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NCT Number: NCT03160248

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

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.

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Key information

Conditions

Nummular Eczema Dermatitis Dermatitis Eczema Eczema Nummular Dermatitis Skin Diseases Skin Diseases, Eczematous Skin and Connective Tissue Diseases

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Technical University Munich - Department of Dermatology

Munich, Bavaria, 80805, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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
  • History of allergy to any component of the study medication
  • Current use of strong cytochrome P450 enzyme inducers (eg, rifampicin, phenobarbital, carbamazepine, phenytoin and St John's wort)
  • Patients with rare hereditary problems of galactose intolerance, lapp lactase deficiency or glucose-galactose malabsorption
  • Evidence of acute contact dermatitis at screening
  • Evidence of underweight, defined as BMI < 18,5 kg/m2
  • Evidence of Zink deficiency defined as Zink level < 20 µg/dL in serum

Treatment and study plan

Apremilast

Drug

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

Placebo oral tablet

Drug

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

Primary outcomes

  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 outcomes

  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 outcomes

  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).

Sponsors and collaborators

Lead sponsor

Technical University of Munich

Other

Collaborators

  • Celgene Corporation

Registry information

Official study title

An Investigator-initiated, Randomized, Double-blind, Placebo Controlled Study of Apremilast to Demonstrate Efficacy in Subjects With Nummular Eczema

Acronym: APREMINUM

Important dates

Study start
2017
Primary completion
2021
Study completion
2021
First posted
May 19, 2017
Registry last updated
Oct 8, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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