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

• ClinicalTrials.gov Identifier: NCT03553433
• Recruitment Status: Unknown
• First Posted: June 12, 2018
• Last Update Posted: June 12, 2018
• Sponsor: University of Zurich
• Information provided by (Responsible Party): University of Zurich

Study Description

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

Condition or disease	Intervention/treatment	Phase
Psoriasis of Scalp; Psoriasis Vulgaris	Drug: Apremilast 30mg; Drug: Placebo Oral Tablet	Phase 4

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 Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 90 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Masking Description: Double-blind
• Primary Purpose: Treatment
• 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
• Estimated Study Start Date: June 2018
• Estimated Primary Completion Date: December 2019
• Estimated Study Completion Date: June 2020

Arms and Interventions

Arm	Intervention/treatment
Experimental: Verum; Apremilast 30mg bd	Drug: Apremilast 30mg; Anti-psoriatic drug; Other Name: Otezla
Placebo Comparator: Placebo Oral Tablet; Excipiens	Drug: Placebo Oral Tablet; Indistinguishable tablets not containing apremilast, Placebo Oral Tablet; Other Name: Placebo

Outcome Measures

Primary Outcome Measures :

1. Scalp VAS Pruritus assessment [ Time Frame: Weeks 16 ]
   Pruritus VAS Scale (0 - 100)

Secondary Outcome Measures :

1. Scalp VAS Pruritus assessment [ Time Frame: Weeks 0, 4, 32, 52 ]
   Pruritus VAS Scale (0 - 100)
2. % BSA [ Time Frame: Weeks 0, 4, 16, 32, 52 ]
   Body surface area
3. % BSA of scalp [ Time Frame: Weeks 0, 4, 16, 32, 52 ]
   Body surface area of scalp
4. PrecisePASI [ Time Frame: Weeks 0, 4, 16, 32, 52 ]
   Psoriasis Area and Severity Index, modified to measure in percentages
5. PGA [ Time Frame: Weeks 0, 4, 16, 32, 52 ]
   Physicians Global Assessment (0 - 5)
6. Scalp-PGA [ Time Frame: Weeks 0, 4, 16, 32, 52 ]
   Physicians Global Assessment of the Scalp (0 - 5)
7. DLQI [ Time Frame: Weeks 0, 4, 16, 32, 52 ]
   Skin related Quality of life (0 to 30)
8. Scalpdex [ Time Frame: Weeks 0, 4, 16, 32, 52 ]
   23 items related to scalp symptoms
9. PSSI [ Time Frame: Weeks 0, 4, 16, 32, 52 ]
   Psoriasis score measuring intensity on the scalp
10. VAS pruritus assessment [ Time Frame: Weeks 0, 4, 16, 32, 52 ]
    Pruritus VAS Scale (0 - 100)
11. EQ-5D [ Time Frame: Weeks 0, 4, 16, 32, 52 ]
    Health-related Quality of Life Instrument

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Contacts

Contact: Alexander Navarini, MD PhD; 0041442551111; alexander.navarini@usz.ch

Contact: Karolina Papageorgiou, MD; 0041442551111; karolina.papageorgiou@usz.ch

Locations

Switzerland

KSSG

Saint Gallen, SG, Switzerland

Contact: Antonio Cozzio, MD PhD +41 71 494 20 30 antonio.cozzio@kssg.ch

Inselspital

Bern, Switzerland

Contact: Nikhil Yawalkar, MD +41 (31) 632 22 88 nikhil.yawalkar@insel.ch

CHUV

Lausanne, Switzerland

Contact: Curdin Conrad, MD +41 21 314 0400 curdin.conrad@chuv.ch

Department of Dermatology, University Hospital Zurich

Zurich, Switzerland, 8091

Sponsors and Collaborators

University of Zurich

Investigators

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

More Information

• Responsible Party: University of Zurich
• ClinicalTrials.gov Identifier: NCT03553433
• Other Study ID Numbers: DER-USZ-AAN-021
• First Posted: June 12, 2018
• Last Update Posted: June 12, 2018
• Last Verified: June 2018

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University of Zurich:

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

Additional relevant MeSH terms:

Psoriasis; Pruritus; Skin Diseases, Papulosquamous; Skin Diseases; Skin Manifestations; Apremilast; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Analgesics; Sensory System Agents; Peripheral Nervous System Agents; Physiological Effects of Drugs; Anti-Inflammatory Agents; Antirheumatic Agents; Phosphodiesterase 4 Inhibitors; Phosphodiesterase Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action