Apremilast Treatment for Pruritus and Quality of Life in Scalp Psoriasis

Psoriasis Vulgaris Clinical Trial

— APRESCALP  

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03553433
• Other study ID #: DER-USZ-AAN-021
• Status: Not yet recruiting
• Phase: Phase 4
• Start date: June 2018
• Est. completion date: June 2020

Study information

• Verified date: June 2018
• Source: University of Zurich
• Contact: Alexander Navarini, MD PhD
• Phone: 0041442551111
• Email: alexander.navarini[@]usz.ch
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 90
• Est. completion date: June 2020
• Est. primary completion date: December 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Pruritus
• Psoriasis
• Psoriasis of Scalp
• Psoriasis Vulgaris

Intervention

Drug:
• Apremilast 30mg
Anti-psoriatic drug
• Placebo Oral Tablet
Indistinguishable tablets not containing apremilast, Placebo Oral Tablet

Locations

Country	Name	City	State
Switzerland	Inselspital	Bern
Switzerland	CHUV	Lausanne
Switzerland	KSSG	Saint Gallen	SG
Switzerland	Department of Dermatology, University Hospital Zurich	Zurich

Sponsors (1)

Lead Sponsor	Collaborator
University of Zurich

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Scalp VAS Pruritus assessment	Pruritus VAS Scale (0 - 100)	Weeks 16
Secondary	Scalp VAS Pruritus assessment	Pruritus VAS Scale (0 - 100)	Weeks 0, 4, 32, 52
Secondary	% BSA	Body surface area	Weeks 0, 4, 16, 32, 52
Secondary	% BSA of scalp	Body surface area of scalp	Weeks 0, 4, 16, 32, 52
Secondary	PrecisePASI	Psoriasis Area and Severity Index, modified to measure in percentages	Weeks 0, 4, 16, 32, 52
Secondary	PGA	Physicians Global Assessment (0 - 5)	Weeks 0, 4, 16, 32, 52
Secondary	Scalp-PGA	Physicians Global Assessment of the Scalp (0 - 5)	Weeks 0, 4, 16, 32, 52
Secondary	DLQI	Skin related Quality of life (0 to 30)	Weeks 0, 4, 16, 32, 52
Secondary	Scalpdex	23 items related to scalp symptoms	Weeks 0, 4, 16, 32, 52
Secondary	PSSI	Psoriasis score measuring intensity on the scalp	Weeks 0, 4, 16, 32, 52
Secondary	VAS pruritus assessment	Pruritus VAS Scale (0 - 100)	Weeks 0, 4, 16, 32, 52
Secondary	EQ-5D	Health-related Quality of Life Instrument	Weeks 0, 4, 16, 32, 52