Apremilast Treatment for Pruritus and Quality of Life in Scalp Psoriasis (APRESCALP)

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

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 Overview

• Status: Unknown
• Conditions: Psoriasis Vulgaris; Psoriasis of Scalp
• Intervention / Treatment: Drug: Apremilast 30mg; Drug: Placebo Oral Tablet

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.

• Study Type: Interventional
• Enrollment (Anticipated): 90
• Phase: Phase 4

Contacts and Locations

Study Locations

• Switzerland
  • Bern, Switzerland
    • Inselspital
  • Lausanne, Switzerland
    • CHUV
  • Zurich, Switzerland, 8091
    • Department of Dermatology, University Hospital Zurich
  • SG
    • Saint Gallen, SG, Switzerland
      • KSSG

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Verum; Apremilast 30mg bd	Drug: Apremilast 30mg; Anti-psoriatic drug; Other Names: Otezla
PLACEBO_COMPARATOR: Placebo Oral Tablet; Excipiens	Drug: Placebo Oral Tablet; Indistinguishable tablets not containing apremilast, Placebo Oral Tablet; Other Names: Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Scalp VAS Pruritus assessment	Pruritus VAS Scale (0 - 100)	Weeks 16

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University of Zurich
• Investigators: Principal Investigator: Alexander Navarini, MD PhD, University of Zurich

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): June 1, 2018
• Primary Completion (ANTICIPATED): December 1, 2019
• Study Completion (ANTICIPATED): June 1, 2020

Study Registration Dates

• First Submitted: April 18, 2018
• First Submitted That Met QC Criteria: June 11, 2018
• First Posted (ACTUAL): June 12, 2018

Study Record Updates

• Last Update Posted (ACTUAL): June 12, 2018
• Last Update Submitted That Met QC Criteria: June 11, 2018
• Last Verified: June 1, 2018

More Information

Terms related to this study

• Keywords: quality of life; placebo; pruritus; apremilast; oral drug
• Additional Relevant MeSH Terms: Skin Diseases; Skin Diseases, Papulosquamous; Skin Manifestations; Psoriasis; Pruritus; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Phosphodiesterase Inhibitors; Phosphodiesterase 4 Inhibitors; Apremilast
• Other Study ID Numbers: DER-USZ-AAN-021

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No