Clinical trial NCT05174065: Phase 3, Randomized Study of Apremilast in Japanese Participants With Palmoplantar Pustulosis (PPP)
Official title: A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Apremilast (AMG 407) in Japanese Subjects With Palmoplantar Pustulosis (PPP)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Palmoplantar Pustulosis
Keywords: Palmoplantar Pustulosis
PPP
AMG 407
Apremilast
Otezla
Lead sponsor: Amgen
Sponsor class: INDUSTRY
First posted: 2021-12-30
Enrollment: 176
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The primary objective of the study is to evaluate the efficacy of apremilast (AMG 407) twice daily (BID) compared with placebo in participants with Palmoplantar Pustulosis (PPP).


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

Primary outcomes:
measure: Percentage of Participants Who Achieved at Least a 50% Reduction From Baseline in Palmoplantar Pustulosis Area and Severity Index (PPPASI) Total Score (PPPASI-50) at Week 16
timeFrame: Baseline and Week 16
Secondary outcomes:
measure: Change From Baseline in PPPASI Total Score at Week 16
timeFrame: Baseline and Week 16
measure: Change From Baseline in Palmoplantar Pustulosis Severity Index (PPSI) Total Score at Week 16
timeFrame: Baseline and Week 16
measure: Change From Baseline in Visual Analogue Scale (VAS) Assessment for PPP Symptoms (Pruritus) at Week 16
timeFrame: Baseline and Week 16
measure: Change From Baseline in VAS Assessment for PPP Symptoms (Pain/Discomfort) at Week 16
timeFrame: Baseline and Week 16
measure: Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score at Week 16
timeFrame: Baseline and Week 16
measure: Number of Participants Who Experienced a Treatment-emergent Adverse Event (TEAE)
timeFrame: Placebo-controlled period: Day 1 to Week 16; Apremilast exposure period : Apremilast Day 1 to a maximum of Week 52 (plus 4 weeks safety follow-up)
Other outcomes:
Locations:
city: Nagakute-shi
country: Japan
facility: Aichi Medical University Hospital
state: Aichi
city: Nagoya-shi
country: Japan
facility: Nagoya City University Hospital
state: Aichi
city: Sakura-shi
country: Japan
facility: Toho University Sakura Medical Center
state: Chiba
city: Toon-shi
country: Japan
facility: Ehime University Hospital
state: Ehime
city: Fukuoka-shi
country: Japan
facility: Kusuhara Dermatology Clinic
state: Fukuoka
city: Fukuoka-shi
country: Japan
facility: Fukuoka University Hospital
state: Fukuoka
city: Kasuga-shi
country: Japan
facility: Higuchi Dermatology Urology Clinic
state: Fukuoka
city: Kurume-shi
country: Japan
facility: Kurume University Hospital
state: Fukuoka
city: Ogori-shi
country: Japan
facility: Nagata Dermatology Clinic
state: Fukuoka
city: Fukushima-shi
country: Japan
facility: Fukushima Medical University Hospital
state: Fukushima
city: Minokamo-shi
country: Japan
facility: Central Japan International Medical Center
state: Gifu
city: Asahikawa-shi
country: Japan
facility: Motomachi Dermatology Clinic
state: Hokkaido
city: Asahikawa-shi
country: Japan
facility: Asahikawa Medical University Hospital
state: Hokkaido
city: Chitose-shi
country: Japan
facility: Medical corporation kojinkai Chitose dermatology and plastic surgery clinic
state: Hokkaido
city: Sapporo-shi
country: Japan
facility: Shinoro Dermatology Clinic
state: Hokkaido
city: Sapporo-shi
country: Japan
facility: Medical Corporation Kojinkai Kitago Dermatology Clinic
state: Hokkaido
city: Sapporo-shi
country: Japan
facility: Shibaki Dermatology Clinic
state: Hokkaido
city: Sapporo-shi
country: Japan
facility: Medical Corporation Kojinkai Sapporo Skin Clinic
state: Hokkaido
city: Kobe-shi
country: Japan
facility: Kobe University Hospital
state: Hyogo
city: Mito-shi
country: Japan
facility: Mito Kyodo General Hospital
state: Ibaraki
city: Kanazawa-shi
country: Japan
facility: Ishikawa Prefectural Central Hospital
state: Ishikawa
city: Takamatsu-shi
country: Japan
facility: Takamatsu Red Cross Hospital
state: Kagawa
city: Kagoshima-shi
country: Japan
facility: Kagoshima University Hospital
state: Kagoshima
city: Yokohama-shi
country: Japan
facility: Nomura Dermatology Clinic
state: Kanagawa
city: Nankoku-shi
country: Japan
facility: Kochi Medical School Hospital
state: Kochi
city: Nagaoka-shi
country: Japan
facility: Nagaoka Red Cross Hospital
state: Niigata
city: Yufu-shi
country: Japan
facility: Oita University Hospital
state: Oita
city: Osaka-shi
country: Japan
facility: Nippon Life Hospital
state: Osaka
city: Osaka-shi
country: Japan
facility: Medical Corporation Goto Dermatology Clinic
state: Osaka
city: Sakai-shi
country: Japan
facility: Dermatology and Ophthalmology Kume Clinic
state: Osaka
city: Takatsuki-shi
country: Japan
facility: Yoshikawa Skin Clinic
state: Osaka
city: Koshigaya-shi
country: Japan
facility: Dokkyo Medical University Saitama Medical Center
state: Saitama
city: Saitama-shi
country: Japan
facility: Pansy Skin Clinic
state: Saitama
city: Shimotsuke-shi
country: Japan
facility: Jichi Medical University Hospital
state: Tochigi
city: Chiyoda-ku
country: Japan
facility: Tokyo Teishin Hospital
state: Tokyo
city: Itabashi-ku
country: Japan
facility: Teikyo University Hospital
state: Tokyo
city: Itabashi-ku
country: Japan
facility: Nihon University Itabashi Hospital
state: Tokyo
city: Shinjuku-ku
country: Japan
facility: Tokyo Medical University Hospital
state: Tokyo
city: Shinjuku-ku
country: Japan
facility: Seibo International Catholic Hospital
state: Tokyo
city: Kofu-shi
country: Japan
facility: Yamanashi Prefectural Central Hospital
state: Yamanashi
Study officials:
affiliation: Amgen
name: MD
role: STUDY_DIRECTOR
References: