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

JRCT ID: jRCT2031210662

Registered date:11/03/2022

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: Palmoplantar Pustulosis
• Date of first enrollment: 08/03/2022
• Target sample size: 170
• Study type: Interventional

Intervention(s)

- Experimental: Apremilast
Apremilast will be administered to participants twice daily (BID)
Intervention: Drug: Apremilast

- Experimental: Placebo and Apremilast
Matching placebo will be administered to participants twice daily (BID) until week 16. After week 16, Apremilast will be administered to participants BID.
Interventions:
Drug: Apremilast
Drug: Placebo

Outcome(s)

Primary Outcome

1. Number of participants achieving at least 50% reduction from baseline in Palmoplantar Pustulosis Area and Severity Index (PPPASI) total score (PPPASI-50) at week 16 [ Time Frame: 16 weeks ]
PPPASI is a disease-specific efficacy assessment tool used by Investigators established to detect a change of disease status on palms or soles. PPPASI produces numeric scores that can range from 0 to 72. A higher score indicates more severe disease.

Secondary Outcome

1. Change from baseline in PPPASI total score at week 16 [ Time Frame: 16 weeks ]
2. Change from baseline in Palmoplantar Pustulosis Severity Index (PPSI) total score at week 16 [ Time Frame: 16 weeks ]
PPSI is a disease-specific efficacy assessment established to detect a change of disease status on a specified palm or sole.
PPSI produces numeric scores that can range from 0 to 12. A higher score indicates more severe disease.
3. Change from baseline in Visual Analogue Scale (VAS) assessment for Palmoplantar Pustulosis (PPP) symptoms (pruritis and pain/discomfort) at week 16 [ Time Frame: 16 weeks ]
Participants will use VAS (with scores ranging from 0 to 100, with 100 being most severe) to assess the degree of PPP pruritis and pain/discomfort and on the hands and feet
4. Change from Baseline in Dermatology Life Quality Index (DLQI) total score at week 16 [ Time Frame: 16 weeks ]
DLQI is a skin disease-specific Quality of Life (QoL) questionnaire comprised of 10 items assessing the participant's status over the previous week. A numeric score ranging from 0 to 30 is produced with higher scores indicating increased disease severity
5. Number of participants with treatment-emergent adverse events [ Time Frame: 56 weeks ]

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: <= 99age old
• Gender: Both

Include criteria

1. Japanese participants >= 18 years of age upon entry into initial screening
2. Palmoplantar pustulosis diagnosis with or without pustulotic arthro-osteitis (PAO) for no less than 24 weeks
3. PPPASI total score of >=12 at screening and at baseline
4. Moderate or severe pustules/vesicles on palms or soles (PPPASI severity score >=2) at screening and at baseline
5. Inadequate response (defined as repeated relapsing-remitting in the same location for a 24-week period) to topical treatments prior to or at screening

Exclude criteria

1. Changes in disease severity during screening (PPPASI total score change >= 5 improvement, from screening to baseline)
2. Periodontitis requiring treatment
3. Chronic or recurrent tonsillitis or sinusitis requiring any continuous treatment
4. Has a diagnosis of plaque-type psoriasis at baseline
5. Has the presence of pustular psoriasis on any part of the body other than the palms and soles
6. Has evidence of skin conditions of hand and feet at baseline that would interfere with evaluations of the effect of Investigational Product
7. Has unstable cardiovascular disease, defined as a recent clinical deterioration or a cardiac hospitalization within 12 weeks prior to screening
8. Malignancy or history of malignancy
9. Participant has received any procedures for focal infection within 24 weeks of baseline
10. Female participants who are breastfeeding or who plan to breastfeed while on study
11. Female participants of childbearing potential with a positive pregnancy test
12. Had prior treatment with apremilast
13. 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

Related Information

• Primary Sponsor: Kimura Takeshi
• Secondary ID(s): NCT05174065