität München
ClinicalTrials.gov Identifier: NCT03160248    
Other Study ID Numbers: AP-CL-ECZ-PI-006539
First Posted: May 19, 2017    Key Record Dates
Last Update Posted: April 13, 2021
Last Verified: October 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Dermatitis
Eczema
Skin Diseases
Skin Diseases, Eczematous
Apremilast
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents