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A Phase 3 Study in Participants With Moderate to Severe Psoriasis (UNCOVER-2) (UNCOVER-2)

Primary Purpose

Psoriasis

Status

Completed

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

80 mg ixekizumab Dosing Regimen

50 mg etanercept

Placebo

About this trial

This is an interventional treatment trial for Psoriasis

Eligibility Criteria

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

Inclusion Criteria:

Present with chronic plaque psoriasis based on a confirmed diagnosis of chronic plaque psoriasis for at least 6 months prior to first dose of study drug
At least 10% Body Surface Area (BSA) of psoriasis at screening and at first dose of study drug
Static Physician Global Assessment (sPGA) score of at least 3 and Psoriasis Area and Severity Index (PASI) score of at least 12 at screening and at first dose of study drug
Candidate for phototherapy and/or systemic therapy
Men must agree to use a reliable method of birth control or remain abstinent during the study
Women must agree to use reliable birth control or remain abstinent during the study and for at least 12 weeks after stopping treatment

Exclusion Criteria:

Pustular, erythrodermic, and/or guttate forms of psoriasis
History of drug-induced psoriasis
Prior use of etanercept
Clinically significant flare of psoriasis during the 12 weeks prior to randomization
Concurrent or recent use of any biologic agent
Received non-biologic systemic psoriasis therapy or phototherapy (including psoralens and ultraviolet A [PUVA], ultraviolet B [UVB]) within the previous 4 weeks; or had topical psoriasis treatment within the previous 2 weeks prior to randomization
Cannot avoid excessive sun exposure or use of tanning booths for at least 4 weeks prior to randomization and during the study
Have participated in any study with interleukin 17 (IL-17) antagonists, including ixekizumab
Serious disorder or illness other than plaque psoriasis
Serious infection within the last 3 months
Breastfeeding or nursing (lactating) women

Sites / Locations

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For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Active Comparator

Placebo Comparator

Arm Label

80 mg ixekizumab Dosing Regimen 1

80 mg ixekizumab Dosing Regimen 2

80 mg ixekizumab Dosing Regimen 3

50 mg etanercept

Placebo for ixekizumab

Arm Description

Administered by two 80 mg subcutaneous (SC) injections at Week 0, then one 80 mg SC injection per Dosing Regimen 1 until Week 12. At Week 12, ixekizumab responders are re-randomized to placebo, Dosing Regimen 2 or Dosing Regimen 3. Ixekizumab non-responders are assigned to Dosing Regimen 2.

Administered by two 80 mg SC injections at Week 0, then one 80 mg SC injection per Dosing Regimen 2 until Week 12. At Week 12, ixekizumab responders are re-randomized to placebo, Dosing Regimen 2 or Dosing Regimen 3. Ixekizumab non-responders are assigned to Dosing Regimen 2.

Dosing Regimen 3 is not used until Week 12. At Week 12, ixekizumab responders re-randomized to this arm will receive Dosing Regimen 3.

Administered by one 50 mg SC injection twice weekly starting at Week 0 up to Week 12. At Week 12, etanercept responders are assigned to placebo, and nonresponders to Dosing Regimen 2.

Placebo for ixekizumab administered by two SC injections at Week 0, then one SC injection per Dosing Regimen 1 until Week 12. At Week 12, placebo responders are assigned to placebo, and nonresponders to Dosing Regimen 2. Placebo for etanercept administered by one SC injection twice weekly starting at Week 0 up to Week 12 was used to blind etanercept injections for Dosing Regimen 1, Dosing Regimen 2, and Placebo Comparator groups.

Outcomes

Primary Outcome Measures

Percentage of Participants With a Static Physician Global Assessment (sPGA) of (0,1) (Efficacy of Ixekizumab in Participants With Moderate to Severe Chronic Plaque Psoriasis. Measure: Static Physician Global Assessment [sPGA])

The sPGA is the physician's determination of the participant's Psoriasis (Ps) lesions overall at a given time point. Lesions were categorized by descriptions for induration, erythema, and scaling. Participant's Ps was assessed as 0 (clear), 1 (minimal), 2 (mild), 3 (moderate), 4 (severe), or 5 (very severe). An sPGA responder was defined as having a post-baseline sPGA score of "0" or "1" with at least a 2-point improvement from baseline.

Percentage of Participants Achieving Psoriasis Area and Severity Index (PASI) ≥75% (PASI75) Improvement (Efficacy of Ixekizumab in Participants With Moderate to Severe Chronic Plaque Psoriasis. Measure: Psoriasis Area and Severity Index [PASI])

The PASI combines the extent of body surface involvement in 4 anatomical regions (head, trunk, arms, and legs). For each region the percent area of skin involved was estimated from 0 (0%) to 6 (90%-100%) and severity was estimated by clinical signs of erythema, induration and scaling with a scores range from 0 (no involvement) to 4 (severe involvement). Each area is scored separately and the scores then combined for the final PASI. Final PASI calculated as: sum of severity parameters for each region * area score * weighing factor (head [0.1], upper limbs [0.2], trunk [0.3], lower limbs [0.4]). Overall scores range from 0 (no Ps) to 72 (the most severe disease). Participants achieving PASI75 were defined as having an improvement of ≥75% in the PASI score compared to baseline.

Secondary Outcome Measures

Percentage of Participants Achieving an sPGA (0) (Efficacy of Ixekizumab in Participants With Moderate to Severe Chronic Plaque Psoriasis. Measure: [sPGA])

The sPGA is the physician's determination of the participant's Ps lesions overall at a given time point. Lesions were categorized by descriptions for induration, erythema, and scaling. Participant's Ps was assessed as 0 (clear), 1 (minimal), 2 (mild), 3 (moderate), 4 (severe), or 5 (very severe).

Percentage of Participants Achieving PASI 90% (PASI90) (Efficacy of Ixekizumab in Participants With Moderate to Severe Chronic Plaque Psoriasis. Measure: [PASI])

The PASI combines the extent of body surface involvement in 4 anatomical regions (head, trunk, arms, and legs). For each region the percent area of skin involved was estimated from 0 (0%) to 6 (90%-100%) and severity was estimated by clinical signs of erythema, induration and scaling with a scores range from 0 (no involvement) to 4 (severe involvement). Each area is scored by itself and the scores were then combined for the final PASI. Final PASI calculated as: sum of severity parameters for each region * area score * weighing factor (head [0.1], upper limbs [0.2], trunk [0.3], lower limbs [0.4]). Overall scores range from 0 (no Ps) to 72 (the most severe disease). Participants achieving PASI90 were defined as having an improvement of ≥90% in the PASI score compared to baseline.

Percentage of Participants Achieving PASI 100% (PASI100)

The PASI combines the extent of body surface involvement in 4 anatomical regions (head, trunk, arms, and legs). For each region the percent area of skin involved was estimated from 0 (0%) to 6 (90%-100%) and severity was estimated by clinical signs of erythema, induration and scaling with a scores range from 0 (no involvement) to 4 (severe involvement). Each area is scored by itself and the scores were then combined for the final PASI. Final PASI calculated as: sum of severity parameters for each region * area score * weighing factor (head [0.1], upper limbs [0.2], trunk [0.3], lower limbs [0.4]). Overall scores range from 0 (no Ps) to 72 (the most severe disease). Participants achieving PASI100 were defined as having an improvement of 100% in the PASI score compared to baseline.

Percentage of Participants Maintaining an sPGA (0,1) From Week 12 After Re-randomization at Start of Maintenance Dosing Period to Week 60

Percentage of Participants With Itching Severity (Itch Numeric Rating Scale [NRI]) Score ≥4 Point Reduction From Baseline

The Itch Numeric Rating Scale (NRS) is a participant-administered, 11-point horizontal scale anchored at 0 and 10, with 0 representing "no itch" and 10 representing "worst itch imaginable". The number and percentage of participants achieving an Itch NRS ≥4 point reduction from baseline were presented by treatment group for participants who had a baseline Itch NRS ≥4. Describes worst level of itching in past 24 hours.

Change From Baseline in Dermatology-Specific Quality of Life Index (DLQI) Total Score (Quality of Life and Outcome Assessments. Measures: Participant Reported Outcomes [PRO])

DLQI is a participant-administered, 10-question, validated, quality-of-life questionnaire that covers 6 domains, including symptoms and feelings, daily activities, leisure, work and school, personal relationships, and treatment. Response categories include 0 (not at all), 1 (a little), 2 (a lot), and 3 (very much); and "not relevant" and unanswered responses were scored as "0." Total scores range from 0 to 30, with higher score indicating greater quality of life impairment. A 5-point change from baseline is considered clinically relevant. Least Squares (LS) Mean change from baseline was calculated using mixed model repeated measures (MMRM) with baseline score as covariate, treatment, pooled center, visit and treatment-by-visit interaction as fixed effects.

Change From Baseline in Nail Psoriasis Severity Index (NAPSI)

The NAPSI scale is used to evaluate the severity of fingernail bed Ps and fingernail matrix Ps. The fingernail bed and fingernail matrix are each divided into quadrants. Each fingernail is given a score for fingernail bed Ps and fingernail matrix Ps, each with scores of 0 (none) to 4 (Ps in all 4 quadrants), depending on the presence (score of 1) or absence (score of 0) of Ps in each quadrant of the fingernail bed or matrix. The NAPSI score of a fingernail is the sum of scores from each quadrant of the fingernail bed and fingernail matrix (maximum of 8). The total NAPSI score equals the sum of all fingernails and ranges from 0 to 80 with higher scores indicating more severe Ps. LS mean change from baseline in NAPSI score was calculated using MMRM with baseline score as covariate, treatment, pooled center, visit and treatment-by-visit interaction as fixed effects.

Change From Baseline Psoriasis Scalp Severity Index (PSSI) Score

The PSSI is a physician assessment of erythema, induration and desquamation and percent of scalp that is covered with a scores range from 0 (none) to 4 (very severe). The composite score is derived from the sum of scores for erythema, induration, and desquamation multiplied by the score recorded for the extent of the scalp area involved, 1 (<10%) to 6 (90%-100%) with a total scores range from 0 (less severity) to 72 (more severity), with lower scores indicating less severity. LS mean change from baseline in PSSI score was calculated using MMRM with baseline score as a covariate, treatment, pooled center, visit, and treatment-by-visit interaction as fixed effects.

Change From Baseline in Percent of Body Surface Area (BSA) Involvement of Psoriasis

The percentage involvement of psoriasis on each participant's body surface area was assessed by the investigator on a continuous scale from 0% (no involvement) to 100% (full involvement), in which 1% corresponds to the size of the participant's hand including palm, fingers and thumb. LS mean change from baseline in BSA was calculated using MMRM with baseline BSA as a covariate, treatment, pooled center, visit, and treatment-by-visit interaction as fixed effects.

Change From Baseline in Quick Inventory of Depressive Symptomatology-Self Report 16 Items (QIDS-SR16) Total Score

The QIDS-SR16 is a self-administered, 16-item instrument in which a participant is asked to consider each statement as it relates to the way they have felt for the past 7 days. There is a 4-point scale for each item ranging from 0 (best) to 3 (worst). The 16 items are scored to give 9 individual depression domains (sad mood, concentration, self-criticism, suicidal ideation, interest, energy/fatigue, sleep disturbance [initial, middle and late insomnia or hypersomnia], decrease/increase in appetite/weight, and psychomotor agitation/retardation), which are summed to give a single score ranging from 0 to 27, with higher scores denoting greater symptom severity. LS mean change from baseline in total QIDS-SR16 score was calculated using the analysis of covariance (ANCOVA) model with treatment, pooled center and baseline QIDS total score.

Change From Baseline in All Scores of the Work Productivity Activity Impairment Questionnaire-Psoriasis (WPAI-PSO)

The (WPAI-PSO) is a 6-item instrument used to assess the impact of psoriasis on productivity impairment within the past 7 days and has four domains, namely, absenteeism, presenteeism (reduced productivity while at work), an overall work impairment score, and impairment in daily activities performed outside of work. Four scores are derived as percentages: absenteeism, presenteeism, overall work impairment (absenteeism and presenteeism), and impairment in activities performed outside of work. Percentage is calculated as each score * 100 and ranges from 0 to 100; greater scores indicate greater impairment. LS mean change from baseline in each WPAI-PSO score was calculated using the (ANCOVA) model with treatment, pooled center and baseline WPAI value.

Change From Baseline in Medical Outcomes Study 36-Item Short Form Health Survey (SF-36) and Physical Component Summary (PCS) and Mental Component Summary (MCS) Scores

The SF-36 is a participant-reported outcome measure evaluating participant's health status. It comprises 36 items covering 8 domains: physical functioning, role physical, role emotional, bodily pain, vitality, social functioning, mental health, and general health. Items are answered on Likert scales of varying lengths. The 8 domains are regrouped into the PCS and MCS scores. The summary scores range from 0 to 100, with higher scores indicating better levels of function and/or better health. In this study, the SF-36 acute version was used, which has a 1 week recall period. LS mean change from baseline in SF-36 score was calculated using the ANCOVA model with treatment, pooled center and baseline SF-36 score.

Change From Baseline in Patient's Global Assessment (PatGA) of Disease Severity

The Patient's Global Assessment of Disease Severity is a single-item patient reported outcome measure on which participants are asked to rate by circling a number on a 0 to 5 NRS the severity of their psoriasis "today" from 0 (Clear) = no psoriasis to 5 (Severe) = the worst their psoriasis has ever been. LS mean change from baseline in patient's global assessment of disease severity score was calculated using (MMRM) with baseline score as a covariate, treatment, pooled center, visit, and treatment-by-visit interaction as fixed effects.

Percentage of Participants Achieving Palmoplantar PASI (PPASI) of ≥50% (PPASI50), ≥75% (PPASI75) or 100% (PPASI100) Improvement

The Palmoplantar PASI is a composite score derived from the sum scores for erythema, induration, and desquamation multiplied by a score for the extent of palm and sole area involvement, ranging from 0 to 72. The PPASI was only assessed if participants have palmoplantar psoriasis at baseline. Participants achieving PPASI50, PPASI75 or PASI100 were defined as having an improvement of at least 50%, 75%, or of 100%, respectively, in the PPASI scores compared to baseline.

Percentage of Participants With Anti-Ixekizumab Antibodies

Percentage of participants with treatment-emergent positive anti-ixekizumab antibodies was summarized by treatment group. Percentage was calculated based on the # of evaluable participants and was calculated by number of participants with treatment-emergent positive anti-ixekizumab antibodies / number of evaluable participants * 100%.

Full Information

NCT ID

NCT01597245

First Posted

May 10, 2012

Last Updated

June 9, 2020

Sponsor

Eli Lilly and Company

1. Study Identification

Unique Protocol Identification Number

NCT01597245

Brief Title

A Phase 3 Study in Participants With Moderate to Severe Psoriasis (UNCOVER-2)

Acronym

UNCOVER-2

Official Title

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study Comparing the Efficacy and Safety of LY2439821 to Etanercept and Placebo in Patients With Moderate-to-Severe Plaque Psoriasis

Study Type

Interventional

2. Study Status

Record Verification Date

August 2019

Overall Recruitment Status

Completed

Study Start Date

May 18, 2012 (Actual)

Primary Completion Date

March 25, 2014 (Actual)

Study Completion Date

June 18, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Eli Lilly and Company

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

This study will assess the safety and efficacy of ixekizumab (LY2439821) compared to etanercept and placebo in participants with moderate to severe chronic plaque psoriasis.

6. Conditions and Keywords

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

Psoriasis

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

1224 (Actual)

8. Arms, Groups, and Interventions

Arm Title

80 mg ixekizumab Dosing Regimen 1

Arm Type

Experimental

Arm Description

Arm Title

80 mg ixekizumab Dosing Regimen 2

Arm Type

Experimental

Arm Description

Arm Title

80 mg ixekizumab Dosing Regimen 3

Arm Type

Experimental

Arm Description

Dosing Regimen 3 is not used until Week 12. At Week 12, ixekizumab responders re-randomized to this arm will receive Dosing Regimen 3.

Arm Title

50 mg etanercept

Arm Type

Active Comparator

Arm Description

Administered by one 50 mg SC injection twice weekly starting at Week 0 up to Week 12. At Week 12, etanercept responders are assigned to placebo, and nonresponders to Dosing Regimen 2.

Arm Title

Placebo for ixekizumab

Arm Type

Placebo Comparator

Arm Description

Intervention Type

Drug

Intervention Name(s)

80 mg ixekizumab Dosing Regimen

Other Intervention Name(s)

LY2439821

Intervention Description

Administered SC

Intervention Type

Drug

Intervention Name(s)

50 mg etanercept

Intervention Description

Administered SC

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Administered SC

Primary Outcome Measure Information:

Title

Description

Time Frame

Week 12

Title

Description

Time Frame

Week 12

Secondary Outcome Measure Information:

Title

Percentage of Participants Achieving an sPGA (0) (Efficacy of Ixekizumab in Participants With Moderate to Severe Chronic Plaque Psoriasis. Measure: [sPGA])

Description

Time Frame

Week 12

Title

Percentage of Participants Achieving PASI 90% (PASI90) (Efficacy of Ixekizumab in Participants With Moderate to Severe Chronic Plaque Psoriasis. Measure: [PASI])

Description

The PASI combines the extent of body surface involvement in 4 anatomical regions (head, trunk, arms, and legs). For each region the percent area of skin involved was estimated from 0 (0%) to 6 (90%-100%) and severity was estimated by clinical signs of erythema, induration and scaling with a scores range from 0 (no involvement) to 4 (severe involvement). Each area is scored by itself and the scores were then combined for the final PASI. Final PASI calculated as: sum of severity parameters for each region * area score * weighing factor (head [0.1], upper limbs [0.2], trunk [0.3], lower limbs [0.4]). Overall scores range from 0 (no Ps) to 72 (the most severe disease). Participants achieving PASI90 were defined as having an improvement of ≥90% in the PASI score compared to baseline.

Time Frame

Week 12

Title

Percentage of Participants Achieving PASI 100% (PASI100)

Description

The PASI combines the extent of body surface involvement in 4 anatomical regions (head, trunk, arms, and legs). For each region the percent area of skin involved was estimated from 0 (0%) to 6 (90%-100%) and severity was estimated by clinical signs of erythema, induration and scaling with a scores range from 0 (no involvement) to 4 (severe involvement). Each area is scored by itself and the scores were then combined for the final PASI. Final PASI calculated as: sum of severity parameters for each region * area score * weighing factor (head [0.1], upper limbs [0.2], trunk [0.3], lower limbs [0.4]). Overall scores range from 0 (no Ps) to 72 (the most severe disease). Participants achieving PASI100 were defined as having an improvement of 100% in the PASI score compared to baseline.

Time Frame

Week 12

Title

Percentage of Participants Maintaining an sPGA (0,1) From Week 12 After Re-randomization at Start of Maintenance Dosing Period to Week 60

Description

Time Frame

Week 60

Title

Percentage of Participants With Itching Severity (Itch Numeric Rating Scale [NRI]) Score ≥4 Point Reduction From Baseline

Description

Time Frame

Week 12

Title

Change From Baseline in Dermatology-Specific Quality of Life Index (DLQI) Total Score (Quality of Life and Outcome Assessments. Measures: Participant Reported Outcomes [PRO])

Description

Time Frame

Baseline, Week 12

Title

Change From Baseline in Nail Psoriasis Severity Index (NAPSI)

Description

Time Frame

Baseline, Week 12

Title

Change From Baseline Psoriasis Scalp Severity Index (PSSI) Score

Description

Time Frame

Baseline, Week 12

Title

Change From Baseline in Percent of Body Surface Area (BSA) Involvement of Psoriasis

Description

Time Frame

Baseline, Week 12

Title

Change From Baseline in Quick Inventory of Depressive Symptomatology-Self Report 16 Items (QIDS-SR16) Total Score

Description

Time Frame

Baseline, Week 12

Title

Change From Baseline in All Scores of the Work Productivity Activity Impairment Questionnaire-Psoriasis (WPAI-PSO)

Description

Time Frame

Baseline, Week 12

Title

Change From Baseline in Medical Outcomes Study 36-Item Short Form Health Survey (SF-36) and Physical Component Summary (PCS) and Mental Component Summary (MCS) Scores

Description

Time Frame

Baseline, Week 12

Title

Change From Baseline in Patient's Global Assessment (PatGA) of Disease Severity

Description

Time Frame

Baseline, 12 weeks

Title

Percentage of Participants Achieving Palmoplantar PASI (PPASI) of ≥50% (PPASI50), ≥75% (PPASI75) or 100% (PPASI100) Improvement

Description

Time Frame

Week 12

Title

Percentage of Participants With Anti-Ixekizumab Antibodies

Description

Time Frame

Baseline to Week 12

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Present with chronic plaque psoriasis based on a confirmed diagnosis of chronic plaque psoriasis for at least 6 months prior to first dose of study drug At least 10% Body Surface Area (BSA) of psoriasis at screening and at first dose of study drug Static Physician Global Assessment (sPGA) score of at least 3 and Psoriasis Area and Severity Index (PASI) score of at least 12 at screening and at first dose of study drug Candidate for phototherapy and/or systemic therapy Men must agree to use a reliable method of birth control or remain abstinent during the study Women must agree to use reliable birth control or remain abstinent during the study and for at least 12 weeks after stopping treatment Exclusion Criteria: Pustular, erythrodermic, and/or guttate forms of psoriasis History of drug-induced psoriasis Prior use of etanercept Clinically significant flare of psoriasis during the 12 weeks prior to randomization Concurrent or recent use of any biologic agent Received non-biologic systemic psoriasis therapy or phototherapy (including psoralens and ultraviolet A [PUVA], ultraviolet B [UVB]) within the previous 4 weeks; or had topical psoriasis treatment within the previous 2 weeks prior to randomization Cannot avoid excessive sun exposure or use of tanning booths for at least 4 weeks prior to randomization and during the study Have participated in any study with interleukin 17 (IL-17) antagonists, including ixekizumab Serious disorder or illness other than plaque psoriasis Serious infection within the last 3 months Breastfeeding or nursing (lactating) women

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)

Organizational Affiliation

Eli Lilly and Company

Official's Role

Study Director

Facility Information:

Facility Name

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

City

Phoenix

State/Province

Arizona

ZIP/Postal Code

85032

Country

United States

Facility Name

City

Scottsdale

State/Province

Arizona

ZIP/Postal Code

85254

Country

United States

Facility Name

City

Little Rock

State/Province

Arkansas

ZIP/Postal Code

72204

Country

United States

Facility Name

City

Riverside

State/Province

California

ZIP/Postal Code

92505

Country

United States

Facility Name

City

San Diego

State/Province

California

ZIP/Postal Code

92123

Country

United States

Facility Name

City

Denver

State/Province

Colorado

ZIP/Postal Code

80220

Country

United States

Facility Name

City

Farmington

State/Province

Connecticut

ZIP/Postal Code

06030

Country

United States

Facility Name

City

Washington

State/Province

District of Columbia

ZIP/Postal Code

20037

Country

United States

Facility Name

City

Boca Raton

State/Province

Florida

ZIP/Postal Code

33431

Country

United States

Facility Name

City

DeLand

State/Province

Florida

ZIP/Postal Code

32720

Country

United States

Facility Name

City

Jacksonville

State/Province

Florida

ZIP/Postal Code

32204

Country

United States

Facility Name

City

Tampa

State/Province

Florida

ZIP/Postal Code

33612

Country

United States

Facility Name

City

West Palm Beach

State/Province

Florida

ZIP/Postal Code

33409

Country

United States

Facility Name

City

Alpharetta

State/Province

Georgia

ZIP/Postal Code

30022

Country

United States

Facility Name

City

Atlanta

State/Province

Georgia

ZIP/Postal Code

30327

Country

United States

Facility Name

City

Plainfield

State/Province

Indiana

ZIP/Postal Code

46168

Country

United States

Facility Name

City

Overland Park

State/Province

Kansas

ZIP/Postal Code

66215

Country

United States

Facility Name

City

Baton Rouge

State/Province

Louisiana

ZIP/Postal Code

70809

Country

United States

Facility Name

City

Silver Spring

State/Province

Maryland

ZIP/Postal Code

20902

Country

United States

Facility Name

City

Andover

State/Province

Massachusetts

ZIP/Postal Code

01810

Country

United States

Facility Name

City

Worcester

State/Province

Massachusetts

ZIP/Postal Code

01605

Country

United States

Facility Name

City

Saint Louis

State/Province

Missouri

ZIP/Postal Code

63117

Country

United States

Facility Name

City

Paramus

State/Province

New Jersey

ZIP/Postal Code

07652

Country

United States

Facility Name

City

Verona

State/Province

New Jersey

ZIP/Postal Code

07044

Country

United States

Facility Name

City

New York

State/Province

New York

ZIP/Postal Code

10029

Country

United States

Facility Name

City

Wilmington

State/Province

North Carolina

ZIP/Postal Code

28403

Country

United States

Facility Name

City

Norman

State/Province

Oklahoma

ZIP/Postal Code

73071

Country

United States

Facility Name

City

Philadelphia

State/Province

Pennsylvania

ZIP/Postal Code

19103

Country

United States

Facility Name

City

Pittsburgh

State/Province

Pennsylvania

ZIP/Postal Code

15213

Country

United States

Facility Name

City

Greer

State/Province

South Carolina

ZIP/Postal Code

29650

Country

United States

Facility Name

City

Bristol

State/Province

Tennessee

ZIP/Postal Code

37620

Country

United States

Facility Name

City

Knoxville

State/Province

Tennessee

ZIP/Postal Code

37922

Country

United States

Facility Name

City

Arlington

State/Province

Texas

ZIP/Postal Code

76011

Country

United States

Facility Name

City

Austin

State/Province

Texas

ZIP/Postal Code

78705

Country

United States

Facility Name

City

Dallas

State/Province

Texas

ZIP/Postal Code

75230

Country

United States

Facility Name

City

San Antonio

State/Province

Texas

ZIP/Postal Code

78229

Country

United States

Facility Name

City

Webster

State/Province

Texas

ZIP/Postal Code

77598

Country

United States

Facility Name

City

Salt Lake City

State/Province

Utah

ZIP/Postal Code

84132

Country

United States

Facility Name

City

Norfolk

State/Province

Virginia

ZIP/Postal Code

23507

Country

United States

Facility Name

City

Richmond

State/Province

Virginia

ZIP/Postal Code

23294

Country

United States

Facility Name

City

Spokane

State/Province

Washington

ZIP/Postal Code

99204

Country

United States

Facility Name

City

Phillip

State/Province

Australian Capital Territory

ZIP/Postal Code

02606

Country

Australia

Facility Name

City

St. Leonards

State/Province

New South Wales

ZIP/Postal Code

2065

Country

Australia

Facility Name

City

Sydney

State/Province

New South Wales

ZIP/Postal Code

02000

Country

Australia

Facility Name

City

Woolloogabba

State/Province

Queensland

ZIP/Postal Code

4120

Country

Australia

Facility Name

City

Hectorville

State/Province

South Australia

ZIP/Postal Code

05073

Country

Australia

Facility Name

City

Box Hill

State/Province

Victoria

ZIP/Postal Code

3128

Country

Australia

Facility Name

City

Carlton

State/Province

Victoria

ZIP/Postal Code

3053

Country

Australia

Facility Name

City

Feldkirch

ZIP/Postal Code

6807

Country

Austria

Facility Name

City

Graz

ZIP/Postal Code

8036

Country

Austria

Facility Name

City

Innsbruck

ZIP/Postal Code

6020

Country

Austria

Facility Name

City

Vienna

ZIP/Postal Code

A1090

Country

Austria

Facility Name

City

Calgary

State/Province

Alberta

ZIP/Postal Code

T3G 0B4

Country

Canada

Facility Name

City

Edmonton

State/Province

Alberta

ZIP/Postal Code

T5K 1X3

Country

Canada

Facility Name

City

Surrey

State/Province

British Columbia

ZIP/Postal Code

V3R 6A7

Country

Canada

Facility Name

City

Barrie

State/Province

Ontario

ZIP/Postal Code

L4M6L2

Country

Canada

Facility Name

City

Hamilton

State/Province

Ontario

ZIP/Postal Code

L8N1V6

Country

Canada

Facility Name

City

London

State/Province

Ontario

ZIP/Postal Code

N6A 3H7

Country

Canada

Facility Name

City

Markham

State/Province

Ontario

ZIP/Postal Code

L3P1A8

Country

Canada

Facility Name

City

North Bay

State/Province

Ontario

ZIP/Postal Code

P1B 3Z7

Country

Canada

Facility Name

City

Peterborough

State/Province

Ontario

ZIP/Postal Code

K9J 1Z2

Country

Canada

Facility Name

City

Toronto

State/Province

Ontario

ZIP/Postal Code

M5S 3B4

Country

Canada

Facility Name

City

Sainte-Foy

State/Province

Quebec

ZIP/Postal Code

G1V 3T6

Country

Canada

Facility Name

City

Sherbrooke

State/Province

Quebec

ZIP/Postal Code

J1J 2G2

Country

Canada

Facility Name

City

Brno

ZIP/Postal Code

602 00

Country

Czechia

Facility Name

City

Prague

ZIP/Postal Code

150 06

Country

Czechia

Facility Name

City

Amiens

ZIP/Postal Code

80054

Country

France

Facility Name

City

Besancon

ZIP/Postal Code

25030

Country

France

Facility Name

City

Boulogne

ZIP/Postal Code

92104

Country

France

Facility Name

City

Cannes

ZIP/Postal Code

06400

Country

France

Facility Name

City

Chambray Les Tours

ZIP/Postal Code

37170

Country

France

Facility Name

City

Marseille

ZIP/Postal Code

13385

Country

France

Facility Name

City

Nice

ZIP/Postal Code

06202

Country

France

Facility Name

City

Paris

ZIP/Postal Code

75475

Country

France

Facility Name

City

Poitiers

ZIP/Postal Code

86021

Country

France

Facility Name

City

Rouen

ZIP/Postal Code

76036

Country

France

Facility Name

City

Toulouse

ZIP/Postal Code

31059

Country

France

Facility Name

City

Berlin

ZIP/Postal Code

14197

Country

Germany

Facility Name

City

Darmstadt

ZIP/Postal Code

64283

Country

Germany

Facility Name

City

Dresden

ZIP/Postal Code

01307

Country

Germany

Facility Name

City

Essen

ZIP/Postal Code

45122

Country

Germany

Facility Name

City

Giessen

ZIP/Postal Code

35390

Country

Germany

Facility Name

City

Göttingen

ZIP/Postal Code

37075

Country

Germany

Facility Name

City

Hamburg

ZIP/Postal Code

22143

Country

Germany

Facility Name

City

Hannover

ZIP/Postal Code

30449

Country

Germany

Facility Name

City

Jena

ZIP/Postal Code

07740

Country

Germany

Facility Name

City

Osnabrück

ZIP/Postal Code

49078

Country

Germany

Facility Name

City

Tübingen

ZIP/Postal Code

72076

Country

Germany

Facility Name

City

Witten

ZIP/Postal Code

58453

Country

Germany

Facility Name

City

Breda

ZIP/Postal Code

4818 CK

Country

Netherlands

Facility Name

City

Nijmegen

ZIP/Postal Code

6525 GA

Country

Netherlands

Facility Name

City

Rotterdam

Country

Netherlands

Facility Name

City

Gdansk

ZIP/Postal Code

80-952

Country

Poland

Facility Name

City

Kielce

ZIP/Postal Code

25-317

Country

Poland

Facility Name

City

Lodz

ZIP/Postal Code

90-265

Country

Poland

Facility Name

City

Lublin

ZIP/Postal Code

20-081

Country

Poland

Facility Name

City

Opole

ZIP/Postal Code

48-080

Country

Poland

Facility Name

City

Szczecin

ZIP/Postal Code

70-111

Country

Poland

Facility Name

City

Warsaw

ZIP/Postal Code

02-507

Country

Poland

Facility Name

City

Bucharest

ZIP/Postal Code

020125

Country

Romania

Facility Name

City

Craiova

ZIP/Postal Code

200642

Country

Romania

Facility Name

City

Iasi

ZIP/Postal Code

700381

Country

Romania

Facility Name

City

Timisoara

ZIP/Postal Code

300077

Country

Romania

Facility Name

City

Alcorcón

ZIP/Postal Code

28922

Country

Spain

Facility Name

City

Alicante

ZIP/Postal Code

03010

Country

Spain

Facility Name

City

Badalona

ZIP/Postal Code

08916

Country

Spain

Facility Name

City

Barcelona

ZIP/Postal Code

08025

Country

Spain

Facility Name

City

Las Palmas

ZIP/Postal Code

35010

Country

Spain

Facility Name

City

Madrid

ZIP/Postal Code

28041

Country

Spain

Facility Name

City

Málaga

ZIP/Postal Code

29010

Country

Spain

Facility Name

City

Sevilla

ZIP/Postal Code

41071

Country

Spain

Facility Name

City

Dundee

State/Province

Angus

ZIP/Postal Code

DD1 9SY

Country

United Kingdom

Facility Name

City

London

State/Province

Hampstead

ZIP/Postal Code

NW3 2QG

Country

United Kingdom

Facility Name

City

Glasgow

State/Province

Scotland

ZIP/Postal Code

G11 6NT

Country

United Kingdom

Facility Name

City

Lanarkshire

ZIP/Postal Code

ML6 0JS

Country

United Kingdom

Facility Name

City

Salford

ZIP/Postal Code

M6 8HD

Country

United Kingdom

Facility Name

City

Scunthorpe

ZIP/Postal Code

DN15 7BA

Country

United Kingdom

Facility Name

City

Sheffield

ZIP/Postal Code

S10 2JF

Country

United Kingdom

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

Plan Description: Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.

IPD Sharing Time Frame

Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.

IPD Sharing Access Criteria

A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.

IPD Sharing URL

https://vivli.org

Citations:

PubMed Identifier

35279805

Citation

Elewski BE, Blauvelt A, Gallo G, Wolf E, McKean-Matthews M, Burge R, Merola JF, Gottlieb AB, Guenther LC. Simultaneous Nail and Skin Clearance in Ixekizumab Head-to-Head Trials for Moderate-to-Severe Psoriasis and Psoriatic Arthritis. Dermatol Ther (Heidelb). 2022 Apr;12(4):911-920. doi: 10.1007/s13555-022-00704-2. Epub 2022 Mar 13.

Results Reference

derived

PubMed Identifier

32845588

Citation

Rich P, Goldblum O, Disch D, Lin CY, Merola JF, Elewski B. Nail Psoriasis Does Not Affect Skin Response to Ixekizumab in Patients With Moderate-To-Severe Psoriasis. J Drugs Dermatol. 2020 Aug 1;19(8):741-746. doi: 10.36849/JDD.2020.5116.

Results Reference

derived

PubMed Identifier

32200512

Citation

Leonardi C, Reich K, Foley P, Torii H, Gerdes S, Guenther L, Gooderham M, Ferris LK, Griffiths CEM, ElMaraghy H, Crane H, Patel H, Burge R, Gallo G, Shrom D, Leung A, Lin CY, Papp K. Efficacy and Safety of Ixekizumab Through 5 Years in Moderate-to-Severe Psoriasis: Long-Term Results from the UNCOVER-1 and UNCOVER-2 Phase-3 Randomized Controlled Trials. Dermatol Ther (Heidelb). 2020 Jun;10(3):431-447. doi: 10.1007/s13555-020-00367-x. Epub 2020 Mar 21.

Results Reference

derived

PubMed Identifier

30465321

Citation

Yosipovitch G, Reich A, Steinhoff M, Beselin A, Kent T, Dossenbach M, Berggren L, Henneges C, Luger T. Impact of Ixekizumab Treatment on Itch and Psoriasis Area and Severity Index in Patients with Moderate-to-Severe Plaque Psoriasis: An Integrated Analysis of Two Phase III Randomized Studies. Dermatol Ther (Heidelb). 2018 Dec;8(4):621-637. doi: 10.1007/s13555-018-0267-9. Epub 2018 Nov 21.

Results Reference

derived

PubMed Identifier

28074446

Citation

Blauvelt A, Papp KA, Griffiths CEM, Puig L, Weisman J, Dutronc Y, Kerr LF, Ilo D, Mallbris L, Augustin M. Efficacy and Safety of Switching to Ixekizumab in Etanercept Non-Responders: A Subanalysis from Two Phase III Randomized Clinical Trials in Moderate-to-Severe Plaque Psoriasis (UNCOVER-2 and -3). Am J Clin Dermatol. 2017 Apr;18(2):273-280. doi: 10.1007/s40257-016-0246-9. Erratum In: Am J Clin Dermatol. 2018 Mar 29;:

Results Reference

derived

PubMed Identifier

27299809

Citation

Gordon KB, Blauvelt A, Papp KA, Langley RG, Luger T, Ohtsuki M, Reich K, Amato D, Ball SG, Braun DK, Cameron GS, Erickson J, Konrad RJ, Muram TM, Nickoloff BJ, Osuntokun OO, Secrest RJ, Zhao F, Mallbris L, Leonardi CL; UNCOVER-1 Study Group; UNCOVER-2 Study Group; UNCOVER-3 Study Group. Phase 3 Trials of Ixekizumab in Moderate-to-Severe Plaque Psoriasis. N Engl J Med. 2016 Jul 28;375(4):345-56. doi: 10.1056/NEJMoa1512711. Epub 2016 Jun 8.

Results Reference

derived

PubMed Identifier

26953848

Citation

Armstrong AW, Lynde CW, McBride SR, Stahle M, Edson-Heredia E, Zhu B, Amato D, Nikai E, Yang FE, Gordon KB. Effect of Ixekizumab Treatment on Work Productivity for Patients With Moderate-to-Severe Plaque Psoriasis: Analysis of Results From 3 Randomized Phase 3 Clinical Trials. JAMA Dermatol. 2016 Jun 1;152(6):661-9. doi: 10.1001/jamadermatol.2016.0269.

Results Reference

derived

PubMed Identifier

26072109

Citation

Griffiths CE, Reich K, Lebwohl M, van de Kerkhof P, Paul C, Menter A, Cameron GS, Erickson J, Zhang L, Secrest RJ, Ball S, Braun DK, Osuntokun OO, Heffernan MP, Nickoloff BJ, Papp K; UNCOVER-2 and UNCOVER-3 investigators. Comparison of ixekizumab with etanercept or placebo in moderate-to-severe psoriasis (UNCOVER-2 and UNCOVER-3): results from two phase 3 randomised trials. Lancet. 2015 Aug 8;386(9993):541-51. doi: 10.1016/S0140-6736(15)60125-8. Epub 2015 Jun 10.

Results Reference

derived

Learn more about this trial

A Phase 3 Study in Participants With Moderate to Severe Psoriasis (UNCOVER-2)

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