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Sponsor ID
CC-10004-PPP-001

A study to evaluate the efficacy and safety of apremilast (CC-10004) in Japanese subjects with Palmoplantar pustulosis

Sponsor ID
CC-10004-PPP-001
Clinicaltrials.gov ID
NCT04057937
EUCTIS ID
N/A
EudraCT ID
N/A
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Study Details

This study will evaluate whether apremilast is better than placebo (inactive substance in the same form as the drug) for the treatment in Japanese subjects with PPP. This study also will evaluate the safety and tolerability of apremilast in Japanese subjects with PPP.CC-10004-PPP-001 is a multicenter, randomized, double-blind, placebo-controlled, parallel group, Phase 2 study of apremilast in Japanese subjects with PPP and inadequate response to treatment with topical steroid and/or topical vitamin D3 derivative preparations.

The placebo-controlled period will be 16 weeks and patients will receive apremilast or placebo. After the 16-week placebo-controlled period, all subjects will receive apremilast for 16 weeks. All subjects will have their final study visit 4 weeks after stopping apremilast treatment.

Additional Study Details

Phase
Phase 2
Product
N/A
Type
Interventional
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment
90
Additional Study Details

Protocol Summary

Primary Outcome Measures

Percentage of Participants who Achieve a Palmo-plantar Pustulosis Area and Severity Index (PPPASI-50) at Week 16

Timeframe: At Week 16

Secondary Outcome Measures

Percentage of Participants who Achieve a PPPASI-50 at All Other Visits in Placebo-controlled Phase

Timeframe: Weeks 2 to 14

Percentage of Participants who Achieve a PPPASI-75 at Each Visit in Placebo-controlled Phase

Timeframe: Weeks 2 to 16

Area Under the Curve (AUC) of PPPASI Total Score from Baseline through Week 16

Timeframe: Baseline to Week 16

Percent Change from Baseline in PPPASI Total Score by Visit in Placebo-controlled Phase .

Timeframe: Baseline to Week 16

AUC for Palmo-plantar Severity Index (PPSI) Total Score from Baseline through Week 16

Timeframe: Baseline to Week 16

Percent Change from Baseline in PPSI Total Score by Visit in Placebo-controlled Phase

Timeframe: Baseline to Week 16

Percentage of Participants Achieving a Physician’s Global Assessment (PGA) score of Clear (0) or Minimal (1) by Visit in Placebo-controlled Phase

Timeframe: Weeks 2 to 16

Percent Change from Baseline in Participant Visual AnalogueScale (VAS) Assessment for PPP Symptoms

Timeframe: Baseline and Weeks 2,4,6,8,12,16

Study Documents

Plain Language Summary of Results
Available Language(s): English, Japanese
Download Document(s)

Locations

Location
Status
Contact Us
Location
Research Site
Fukuoka-shi, Fukuoka, Japan, 814-0180
Status
Recruiting
Location
Research Site
Itabashi-ku, Tokyo, Japan, 173-8606
Status
Recruiting
Location
Research Site
Itabashi-ku, Japan, 173-8610
Status
Recruiting
Location
Research Site
Izumo, Shimane, Japan, 693-8501
Status
Recruiting
Location
Research Site
Kofu, Japan, 400-0027
Status
Recruiting
Location
Research Site
Nagoya, Aichi, Japan, 467-8602
Status
Recruiting
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Study Info
Age
20+ years
Condition
  • Pustulosis
    • Sex
    All
    Trial Dates
    Oct 2019 - Jan 2021
    Inclusion and Exclusion Criteria
    Inclusion Criteria:
    Subjects must satisfy the following criteria to be enrolled in the study: 1. Subject has a diagnosis of Palmoplantar Pustulosis with or without pustulotic arthro-osteitis (PAO) for at least 24 weeks before screening. 2. Subject has a total score of PPPASI: ≥ 12 at screening and baseline. 3. Subject has moderate or severe pustules/vesicles on palms or soles (PPPASI severity score: ≥ 2) at screening and baseline. 4. Subject has inadequate response to treatment with topical steroid and/or topical vitamin D3 derivative preparations prior to or at screening.
    Exclusion Criteria:
    The presence of any of the following will exclude a subject from enrollment: 1. Subject has a diagnosis of plaque-type psoriasis. 2. Subject has the presence of pustular psoriasis in any part of the body other than the palms and soles. 3. Subject has obvious improvement during screening (≥ 5 PPPASI total score improvement during the screening). 4. Subject has received any procedures for focal infection (e.g, tonsillectomy and dental therapy) within 24 weeks of baseline. 5. Subject has periodontitis obviously requiring treatment at screening. 6. Subject has chronic or recurrent tonsillitis or sinusitis requiring any continuous treatment for a month or more at screening. 7. Subject has evidence of skin conditions of hands and feet that would interfere with evaluations of the effect of study medication. 8. Subject is pregnant or breastfeeding.