A Study to Evaluate the Efficacy and Safety of Apremilast (CC-10004) in Japanese Subjects With Palmoplantar Pustulosis

Study Purpose

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.

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	20 Years and Over
Gender	All

More Inclusion & 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.

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.	NCT04057937
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 2
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.	Palmoplantaris Pustulosis
Study Website:	View Trial Website

Arms & Interventions

Arms

Experimental: 30 mg Apremilast twice daily (BID) from week 0 to 32

Subject will received Apremilast 30 mg BID from Week 0 to Week 32 weeks. Dose titration will be implemented in the first week of this study.

Placebo Comparator: Placebo and Apremilast

Subject will receive Placebo BID from Week 0 to Week 16 and will receive 30 mg Apremilast BID from week 16 to 32. Dose titration will be implemented in the first week of subject switch to receive Apremilast.

Interventions

Drug: - Apremilast

Apremilast

Drug: - Placebo

Placebo

Contact a Trial Team

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International Sites

Research Site, Ichinomiya, Aichi, Japan

Status

Recruiting

Address

Research Site

Ichinomiya, Aichi, 491-8558

Site Contact

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