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

A regiszterben nem jelölt feltételek

• 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