Apremilast Treatment for Pruritus and Quality of Life in Scalp Psoriasis

NCT03553433 | Unknown Phase 4

• 1 other identifier: DER-USZ-AAN-021
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 4

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

Conditions

Psoriasis of Scalp; Psoriasis Vulgaris

Keywords

apremilast; quality of life; pruritus; oral drug; placebo

Outcome Measures

Primary Outcomes (1)

• Scalp VAS Pruritus assessment

  Pruritus VAS Scale (0 - 100)

  Weeks 16

Secondary Outcomes (11)

• Scalp VAS Pruritus assessment

  Weeks 0, 4, 32, 52

• % BSA

  Weeks 0, 4, 16, 32, 52

• % BSA of scalp

  Weeks 0, 4, 16, 32, 52

• PrecisePASI

  Weeks 0, 4, 16, 32, 52

• PGA

  Weeks 0, 4, 16, 32, 52

Study Arms (2)

Verum

EXPERIMENTAL

Apremilast 30mg bd

Drug: Apremilast 30mg

Placebo Oral Tablet

PLACEBO COMPARATOR

Excipiens

Drug: Placebo Oral Tablet

Interventions

Apremilast 30mg DRUG

Anti-psoriatic drug

Also known as: Otezla

Verum

Placebo Oral Tablet DRUG

Indistinguishable tablets not containing apremilast, Placebo Oral Tablet

Also known as: Placebo

Placebo Oral Tablet

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult (\>18yrs);
• Signed informed consent
• 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;
• Psoriatic lesions with DLQI \>10 and involvement of \>20% of the scalp and pruritus with a VAS score of \> 50 (0-100);
• Candidate for systemic therapy;
• 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;
• 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.

You may not qualify if:

• 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;
• Use of any anti-psoriatic therapy last administered less than 4 weeks of start of study drug such as
• 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
• weeks for immunosuppressive / -modulating drugs including cyclosporine A, methotrexate, azathioprine, mycophenolate mofetil, fumaric acid esters, retinoids, JAK inhibitors, corticosteroids, any other experimental drug, etc.
• Topical medications (eg. Corticosteroids) except coal tar shampoo, and/or salicylic acid scalp preparations on scalp lesions.
• weeks for phototherapy (ie, UVB, PUVA).
• 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;
• Positive serology for hepatitis B, hepatitis C, HIV indicating acute or chronic infection;
• Chronic recurring bacterial infections or active TB;
• Positive pregnancy test at Screening or at the Baseline visit;
• Female subjects who are pregnant or breast-feeding or considering becoming pregnant during the study;
• History of clinically significant alcohol or drug abuse in the last 12 months;
• Known hypersensitivity to the excipients of Otezla® as stated in the label;
• Subject is considered by the Investigator, for any reason, to be an unsuitable candidate for the study.
• 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.

Sponsors & Collaborators

• University of Zurich: lead

Study Sites (4)

KSSG

Sankt Gallen, Canton of St. Gallen, Switzerland

Location

Inselspital

Bern, Switzerland

Location

CHUV

Lausanne, Switzerland

Location

Department of Dermatology, University Hospital Zurich

Zurich, 8091, Switzerland

Location

MeSH Terms

Conditions

Pruritus

Interventions

apremilast

Condition Hierarchy (Ancestors)

Skin Diseases; Skin and Connective Tissue Diseases; Skin Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Alexander Navarini, MD PhD

  University of Zurich

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Alexander Navarini, MD PhD

CONTACT

0041442551111; alexander.navarini@usz.ch

Karolina Papageorgiou, MD

CONTACT

0041442551111; karolina.papageorgiou@usz.ch

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Double-blind
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 18, 2018
• First Posted: June 12, 2018
• Study Start: June 1, 2018
• Primary Completion: December 1, 2019
• Study Completion: June 1, 2020
• Last Updated: June 12, 2018

Record last verified: 2018-06

Data Sharing

• IPD Sharing: Will not share

Locations

CH (4)