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

Primary Purpose

Psoriasis

Status

Completed

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

Placebo

50 mg etanercept

80 mg ixekizumab

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:

Presents with chronic plaque psoriasis based on a confirmed diagnosis of chronic psoriasis for at least 6 months prior to randomization
At least 10% Body Surface Area (BSA) of Psoriasis at screening and at randomization
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 randomization
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

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.
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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.
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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.
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Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Placebo Comparator

Active Comparator

Experimental

Arm Label

Placebo

50 mg etanercept

80 mg ixekizumab Dosing Regimen 2

80 mg ixekizumab Dosing Regimen 1

Arm Description

Placebo for ixekizumab administered by two SC injections at Week 0, then one SC injection per Dosing Regimen 1 until Week 12. Placebo for etanercept administered by one SC injection twice weekly starting at Week 0 up to Week 12. At Week 12, participants are assigned to Dosing Regimen 2.

Administered by SC injections twice weekly starting at Week 0 up to Week 12. At Week 12, arm is 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 264.

Administered by two 80 milligram (mg) subcutaneous (SC) injections at Week 0, then one 80 mg SC injection per Dosing Regimen 1 until Week 12. At Week 12, arm is assigned to Dosing Regimen 2.

Outcomes

Primary Outcome Measures

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

The sPGA is a physician's determination of the participant's psoriasis lesions overall at a given time point categorized by descriptions for induration, erythema, and scaling. For the analysis of responses, the participant's psoriasis is assessed as clear (0), minimal (1), mild (2), moderate (3), severe (4), or very severe (5). An sPGA (0,1) response was defined as a post-baseline sPGA score of 0 or 1.

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

The PASI combines assessments of the extent of body-surface involvement in 4 anatomical regions (head, trunk, arms, and legs) and the severity of desquamation (scaling), erythema, and plaque induration/infiltration (thickness) in each region, yielding an overall score of 0 for no psoriasis to 72 for the most severe disease. Participants achieving PASI 75 was defined as having an improvement of at least 75% in the PASI scores compared to baseline.

Secondary Outcome Measures

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

The sPGA is a physician's determination of the participant's psoriasis lesions overall at a given time point categorized by descriptions for induration, erythema, and scaling. For the analysis of responses, the participant's psoriasis is assessed as clear (0), minimal (1), mild (2), moderate (3), severe (4), or very severe (5). An sPGA (0) response was defined as a post-baseline sPGA score of 0.

Number of Participants Achieving ≥90% (PASI 90) Improvement (Efficacy of Ixekizumab in Participants With Moderate to Severe Chronic Plaque Psoriasis. Measure: PASI)

The PASI combines assessments of the extent of body-surface involvement in 4 anatomical regions (head, trunk, arms, and legs) and the severity of desquamation (scaling), erythema, and plaque induration/infiltration (thickness) in each region, yielding an overall score of 0 for no psoriasis to 72 for the most severe disease. Participants achieving PASI 90 were defined as having an improvement of at least 90% in the PASI scores compared to baseline.

Number of Participants Achieving 100% (PASI 100) Improvement (Efficacy of Ixekizumab in Participants With Moderate to Severe Chronic Plaque Psoriasis. Measure: PASI)

The PASI combines assessments of the extent of body-surface involvement in 4 anatomical regions (head, trunk, arms, and legs) and the severity of desquamation (scaling), erythema, and plaque induration/infiltration (thickness) in each region, yielding an overall score of 0 for no psoriasis to 72 for the most severe disease. Participants achieving PASI 100 were defined as having an improvement of at least 100% in the PASI scores compared to baseline.

Number of Participants Achieving an Itch Numeric Rating Scale (NRS) ≥4 Point Reduction [Quality of Life and Outcome Assessments. Measures: Patient Reported Outcomes (PRO)]

The Itch NRS is a participant-administered single-item 11-point horizontal scale anchored at 0 and 10, with 0 representing "no itch" and 10 representing "worst itch imaginable." Participants indicate their overall severity of itching from Psoriasis by circling the number that best describes the worst level of itching in the past 24 hours.

Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score

The DLQI is a simple, participant-administered, 10 question, validated, quality-of-life questionnaire that covers 6 domains: symptoms and feelings, daily activities, leisure, work and school, personal relationships, and treatment. Response categories include "not at all," "a lot," and "very much," with corresponding scores of 1, 2, and 3, respectively, and unanswered ("not relevant") responses scored as "0." Totals range from 0 to 30 (less to more impairment), and a 5 point change from baseline is considered clinically relevant. Least Square (LS) Means in total DLQI score were 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) Score

The NAPSI is a numeric, reproducible, objective tool used to evaluate the severity of fingernail bed psoriasis and fingernail matrix psoriasis by area of involvement in the fingernail unit. The fingernail is divided with imaginary horizontal and longitudinal lines into quadrants. Each fingernail is given a score for fingernail bed psoriasis: 0 (none) to 4 (psoriasis in 4 quadrants of the nail) and fingernail matrix psoriasis (0 to 4) depending on the presence (score of 1) or absence (score of 0) of any of the features of fingernail bed and fingernail matrix psoriasis in each quadrant. The NAPSI score of a fingernail is the sum of scores in fingernail bed and fingernail matrix from each quadrant (maximum of 8). Each fingernail is evaluated, and the sum of all the fingernails is the total NAPSI score (range, 0 to 80). LS Means in NAPSI score were calculated using MMRM with baseline score as covariate, treatment, pooled center, visit and treatment-by-visit interaction as fixed effects.

Percent of Body Surface Area (BSA) Involvement of Psoriasis

Percentage involvement of psoriasis on each participants 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 Means in BSA were calculated using MMRM with baseline BSA as covariate, treatment, pooled center, visit and treatment-by-visit interaction as fixed effects.

Change From Baseline in Psoriasis Scalp Severity Index (PSSI) Score

PSSI is a composite score ranging from 0 (best) to 72 (worst), derived from the sum scores for erythema, induration, and desquamation multiplied by a score for the extent of scalp area involved. LS Means in PSSI score were calculated using MMRM with baseline score as 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 [Quality of Life and Outcome Assessments. Measures: Patient Reported Outcomes (PRO)]

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 Means in total QIDS-SR16 score were 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. It has four domains: 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 ranged from 0 to 100. Higher scores indicate greater impairment in productivity. LS Means in each WPAI-PSO score were calculated using the ANCOVA model with treatment, pooled center and baseline WPAI-PSO score.

Change From Baseline in Medical Outcomes Study 36-Item Short Form (SF-36) Health Survey, 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 Means in SF-36 score were calculated using the ANCOVA model with treatment, pooled center and baseline SF-36 score.

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

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

Number of Participants Achieving Palmoplantar PASI of ≥50% (PPASI 50) Improvement

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. Participants achieving PPASI 50 were defined as having an improvement of at least 50% in the PPASI scores compared to baseline.

Number of Participants Achieving Palmoplantar PASI of ≥75% (PPASI 75) Improvement

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. Participants achieving PPASI 75 were defined as having an improvement of at least 75% in the PPASI scores compared to baseline.

Number of Participants Achieving Palmoplantar PASI of 100% (PPASI 100) Improvement

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. Participants achieving PPASI 100 were defined as having an improvement of 100% in the PPASI scores compared to baseline.

Number of Participants With Treatment-Emergent Anti-Ixekizumab Antibodies

The percentage of participants with treatment-emergent positive anti-ixekizumab antibodies at any time post-baseline were summarized by treatment group. Percentage of participants with treatment-emergent positive anti-ixekizumab antibodies were calculated as: number of participants with an evaluable baseline sample and ≥1 evaluable post-baseline sample/number of participants in the analysis population * 100.

Full Information

NCT ID

NCT01646177

First Posted

July 18, 2012

Last Updated

July 17, 2020

Sponsor

Eli Lilly and Company

1. Study Identification

Unique Protocol Identification Number

NCT01646177

Brief Title

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

Acronym

UNCOVER-3

Official Title

A 12-Week 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 With a Long-Term Extension Period

Study Type

Interventional

2. Study Status

Record Verification Date

November 1, 2019

Overall Recruitment Status

Completed

Study Start Date

July 28, 2012 (Actual)

Primary Completion Date

May 22, 2014 (Actual)

Study Completion Date

July 22, 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

1346 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Arm Title

50 mg etanercept

Arm Type

Active Comparator

Arm Description

Administered by SC injections twice weekly starting at Week 0 up to Week 12. At Week 12, arm is assigned to Dosing Regimen 2

Arm Title

80 mg ixekizumab Dosing Regimen 2

Arm Type

Experimental

Arm Description

Administered by two 80 mg SC injections at Week 0, then one 80 mg SC injection per Dosing Regimen 2 until Week 264.

Arm Title

80 mg ixekizumab Dosing Regimen 1

Arm Type

Experimental

Arm Description

Administered by two 80 milligram (mg) subcutaneous (SC) injections at Week 0, then one 80 mg SC injection per Dosing Regimen 1 until Week 12. At Week 12, arm is assigned to Dosing Regimen 2.

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Administered SC

Intervention Type

Drug

Intervention Name(s)

50 mg etanercept

Intervention Description

Administered SC

Intervention Type

Drug

Intervention Name(s)

80 mg ixekizumab

Other Intervention Name(s)

LY2439821

Intervention Description

Administered SC

Primary Outcome Measure Information:

Title

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

Description

Time Frame

Week 12

Title

Description

Time Frame

Week 12

Secondary Outcome Measure Information:

Title

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

Description

The sPGA is a physician's determination of the participant's psoriasis lesions overall at a given time point categorized by descriptions for induration, erythema, and scaling. For the analysis of responses, the participant's psoriasis is assessed as clear (0), minimal (1), mild (2), moderate (3), severe (4), or very severe (5). An sPGA (0) response was defined as a post-baseline sPGA score of 0.

Time Frame

Week 12

Title

Number of Participants Achieving ≥90% (PASI 90) Improvement (Efficacy of Ixekizumab in Participants With Moderate to Severe Chronic Plaque Psoriasis. Measure: PASI)

Description

The PASI combines assessments of the extent of body-surface involvement in 4 anatomical regions (head, trunk, arms, and legs) and the severity of desquamation (scaling), erythema, and plaque induration/infiltration (thickness) in each region, yielding an overall score of 0 for no psoriasis to 72 for the most severe disease. Participants achieving PASI 90 were defined as having an improvement of at least 90% in the PASI scores compared to baseline.

Time Frame

Week 12

Title

Number of Participants Achieving 100% (PASI 100) Improvement (Efficacy of Ixekizumab in Participants With Moderate to Severe Chronic Plaque Psoriasis. Measure: PASI)

Description

The PASI combines assessments of the extent of body-surface involvement in 4 anatomical regions (head, trunk, arms, and legs) and the severity of desquamation (scaling), erythema, and plaque induration/infiltration (thickness) in each region, yielding an overall score of 0 for no psoriasis to 72 for the most severe disease. Participants achieving PASI 100 were defined as having an improvement of at least 100% in the PASI scores compared to baseline.

Time Frame

Week 12

Title

Number of Participants Achieving an Itch Numeric Rating Scale (NRS) ≥4 Point Reduction [Quality of Life and Outcome Assessments. Measures: Patient Reported Outcomes (PRO)]

Description

Time Frame

Week 12

Title

Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score

Description

Time Frame

Baseline, Week 12

Title

Change From Baseline in Nail Psoriasis Severity Index (NAPSI) Score

Description

Time Frame

Baseline, Week 12

Title

Percent of Body Surface Area (BSA) Involvement of Psoriasis

Description

Time Frame

Week 12

Title

Change From Baseline in Psoriasis Scalp Severity Index (PSSI) Score

Description

Time Frame

Baseline, Week 12

Title

Change From Baseline in Quick Inventory of Depressive Symptomatology-Self Report 16 Items (QIDS-SR16) Total Score [Quality of Life and Outcome Assessments. Measures: Patient Reported Outcomes (PRO)]

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 (SF-36) Health Survey, 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 of Disease Severity

Description

Time Frame

Baseline, Week 12

Title

Number of Participants Achieving Palmoplantar PASI of ≥50% (PPASI 50) Improvement

Description

Time Frame

Week 12

Title

Number of Participants Achieving Palmoplantar PASI of ≥75% (PPASI 75) Improvement

Description

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. Participants achieving PPASI 75 were defined as having an improvement of at least 75% in the PPASI scores compared to baseline.

Time Frame

Week 12

Title

Number of Participants Achieving Palmoplantar PASI of 100% (PPASI 100) Improvement

Description

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. Participants achieving PPASI 100 were defined as having an improvement of 100% in the PPASI scores compared to baseline.

Time Frame

Week 12

Title

Number of Participants With Treatment-Emergent Anti-Ixekizumab Antibodies

Description

Time Frame

Week 12

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Presents with chronic plaque psoriasis based on a confirmed diagnosis of chronic psoriasis for at least 6 months prior to randomization At least 10% Body Surface Area (BSA) of Psoriasis at screening and at randomization 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 randomization 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

Anaheim

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California

ZIP/Postal Code

92801

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United States

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Bakersfield

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California

ZIP/Postal Code

93309

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United States

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Bell Gardens

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California

ZIP/Postal Code

90201

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United States

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Beverly Hills

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California

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90212

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United States

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Irvine

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California

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92697

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United States

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Los Angeles

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California

ZIP/Postal Code

90045

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United States

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Oceanside

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California

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92056

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United States

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San Diego

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California

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92123

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United States

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Santa Monica

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California

ZIP/Postal Code

90404

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United States

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Aurora

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Colorado

ZIP/Postal Code

80045

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United States

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New Haven

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Connecticut

ZIP/Postal Code

06511

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United States

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Edgewater

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Florida

ZIP/Postal Code

32132

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United States

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Jacksonville

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Florida

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32216

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United States

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Miami

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Florida

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33144

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United States

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Ocala

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Florida

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34471

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United States

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Ormond Beach

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Florida

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32174

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United States

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Arlington Heights

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Illinois

ZIP/Postal Code

60005

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United States

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Chicago

State/Province

Illinois

ZIP/Postal Code

60611

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United States

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Skokie

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Illinois

ZIP/Postal Code

60077

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United States

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Indianapolis

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Indiana

ZIP/Postal Code

46256

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United States

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West Des Moines

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Iowa

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50265

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United States

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Louisville

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Kentucky

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40217

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United States

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Owensboro

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Kentucky

ZIP/Postal Code

42303

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United States

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Boston

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Massachusetts

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02111

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United States

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Ann Arbor

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Michigan

ZIP/Postal Code

48109

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United States

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Omaha

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Nebraska

ZIP/Postal Code

68144

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United States

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Henderson

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Nevada

ZIP/Postal Code

89074

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United States

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Newington

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New Hampshire

ZIP/Postal Code

03801

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United States

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East Windsor

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New Jersey

ZIP/Postal Code

08520

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United States

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Albuquerque

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New Mexico

ZIP/Postal Code

87106

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United States

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New York

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New York

ZIP/Postal Code

10075

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United States

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Stony Brook

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New York

ZIP/Postal Code

11790

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United States

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High Point

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North Carolina

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27262

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United States

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Winston-Salem

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North Carolina

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27157

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United States

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Portland

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Oregon

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97223

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United States

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Hazleton

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Pennsylvania

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18201

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United States

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Anderson

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South Carolina

ZIP/Postal Code

29621

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United States

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Dallas

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Texas

ZIP/Postal Code

75246

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United States

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San Antonio

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Texas

ZIP/Postal Code

78229

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United States

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Salt Lake City

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Utah

ZIP/Postal Code

84132

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United States

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West Jordan

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Utah

ZIP/Postal Code

84088

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United States

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Buenos Aires

ZIP/Postal Code

C1055AA0

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Argentina

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Ciudad Autónoma De Buenosaire

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C1199ABD

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Argentina

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Plovdiv

ZIP/Postal Code

4000

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Bulgaria

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Sofia

ZIP/Postal Code

1632

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Bulgaria

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Varna

ZIP/Postal Code

9010

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Bulgaria

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Calgary

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Alberta

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T3A 2N1

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Canada

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Vancouver

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British Columbia

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V5Z-3Y1

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Canada

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Halifax

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Nova Scotia

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B3H0A2

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Canada

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Brampton

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Ontario

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L6R 0W3

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Canada

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Ottawa

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Ontario

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K2G 6E2

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Canada

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Richmond Hill

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Ontario

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L4B 1A5

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Canada

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Waterloo

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Ontario

ZIP/Postal Code

N2J 1C4

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Canada

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Windsor

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Ontario

ZIP/Postal Code

N8W5L7

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Canada

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Drummondville

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Quebec

ZIP/Postal Code

J2B 5L4

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Canada

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Montreal

State/Province

Quebec

ZIP/Postal Code

H2K4L5

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Canada

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Santiago

ZIP/Postal Code

8420383

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Chile

Facility Name

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Augsburg

ZIP/Postal Code

86179

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Germany

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Berlin

ZIP/Postal Code

13125

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Germany

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Bonn

ZIP/Postal Code

53111

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Germany

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Dresden

ZIP/Postal Code

01069

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Germany

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Erfurt

ZIP/Postal Code

99084

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Germany

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Ergolding

ZIP/Postal Code

84038

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Germany

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Frankfurt

ZIP/Postal Code

60596

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Germany

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Freiburg

ZIP/Postal Code

79100

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Germany

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Freising

ZIP/Postal Code

85354

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Germany

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Friedrichshafen

ZIP/Postal Code

88045

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Germany

Facility Name

City

Gera

ZIP/Postal Code

07548

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Germany

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Hamburg

ZIP/Postal Code

20253

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Germany

Facility Name

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Hanau

ZIP/Postal Code

63450

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Germany

Facility Name

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Kiel

ZIP/Postal Code

24148

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Germany

Facility Name

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Leipzig

ZIP/Postal Code

04103

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Germany

Facility Name

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Mahlow

ZIP/Postal Code

15831

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Germany

Facility Name

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Mainz

ZIP/Postal Code

55131

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Germany

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Mannheim

ZIP/Postal Code

68167

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Germany

Facility Name

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Mönchengladbach

ZIP/Postal Code

41236

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Germany

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Münster

ZIP/Postal Code

48159

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Germany

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Northeim

ZIP/Postal Code

37154

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Germany

Facility Name

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Schwerin

ZIP/Postal Code

19055

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Germany

Facility Name

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Würzburg

ZIP/Postal Code

97080

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Germany

Facility Name

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Budapest

ZIP/Postal Code

1036

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Hungary

Facility Name

City

Debrecen

ZIP/Postal Code

4032

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Hungary

Facility Name

City

Kecskemet

ZIP/Postal Code

6000

Country

Hungary

Facility Name

City

Mako

ZIP/Postal Code

6900

Country

Hungary

Facility Name

City

Miskolc

ZIP/Postal Code

3529

Country

Hungary

Facility Name

City

Oroshaza

ZIP/Postal Code

5900

Country

Hungary

Facility Name

City

Pecs

ZIP/Postal Code

7632

Country

Hungary

Facility Name

City

Szeged

ZIP/Postal Code

H-6720

Country

Hungary

Facility Name

City

Szolnok

ZIP/Postal Code

H-5000

Country

Hungary

Facility Name

City

Szombathely

ZIP/Postal Code

9700

Country

Hungary

Facility Name

City

Veszprem

ZIP/Postal Code

8200

Country

Hungary

Facility Name

City

Monterrey

ZIP/Postal Code

64460

Country

Mexico

Facility Name

City

Bialystok

ZIP/Postal Code

15-017

Country

Poland

Facility Name

City

Krakow

ZIP/Postal Code

30-510

Country

Poland

Facility Name

City

Warsaw

ZIP/Postal Code

02-201

Country

Poland

Facility Name

City

Krasnodar

ZIP/Postal Code

350020

Country

Russian Federation

Facility Name

City

Moscow

ZIP/Postal Code

127473

Country

Russian Federation

Facility Name

City

Saint Petersburg

ZIP/Postal Code

194356

Country

Russian Federation

Facility Name

City

Sankt-Peterburg

ZIP/Postal Code

195112

Country

Russian Federation

Facility Name

City

Smolensk

ZIP/Postal Code

214019

Country

Russian Federation

Facility Name

City

Yaroslavl

ZIP/Postal Code

150002

Country

Russian Federation

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing 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 European Union (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

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PubMed Identifier

33253833

Citation

Blauvelt A, Lebwohl MG, Mabuchi T, Leung A, Garrelts A, Crane H, ElMaraghy H, Patel H, Ridenour T, See K, Gallo G, Paul C. Long-term efficacy and safety of ixekizumab: A 5-year analysis of the UNCOVER-3 randomized controlled trial. J Am Acad Dermatol. 2021 Aug;85(2):360-368. doi: 10.1016/j.jaad.2020.11.022. Epub 2020 Nov 28.

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

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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

29751001

Citation

Reich K, Jackson K, Ball S, Garces S, Kerr L, Chua L, Muram TM, Blauvelt A. Ixekizumab Pharmacokinetics, Anti-Drug Antibodies, and Efficacy through 60 Weeks of Treatment of Moderate to Severe Plaque Psoriasis. J Invest Dermatol. 2018 Oct;138(10):2168-2173. doi: 10.1016/j.jid.2018.04.019. Epub 2018 May 8.

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

27910156

Citation

van de Kerkhof P, Guenther L, Gottlieb AB, Sebastian M, Wu JJ, Foley P, Morita A, Goldblum O, Zhang L, Erickson J, Ball S, Rich P. Ixekizumab treatment improves fingernail psoriasis in patients with moderate-to-severe psoriasis: results from the randomized, controlled and open-label phases of UNCOVER-3. J Eur Acad Dermatol Venereol. 2017 Mar;31(3):477-482. doi: 10.1111/jdv.14033. Epub 2016 Dec 2.

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

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Learn more about this trial

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

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