Apremilast for Erythema Multiforme

(AEM Trial)

Overseen By Joshua S Bryer, BA

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Robert Micheletti

Must not be taking: Immunosuppressive medications

Disqualifiers: Uncontrolled major diseases, Psychiatric illness, Substance abuse, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 4 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 24 weeks

8 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial does not specify if you must stop taking your current medications, but it does exclude those using immunosuppressive medications for other diseases. It's best to discuss your current medications with the study team.

What data supports the effectiveness of the drug Apremilast for treating erythema multiforme?

Research shows that Apremilast has been successful in completely clearing oral lesions in patients with recurrent erythema multiforme, even in those who did not respond to other standard treatments. ^{1 2 3 4 5}

Is Apremilast generally safe for humans?

Apremilast (Otezla) is considered to have a favorable safety profile, with common side effects including headache, nausea, diarrhea, and upper respiratory infections. It does not require specific pre-screening or ongoing lab monitoring, making it easier to use compared to some other treatments. ^{1 2 3 5 6}

How is the drug Apremilast unique for treating erythema multiforme?

Apremilast is unique for treating erythema multiforme because it is an oral medication that has shown success in patients who did not respond to standard antiviral and immunosuppressive therapies. It works by inhibiting an enzyme called PDE-4, which helps reduce inflammation, and it has a favorable safety profile with no need for extensive monitoring. ^{1 2 3 4 5}

Research Team

Robert G Micheletti, MD

Principal Investigator

University of Pennsylvania

Eligibility Criteria

Adults aged 18-89 with chronic erythema multiforme (EM) that's resistant to standard treatments can join this trial. They must have had multiple EM flares in the past year, be generally healthy, and willing to follow study procedures for 6 months. Pregnant or breastfeeding individuals, those with serious uncontrolled conditions, a history of certain psychiatric issues or substance abuse cannot participate.

Inclusion Criteria

I am not pregnant and will use birth control during and after the study.

I have been diagnosed with erythema multiforme by a dermatologist.

Willing and able to provide personally signed and dated informed consent form

Exclusion Criteria

I haven't taken any experimental drugs recently.

I cannot take Apremilast due to health risks listed in its guidelines.

Any condition, including the presence of laboratory abnormalities, which would place the subject at unacceptable risk if they were to participate in the study

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive apremilast for 6 months to evaluate changes in pain and EM flares

24 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment, including changes in pain and flare frequency

12 weeks

Treatment Details

Interventions

• Apremilast

Trial Overview The trial is testing Apremilast (Otezla), which is already used for a similar condition called Bechet's Disease. Participants will take Apremilast for six months to see if it reduces pain and the number of EM flares compared to their experiences before starting treatment.

Apremilast is already approved in United States, European Union, Canada, Japan for the following indications:

Approved in United States as Otezla for:

• Psoriatic arthritis
• Plaque psoriasis
• Behçet’s disease

Approved in European Union as Otezla for:

• Psoriatic arthritis
• Plaque psoriasis
• Behçet’s disease

Approved in Canada as Otezla for:

• Psoriatic arthritis
• Plaque psoriasis

Approved in Japan as Otezla for:

• Psoriatic arthritis
• Plaque psoriasis

Who Is Running the Clinical Trial?

Robert Micheletti

Lead Sponsor

Trials

1

Recruited

8+

Findings from Research

Apremilast (Otezla®) is an effective oral medication for managing psoriasis, psoriatic arthritis, and recently approved for treating oral ulcerations in Behçet's disease, with a favorable side effect profile compared to other DMARDs.

This report highlights a rare case of laryngeal pseudotumor in a patient using apremilast for plaque psoriasis, suggesting the need for awareness of potential uncommon side effects even with well-tolerated medications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pseudotumor of the Larynx: A Previously Unreported Side Effect of Apremilast. Ntouniadakis, E., Landström, F.[2021]

In a small study of three patients with recurrent erythema multiforme and oral lesions, treatment with apremilast (30-60 mg daily) resulted in complete clearance of the lesions for all participants, even those who did not respond to other standard therapies.

Apremilast may be a promising treatment option for patients with recurrent erythema multiforme who have not found relief from antiviral and immunosuppressive treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Apremilast for treatment of recurrent erythema multiforme. Chen, T., Levitt, J., Geller, L.[2017]

Apremilast is an oral medication that inhibits PDE-4, showing efficacy in treating active psoriatic arthritis, and has received its first global approval in the USA for this condition.

The drug is also under review for approval in Canada and Europe for psoriatic arthritis and plaque psoriasis, indicating its potential as a widely used treatment option for these inflammatory conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Apremilast: first global approval. Poole, RM., Ballantyne, AD.[2021]

Apremilast (Otezla) is an oral medication specifically designed for adults suffering from psoriasis and psoriatic arthritis, providing a new treatment option for these conditions.

Clinical studies have demonstrated that apremilast effectively reduces the severity of psoriasis symptoms and improves joint function in patients with psoriatic arthritis, making it a valuable addition to existing therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Apremilast (Otezla): A New Oral Treatment for Adults With Psoriasis and Psoriatic Arthritis. Zerilli, T., Ocheretyaner, E.[2020]

Apremilast is an effective oral treatment for plaque psoriasis and psoriatic arthritis, showing proven and durable efficacy in managing these conditions.

It has a favorable safety profile, requiring no specific pre-screening or ongoing laboratory monitoring, making it a convenient option for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

▼ Apremilast for psoriasis and psoriatic arthritis. [2015]

Apremilast, a phosphodiesterase 4 inhibitor, has shown complete and long-lasting resolution of erythrodermic psoriasis (EP) when used as a first-line monotherapy, suggesting it could be a promising treatment option.

Unlike traditional therapies like cyclosporine and infliximab, which have significant adverse effects, apremilast has a comparatively safer side effect profile, making it a potentially better choice for patients with EP.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Complete resolution of erythrodermic psoriasis with first-line apremilast monotherapy. Krishnamoorthy, G., Kotecha, A., Pimentel, J.[2021]

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

Pseudotumor of the Larynx: A Previously Unreported Side Effect of Apremilast. [2021]

2. United States pubmed.ncbi.nlm.nih.gov

Apremilast for treatment of recurrent erythema multiforme. [2017]

3. New Zealand pubmed.ncbi.nlm.nih.gov

Apremilast: first global approval. [2021]

4. United States pubmed.ncbi.nlm.nih.gov

Apremilast (Otezla): A New Oral Treatment for Adults With Psoriasis and Psoriatic Arthritis. [2020]

5. England pubmed.ncbi.nlm.nih.gov

▼ Apremilast for psoriasis and psoriatic arthritis. [2015]

6. England pubmed.ncbi.nlm.nih.gov

Complete resolution of erythrodermic psoriasis with first-line apremilast monotherapy. [2021]