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

Study Purpose

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 Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years - 99 Years
Gender	All

More Inclusion & Exclusion 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

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT05174065
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	Phase 3
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Amgen
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	MD
Principal Investigator Affiliation	Amgen
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Industry
Overall Status	Recruiting
Countries	Japan
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Palmoplantar Pustulosis
Study Website:	View Trial Website

Arms & Interventions

Arms

Experimental: Apremilast

Apremilast will be administered to participants twice daily (BID)

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

Oral tablets

Drug: - Placebo

Oral tablets

Contact a Trial Team

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International Sites

Aichi Medical University Hospital, Nagakute-shi, Aichi, Japan

Status

Recruiting

Address

Aichi Medical University Hospital

Nagakute-shi, Aichi, 480-1195

Site Contact

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