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

Primary Purpose

Psoriasis of Scalp, Psoriasis Vulgaris

Status
Unknown status
Phase
Phase 4
Locations
Switzerland
Study Type
Interventional
Intervention
Apremilast 30mg
Placebo Oral Tablet
Sponsored by
University of Zurich
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Psoriasis of Scalp focused on measuring apremilast, quality of life, pruritus, oral drug, placebo

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • KSSG
  • Inselspital
  • CHUV
  • Department of Dermatology, University Hospital Zurich

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Verum

Placebo Oral Tablet

Arm Description

Apremilast 30mg bd

Excipiens

Outcomes

Primary Outcome Measures

Scalp VAS Pruritus assessment
Pruritus VAS Scale (0 - 100)

Secondary Outcome Measures

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

Full Information

First Posted
April 18, 2018
Last Updated
June 11, 2018
Sponsor
University of Zurich
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1. Study Identification

Unique Protocol Identification Number
NCT03553433
Brief Title
Apremilast Treatment for Pruritus and Quality of Life in Scalp Psoriasis
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
June 2018
Overall Recruitment Status
Unknown status
Study Start Date
June 2018 (Anticipated)
Primary Completion Date
December 2019 (Anticipated)
Study Completion Date
June 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Zurich

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psoriasis of Scalp, Psoriasis Vulgaris
Keywords
apremilast, quality of life, pruritus, oral drug, placebo

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
Double-blind
Allocation
Randomized
Enrollment
90 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Verum
Arm Type
Experimental
Arm Description
Apremilast 30mg bd
Arm Title
Placebo Oral Tablet
Arm Type
Placebo Comparator
Arm Description
Excipiens
Intervention Type
Drug
Intervention Name(s)
Apremilast 30mg
Other Intervention Name(s)
Otezla
Intervention Description
Anti-psoriatic drug
Intervention Type
Drug
Intervention Name(s)
Placebo Oral Tablet
Other Intervention Name(s)
Placebo
Intervention Description
Indistinguishable tablets not containing apremilast, Placebo Oral Tablet
Primary Outcome Measure Information:
Title
Scalp VAS Pruritus assessment
Description
Pruritus VAS Scale (0 - 100)
Time Frame
Weeks 16
Secondary Outcome Measure Information:
Title
Scalp VAS Pruritus assessment
Description
Pruritus VAS Scale (0 - 100)
Time Frame
Weeks 0, 4, 32, 52
Title
% BSA
Description
Body surface area
Time Frame
Weeks 0, 4, 16, 32, 52
Title
% BSA of scalp
Description
Body surface area of scalp
Time Frame
Weeks 0, 4, 16, 32, 52
Title
PrecisePASI
Description
Psoriasis Area and Severity Index, modified to measure in percentages
Time Frame
Weeks 0, 4, 16, 32, 52
Title
PGA
Description
Physicians Global Assessment (0 - 5)
Time Frame
Weeks 0, 4, 16, 32, 52
Title
Scalp-PGA
Description
Physicians Global Assessment of the Scalp (0 - 5)
Time Frame
Weeks 0, 4, 16, 32, 52
Title
DLQI
Description
Skin related Quality of life (0 to 30)
Time Frame
Weeks 0, 4, 16, 32, 52
Title
Scalpdex
Description
23 items related to scalp symptoms
Time Frame
Weeks 0, 4, 16, 32, 52
Title
PSSI
Description
Psoriasis score measuring intensity on the scalp
Time Frame
Weeks 0, 4, 16, 32, 52
Title
VAS pruritus assessment
Description
Pruritus VAS Scale (0 - 100)
Time Frame
Weeks 0, 4, 16, 32, 52
Title
EQ-5D
Description
Health-related Quality of Life Instrument
Time Frame
Weeks 0, 4, 16, 32, 52

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria: 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. Creatinine < 80 umol/l at Inclusion Exclusion criteria: 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 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. Topical medications (eg. Corticosteroids) except coal tar shampoo, and/or salicylic acid scalp preparations on scalp lesions. 4 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Alexander Navarini, MD PhD
Phone
0041442551111
Email
alexander.navarini@usz.ch
First Name & Middle Initial & Last Name or Official Title & Degree
Karolina Papageorgiou, MD
Phone
0041442551111
Email
karolina.papageorgiou@usz.ch
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alexander Navarini, MD PhD
Organizational Affiliation
University of Zurich
Official's Role
Principal Investigator
Facility Information:
Facility Name
KSSG
City
Saint Gallen
State/Province
SG
Country
Switzerland
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Antonio Cozzio, MD PhD
Phone
+41 71 494 20 30
Email
antonio.cozzio@kssg.ch
Facility Name
Inselspital
City
Bern
Country
Switzerland
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nikhil Yawalkar, MD
Phone
+41 (31) 632 22 88
Email
nikhil.yawalkar@insel.ch
Facility Name
CHUV
City
Lausanne
Country
Switzerland
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Curdin Conrad, MD
Phone
+41 21 314 0400
Email
curdin.conrad@chuv.ch
Facility Name
Department of Dermatology, University Hospital Zurich
City
Zurich
ZIP/Postal Code
8091
Country
Switzerland

12. IPD Sharing Statement

Plan to Share IPD
No

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Apremilast Treatment for Pruritus and Quality of Life in Scalp Psoriasis

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