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A Study of the Efficacy and Safety of Apremilast (CC-10004) in Subjects With Moderate to Severe Plaque Psoriasis of the Scalp (STYLE)

Primary Purpose

Psoriasis

Status

Completed

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

Apremilast

Placebo

About this trial

This is an interventional treatment trial for Psoriasis focused on measuring Plaque Psoriasis, Scalp, Double-Blind, Efficacy, Safety, CC-10004, Apremilast, Otezla, Itch, Head

Eligibility Criteria

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

Inclusion Criteria:

Subjects must satisfy the following criteria to be enrolled in the study:

Males or females, ≥ 18 years of age at the time of signing the informed consent document
Be willing and able to adhere to the study visit schedule and other protocol requirements.
Have a diagnosis of moderate to severe plaque psoriasis of the scalp at screening and baseline
Must be a candidate for phototherapy and/or systemic therapy for either body or scalp psoriasis lesions.
Have moderate to severe plaque psoriasis at screening and baseline
Must be in good health (except for psoriasis) as judged by the Investigator, based on medical history, physical examination, 12-lead electrocardiogram (ECG), clinical laboratories, and urinalysis
Must meet laboratory criteria
Females of childbearing potential (FCBP)* must have a negative pregnancy test at screening and baseline. While on investigational product (IP) and for at least 28 days after taking the last dose of investigational product, FCBP who engage in activity in which conception is possible - must use one of the approved contraceptive** options described below:

Option 1: Any one of the following highly effective methods: hormonal contraception (oral, injection, implant, transdermal patch, vaginal ring); intrauterine device (IUD); tubal ligation; or partner's vasectomy; OR Option 2: Male or female condom (latex condom or nonlatex condom NOT made out of natural [animal] membrane [for example, polyurethane]; PLUS one additional barrier method: (a) diaphragm with spermicide; (b) cervical cap with spermicide; or (c) contraceptive sponge with spermicide.

*A female of childbearing potential is a sexually mature female who 1) has not undergone a hysterectomy (the surgical removal of the uterus) or bilateral oophorectomy (the surgical removal of both ovaries) or 2) has not been postmenopausal for at least 24 consecutive months (that is, has had menses at any time during the preceding 24 consecutive months).

** The female subject's chosen form of contraception must be effective by the time the female subject is randomized into the study (for example, hormonal contraception should be initiated at least 28 days before randomization).

Exclusion Criteria:

The presence of any of the following will exclude a subject from enrollment:

Other than psoriasis, history of any clinically significant uncontrolled disease.

Any condition, including the presence of laboratory abnormalities, which would place the subject at unacceptable risk if he/she were to participate in the study.

Pregnant or breast feeding
Hepatitis B surface antigen positive at screening
Anti-hepatitis C antibody positive at screening
Active tuberculosis (TB) or a history of incompletely treated TB
Clinically significant abnormality on 12-lead electrocardiogram (ECG) at screening
History of positive human immunodeficiency virus (HIV), or have congenital or acquired immunodeficiency (eg, common variable immunodeficiency disease)
Active substance abuse or a history of substance abuse within 6 months prior to signing the informed consent form.
Bacterial infections requiring treatment with oral or injectable antibiotics, or significant viral or fungal infections, within 4 weeks of signing the informed consent form.
Malignancy or history of malignancy, except for treated (i.e., cured) basal cell or squamous cell in situ skin carcinomas or treated (i.e., cured) cervical intraepithelial neoplasia (CIN) or carcinoma in situ of the cervix with no evidence of recurrence within 5 years of signing the informed consent.
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.
Psoriasis flare/rebound within 4 weeks of signing the informed consent form or between the screening and baseline visits.
Topical therapy within 2 weeks prior to randomization; Conventional systemic therapy for psoriasis within 4 weeks prior to randomization; Intralesional corticosteroids on the scalp within 2 weeks prior to randomization; Phototherapy treatment of body or scalp psoriasi lesions within 4 weeks prior to randomization; Biologic therapy between 12 weeks to 24 weeks prior to randomization
Use of any investigational drug beginning 4 weeks prior to randomization, or 5 pharmacokinetic/pharmacodynamic half-lives, if known (whichever is longer)
Prolonged sun exposure or use of tanning booths or other ultraviolet (UV) light sources
Prior treatment with apremilast
History of allergy or hypersensitivity to any components of the Investigational product.

Sites / Locations

Northwest Arkansas Clinical Trials Center, PLLC / Hull Dermatology
Tien Q. Nguyen MD Inc
Dermatology Research Associates
San Luis Dermatology and Laser Clinic
University of Connecticut
Florida Academic Centers Research and Education
International Dermatology Research
Renstar Medical Research
Dermatologic Surgery Specialists, P.C.
MedaPhase INC
The Indiana Clinical Trials Center, PC
DS Research
DS Research
Dermatology and Advanced Aesthetics
Lawrence Green, MD, LLC
Central Dermatology
Skin Specialists, PC
Psoriasis Treatment Center of Central New Jersey
SUNY Downstate Medical Center
Forest Hills Dermatology Group
Icahn School of Medicine at Mount Sinai Medical Center
Sadick Research Group
Wake Forest University Health Sciences
Wright State Physicians
University of Pittsburgh Medical Center
Austin Dermatology Associates
Modern Research Associates PLLC
Center for Clinical Studies
University of Utah
Virginia Clinical Research Inc
Eastern Virginia Medical School
Medical College of Wisconsin
Kirk Barber Research
Institute for Skin Advancement
Chih-Ho Hong Medical, Inc.
Enverus Medical Research
Wiseman Dermatology Research Inc.
Lynderm Research
North Bay Dermatology Center
Skin Center for Dermatology
Centre For Dermatology and Cosmetic Surgery
The Toronto Dermatology Centre
K. Papp Clinical Research
XLR8 Medical Research
Centre de Recherche Dermatologique du Quebec Metropolitain CRDQ

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Apremilast 30 mg BID

Placebo

Arm Description

Apremilast 30 mg tablets orally twice daily (BID) during Weeks 0 to 32

Placebo tablets BID during weeks 0 to 16; at week 16, placebo participants were switched to apremilast 30 mg tablets BID for 16 weeks (from Week 16 to Week 32)

Outcomes

Primary Outcome Measures

Percentage of Participants With Scalp Physician Global Assessment (ScPGA) Score of Clear (0) or Almost Clear (1) With at Least a 2-Point Reduction From Baseline

The ScPGA is a measurement of overall scalp involvement by the investigator at the time of evaluation. The ScPGA is a 5-point scale ranging from 0 (clear) to 4 (severe), incorporating an assessment of the severity of the 3 primary signs of the disease: erythema, scaling, and plaque elevation. When making the assessment of overall scalp severity, the investigator factored in areas that had already been cleared (ie, had scores of 0), not limited to the evaluation of remaining lesions for severity; consequently, the severity of each sign was averaged across all areas of involvement, including cleared lesions.

Secondary Outcome Measures

Percentage of Participants With ≥ 4-Point Reduction (Improvement) From Baseline in the Whole Body Itch Numeric Rating Score at Week 16

The Whole Body Itch NRS scale is an 11-point scale to assess whole body itch. The scale ranges from 0-10, where "0" represents no itch, and "10" represents the worst imaginable itch, and a 4-point change from baseline was shown to be optimal for demonstrating a level of clinically meaningful improvement in itch severity. NRS response was defined as a ≥ 4-point reduction (improvement) from baseline.

Percentage of Participants With ≥ 4-Point Reduction (Improvement) From Baseline in the Scalp Itch Numeric Rating Score (NRS) at Week 16

The scalp itch NRS is a 11-point scale to assess scalp itch. The scale ranges from 0-10, where "0" represents no itch, and "10" represents the worst imaginable itch.

Percentage of Participants With ≥ 4-Point Reduction (Improvement) From Baseline in the Whole Body Itch NRS Score by Visit in the Placebo-Controlled Phase

The Whole Body Itch NRS scale is a 11-point scale to assess whole body itch. The scale ranges from 0-10, where "0" represents no itch, and "10" represents the worst imaginable itch, and a 4-point change from baseline was shown to be optimal for demonstrating a level of clinically meaningful improvement in itch severity.

Percentage of Participants With ≥ 4-Point Reduction (Improvement) From Baseline in the Scalp Itch NRS Score by Visit in the Placebo-Controlled Phase

The scalp itch NRS is a 11-point scale to assess scalp itch. The scale ranges from 0-10, where "0" represents no itch, and "10" represents the worst imaginable itch.

Change From Baseline in Dermatological Life Quality Index (DLQI) Total Score at Week 16

DLQI is questionnaire for use in a dermatology clinical setting to assess limitations related to the impact of skin disease. The instrument contains ten items dealing with the participant's skin. With the exception of Item Number 7, the participant responds on a four-point scale, ranging from "Very Much" (score 3) to "Not at All" or "Not relevant" (score 0). Item Number 7 is a multi-part item, the first part of which ascertains whether the participant's skin prevented them from working or studying (Yes or No, scores 3 or 0 respectively), and if "No," then the subject is asked how much of a problem the skin has been at work or study over the past week, with response alternatives being "A lot," "A little," or "Not at all" (scores 2, 1, or 0 respectively). The DLQI total score was derived by summing all item scores, and has a possible range of 0 to 30, with 30 corresponding to the worst quality of life, and 0 corresponding to the best.

Number of Participants With Treatment Emergent Adverse Events (TEAE) During the Placebo-Controlled Phase

A TEAE is an AE with a start date on or after the date of the first dose of study drug and no later than 28 days after the last dose of study drug. A serious AE (SAE) is any untoward AE that is fatal, life-threatening, results in persistent or significant disability or incapacity, requires or prolongs existing in-patient hospitalization, is a congenital anomaly/birth defect, or is a condition that may jeopardize or may require intervention to prevent one of the outcomes above. The severity of AEs was assessed based on the following scale: Mild = asymptomatic or mild symptoms, clinical or diagnostic observations only; Moderate = symptoms cause moderate discomfort; Severe = could be non-serious or serious) = symptoms causing severe pain discomfort.

Number of Participants With Treatment Emergent Adverse Events During the Apremilast-Extension Phase

Number of Participants With Treatment Emergent Adverse Events During the Apremilast-Exposure Period

The apremilast-exposure period started on the date of the first dose of apremilast (Week 0 for participants originally randomized to apremilast or Week 16 for participants originally randomized to placebo) to the last dose of apremilast. A TEAE is an AE with a start date on or after the date of the first dose of study drug and no later than 28 days after the last dose of study drug. A serious AE (SAE) is any untoward AE that is fatal, life-threatening, results in persistent or significant disability or incapacity, requires or prolongs existing in-patient hospitalization, is a congenital anomaly/birth defect, or is a condition that may jeopardize or may require intervention to prevent one of the outcomes above. The severity of AEs was assessed based on the following scale: Mild = asymptomatic or mild symptoms, clinical or diagnostic observations only; Moderate = symptoms cause moderate discomfort; Severe = could be non-serious or serious) = symptoms causing severe pain discomfort.

Full Information

NCT ID

NCT03123471

First Posted

April 18, 2017

Last Updated

April 28, 2020

Sponsor

Amgen

1. Study Identification

Unique Protocol Identification Number

NCT03123471

Brief Title

A Study of the Efficacy and Safety of Apremilast (CC-10004) in Subjects With Moderate to Severe Plaque Psoriasis of the Scalp

Acronym

STYLE

Official Title

A Phase 3, Multi-Center, Randomized, Placebo-Controlled, Double-Blind, Study of the Efficacy and Safety of Apremilast (CC-10004) in Subjects With Moderate to Severe Plaque Psoriasis of the Scalp

Study Type

Interventional

2. Study Status

Record Verification Date

April 2020

Overall Recruitment Status

Completed

Study Start Date

May 16, 2017 (Actual)

Primary Completion Date

August 13, 2018 (Actual)

Study Completion Date

January 9, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Amgen

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

This is a Phase 3, multicenter, randomized, placebo-controlled, double-blind study of the efficacy and safety of apremilast (CC-10004) in subjects with moderate to severe plaque psoriasis of the scalp. Approximately 300 subjects with moderate to severe plaque psoriasis of the scalp will be randomized 2:1 to receive either apremilast 30 mg twice daily (BID) or placebo for the first 16 weeks.

Detailed Description

The study will consist of four phases: Screening Phase - up to 35 days Double-blind Placebo-controlled Phase- Weeks 0 to 16 Subjects will receive treatment with one of the following: apremilast 30 mg tablets orally BID or placebo tablets (identical in appearance to apremilast 30 mg tablets) orally BID Apremilast Extension Phase - Weeks 16 to 32 All subjects who had received placebo during the placebo-controlled phase will be switched to apremilast 30 mg BID (or continue with) apremilast. At Week 16, all subjects will maintain this dosing through Week 32. Observational Follow-up Phase Four-week Post-Treatment Observational Follow-up Phase for all subjects who complete the study or discontinue from the study early.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Psoriasis

Keywords

Plaque Psoriasis, Scalp, Double-Blind, Efficacy, Safety, CC-10004, Apremilast, Otezla, Itch, Head

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

303 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Apremilast 30 mg BID

Arm Type

Experimental

Arm Description

Apremilast 30 mg tablets orally twice daily (BID) during Weeks 0 to 32

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Placebo tablets BID during weeks 0 to 16; at week 16, placebo participants were switched to apremilast 30 mg tablets BID for 16 weeks (from Week 16 to Week 32)

Intervention Type

Drug

Intervention Name(s)

Apremilast

Other Intervention Name(s)

CC-10004

Intervention Description

Apremilast 30 mg tablets BID from weeks 0 to 32.

Intervention Type

Other

Intervention Name(s)

Placebo

Intervention Description

Placebo tablets twice daily (BID) for 16 weeks; placebo participants were switched to apremilast 30 mg at week 16.

Primary Outcome Measure Information:

Title

Percentage of Participants With Scalp Physician Global Assessment (ScPGA) Score of Clear (0) or Almost Clear (1) With at Least a 2-Point Reduction From Baseline

Description

Time Frame

Baseline to Week 16

Secondary Outcome Measure Information:

Title

Percentage of Participants With ≥ 4-Point Reduction (Improvement) From Baseline in the Whole Body Itch Numeric Rating Score at Week 16

Description

Time Frame

Baseline to Week 16

Title

Percentage of Participants With ≥ 4-Point Reduction (Improvement) From Baseline in the Scalp Itch Numeric Rating Score (NRS) at Week 16

Description

The scalp itch NRS is a 11-point scale to assess scalp itch. The scale ranges from 0-10, where "0" represents no itch, and "10" represents the worst imaginable itch.

Time Frame

Baseline to Week 16

Title

Percentage of Participants With ≥ 4-Point Reduction (Improvement) From Baseline in the Whole Body Itch NRS Score by Visit in the Placebo-Controlled Phase

Description

Time Frame

Baseline to Weeks 2, 4, 6, 8 and 12

Title

Percentage of Participants With ≥ 4-Point Reduction (Improvement) From Baseline in the Scalp Itch NRS Score by Visit in the Placebo-Controlled Phase

Description

The scalp itch NRS is a 11-point scale to assess scalp itch. The scale ranges from 0-10, where "0" represents no itch, and "10" represents the worst imaginable itch.

Time Frame

Baseline to Weeks 2, 4, 8 and 12

Title

Change From Baseline in Dermatological Life Quality Index (DLQI) Total Score at Week 16

Description

Time Frame

Baseline to Week 16

Title

Number of Participants With Treatment Emergent Adverse Events (TEAE) During the Placebo-Controlled Phase

Description

Time Frame

Week 0 to Week 16; mean duration of exposure was 14.5 weeks and 14.6 weeks for participants randomized to placebo and apremilast respectively.

Title

Number of Participants With Treatment Emergent Adverse Events During the Apremilast-Extension Phase

Description

Time Frame

Weeks 16 to Week 32; the mean treatment duration was 14.6 weeks and 15.3 weeks in the APR 30/APR 30 BID and placebo/APR 30 BID arms, respectively

Title

Number of Participants With Treatment Emergent Adverse Events During the Apremilast-Exposure Period

Description

Time Frame

Week 0 to 32;

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Subjects must satisfy the following criteria to be enrolled in the study: Males or females, ≥ 18 years of age at the time of signing the informed consent document Be willing and able to adhere to the study visit schedule and other protocol requirements. Have a diagnosis of moderate to severe plaque psoriasis of the scalp at screening and baseline Must be a candidate for phototherapy and/or systemic therapy for either body or scalp psoriasis lesions. Have moderate to severe plaque psoriasis at screening and baseline Must be in good health (except for psoriasis) as judged by the Investigator, based on medical history, physical examination, 12-lead electrocardiogram (ECG), clinical laboratories, and urinalysis Must meet laboratory criteria Females of childbearing potential (FCBP)* must have a negative pregnancy test at screening and baseline. While on investigational product (IP) and for at least 28 days after taking the last dose of investigational product, FCBP who engage in activity in which conception is possible - must use one of the approved contraceptive** options described below: Option 1: Any one of the following highly effective methods: hormonal contraception (oral, injection, implant, transdermal patch, vaginal ring); intrauterine device (IUD); tubal ligation; or partner's vasectomy; OR Option 2: Male or female condom (latex condom or nonlatex condom NOT made out of natural [animal] membrane [for example, polyurethane]; PLUS one additional barrier method: (a) diaphragm with spermicide; (b) cervical cap with spermicide; or (c) contraceptive sponge with spermicide. *A female of childbearing potential is a sexually mature female who 1) has not undergone a hysterectomy (the surgical removal of the uterus) or bilateral oophorectomy (the surgical removal of both ovaries) or 2) has not been postmenopausal for at least 24 consecutive months (that is, has had menses at any time during the preceding 24 consecutive months). ** The female subject's chosen form of contraception must be effective by the time the female subject is randomized into the study (for example, hormonal contraception should be initiated at least 28 days before randomization). Exclusion Criteria: The presence of any of the following will exclude a subject from enrollment: Other than psoriasis, history of any clinically significant uncontrolled disease. Any condition, including the presence of laboratory abnormalities, which would place the subject at unacceptable risk if he/she were to participate in the study. Pregnant or breast feeding Hepatitis B surface antigen positive at screening Anti-hepatitis C antibody positive at screening Active tuberculosis (TB) or a history of incompletely treated TB Clinically significant abnormality on 12-lead electrocardiogram (ECG) at screening History of positive human immunodeficiency virus (HIV), or have congenital or acquired immunodeficiency (eg, common variable immunodeficiency disease) Active substance abuse or a history of substance abuse within 6 months prior to signing the informed consent form. Bacterial infections requiring treatment with oral or injectable antibiotics, or significant viral or fungal infections, within 4 weeks of signing the informed consent form. Malignancy or history of malignancy, except for treated (i.e., cured) basal cell or squamous cell in situ skin carcinomas or treated (i.e., cured) cervical intraepithelial neoplasia (CIN) or carcinoma in situ of the cervix with no evidence of recurrence within 5 years of signing the informed consent. 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. Psoriasis flare/rebound within 4 weeks of signing the informed consent form or between the screening and baseline visits. Topical therapy within 2 weeks prior to randomization; Conventional systemic therapy for psoriasis within 4 weeks prior to randomization; Intralesional corticosteroids on the scalp within 2 weeks prior to randomization; Phototherapy treatment of body or scalp psoriasi lesions within 4 weeks prior to randomization; Biologic therapy between 12 weeks to 24 weeks prior to randomization Use of any investigational drug beginning 4 weeks prior to randomization, or 5 pharmacokinetic/pharmacodynamic half-lives, if known (whichever is longer) Prolonged sun exposure or use of tanning booths or other ultraviolet (UV) light sources Prior treatment with apremilast History of allergy or hypersensitivity to any components of the Investigational product.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Organizational Affiliation

Amgen

Official's Role

Study Director

Facility Information:

Facility Name

Northwest Arkansas Clinical Trials Center, PLLC / Hull Dermatology

City

Rogers

State/Province

Arkansas

ZIP/Postal Code

72758

Country

United States

Facility Name

Tien Q. Nguyen MD Inc

City

Fountain Valley

State/Province

California

ZIP/Postal Code

92708

Country

United States

Facility Name

Dermatology Research Associates

City

Los Angeles

State/Province

California

ZIP/Postal Code

90045

Country

United States

Facility Name

San Luis Dermatology and Laser Clinic

City

San Luis Obispo

State/Province

California

ZIP/Postal Code

93405

Country

United States

Facility Name

University of Connecticut

City

Farmington

State/Province

Connecticut

ZIP/Postal Code

06030

Country

United States

Facility Name

Florida Academic Centers Research and Education

City

Coral Gables

State/Province

Florida

ZIP/Postal Code

33134

Country

United States

Facility Name

International Dermatology Research

City

Miami

State/Province

Florida

ZIP/Postal Code

33144

Country

United States

Facility Name

Renstar Medical Research

City

Ocala

State/Province

Florida

ZIP/Postal Code

34470

Country

United States

Facility Name

Dermatologic Surgery Specialists, P.C.

City

Macon

State/Province

Georgia

ZIP/Postal Code

31217

Country

United States

Facility Name

MedaPhase INC

City

Newnan

State/Province

Georgia

ZIP/Postal Code

30263

Country

United States

Facility Name

The Indiana Clinical Trials Center, PC

City

Plainfield

State/Province

Indiana

ZIP/Postal Code

46168

Country

United States

Facility Name

DS Research

City

Louisville

State/Province

Kentucky

ZIP/Postal Code

40202

Country

United States

Facility Name

DS Research

City

Louisville

State/Province

Kentucky

ZIP/Postal Code

40241

Country

United States

Facility Name

Dermatology and Advanced Aesthetics

City

Lake Charles

State/Province

Louisiana

ZIP/Postal Code

70605

Country

United States

Facility Name

Lawrence Green, MD, LLC

City

Rockville

State/Province

Maryland

ZIP/Postal Code

20850

Country

United States

Facility Name

Central Dermatology

City

Saint Louis

State/Province

Missouri

ZIP/Postal Code

63117

Country

United States

Facility Name

Skin Specialists, PC

City

Omaha

State/Province

Nebraska

ZIP/Postal Code

68144

Country

United States

Facility Name

Psoriasis Treatment Center of Central New Jersey

City

East Windsor

State/Province

New Jersey

ZIP/Postal Code

08520

Country

United States

Facility Name

SUNY Downstate Medical Center

City

Brooklyn

State/Province

New York

ZIP/Postal Code

11203

Country

United States

Facility Name

Forest Hills Dermatology Group

City

Forest Hills

State/Province

New York

ZIP/Postal Code

11375

Country

United States

Facility Name

Icahn School of Medicine at Mount Sinai Medical Center

City

New York

State/Province

New York

ZIP/Postal Code

10029

Country

United States

Facility Name

Sadick Research Group

City

New York

State/Province

New York

ZIP/Postal Code

10075

Country

United States

Facility Name

Wake Forest University Health Sciences

City

Winston-Salem

State/Province

North Carolina

ZIP/Postal Code

27104

Country

United States

Facility Name

Wright State Physicians

City

Fairborn

State/Province

Ohio

ZIP/Postal Code

45324

Country

United States

Facility Name

University of Pittsburgh Medical Center

City

Pittsburgh

State/Province

Pennsylvania

ZIP/Postal Code

15213

Country

United States

Facility Name

Austin Dermatology Associates

City

Austin

State/Province

Texas

ZIP/Postal Code

78705

Country

United States

Facility Name

Modern Research Associates PLLC

City

Dallas

State/Province

Texas

ZIP/Postal Code

75231

Country

United States

Facility Name

Center for Clinical Studies

City

Webster

State/Province

Texas

ZIP/Postal Code

77598

Country

United States

Facility Name

University of Utah

City

Salt Lake City

State/Province

Utah

ZIP/Postal Code

84107

Country

United States

Facility Name

Virginia Clinical Research Inc

City

Norfolk

State/Province

Virginia

ZIP/Postal Code

23502

Country

United States

Facility Name

Eastern Virginia Medical School

City

Norfolk

State/Province

Virginia

ZIP/Postal Code

23507

Country

United States

Facility Name

Medical College of Wisconsin

City

Milwaukee

State/Province

Wisconsin

ZIP/Postal Code

53226

Country

United States

Facility Name

Kirk Barber Research

City

Calgary

State/Province

Alberta

ZIP/Postal Code

T2G 1B1

Country

Canada

Facility Name

Institute for Skin Advancement

City

Calgary

State/Province

Alberta

ZIP/Postal Code

T3A 2N1

Country

Canada

Facility Name

Chih-Ho Hong Medical, Inc.

City

Surrey

State/Province

British Columbia

ZIP/Postal Code

V3R 6A7

Country

Canada

Facility Name

Enverus Medical Research

City

Surrey

State/Province

British Columbia

ZIP/Postal Code

V3V 0C6

Country

Canada

Facility Name

Wiseman Dermatology Research Inc.

City

Winnipeg

State/Province

Manitoba

ZIP/Postal Code

R3M 3Z4

Country

Canada

Facility Name

Lynderm Research

City

Markham

State/Province

Ontario

ZIP/Postal Code

L3P1X2

Country

Canada

Facility Name

North Bay Dermatology Center

City

North Bay

State/Province

Ontario

ZIP/Postal Code

P1B 3Z7

Country

Canada

Facility Name

Skin Center for Dermatology

City

Peterborough

State/Province

Ontario

ZIP/Postal Code

K9J 5K2

Country

Canada

Facility Name

Centre For Dermatology and Cosmetic Surgery

City

Richmond Hill

State/Province

Ontario

ZIP/Postal Code

L4B 1A5

Country

Canada

Facility Name

The Toronto Dermatology Centre

City

Toronto

State/Province

Ontario

ZIP/Postal Code

M3H 5Y8

Country

Canada

Facility Name

K. Papp Clinical Research

City

Waterloo

State/Province

Ontario

ZIP/Postal Code

N2J 1C4

Country

Canada

Facility Name

XLR8 Medical Research

City

Windsor

State/Province

Ontario

ZIP/Postal Code

N8W 1E6

Country

Canada

Facility Name

Centre de Recherche Dermatologique du Quebec Metropolitain CRDQ

City

Quebec

ZIP/Postal Code

G1V 4X7

Country

Canada

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request

IPD Sharing Time Frame

Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.

IPD Sharing Access Criteria

Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors. If not approved, a Data Sharing Independent Review Panel will arbitrate and make the final decision. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the URL below.

IPD Sharing URL

http://www.amgen.com/datasharing

Citations:

PubMed Identifier

30747550

Citation

Wang Y, Coyne K, Sofen H, Santanello N, Currie B, Zhang Z, Nograles K. Qualitative analysis and reproducibility assessment of the Scalp Itch Numeric Rating Scale among patients with moderate to severe plaque psoriasis of the scalp. J Dermatolog Treat. 2019 Dec;30(8):775-783. doi: 10.1080/09546634.2019.1577546. Epub 2019 Mar 5.

Results Reference

derived

Learn more about this trial

A Study of the Efficacy and Safety of Apremilast (CC-10004) in Subjects With Moderate to Severe Plaque Psoriasis of the Scalp

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