Phase 3, Randomized Study of Apremilast in Japanese Participants With Palmoplantar Pustulosis (PPP)

• Status: Not yet recruiting
• Trial end date: 2024-06-03
• Target enrollment: 0
• Participant gender: All

Summary

The primary objective of the study is to evaluate the efficacy of apremilast (AMG 407) twice daily (BID) compared with placebo in participants with Palmoplantar Pustulosis (PPP).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Amgen
• Treatments: Apremilast

Criteria

Key Inclusion Criteria

• Japanese participants ≥ 20 years of age upon entry into initial screening

• Palmoplantar pustulosis diagnosis with or without pustulotic arthro-osteitis (PAO) for no less than 24 weeks

• PPPASI total score of ≥12 at screening and at baseline

• Moderate or severe pustules/vesicles on palms or soles (PPPASI severity score ≥2) at screening and at baseline

• Inadequate response (defined as repeated relapsing-remitting in the same location for a 24-week period) to topical treatments prior to or at screening Key Exclusion Criteria

• Changes in disease severity during screening (PPPASI total score change ≥ 5 improvement, from screening to baseline)

• Periodontitis requiring treatment

• Chronic or recurrent tonsillitis or sinusitis requiring any continuous treatment

• Has a diagnosis of plaque-type psoriasis at baseline

• Has the presence of pustular psoriasis on any part of the body other than the palms and soles

• Has evidence of skin conditions of hand and feet at baseline that would interfere with evaluations of the effect of Investigational Product

• Has unstable cardiovascular disease, defined as a recent clinical deterioration or a cardiac hospitalization within 12 weeks prior to screening

• Malignancy or history of malignancy

• Participant has received any procedures for focal infection within 24 weeks of baseline

• Female participants who are breastfeeding or who plan to breastfeed while on study

• Female participants of childbearing potential with a positive pregnancy test

• Had prior treatment with apremilast

• Has a prior medical history of suicide attempt at any time in the participant's lifetime prior to signing of informed consent or randomization, or major psychiatric illness requiring hospitalization within the last 3 years prior to signing of informed consent