Apremilast Treatment for Pruritus and Quality of Life in Scalp Psoriasis
A phase 4 multicenter, randomized, placebo-controlled Study evaluating the Effect of Apremilast on Pruritus and Quality of Life of Patients with moderate-to-severe Scalp Psoriasis
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||18 Years and Over|
Inclusion criteria:1. Adult (>18yrs); 2. Signed informed consent 3. Clinical diagnosis of chronic plaque psoriasis for at least 3 months as determined by the subject's medical history and confirmation of diagnosis through physical examination by the Investigator; 4. Psoriatic lesions with DLQI >10 and involvement of >20% of the scalp and pruritus with a VAS score of > 50 (0-100); 5. Candidate for systemic therapy; 6. Females who are of child-bearing potential should be practicing birth control throughout the study and for 70 days after the last dose of study drug; 7. Subject is judged to be in good health as determined by the Investigator based upon the results of medical history, laboratory profile and physical examination. 8. Creatinine < 80 umol/l at Inclusion
Exclusion criteria:1. Erythrodermic Ps, medication-induced or medication-exacerbated Ps or new onset guttate Ps or other skin conditions at the time of the screening visit (e.g. eczema) that would interfere with evaluations of the effect of the investigational product on Ps; 2. Use of any anti-psoriatic therapy last administered less than 4 weeks of start of study drug such as 1. Three months or 5 PK half-lives, whichever is longer, for biologics tumor necrosis factor (TNF) antagonists, interleukin (IL) 12/23/17 inhibitors or other biologic drugs 2. 4 weeks for immunosuppressive / -modulating drugs including cyclosporine A, methotrexate, azathioprine, mycophenolate mofetil, fumaric acid esters, retinoids, JAK inhibitors, corticosteroids, any other experimental drug, etc. 3. Topical medications (eg. Corticosteroids) except coal tar shampoo, and/or salicylic acid scalp preparations on scalp lesions. 4. 4 weeks for phototherapy (ie, UVB, PUVA). 3. Infection(s) requiring treatment with intravenous (IV) anti-infectives within 30 days prior to the Baseline visit or oral anti-infectives within 14 days prior to the Baseline visit; 4. Positive serology for hepatitis B, hepatitis C, HIV indicating acute or chronic infection; 5. Chronic recurring bacterial infections or active TB; 6. Positive pregnancy test at Screening or at the Baseline visit; 7. Female subjects who are pregnant or breast-feeding or considering becoming pregnant during the study; 8. History of clinically significant alcohol or drug abuse in the last 12 months; 9. Known hypersensitivity to the excipients of Otezla® as stated in the label; 10. Subject is considered by the Investigator, for any reason, to be an unsuitable candidate for the study. 11. Prior history of suicide attempt at any time in the subject's life time prior to signing the informed consent and randomization, or major psychiatric illness requiring hospitalization within the last 3 years prior to signing the informed consent.
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.
|University of Zurich|
The person who is responsible for the scientific and technical direction of the entire clinical study.
|Alexander Navarini, MD PhD|
|Principal Investigator Affiliation||University of Zurich|
Category of organization(s) involved as sponsor (and collaborator) supporting the trial.
|Overall Status||Not yet recruiting|
The disease, disorder, syndrome, illness, or injury that is being studied.
|Psoriasis of Scalp, Psoriasis Vulgaris|
The scalp is the most frequently affected body region in psoriasis. Scalp Psoriasis can impair the quality of life greatly due to pruritus. This is however not usually investigated as a primary outcome of treatments. This study will investigate the effects of apremilast on the pruritus and quality of life and other patient reported outcomes in patients with scalp psoriasis.
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