Trial Outcomes & Findings for Apremilast for Erythema Multiforme (NCT NCT05875714)

NCT ID: NCT05875714

Last Updated: 2026-06-03

Results Overview

Number of flares occurring in 24 weeks on apremilast compared to the preceding 24 weeks

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

6 participants

Primary outcome timeframe

24 weeks

Results posted on

2026-06-03

Participant Flow

Six patients with recurrent and treatment-refractory erythema multiforme were enrolled in this study from the Department of Dermatology at the University of Pennsylvania.

Participant milestones

Participant milestones
Measure	Open Label Intervention Patients received apremilast 30mg twice daily (following dose titration) for a 24-week course. Patients were evaluated again at week-36, 12 weeks following completion of the treatment course.
Overall Study STARTED	6
Overall Study COMPLETED	3
Overall Study NOT COMPLETED	3

Reasons for withdrawal

Reasons for withdrawal
Measure	Open Label Intervention Patients received apremilast 30mg twice daily (following dose titration) for a 24-week course. Patients were evaluated again at week-36, 12 weeks following completion of the treatment course.
Overall Study Adverse Event	1
Overall Study Withdrawal by Subject	1
Overall Study Lost to Follow-up	1

Baseline Characteristics

Apremilast for Erythema Multiforme

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Open Label Intervention n=6 Participants Patients received apremilast 30mg twice daily (following dose titration) for a 24-week course. Patients were evaluated again at week-36, 12 weeks following completion of the treatment course.
Age, Continuous	28.7 years n=20 Participants
Sex: Female, Male Female	3 Participants n=20 Participants
Sex: Female, Male Male	3 Participants n=20 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=20 Participants
Race (NIH/OMB) Asian	0 Participants n=20 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=20 Participants
Race (NIH/OMB) Black or African American	3 Participants n=20 Participants
Race (NIH/OMB) White	3 Participants n=20 Participants
Race (NIH/OMB) More than one race	0 Participants n=20 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=20 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=20 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	6 Participants n=20 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=20 Participants
Number of Erythema Multiforme Flares in Preceding 6 months	6.3 number of flares n=20 Participants
Average Duration of Erythema Multiforme Flares in Preceding 6 Months	8 days n=20 Participants
Pain (units on a 0-10 scale; maximum = 10) with Flares of Erythema Multiforme in Preceding 6 Months	7.5 units on a 0-10 scale; max pain = 10 n=20 Participants
Autoimmune Bullous Disease Quality of Life Scale	24.5 Units on a 0-51 scale; higher is worse n=20 Participants
Investigator Global Assessment of Disease Severity	6.5 units on a 0-10 scale; max severity = 10 n=20 Participants

PRIMARY outcome

Timeframe: 24 weeks

Population: Three patients completed the study

Number of flares occurring in 24 weeks on apremilast compared to the preceding 24 weeks

Outcome measures

Outcome measures
Measure	Open Label Intervention n=3 Participants Patients received apremilast 30mg twice daily (following dose titration) for a 24-week course. Patients were evaluated again at week-36, 12 weeks following completion of the treatment course.
Erythema Multiforme Flares on Medication	1.7 Number of flares Interval 0.0 to 4.0

SECONDARY outcome

Timeframe: 24 weeks

Average pain severity of erythema multiforme at 24-week evaluation (units on a 0 to 10 scale; 10 = maximum pain)

Outcome measures

Outcome measures
Measure	Open Label Intervention n=3 Participants Patients received apremilast 30mg twice daily (following dose titration) for a 24-week course. Patients were evaluated again at week-36, 12 weeks following completion of the treatment course.
Pain on Medication	4 units on a 0-10 scale; max pain = 10 Interval 0.0 to 8.0

SECONDARY outcome

Timeframe: 36 weeks

Number of erythema multiforme flares occurring in the 12 weeks after completing the 24-week course of apremilast

Outcome measures

Outcome measures
Measure	Open Label Intervention n=3 Participants Patients received apremilast 30mg twice daily (following dose titration) for a 24-week course. Patients were evaluated again at week-36, 12 weeks following completion of the treatment course.
Number of Flares Weeks 24-36	0.7 Number of flares Interval 0.0 to 1.0

SECONDARY outcome

Timeframe: 36 weeks

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

Outcome measures

Outcome measures
Measure	Open Label Intervention n=3 Participants Patients received apremilast 30mg twice daily (following dose titration) for a 24-week course. Patients were evaluated again at week-36, 12 weeks following completion of the treatment course.
Average Pain Associated With Flares in Weeks 24-36	4.7 Units on a 0-10 scale; 10 = max pain Interval 0.0 to 10.0

SECONDARY outcome

Timeframe: 24-weeks

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

Outcome measures

Outcome measures
Measure	Open Label Intervention n=3 Participants Patients received apremilast 30mg twice daily (following dose titration) for a 24-week course. Patients were evaluated again at week-36, 12 weeks following completion of the treatment course.
Autoimmune Bullous Disease Quality of Life Score	4 units on a 0-51 scale; higher is worse Interval 0.0 to 12.0

SECONDARY outcome

Timeframe: 24 weeks

Investigator global assessment of disease severity (units on a 0-10 scale; 10 is max severity)

Outcome measures

Outcome measures
Measure	Open Label Intervention n=3 Participants Patients received apremilast 30mg twice daily (following dose titration) for a 24-week course. Patients were evaluated again at week-36, 12 weeks following completion of the treatment course.
Investigator Global Assessment	1 Units on a 0-10 scale; 10 = max severity Interval 0.0 to 3.0

SECONDARY outcome

Timeframe: Week 36

Outcome measures

Outcome measures
Measure	Open Label Intervention n=3 Participants Patients received apremilast 30mg twice daily (following dose titration) for a 24-week course. Patients were evaluated again at week-36, 12 weeks following completion of the treatment course.
Autoimmune Bullous Disease Quality of Life Score	0 units on a 0-51 scale; higher is worse Interval 0.0 to 0.0

SECONDARY outcome

Timeframe: Week 36

Outcome measures

Outcome measures
Measure	Open Label Intervention n=3 Participants Patients received apremilast 30mg twice daily (following dose titration) for a 24-week course. Patients were evaluated again at week-36, 12 weeks following completion of the treatment course.
Investigator Global Assessment--week 36	1.3 Units on a 0-10 scale; 10 = max severity Interval 0.0 to 3.0

Adverse Events

Open Label Intervention

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Open Label Intervention n=6 participants at risk Patients received apremilast 30mg twice daily (following dose titration) for a 24-week course. Patients were evaluated again at week-36, 12 weeks following completion of the treatment course.
Nervous system disorders headache	16.7% 1/6 • From enrollment until week 36 (12 weeks after cessation of apremilast)

Additional Information

Robert Micheletti

University of Pennsylvania

Phone: 2156622737

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place