Clinical trial NCT03553433: Apremilast Treatment for Pruritus and Quality of Life in Scalp Psoriasis
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Psoriasis of Scalp
Psoriasis Vulgaris
Keywords: apremilast
quality of life
pruritus
oral drug
placebo
Lead sponsor: University of Zurich
Sponsor class: OTHER
First posted: 2018-06-12
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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

Detailed description: 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.

Eligibility 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.

Primary outcomes:
measure: Scalp VAS Pruritus assessment
timeFrame: Weeks 16
Secondary outcomes:
measure: Scalp VAS Pruritus assessment
timeFrame: Weeks 0, 4, 32, 52
measure: % BSA
timeFrame: Weeks 0, 4, 16, 32, 52
measure: % BSA of scalp
timeFrame: Weeks 0, 4, 16, 32, 52
measure: PrecisePASI
timeFrame: Weeks 0, 4, 16, 32, 52
measure: PGA
timeFrame: Weeks 0, 4, 16, 32, 52
measure: Scalp-PGA
timeFrame: Weeks 0, 4, 16, 32, 52
measure: DLQI
timeFrame: Weeks 0, 4, 16, 32, 52
measure: Scalpdex
timeFrame: Weeks 0, 4, 16, 32, 52
measure: PSSI
timeFrame: Weeks 0, 4, 16, 32, 52
measure: VAS pruritus assessment
timeFrame: Weeks 0, 4, 16, 32, 52
measure: EQ-5D
timeFrame: Weeks 0, 4, 16, 32, 52
Other outcomes:
Locations:
city: Saint Gallen
country: Switzerland
facility: KSSG
state: SG
city: Bern
country: Switzerland
facility: Inselspital
city: Lausanne
country: Switzerland
facility: CHUV
city: Zurich
country: Switzerland
facility: Department of Dermatology, University Hospital Zurich
Study officials:
affiliation: University of Zurich
name: Alexander Navarini, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: