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

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ClinicalTrials.gov Identifier: NCT03553433
Recruitment Status : Not yet recruiting
First Posted : June 12, 2018
Last Update Posted : June 12, 2018
Sponsor:
Information provided by (Responsible Party):
University of Zurich

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 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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Itching Psoriasis
Drug Information available for: Apremilast

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




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



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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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03553433


Contacts
Contact: Alexander Navarini, MD PhD 0041442551111 alexander.navarini@usz.ch
Contact: Karolina Papageorgiou, MD 0041442551111 karolina.papageorgiou@usz.ch

Locations
Switzerland
KSSG Not yet recruiting
Saint Gallen, SG, Switzerland
Contact: Antonio Cozzio, MD PhD    +41 71 494 20 30    antonio.cozzio@kssg.ch   
Inselspital Not yet recruiting
Bern, Switzerland
Contact: Nikhil Yawalkar, MD    +41 (31) 632 22 88    nikhil.yawalkar@insel.ch   
CHUV Not yet recruiting
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

Responsible Party: University of Zurich
ClinicalTrials.gov Identifier: NCT03553433     History of Changes
Other Study ID Numbers: DER-USZ-AAN-021
First Posted: June 12, 2018    Key Record Dates
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
Signs and Symptoms
Apremilast
Thalidomide
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
Immunosuppressive Agents
Immunologic Factors
Leprostatic Agents
Anti-Bacterial Agents
Anti-Infective Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors
Antineoplastic Agents