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

Launched by AMGEN · Dec 14, 2021

Keywords

ClinConnect Summary

No description provided

Gender

ALL

Eligibility criteria

• • 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