Apremilast Treatment for Pruritus and Quality of Life in Scalp Psoriasis

Study Purpose

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

Recruitment Criteria

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

Accepts Healthy Volunteers
No

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.

Study Type
Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

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.

Trial Details

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.

Trial ID:
NCT03553433

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
Phase 4

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Lead Sponsor
University of Zurich

The person who is responsible for the scientific and technical direction of the entire clinical study.

Principal Investigator
Alexander Navarini, MD PhD
Principal Investigator Affiliation University of Zurich

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Agency Class
Other
Overall Status Not yet recruiting
Countries Switzerland

The disease, disorder, syndrome, illness, or injury that is being studied.

Conditions
Psoriasis of Scalp, Psoriasis Vulgaris
Additional Details

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.

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.

International Sites

Zurich, Switzerland

Status

Address

Department of Dermatology, University Hospital Zurich

Zurich, , 8091

CHUV, Lausanne, Switzerland

Status

Not yet recruiting

Address

CHUV

Lausanne, ,

Site Contact

Curdin Conrad, MD

[email protected]

+41 21 314 0400

Inselspital, Bern, Switzerland

Status

Not yet recruiting

Address

Inselspital

Bern, ,

Site Contact

Nikhil Yawalkar, MD

[email protected]

+41 (31) 632 22 88

KSSG, Saint Gallen, SG, Switzerland

Status

Not yet recruiting

Address

KSSG

Saint Gallen, SG,

Site Contact

Antonio Cozzio, MD PhD

[email protected]

+41 71 494 20 30

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