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A Phase 4 Study of Efficacy and Safety of Apremilast in Subjects With Moderate Plaque Psoriasis. (UNVEIL)

Primary Purpose

Parapsoriasis

Status

Completed

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

Apremilast

Placebo

Placebo-Apremilast

About this trial

This is an interventional treatment trial for Parapsoriasis focused on measuring Parapsoriasis, Plaque Psoriasis, CC-10004, Apremilast, Moderate Plaque Psoriasis, Safety

Eligibility Criteria

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

Inclusion Criteria:

Males or females, ≥ 18 years of age at the time of signing the informed consent document.
Understand and voluntarily sign an informed consent document prior to any study related assessments/procedures being conducted.
Able to adhere to the study visit schedule and other protocol requirements.
Diagnosis of chronic plaque psoriasis for at least 6 months prior to signing the informed consent.
Have moderate plaque psoriasis at screening and baseline as defined by
1. BSA (Body Surface Area)5% to 10% and
2. sPGA (Physician's Global Assessment) 3 (moderate) based on a 0 to 5 point scale
Must be in general good health (except for psoriasis) as judged by the investigator, based on medical history, physical examination, and clinical laboratories.
No prior exposure to systemic treatments or biologics for the treatment of psoriatic arthritis, psoriasis, or any other indication that could impact the assessment of psoriasis.
Females of childbearing potential (FCBP)must have a negative pregnancy test at Screening and Baseline. While on investigational product 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.
Male subjects (including those who have had a vasectomy) who engage in activity in which conception is possible must use barrier contraception (male latex condom or nonlatex condom NOT made out of natural [animal] membrane [for example, polyurethane]) while on investigational product and for at least 28 days after the last dose of investigational product

Exclusion Criteria:

Other than psoriasis, any clinically significant (as determined by the Investigator) cardiac, endocrinologic, pulmonary, neurologic, psychiatric, hepatic, renal, hematologic,immunologic disease, or other major disease that is currently uncontrolled.
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.
Any condition, including other inflammatory diseases or dermatologic conditions, which confounds the ability to interpret data from the study, including other types of psoriasis (ie, erythrodermic, guttate, inverse, or pustular psoriasis), other than plaque psoriasis.
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.
Pregnant or breast feeding.
Active substance abuse or a history of substance abuse within 6 months prior to signing the informed consent.
Malignancy or history of malignancy, except for:
1. treated (ie, cured) basal cell or squamous cell in situ skin carcinomas;
2. treated (ie, 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.
Topical therapy within 2 weeks of randomization (including, but not limited to, topical corticosteroids, retinoids or vitamin D analog preparations, tacrolimus, pimecrolimus, or anthralin/dithranol). Use of phototherapy within 4 weeks prior to randomization.
Use of any investigational drug within 4 weeks prior to randomization, or 5 pharmacokinetic/pharmacodynamic half-lives, if known (whichever is longer).
Prolonged sun exposure or use of tanning booths, which may confound the ability to interpret data from the study.
Prior treatment with apremilast.

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Apremilast

Placebo

Arm Description

Apremilast 30 mg tablets orally twice daily (BID) weeks 0 to 52.

Placebo tablets BID during Weeks 0 to 16; at week 16, placebo participants were switched to apremilast 30 mg tablets BID for 36 weeks (from week 16 to week 52)

Outcomes

Primary Outcome Measures

Mean Percentage Change From Baseline in the Product of BSA (%) and the sPGA Which is Considered as the Total Psoriasis Severity Index at Week 16

BSA is a measurement of involved skin. The overall BSA affected by psoriasis is estimated based on the palm area of the participant's hand (entire palmar surface or "handprint" including the fingers), which equates to approximately 1% of total body surface area. The sPGA is a 6-point scale ranging from 0 (clear), 1 (almost clear), 2 (mild), 3 (moderate), to 4 (severe), 5 (very severe) incorporating a separate assessment of the severity of the three primary signs of the plaques of all involved areas: erythema, scaling and plaque elevation with an overall sPGA calculated as (E + I + D)/3. Scores for each assessment are rounded to the nearest whole number to result in the final score. The range of BSA*sPGA mean percentage change from baseline to week 16 (end of phase) were -100 to 344.4 and -100 to 100 for the placebo and apremilast groups respectively. Higher scores represented worse outcomes.

Secondary Outcome Measures

Mean Change From Baseline in the Dermatology Life Quality Index (DLQI) Total Score at Week 16

DLQI is a simple, compact, and practical 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 participant 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 is derived by summing all item scores, which has a possible range of 0 to 30, with 30 corresponding to the worst quality of life, and 0 corresponding to the best.

Percentage of Participants Who Achieved a sPGA Score of Clear (0) or Almost Clear (1) at Week 16 From Baseline

The sPGA is an assessment by the investigator of the overall disease severity at the time of evaluation. Erythema (E), induration (I), and desquamation (D) are scored on a 6-point scale, ranging from 0 (clear) to 5 (very severe), with an overall sPGA calculated as (E + I + D)/3. Scores for each assessment are averaged and rounded to the nearest whole number to result in the final sPGA score.

Percentage of Participants Who Achieved a Clear (0) or Very Mild (1) on Patient Global Assessment (PtGA) Scale at Week 16 From Baseline

The PtGA response rate is defined as the percentage of participants achieving 0 (clear) or 1 (very mild) on the PtGA scale at Week 16. The PtGA is the assessment by the participant of the overall disease severity at the time of evaluation. The PtGA is a 5-point scale ranging from 0 (clear) to 4 (severe).

Mean Change From Baseline in Pruritus Visual Analog Scale (VAS)

The Pruritus VAS assessment was conducted at the baseline visit and each post-baseline visit. The participant was asked to place a vertical stroke on a 100 mm VAS on which the left-hand boundary (0) represents no itch, and the right-hand boundary (100) represents itch as severe as can be imagined. The distance from the mark to the left-hand boundary will be recorded. The Pruritus VAS score ranges from 0 to 100. Higher scores correspond to more severe symptom.

Percentage of Participants With Scalp Psoriasis Who Achieved a Clear (0) or Minimal (1) on Scalp Physician's Global Assessment (ScPGA) Scale at Week 16.

The ScPGA assessed scalp involvement, if present at baseline. The 6-point ScPGA scale includes three dimensions (Plaque Thickening, Scaling, and Erythema) and a global assessment. Scores range from 0 (clear), 1 (minimal), 2 (mild), 3 (moderate), 4 (severe), to 5 (very severe). Analysis of ScPGA was restricted to the participants with scalp involvement at baseline.

Treatment Satisfaction Questionnaire for Medication (TSQM) Version II at Week 16

The TSQM version II is an 11-question self-administered instrument to understand a participation's satisfaction with the current therapy. The TSQM scale comprises four domains, on which participants evaluate their medication (i.e., effectiveness, side effects, convenience and global satisfaction. TSQM scores range from 0 to 100 for each domain; a higher score mean indicates higher satisfaction with treatment.

Treatment Satisfaction Questionnaire for Medication (TSQM) Version II at Week 52

The TSQM version II is an 11-question self-administered instrument to understand a participants satisfaction on the current therapy. The TSQM scale comprises four domains, on which participants evaluate their medication (i.e., effectiveness, side effects, convenience and global satisfaction. TSQM scores range from 0 to 100 for each domain; a higher score indicates higher satisfaction with treatment.

Mean Percentage Change From Baseline in Psoriasis Area Severity Index Score (PASI) at Week 16

The PASI score is a measure of psoriatic disease severity taking into account qualitative lesion characteristics (erythema, thickness, and scaling) and degree of skin surface area involvement on defined anatomical regions. Erythema, thickness, and scaling are scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement). PASI scores range from 0 to 72, with higher scores reflecting greater disease severity.

Percentage of Participants Who Achieved at Least a 50% Improvement (Response) in the Psoriasis Area and Severity Index (PASI)-50 From Baseline at Week 16.

Percentage of Participants Who Achieved at Least a 75% Improvement (Response) in the Psoriasis Area and Severity Index (PASI)-75 From Baseline at Week 16

Mean Percentage Change From Baseline in the Product of BSA (%) x sPGA at Week 52

Percentage of Participants With Scalp Psoriasis Who Were Initially Randomized to Apremilast and Maintained the Scalp Physician's Global Assessment (ScPGA) Response From Week 16 to Week 52.

The ScPGA will assess scalp involvement, if present at baseline. The 6-point ScPGA scale includes three dimensions (Plaque Thickening, Scaling, and Erythema) and a global assessment with scores range from 0 (clear), 1 (minimal), 2 (mild), 3 (moderate), 4 (severe), to 5 (very severe). Analysis of ScPGA is restricted to the participants with scalp involvement at baseline.

Number of Participants Who Experienced Treatment-Emergent Adverse Events (TEAEs) During the Placebo Controlled Phase

Treatment-Emergent Adverse Events (TEAEs) are defined as any AEs that begin or worsen on or after the start of study drug through 28 days after the last dose of study drug or study treatment discontinuation date, whichever was later. A serious AE (SAE) is any untoward adverse event 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 the patient or may require intervention to prevent one of the outcomes listed above.

Number of Participants Who Experienced Treatment-emergent Adverse Events (TEAEs) During the Apremilast-Exposure Phase

Full Information

NCT ID

NCT02425826

First Posted

April 3, 2015

Last Updated

June 1, 2023

Sponsor

Amgen

1. Study Identification

Unique Protocol Identification Number

NCT02425826

Brief Title

A Phase 4 Study of Efficacy and Safety of Apremilast in Subjects With Moderate Plaque Psoriasis.

Acronym

UNVEIL

Official Title

A Phase 4, Multicenter, Randomized, Placebo-controlled, Double-blind, Study of the Efficacy and Safety of Apremilast (CC-10004) in Subjects With Moderate Plaque Psoriasis

Study Type

Interventional

2. Study Status

Record Verification Date

April 2020

Overall Recruitment Status

Completed

Study Start Date

April 20, 2015 (Actual)

Primary Completion Date

February 12, 2016 (Actual)

Study Completion Date

November 22, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Amgen

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

This study will evaluate the clinical efficacy, the patients quality of life, and safety of oral apremilast 30 mg twice daily (BID) compared to placebo, in adult patients with moderate plaque psoriasis during the 16 week Placebo controlled Phase and then upto 1 year in the Extension Phase of the trial.

Detailed Description

This is a Phase 4, multicenter, randomized, placebo-controlled, double-blind study of the efficacy and safety of apremilast in subjects with moderate plaque psoriasis. 221 participants were randomized 2 (apremilast):1 (placebo) at approximately 25 sites in the United States. Those randomized to the apremilast treatment group received apremilast 30 mg tablets orally twice daily for 52 weeks. Those randomized to the placebo treatment group received placebo tablets (identical in appearance to the apremilast 30 mg tablets) orally twice daily (BID) for 16 weeks. Beginning Week 16, those initially randomized to placebo were switched to receive apremilast 30 mg BID for an additional 36 weeks (52 weeks total). Study enrolled adult patients with stable moderate plaque psoriasis, who are naïve to systemic psoriasis treatments.

6. Conditions and Keywords

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

Parapsoriasis

Keywords

Parapsoriasis, Plaque Psoriasis, CC-10004, Apremilast, Moderate Plaque Psoriasis, Safety

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

221 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Apremilast

Arm Type

Experimental

Arm Description

Apremilast 30 mg tablets orally twice daily (BID) weeks 0 to 52.

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 36 weeks (from week 16 to week 52)

Intervention Type

Drug

Intervention Name(s)

Apremilast

Other Intervention Name(s)

CC-10004, Otzela

Intervention Description

Apremilast 30 mg tablets orally twice daily (BID) weeks 0 to 52.

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Participants randomized to the placebo treatment group received placebo tablets (identical in appearance to the apremilast 30 mg tablets) orally BID for from weeks 0-16.

Intervention Type

Drug

Intervention Name(s)

Placebo-Apremilast

Other Intervention Name(s)

Otezla, CC-10004

Intervention Description

At Week 16, those randomized to placebo were switched to apremilast 30mg BID for an additional 36 weeks (52 weeks total)

Primary Outcome Measure Information:

Title

Mean Percentage Change From Baseline in the Product of BSA (%) and the sPGA Which is Considered as the Total Psoriasis Severity Index at Week 16

Description

Time Frame

Baseline to Week 16 (end of phase)

Secondary Outcome Measure Information:

Title

Mean Change From Baseline in the Dermatology Life Quality Index (DLQI) Total Score at Week 16

Description

Time Frame

Baseline to Week 16 (end of phase)

Title

Percentage of Participants Who Achieved a sPGA Score of Clear (0) or Almost Clear (1) at Week 16 From Baseline

Description

Time Frame

Baseline to Week 16 (end of phase)

Title

Percentage of Participants Who Achieved a Clear (0) or Very Mild (1) on Patient Global Assessment (PtGA) Scale at Week 16 From Baseline

Description

Time Frame

Baseline to Week 16 (end of phase)

Title

Mean Change From Baseline in Pruritus Visual Analog Scale (VAS)

Description

Time Frame

Baseline to Weeks 1 and 16 (end of phase)

Title

Percentage of Participants With Scalp Psoriasis Who Achieved a Clear (0) or Minimal (1) on Scalp Physician's Global Assessment (ScPGA) Scale at Week 16.

Description

Time Frame

Baseline to Week 16 (end of phase)

Title

Treatment Satisfaction Questionnaire for Medication (TSQM) Version II at Week 16

Description

Time Frame

Baseline to Week 16 (end of phase)

Title

Treatment Satisfaction Questionnaire for Medication (TSQM) Version II at Week 52

Description

Time Frame

Baseline to week 52

Title

Mean Percentage Change From Baseline in Psoriasis Area Severity Index Score (PASI) at Week 16

Description

Time Frame

Baseline to Week 16 (end of phase)

Title

Percentage of Participants Who Achieved at Least a 50% Improvement (Response) in the Psoriasis Area and Severity Index (PASI)-50 From Baseline at Week 16.

Description

Time Frame

Baseline to Week 16 (end of phase)

Title

Percentage of Participants Who Achieved at Least a 75% Improvement (Response) in the Psoriasis Area and Severity Index (PASI)-75 From Baseline at Week 16

Description

Time Frame

Baseline to Week 16 (end of phase)

Title

Mean Percentage Change From Baseline in the Product of BSA (%) x sPGA at Week 52

Description

Time Frame

Baseline to Week 52

Title

Percentage of Participants With Scalp Psoriasis Who Were Initially Randomized to Apremilast and Maintained the Scalp Physician's Global Assessment (ScPGA) Response From Week 16 to Week 52.

Description

Time Frame

Week 16 to Week 52

Title

Number of Participants Who Experienced Treatment-Emergent Adverse Events (TEAEs) During the Placebo Controlled Phase

Description

Time Frame

From first dose of study drug to Week 16; maximum duration of exposure was 20.1 weeks during placebo controlled phase

Title

Number of Participants Who Experienced Treatment-emergent Adverse Events (TEAEs) During the Apremilast-Exposure Phase

Description

Time Frame

Date of first dose of apremilast during the placebo controlled phase or date of first dose of apremilast after week 16; overall maximum duration of exposure was 61.5 weeks during apremilast-exposure phase

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Males or females, ≥ 18 years of age at the time of signing the informed consent document. Understand and voluntarily sign an informed consent document prior to any study related assessments/procedures being conducted. Able to adhere to the study visit schedule and other protocol requirements. Diagnosis of chronic plaque psoriasis for at least 6 months prior to signing the informed consent. Have moderate plaque psoriasis at screening and baseline as defined by BSA (Body Surface Area)5% to 10% and sPGA (Physician's Global Assessment) 3 (moderate) based on a 0 to 5 point scale Must be in general good health (except for psoriasis) as judged by the investigator, based on medical history, physical examination, and clinical laboratories. No prior exposure to systemic treatments or biologics for the treatment of psoriatic arthritis, psoriasis, or any other indication that could impact the assessment of psoriasis. Females of childbearing potential (FCBP)must have a negative pregnancy test at Screening and Baseline. While on investigational product 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. Male subjects (including those who have had a vasectomy) who engage in activity in which conception is possible must use barrier contraception (male latex condom or nonlatex condom NOT made out of natural [animal] membrane [for example, polyurethane]) while on investigational product and for at least 28 days after the last dose of investigational product Exclusion Criteria: Other than psoriasis, any clinically significant (as determined by the Investigator) cardiac, endocrinologic, pulmonary, neurologic, psychiatric, hepatic, renal, hematologic,immunologic disease, or other major disease that is currently uncontrolled. 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. Any condition, including other inflammatory diseases or dermatologic conditions, which confounds the ability to interpret data from the study, including other types of psoriasis (ie, erythrodermic, guttate, inverse, or pustular psoriasis), other than plaque psoriasis. 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. Pregnant or breast feeding. Active substance abuse or a history of substance abuse within 6 months prior to signing the informed consent. Malignancy or history of malignancy, except for: treated (ie, cured) basal cell or squamous cell in situ skin carcinomas; treated (ie, 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. Topical therapy within 2 weeks of randomization (including, but not limited to, topical corticosteroids, retinoids or vitamin D analog preparations, tacrolimus, pimecrolimus, or anthralin/dithranol). Use of phototherapy within 4 weeks prior to randomization. Use of any investigational drug within 4 weeks prior to randomization, or 5 pharmacokinetic/pharmacodynamic half-lives, if known (whichever is longer). Prolonged sun exposure or use of tanning booths, which may confound the ability to interpret data from the study. Prior treatment with apremilast.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Organizational Affiliation

Amgen

Official's Role

Study Director

Facility Information:

Facility Name

UAB at Birmingham - The Kirklin Clinic

City

Birmingham

State/Province

Alabama

ZIP/Postal Code

35233

Country

United States

Facility Name

Center For Dermatology

City

Fremont

State/Province

California

ZIP/Postal Code

94538

Country

United States

Facility Name

Dermatology Research Associates

City

Los Angeles

State/Province

California

ZIP/Postal Code

90045

Country

United States

Facility Name

Blue Harbor Dermatology

City

Newport Beach

State/Province

California

ZIP/Postal Code

92663

Country

United States

Facility Name

Center for Dermatology and Laser Surgery

City

Sacramento

State/Province

California

ZIP/Postal Code

95819

Country

United States

Facility Name

East Bay Rheumatology Medical

City

San Leandro

State/Province

California

ZIP/Postal Code

94578

Country

United States

Facility Name

Tien Q. Nguyen MD Inc

City

Tustin

State/Province

California

ZIP/Postal Code

92780

Country

United States

Facility Name

UConn Health Center

City

Farmington

State/Province

Connecticut

ZIP/Postal Code

06030

Country

United States

Facility Name

Dermatology Associates

City

Panama City

State/Province

Florida

ZIP/Postal Code

32405-4542

Country

United States

Facility Name

USF Health Faculty Office Building-FOB

City

Tampa

State/Province

Florida

ZIP/Postal Code

33612

Country

United States

Facility Name

Forward Clinical Trials Inc

City

Tampa

State/Province

Florida

ZIP/Postal Code

33624

Country

United States

Facility Name

Dermatologic Surgery Specialists, P.C.

City

Macon

State/Province

Georgia

ZIP/Postal Code

31217

Country

United States

Facility Name

Shideler Clinical Research Center

City

Carmel

State/Province

Indiana

ZIP/Postal Code

46032

Country

United States

Facility Name

Dermatology Specialists, PSC

City

Louisville

State/Province

Kentucky

ZIP/Postal Code

40202

Country

United States

Facility Name

DermResearch, PLLC

City

Louisville

State/Province

Kentucky

ZIP/Postal Code

40217

Country

United States

Facility Name

Lawrence Green, MD, LLC

City

Rockville

State/Province

Maryland

ZIP/Postal Code

20850

Country

United States

Facility Name

Henry Ford Hospital

City

Detroit

State/Province

Michigan

ZIP/Postal Code

48202

Country

United States

Facility Name

Las Vegas Skin and Cancer Clinics

City

Las Vegas

State/Province

Nevada

ZIP/Postal Code

89052

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

Garden City Dermatology

City

Garden City

State/Province

New York

ZIP/Postal Code

11530

Country

United States

Facility Name

Sadick Research Group

City

New York

State/Province

New York

ZIP/Postal Code

10075

Country

United States

Facility Name

Dermatology Associates of Rochester PC

City

Rochester

State/Province

New York

ZIP/Postal Code

14623

Country

United States

Facility Name

University of Cincinnati

City

Cincinnati

State/Province

Ohio

ZIP/Postal Code

45267-0501

Country

United States

Facility Name

Dermatology and Laser Center of Charleston

City

Charleston

State/Province

South Carolina

ZIP/Postal Code

29414

Country

United States

Facility Name

University of Utah School of Medicine

City

Salt Lake City

State/Province

Utah

ZIP/Postal Code

84132

Country

United States

Facility Name

Dermatology Consultants, Inc.

City

Lynchburg

State/Province

Virginia

ZIP/Postal Code

24501

Country

United States

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

34255891

Citation

Reich K, Mrowietz U, Menter A, Griffiths CEM, Bagel J, Strober B, Nunez Gomez N, Shi R, Guerette B, Lebwohl M. Effect of baseline disease severity on achievement of treatment target with apremilast: results from a pooled analysis. J Eur Acad Dermatol Venereol. 2021 Dec;35(12):2409-2414. doi: 10.1111/jdv.17520. Epub 2021 Aug 23.

Results Reference

background

PubMed Identifier

29462231

Citation

Stein Gold L, Bagel J, Lebwohl M, Jackson JM, Chen R, Goncalves J, Levi E, Duffin KC. Efficacy and Safety of Apremilast in Systemic- and Biologic-Naive Patients With Moderate Plaque Psoriasis: 52-Week Results of UNVEIL. J Drugs Dermatol. 2018 Feb 1;17(2):221-228.

Results Reference

derived

Learn more about this trial

A Phase 4 Study of Efficacy and Safety of Apremilast in Subjects With Moderate Plaque Psoriasis.

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A Phase 4 Study of Efficacy and Safety of Apremilast in Subjects With Moderate Plaque Psoriasis. (UNVEIL)

Parapsoriasis

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial