Erythema MultiformePhase 2AEMNCT05875714
Apremilast for Erythema Multiforme
A Phase 2 study testing Apremilast in people with Erythema Multiforme, run by Robert Micheletti at 1 site in United States.
Trial summary
This study is recruiting patients with chronic, treatment resistant erythema multiforme (EM), which is a disease that can affect the skin and mucous membranes (mucocutaneous). EM often impacts quality of life with pain, anorexia, hospitalization, and related long-term issues. Read more about this study
- Who is it for?
- Ages 18 to 89 years
- Conditions the study is for
- Erythema Multiforme
- What is being tested?
- Apremilast
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Jan 2022to 31 Dec 2024
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 89 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects must satisfy the following criteria to be enrolled in the study:
- Presence of oral, genital, or cutaneous erythema multiforme (EM) diagnosed or confirmed by a dermatologist based on clinical and/or histopathologic data.
- EM must be recurrent, defined as having =>2 flares in the six months prior to enrollment (or =>4 flares in the year prior to enrollment).
- EM must be refractory to standard therapy defined as 3-month treatment course with valacyclovir and/or a systemic immunomodulatory therapy such as colchicine, dapsone, azathioprine, mycophenolate mofetil, or methotrexate.
- Must be in general good health (except for disease under study) as judged by the Investigator, based on medical history, physical examination, and clinical laboratories. (NOTE: The definition of good health means a subject does not have uncontrolled significant co-morbid conditions).
- Willing and able to provide personally signed and dated informed consent form.
Show all 11Show fewer
- Stated willingness and ability to comply with all study procedures including adhering to oral apremilast regimen and availability for the duration of the study.
- Adults aged 18-89 years old.
- People of childbearing potential (PCBP) must have a negative pregnancy test at Screening and Baseline. While on investigational product and for at least 28 days after taking the last dose of investigational product, PCBP who engage in activity by which conception is possible must use one of the approved contraceptive options described below:
- Option 1: Any one of the following highly effective methods: hormonal contraception (oral, injection, implant, transdermal patch, vaginal ring); intrauterine device (IUD); tubal ligation; or partner's vasectomy; OR Option 2: External or internal condom (latex condom or nonlatex condom NOT made out of natural [animal] membrane [for example, polyurethane]; PLUS one additional barrier method: (a) diaphragm with spermicide; (b) cervical cap with spermicide; or (c) contraceptive sponge with spermicide.
- NOTE: This criterion is satisfied as "not applicable" (N/A) for those who practice abstinence as part of their usual and customary way of life, so long as this is maintained throughout study period plus 28 days post-treatment; are postmenopausal; or are of male sex/assigned male at birth (AMAB).
Who cannot join
- The presence of any of the following will exclude a subject from enrollment:
- Other than disease under study, any clinically significant (as determined by the Investigator) cardiac, endocrinological, pulmonary, neurologic, psychiatric, hepatic, renal, hematologic, immunologic disease, or other major disease that is currently uncontrolled.
- Any condition, including the presence of laboratory abnormalities, which would place the subject at unacceptable risk if they were to participate in the study.
- Prior history of unmanaged depressive symptoms, suicide attempt at any time in the subject's life time prior to screening or randomization, or major psychiatric illness requiring hospitalization within the last 3 years.
- A score of 4 or higher on Patient Health Questionnaire at screening.
- Pregnant or breast feeding.
Show all 16Show fewer
- Active substance abuse or a history of substance abuse within 6 months prior to Screening.
- Malignancy or history of malignancy, except for:
- treated [ie, cured] basal cell or squamous cell in situ skin carcinomas;
- treated [ie, cured] cervical intraepithelial neoplasia (CIN) or carcinoma in situ of cervix with no evidence of recurrence within the previous 5 years.
- Use of any investigational drug within 4 weeks prior to randomization, or 5 pharmacokinetic/pharmacodynamic half-lives, if known (whichever is longer).
- Prior treatment with apremilast.
- Patient unable to comply with study or conform to treatment diary or regular follow up visits.
- Patients with ocular EM.
- Concomitant use of immunosuppressive medications for treatment of other diseases.
- Patients with contraindications to Apremilast according to package insert.
Trial locations and contacts
1 site in 1 country.
United States1 site
Perelman Center For Advanced Medicine
Philadelphia, Pennsylvania, 19104
About this study
Official title: Apremilast for the Treatment of Refractory Erythema Multiforme
This study is recruiting patients with chronic, treatment resistant erythema multiforme (EM), which is a disease that can affect the skin and mucous membranes (mucocutaneous). EM often impacts quality of life with pain, anorexia, hospitalization, and related long-term issues. While there are medications used to treat EM, no single therapeutic agent has been consistently effective for long-term management of disease. Apremilast (trade name: Otezla) is approved to treat Bechet's Disease, a different but similar mucocutaneous disease. In this study, eligible patients will receive apremilast for 6 months of treatment so we can evaluate if there is a difference in pain and the number of EM flares compared to prior to treatment with apremilast.
- Conditions
- Erythema Multiforme
- Being tested
- Apremilast
- Medical subject headings
- Erythema Multiforme
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ApremilastDrug
Also called Otezla
Apremilast (Otezla), oral medication Day 1: 10 mg in the morning. Day 2: 10 mg in the morning and 10 mg in the evening. Day 3: 10 mg in the morning and 20 mg in the evening. Day 4: 20 mg in the morning and 20 mg in the evening. Day 5: 20 mg in the morning and 30 mg in the evening Day 6: 30 mg twice daily Maintenance dosing: 30 mg twice daily
| Study group | Role | What they receive |
|---|---|---|
| Open label intervention | Experimental | Not described Receives: Drug: Apremilast |
What is being measured
The primary outcome is the main question the study is designed to answer.
Erythema Multiforme Flares on Medication
Number of flares occurring in 24 weeks on apremilast compared to the preceding 24 weeks
Measured: 24 weeks
Secondary outcomes (7)
Pain on Medication
Average pain severity of erythema multiforme at 24-week evaluation (units on a 0 to 10 scale; 10 = maximum pain)
Measured: 24 weeks
Number of Flares Weeks 24-36
Number of erythema multiforme flares occurring in the 12 weeks after completing the 24-week course of apremilast
Measured: 36 weeks
Average Pain Associated With Flares in Weeks 24-36
Average pain severity (units on a 0-10 scale; 10 = maximum pain) associated with erythema multiforme flares occurring in the 12 weeks after completing the 24-week course of apremilast
Measured: 36 weeks
Autoimmune Bullous Disease Quality of Life Score
17-item patient-reported tool developed to measure the significant impact of rare blistering skin conditions (Autoimmune Bullous Diseases or AIBDs) on a person's daily life, focusing on symptoms, physical function, social impact, and psychological well-being
Measured: 24-weeks
Investigator Global Assessment
Investigator global assessment of disease severity (units on a 0-10 scale; 10 is max severity)
Measured: 24 weeks
Autoimmune Bullous Disease Quality of Life Score
Measured: Week 36
Investigator Global Assessment--week 36
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 posted25 May 2023
- Study start13 Jan 2022
- Primary completion31 Dec 2024
- Study completion31 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Erythema MultiformeStudies of the same condition, open and under way.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Robert Micheletti
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Robert Micheletti, University of Pennsylvania
- Investigators
- Robert G Micheletti, MD, Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05875714
- Sponsor's protocol ID
- 842831
- Acronym
- AEM
- Status last verified
- May 2026
- First submitted
- 16 May 2023
- Last updated
- 3 Jun 2026
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Apremilast for the Treatment of Refractory Erythema Multiforme
- ClinicalTrials.gov ID
- NCT05875714
- Acronym / sponsor ID
- AEM / 842831
- Conditions
- Erythema Multiforme
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Robert MichelettiUniversity, hospital or other
- Study start
- 13 Jan 2022 (actual)
- Primary completion
- 31 Dec 2024 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 25 May 2023 (actual)
- Results
- Posted 3 Jun 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is recruiting patients with chronic, treatment resistant erythema multiforme (EM), which is a disease that can affect the skin and mucous membranes (mucocutaneous). EM often impacts quality of life with pain, anorexia, hospitalization, and related long-term issues. While there are medications used to treat EM, no single therapeutic agent has been consistently effective for long-term management of disease. Apremilast (trade name: Otezla) is approved to treat Bechet's Disease, a different but similar mucocutaneous disease. In this study, eligible patients will receive apremilast for 6 months of treatment so we can evaluate if there is a difference in pain and the number of EM flares compared to prior to treatment with apremilast.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Open label intervention | Experimental | Drug: Apremilast |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Presence of oral, genital, or cutaneous erythema multiforme (EM) diagnosed or confirmed by a dermatologist based on clinical and/or histopathologic data.
- EM must be recurrent, defined as having =>2 flares in the six months prior to enrollment (or =>4 flares in the year prior to enrollment).
- EM must be refractory to standard therapy defined as 3-month treatment course with valacyclovir and/or a systemic immunomodulatory therapy such as colchicine, dapsone, azathioprine, mycophenolate mofetil, or methotrexate.
- Must be in general good health (except for disease under study) as judged by the Investigator, based on medical history, physical examination, and clinical laboratories. (NOTE: The definition of good health means a subject does not have uncontrolled significant co-morbid conditions).
- Willing and able to provide personally signed and dated informed consent form.
Key exclusion criteria (16 listed)
- Other than disease under study, any clinically significant (as determined by the Investigator) cardiac, endocrinological, pulmonary, neurologic, psychiatric, hepatic, renal, hematologic, immunologic disease, or other major disease that is currently uncontrolled.
- Any condition, including the presence of laboratory abnormalities, which would place the subject at unacceptable risk if they were to participate in the study.
- Prior history of unmanaged depressive symptoms, suicide attempt at any time in the subject's life time prior to screening or randomization, or major psychiatric illness requiring hospitalization within the last 3 years.
- A score of 4 or higher on Patient Health Questionnaire at screening.
- Pregnant or breast feeding.
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 |
|---|---|---|
| ApremilastAlso: OtezlaApremilast (Otezla), oral medication Day 1: 10 mg in the morning. Day 2: 10 mg in the morning and 10 mg in the evening. Day 3: 10 mg in the morning and 20 mg in the evening. Day 4: 20 mg in the morning and 20 mg in the evening. Day 5: 20 mg in the morning and 30 mg in the evening Day 6: 30 mg twice daily Maintenance dosing: 30 mg twice daily | Drug | Open label intervention |
Primary outcome
Erythema Multiforme Flares on Medication
Time frame: 24 weeks
Number of flares occurring in 24 weeks on apremilast compared to the preceding 24 weeks
7 secondary outcomes
Pain on Medication
Time frame: 24 weeks
Number of Flares Weeks 24-36
Time frame: 36 weeks
Average Pain Associated With Flares in Weeks 24-36
Time frame: 36 weeks
Autoimmune Bullous Disease Quality of Life Score
Time frame: 24-weeks
Investigator Global Assessment
Time frame: 24 weeks
Autoimmune Bullous Disease Quality of Life Score
Time frame: Week 36
Investigator Global Assessment--week 36
Time frame: Week 36
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Erythema Multiforme
Active, not recruitingPhase 2
Autologous Serum Obtained by a Closed-Circuit Collection Device
GVHD, Meibomian Gland Dysfunction (Disorder)
RecruitingObservational study
Comparison of Segmental Body Composition Characteristics in Lipedema and Obesity
Lipedema, Obesity
RecruitingObservational study
ANDREAS Registry (Assessment of Novel Drug-coated Balloon Revascularization: Effectiveness, Angiographic Outcomes, and Safety)
Coronary Artery Disease
Not yet recruitingPhase 1
Subconjunctival Humira for Boston Keratoprosthesis
Penetrating Keratoplasty, Multiple Graft Failure
Active, not recruitingObservational study
Study on Risk Factors and Prognostic Value of Non-target Lesion Progression in Patients With Coronary Artery Disease
Coronary Artery Disease (CAD)
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.
Robert G Micheletti, MD principal investigator
University of Pennsylvania
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 Erythema Multiforme, run by Robert Micheletti at 1 site in United States.
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 11 inclusion and 16 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 3 Jun 2026. 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 United States. 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?
Yes. Results are posted in the registry (first posted 3 Jun 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Erythema Multiforme Flares on Medication (time frame: 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Jun 2026.