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

Key Inclusion Criteria

Japanese participants ≥ 18 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