Clinical trial NCT04057937: A Study to Evaluate the Efficacy and Safety of Apremilast (CC-10004) in Japanese Subjects With Palmoplantar Pustulosis
Official title: A Phase 2, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Apremilast (CC-10004) in the Treatment of Palmoplantar Pustulosis in Japan
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Palmoplantaris Pustulosis
Keywords: Palmoplantar Pustulosis
CC-10004
Apremilast
Only Japanese
Efficacy
Safety
Phase 2
Lead sponsor: Amgen
Sponsor class: INDUSTRY
First posted: 2019-08-15
Enrollment: 90
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility 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.

Primary outcomes:
measure: Percentage of Participants Who Achieve a PPPASI-50 at Week 16
timeFrame: At Week 16
Secondary outcomes:
measure: Percentage of Participants Who Achieve a PPPASI-50 at All Other Visits in Placebo-controlled Phase
timeFrame: Weeks 2 to 14
measure: Percentage of Participants Who Achieve a PPPASI-75 at Each Visit in Placebo-controlled Phase
timeFrame: Weeks 2 to 16
measure: Area Under the Curve (AUC) of PPPASI Total Score From Baseline Through Week 16
timeFrame: Baseline to Week 16
measure: Percent Change From Baseline in PPPASI Total Score by Visit in Placebo-controlled Phase .
timeFrame: Baseline to Week 16
measure: Change From Baseline in PPPASI Total Score at Week 16
timeFrame: Baseline and Week 16
measure: AUC for PPSI Total Score From Baseline Through Week 16
timeFrame: Baseline to Week 16
measure: Percent Change From Baseline in PPSI Total Score by Visit in Placebo-controlled Phase
timeFrame: Baseline to Week 16
measure: Change From Baseline in PPSI Total Score at Week 16
timeFrame: Baseline and Week 16
measure: Percentage of Participants Achieving a PGA Score of Clear (0) or Minimal (1) by Visit in Placebo-controlled Phase
timeFrame: Weeks 2 to 16
measure: Percentage of Participants Achieving a PGA Score of 0 or 1 With At Least a 2 Grade Improvement by Visit in Placebo-controlled Phase.
timeFrame: Weeks 2 to 16
measure: Change From Baseline in Participant VAS Assessment for PPP Symptoms
timeFrame: Baseline and Weeks 2,4,6,8,12,16
Other outcomes:
Locations:
city: Ichinomiya
country: Japan
facility: Research Site
state: Aichi
city: Nagoya
country: Japan
facility: Research Site
state: Aichi
city: Fukuoka-shi
country: Japan
facility: Research Site
state: Fukuoka
city: Sapporo-shi
country: Japan
facility: Research Site
state: Hokkaido
city: Hitachi
country: Japan
facility: Research Site
state: Ibaraki
city: Sagamihara-shi
country: Japan
facility: Research Site
state: Kanagawa
city: Yokohoma-shi
country: Japan
facility: Research Site
state: Kanagawa
city: Yokosuka
country: Japan
facility: Research Site
state: Kanagawa
city: Izumo
country: Japan
facility: Research Site
state: Shimane
city: Chiyoda-ku
country: Japan
facility: Research Site
state: Tokyo
city: Itabashi-ku
country: Japan
facility: Research Site
state: Tokyo
city: Itabashi-ku
country: Japan
facility: Research Site
city: Kisarazu
country: Japan
facility: Research Site
city: Kofu
country: Japan
facility: Research Site
city: Minokamo
country: Japan
facility: Research Site
city: Nankoku-shi
country: Japan
facility: Research Site
city: Osaka
country: Japan
facility: Research Site
city: Sendai
country: Japan
facility: Research Site
city: Shinjuku-ku
country: Japan
facility: Research Site
city: Shinjyuku-ku
country: Japan
facility: Research Site
city: Toon
country: Japan
facility: Research Site
city: Tsu
country: Japan
facility: Research Site
Study officials:
affiliation: Amgen
name: MD
role: STUDY_DIRECTOR
References:
citation: Terui T, Okubo Y, Kobayashi S, Sano S, Morita A, Imafuku S, Tada Y, Abe M, Yaguchi M, Uehara N, Handa T, Tanaka M, Zhang W, Paris M, Murakami M. Efficacy and Safety of Apremilast for the Treatment of Japanese Patients with Palmoplantar Pustulosis: Results from a Phase 2, Randomized, Placebo-Controlled Study. Am J Clin Dermatol. 2023 Sep;24(5):837-847. doi: 10.1007/s40257-023-00788-2. Epub 2023 May 26.
citation: Okubo Y, Terui T, Kobayashi S, Sano S, Morita A, Imafuku S, Tada Y, Abe M, Yaguchi M, Kimura T, Shimauchi J, Zhang W, Amouzadeh H, Murakami M. Exploratory Efficacy Evaluation of Apremilast for the Treatment of Japanese Patients with Palmoplantar Pustulosis: 32-Week Results from a Phase 2, Randomized, Placebo-Controlled Study. Dermatol Ther (Heidelb). 2024 Jul;14(7):1863-1873. doi: 10.1007/s13555-024-01195-z. Epub 2024 Jun 19.