Nummular EczemaPhase 2APREMINUMNCT03160248
An Investigator-initiated Study of Apremilast to Demonstrate Efficacy Nummular Eczema
A Phase 2 study testing Apremilast in people with Nummular Eczema and Eczema, run by Technical University of Munich at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Nummular Eczema, Eczema, Dermatitis Eczema
- What is being tested?
- Apremilast
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 31 participants
- Where
- 1 siteGermany
- Study dates
- 5 Jul 2017to 15 Sep 2021
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Show all 21Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Germany1 site
Technical University Munich - Department of Dermatology
Munich, Bavaria, 80805
About this study
Official title: An Investigator-initiated, Randomized, Double-blind, Placebo Controlled Study of Apremilast to Demonstrate Efficacy in Subjects With 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.
- Conditions
- Nummular Eczema, Eczema, Dermatitis Eczema, Nummular Dermatitis
- Being tested
- Apremilast, Placebo Oral Tablet
- Medical subject headings
- Eczema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ApremilastDrug
This study aims on investigating the efficacy of Apremilast in nummular eczema patients.
Placebo Oral TabletDrug
This study aims on investigating the efficacy of Apremilast in nummular eczema patients - placebo controlled
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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. Receives: Drug: Apremilast; Drug: Placebo Oral Tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: week 16
Secondary outcomes (9)
EASI
EASI 50 score at week 16 and 32 (Eczema Area and Severity Index)
Measured: week 16 and 32
Transepidermal Waterloss (TEWL)
Change From Baseline in Transepidermal Waterloss (TEWL) at week 16 and 32
Measured: week 16 and 32
Histology
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.
Measured: week 16
Use of topical steroids
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.
Measured: week 16 and 32
PGA score Arm 2
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
Measured: week 32
DLQI
Change From Baseline in the Dermatology Life Quality Index (DLQI) Total Score at Week 16 and 32
Measured: week 16 and 32
Pruritus Visual Analog Scale (VAS)
Change From Baseline in Pruritus Visual Analog Scale (VAS) Score at Week 16 and 32
Measured: week 16 and 32
TSQM
Change From Baseline in the Global Satisfaction Subscale of the Treatment Satisfaction Questionnaire for Medication (TSQM) Score at Week 16 and 32
Measured: week 16 and 32
Safety: Safety of Apremilast will be Assessed by Evaluating Adverse Events (AEs) - Type, frequency, severity, and relationship of the AEs to apremilast
Safety of Apremilast will be Assessed by Evaluating Adverse Events (AEs) - Type, frequency, severity, and relationship of the AEs to apremilast
Measured: week 36
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2017
- Study start5 Jul 2017
- Primary completion15 Sep 2021
- Study completion15 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Nummular EczemaStudies of the same condition, open and under way.
- More trials run by Technical University of MunichThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Technical University of Munich
- Sponsor type
- University, hospital or other
- Collaborators
- Celgene Corporation
- Responsible party
- Sponsor
- Investigators
- Kilian Eyerich, Principal investigator, Technical University Munich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03160248
- Sponsor's protocol ID
- AP-CL-ECZ-PI-006539
- Acronym
- APREMINUM
- Status last verified
- Oct 2020
- First submitted
- 17 May 2017
- Last updated
- 8 Oct 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Bohner A, Seiringer P, Kleeberger V, Rogner D, Oesterlin C, Biedermann T, Eyerich K, Lauffer F. A phase IIb single-center study to assess the efficacy of apremilast for the treatment of nummular eczema. J Dtsch Dermatol Ges. 2025 Aug;23(8):959-965. doi: 10.1111/ddg.15786. Epub 2025 Jun 23.
PubMed 40548467
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Investigator-initiated, Randomized, Double-blind, Placebo Controlled Study of Apremilast to Demonstrate Efficacy in Subjects With Nummular Eczema
- ClinicalTrials.gov ID
- NCT03160248
- Acronym / sponsor ID
- APREMINUM / AP-CL-ECZ-PI-006539
- Conditions
- Nummular Eczema, Eczema, Dermatitis Eczema, Nummular Dermatitis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Technical University of MunichUniversity, hospital or other
- Collaborators
- Celgene Corporation
- Study start
- 5 Jul 2017 (actual)
- Primary completion
- 15 Sep 2021 (actual)
- Study completion
- 15 Sep 2021 (actual)
- First posted
- 19 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Apremilast | Experimental | Drug: ApremilastPatients 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). |
| Placebo + Apremilast | Experimental | Drug: Apremilast, Drug: Placebo Oral TabletPatients 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. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (21 listed)
- 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:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ApremilastThis study aims on investigating the efficacy of Apremilast in nummular eczema patients. | Drug | Apremilast, Placebo + Apremilast |
| Placebo Oral TabletThis study aims on investigating the efficacy of Apremilast in nummular eczema patients - placebo controlled | Drug | Placebo + Apremilast |
Primary outcome
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
9 secondary outcomes
EASI
Time frame: week 16 and 32
Transepidermal Waterloss (TEWL)
Time frame: week 16 and 32
Histology
Time frame: week 16
Use of topical steroids
Time frame: week 16 and 32
PGA score Arm 2
Time frame: week 32
DLQI
Time frame: week 16 and 32
Pruritus Visual Analog Scale (VAS)
Time frame: week 16 and 32
TSQM
Time frame: week 16 and 32
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2021.
- Derived from this study: PubMed 40548467Bohner A, Seiringer P, Kleeberger V, Rogner D, Oesterlin C, Biedermann T, Eyerich K, Lauffer F. A phase IIb single-center study to assess the efficacy of apremilast for the treatment of nummular eczema. J Dtsch Dermatol Ges. 2025 Aug;23(8):959-965. doi: 10.1111/ddg.15786. Epub 2025 Jun 23.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kilian Eyerich principal investigator
Technical University Munich
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Apremilast in people with Nummular Eczema and Eczema, run by Technical University of Munich at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PGA (time frame: week 16). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03160248, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2021.