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

Palmoplantar Pustulosis Clinical Trial

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)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05174065
• Other study ID #: 20200195
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: March 8, 2022
• Est. completion date: June 6, 2024

Study information

• Verified date: April 2024
• Source: Amgen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 176
• Est. completion date: June 6, 2024
• Est. primary completion date: August 19, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

• 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

Related Conditions & MeSH terms

• Palmoplantar Pustulosis
• Psoriasis

Intervention

Drug:
• Apremilast
Oral tablets
• Placebo
Oral tablets

Locations

Country	Name	City	State
Japan	Asahikawa Medical University Hospital	Asahikawa-shi	Hokkaido
Japan	Motomachi Dermatology Clinic	Asahikawa-shi	Hokkaido
Japan	Medical corporation kojinkai Chitose dermatology and plastic surgery clinic	Chitose-shi	Hokkaido
Japan	Tokyo Teishin Hospital	Chiyoda-ku	Tokyo
Japan	Fukuoka University Hospital	Fukuoka-shi	Fukuoka
Japan	Kusuhara Dermatology Clinic	Fukuoka-shi	Fukuoka
Japan	Fukushima Medical University Hospital	Fukushima-shi	Fukushima
Japan	Nihon University Itabashi Hospital	Itabashi-ku	Tokyo
Japan	Teikyo University Hospital	Itabashi-ku	Tokyo
Japan	Kagoshima University Hospital	Kagoshima-shi	Kagoshima
Japan	Ishikawa Prefectural Central Hospital	Kanazawa-shi	Ishikawa
Japan	Higuchi Dermatology Urology Clinic	Kasuga-shi	Fukuoka
Japan	Kobe University Hospital	Kobe-shi	Hyogo
Japan	Yamanashi Prefectural Central Hospital	Kofu-shi	Yamanashi
Japan	Dokkyo Medical University Saitama Medical Center	Koshigaya-shi	Saitama
Japan	Kurume University Hospital	Kurume-shi	Fukuoka
Japan	Central Japan International Medical Center	Minokamo-shi	Gifu
Japan	Mito Kyodo General Hospital	Mito-shi	Ibaraki
Japan	Aichi Medical University Hospital	Nagakute-shi	Aichi
Japan	Nagaoka Red Cross Hospital	Nagaoka-shi	Niigata
Japan	Nagoya City University Hospital	Nagoya-shi	Aichi
Japan	Kochi Medical School Hospital	Nankoku-shi	Kochi
Japan	Nagata Dermatology Clinic	Ogori-shi	Fukuoka
Japan	Medical Corporation Goto Dermatology Clinic	Osaka-shi	Osaka
Japan	Nippon Life Hospital	Osaka-shi	Osaka
Japan	Pansy Skin Clinic	Saitama-shi	Saitama
Japan	Dermatology and Ophthalmology Kume Clinic	Sakai-shi	Osaka
Japan	Toho University Sakura Medical Center	Sakura-shi	Chiba
Japan	Medical Corporation Kojinkai Kitago Dermatology Clinic	Sapporo-shi	Hokkaido
Japan	Medical Corporation Kojinkai Sapporo Skin Clinic	Sapporo-shi	Hokkaido
Japan	Shibaki Dermatology Clinic	Sapporo-shi	Hokkaido
Japan	Shinoro Dermatology Clinic	Sapporo-shi	Hokkaido
Japan	Jichi Medical University Hospital	Shimotsuke-shi	Tochigi
Japan	Seibo International Catholic Hospital	Shinjuku-ku	Tokyo
Japan	Tokyo Medical University Hospital	Shinjuku-ku	Tokyo
Japan	Takamatsu Red Cross Hospital	Takamatsu-shi	Kagawa
Japan	Yoshikawa Skin Clinic	Takatsuki-shi	Osaka
Japan	Ehime University Hospital	Toon-shi	Ehime
Japan	Nomura Dermatology Clinic	Yokohama-shi	Kanagawa
Japan	Oita University Hospital	Yufu-shi	Oita

Sponsors (1)

Lead Sponsor	Collaborator
Amgen

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	16 weeks
Secondary	Change from baseline in PPPASI total score at week 16		16 weeks
Secondary	Change from baseline in Palmoplantar Pustulosis Severity Index (PPSI) total score at week 16	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.	16 weeks
Secondary	Change from baseline in Visual Analogue Scale (VAS) assessment for Palmoplantar Pustulosis (PPP) symptoms (pruritis and pain/discomfort) at week 16	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	16 weeks
Secondary	Change from Baseline in Dermatology Life Quality Index (DLQI) total score at week 16	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	16 weeks
Secondary	Number of participants with treatment-emergent adverse events		56 weeks

External Links

•   AmgenTrials clinical trials website