Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms
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.
|Eligible Ages||20 Years and Over|
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.
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.
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.
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.
The person who is responsible for the scientific and technical direction of the entire clinical study.
|Principal Investigator Affiliation||Amgen|
Category of organization(s) involved as sponsor (and collaborator) supporting the trial.
The disease, disorder, syndrome, illness, or injury that is being studied.
|Study Website:||View Trial Website|
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.
Drug: - Apremilast
Drug: - Placebo
Contact a Trial Team
If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.