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A Study Comparing Different Dosing Regimens of Ixekizumab (LY2439821) in Participants With Moderate to Severe Plaque Psoriasis (IXORA-P)

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ClinicalTrials.gov Identifier: NCT02513550
Recruitment Status : Completed
First Posted : July 31, 2015
Results First Posted : April 18, 2018
Last Update Posted : April 18, 2018
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

Brief Summary:
The main purpose of this study is to evaluate the efficacy of ixekizumab dosing regimens in participants with plaque psoriasis.

Condition or disease Intervention/treatment Phase
Plaque Psoriasis Drug: Ixekizumab Drug: Placebo Phase 3

Detailed Description:
The purpose of this study is to evaluate both the safety and efficacy of ixekizumab dosing regimens. There are 3 study periods: Screening Period, Blinded Treatment Dosing Period, and Post-Treatment Follow-Up.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1227 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Multicenter, Randomized, Double-Blind Study Comparing the Efficacy and Safety of Ixekizumab Dosing Regimens in Patients With Moderate-to-Severe Plaque Psoriasis
Study Start Date : August 2015
Actual Primary Completion Date : November 2016
Actual Study Completion Date : August 3, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Psoriasis
Drug Information available for: Ixekizumab

Arm Intervention/treatment
Experimental: 80 mg Ixekizumab Q2W
160 milligrams (mg) ixekizumab given as 2 subcutaneous (SQ) injections at baseline and then 80 mg ixekizumab given as 1 SQ injection every 2 weeks (Q2W) to week 52.
Drug: Ixekizumab
Administered SQ
Other Name: LY2439821

Experimental: 80 mg Ixekizumab Q4W
160 mg ixekizumab given as 2 SQ injections at baseline and then 80 mg ixekizumab given as 1 SQ injection every 4 weeks (Q4W) to week 52. Placebo administered SQ, Q2W to maintain blind.
Drug: Ixekizumab
Administered SQ
Other Name: LY2439821

Drug: Placebo
Administered SQ

Experimental: 80 mg Ixekizumab Q4W/Q2W
160 mg ixekizumab given as 2 SQ injections at baseline and then 80 mg ixekizumab given as one SQ injection Q4W with step-up dosing to Q2 as needed to week 52. Placebo administered SQ, Q2W to maintain blind.
Drug: Ixekizumab
Administered SQ
Other Name: LY2439821

Drug: Placebo
Administered SQ

Experimental: 80 mg Ixekizumab Q2W Maximum Extended Enrollment (ME2) Cohort
160 mg ixekizumab given as 2 SQ injections at baseline and then 80 mg ixekizumab given as 1 SQ injection Q2W to week 52.
Drug: Ixekizumab
Administered SQ
Other Name: LY2439821

Experimental: 80 mg Ixekizumab Q4W Maximum Extended Enrollment Cohort
160 mg ixekizumab given as 2 SQ injections at baseline and then 80 mg ixekizumab given as 1 SQ injection Q4W to week 52. Placebo administered SQ, Q2W to maintain blind.
Drug: Ixekizumab
Administered SQ
Other Name: LY2439821

Drug: Placebo
Administered SQ

Experimental: 80 mg Ixekizumab Q4W/Q2W Maximum Extended Enrollment Cohort
160 mg ixekizumab given as 2 SQ injections at baseline and then 80 mg ixekizumab given as one SQ injection Q4W with step-up dosing to Q2 as needed to week 52. Placebo administered SQ, Q2W to maintain blind.
Drug: Ixekizumab
Administered SQ
Other Name: LY2439821

Drug: Placebo
Administered SQ




Primary Outcome Measures :
  1. Percentage of Participants Achieving Static Physician Global Assessment (sPGA) of (0,1) [ Time Frame: Week 52 ]
    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.

  2. Percentage of Participants Achieving 75% Improvement in Psoriasis Area and Severity Index (PASI 75) [ Time Frame: Week 52 ]
    The PASI combines the extent of body surface involvement in 4 anatomical regions (head, trunk, arms, and legs) and the severity of scaling, redness, and plaque induration/infiltration (thickness) in each region, yielding an overall score of 0 for no Ps to 72 for the most severe disease. 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).


Secondary Outcome Measures :
  1. Percentage of Participants Achieving sPGA (0) [ Time Frame: Week 52 ]
    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). 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.

  2. Percentage of Participants Achieving PASI 90 [ Time Frame: Week 52 ]
    PASI combines the extent of body surface involvement in 4 anatomical regions (head, trunk, arms, and legs) and the severity of scaling, redness, and plaque induration/infiltration (thickness) in each region, yielding an overall score of 0 for no Ps to 72 for the most severe disease. 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).

  3. Percentage of Participants Achieving PASI 100 [ Time Frame: Week 52 ]
    The PASI combines the extent of body surface involvement in 4 anatomical regions (head, trunk, arms, and legs) and the severity of scaling, redness, and plaque induration/infiltration (thickness) in each region, yielding an overall score of 0 for no Ps to 72 for the most severe disease. 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).

  4. Change From Baseline in PASI [ Time Frame: Baseline, Week 52 ]

    The PASI combines the extent of body surface involvement in 4 anatomical regions (head, trunk, arms, and legs) and the severity of scaling, redness, and plaque induration/infiltration (thickness) in each region, yielding an overall score of 0 for no Ps to 72 for the most severe disease.

    Least Squares mean (LSmean) was calculated using Mixed-Effects Model of Repeated Measures (MMRM) analysis including dosing regimen, country, baseline weight category, baseline value, visit, dosing regimen-by-visit, and baseline value-by-visit interactions as fixed factors, with variance-covariance structure set to unstructured.


  5. Percent Improvement in PASI [ Time Frame: Baseline, Week 52 ]

    The PASI combines the extent of body surface involvement in 4 anatomical regions (head, trunk, arms, and legs) and the severity of scaling, redness, and plaque induration/infiltration (thickness) in each region, yielding an overall score of 0 for no Ps to 72 for the most severe disease.

    Least Squares mean (LSmean) was calculated using Mixed-Effects Model of Repeated Measures (MMRM) analysis including dosing regimen, country, baseline weight category, baseline value, visit, dosing regimen-by-visit, and baseline value-by-visit interactions as fixed factors, with variance-covariance structure set to unstructured.


  6. Mean Change From Baseline in Percent Body Surface Area (BSA) Involvement [ Time Frame: Baseline, Week 52 ]

    The percentage involvement of psoriasis on each participant's body surface area (BSA) 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 was calculated using MMRM analysis including dosing regimen, country, baseline weight category, baseline value, visit, dosing regimen-by-visit, and baseline value-by-visit interactions as fixed factors, with variance-covariance structure set to unstructured.


  7. Mean Change From Baseline in Nail Psoriasis Severity Index (NAPSI) Score [ Time Frame: Baseline, Week 52 ]
    The NAPSI is a numeric, reproducible, objective tool for evaluation of fingernail (fn) Ps. This scale is used to evaluate the severity of fn bed Ps and fn matrix Ps by area of involvement in the fn unit. The fn is divided with imaginary horizontal and longitudinal lines into quadrants. Each fn is given a score for fn bed Ps (0 to 4) and fn matrix Ps (0 to 4) depending on presence (score of 1) or absence (score of 0) of any of the features of fn bed and fn matrix Ps in each quadrant. The NAPSI score of a fn is sum of scores in fn bed and fn matrix from each quadrant (maximum of 8). Each fn is evaluated, then the sum of all fn equals the total NAPSI score with a range from 0 to 80 (0 indicates no Ps, 80 indicates worst Ps). LS mean was calculated using MMRM analysis including dosing regimen, country, baseline weight category, baseline value, visit, dosing regimen-by-visit, and baseline value-by-visit interactions as fixed factors, with variance-covariance structure set to unstructured.

  8. Mean Change From Baseline in Psoriasis Scalp Severity Index (PSSI) Score [ Time Frame: Baseline, Week 52 ]
    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 score ranging from 0 (less severity) to 72 (more severity). LS mean change was calculated using MMRM analysis including dosing regimen, country, baseline weight category, baseline value, visit, dosing regimen-by-visit, and baseline value-by-visit interactions as fixed factors, with variance-covariance structure set to unstructured.

  9. Mean Change From Baseline in Palmoplantar PASI (PPASI) [ Time Frame: Baseline, Week 52 ]
    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 (no PPASI) to 72 (most severe PPASI). The PPASI was only assessed if participants have palmoplantar psoriasis at baseline. LS mean was calculated using MMRM analysis including dosing regimen, country, baseline weight category, baseline value, visit, dosing regimen-by-visit, and baseline value-by-visit interactions as fixed factors, with variance-covariance structure set to unstructured.

  10. Percentage of Participants Achieving an Itch Numeric Rating Scale (Itch NRS) ≥4 Point Reduction From Baseline [ Time Frame: Baseline, Week 52 ]
    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." Overall severity of a participant's itching from Ps is indicated by circling the number that best describes the worst level of itching in the past 24 hours.

  11. Percentage of Participants Achieving Dermatology Life Quality Index (DLQI) Total Score of 0 and 1 (DLQI [0,1]) [ Time Frame: Week 52 ]
    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).

  12. Change From Baseline in DLQI Total Score [ Time Frame: Baseline, Week 52 ]
    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). LS mean change was calculated using MMRM analysis including dosing regimen, country, baseline weight category, baseline value, visit, dosing regimen-by-visit, and baseline value-by-visit interactions as fixed factors, with variance-covariance structure set to unstructured.

  13. Change From Baseline in Itch NRS Score [ Time Frame: Baseline, Week 52 ]
    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." Overall severity of a participant's itching from Ps is indicated by circling the number that best describes the worst level of itching in the past 24 hours. LS mean change from baseline in PSSI was calculated using MMRM analysis including dosing regimen, country, baseline weight category, baseline value, visit, dosing regimen-by-visit, and baseline value-by-visit interactions as fixed factors, with variance-covariance structure set to unstructured.

  14. Change From Baseline in Skin Pain Visual Analog Scale (VAS) [ Time Frame: Baseline, Week 52 ]
    The pain VAS is a participant-administered single-item scale designed to measure Skin pain from Psoriasis using a 0-100 millimeter (mm) horizontal VAS. Overall severity of participant's skin pain from Psoriasis is indicated by placing a single mark on the horizontal 100 mm scale from 0 mm (no skin pain) to 100 mm (severe skin pain). LS mean was calculated using MMRM analysis including dosing regimen, country, baseline weight category, baseline value, visit, dosing regimen-by-visit, and baseline value-by-visit interactions as fixed factors, with variance-covariance structure set to unstructured.

  15. Change From Baseline in European Quality of Life - 5 Dimensions 5 Level (EQ-5D-5L) VAS [ Time Frame: Baseline, Week 52 ]
    EQ-5D-5L is a standardized measure of health status used to provide a simple, generic measure of health for clinical and economic appraisal. The EQ-5D-5L consists of 2 components: a descriptive system of the respondent's health and a rating of his/her current health state using a 0 (no pain) to 100mm VAS (severe pain). LS mean was calculated using MMRM analysis including dosing regimen, country, baseline weight category, baseline value, visit, dosing regimen-by-visit, and baseline value-by-visit interactions as fixed factors, with variance-covariance structure set to unstructured.

  16. Pharmacokinetics (PK): Trough Concentration at Steady State (Ctrough,ss) of Ixekizumab [ Time Frame: Predose, Week 4, 12, 24, 36 and 52 Post dose ]
    Trough concentrations at steady state of Ixekizumab were evaluated.

  17. Number of Participants With Anti-Ixekizumab Antibodies [ Time Frame: Baseline through Week 52 ]
    Number of participants with treatment-emergent positive anti-ixekizumab antibodies was summarized by treatment group.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Present with chronic plaque psoriasis for at least 6 months prior to enrollment
  • At least 10% BSA of psoriasis at screening and at enrollment
  • sPGA score of at least 3 and PASI score of at least 12 at screening and at enrollment
  • Candidates for phototherapy and/or systemic therapy
  • Participant must agree to use reliable method of birth control during the study; women must continue using birth control for at least 12 weeks after stopping treatment

Exclusion Criteria:

  • Predominant pattern of pustular, erythrodermic, or guttate forms of psoriasis
  • History of drug-induced psoriasis
  • Cannot avoid excessive sun exposure or use of tanning booths for at least 4 weeks prior to enrollment and during the study
  • Received systemic non-biologic psoriasis therapy or phototherapy within the previous 4 weeks; or had topical psoriasis treatment within the previous 2 weeks prior to enrollment
  • Concurrent or recent use of any biologic agent
  • Have participated in any study with ixekizumab
  • Received a live vaccination within 12 weeks prior to enrollment
  • Serious disorder or illness other than psoriasis
  • Ongoing or serious infection within the last 12 weeks or evidence of tuberculosis
  • Major surgery within 8 weeks of baseline, or will require surgery during the study
  • Breastfeeding or nursing (lactating) women

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02513550


  Show 125 Study Locations
Sponsors and Collaborators
Eli Lilly and Company
Investigators
Study Director: 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) Eli Lilly and Company

Additional Information:
Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT02513550     History of Changes
Other Study ID Numbers: 15988
I1F-MC-RHBP ( Other Identifier: Eli Lilly and Company )
2015-000190-12 ( EudraCT Number )
First Posted: July 31, 2015    Key Record Dates
Results First Posted: April 18, 2018
Last Update Posted: April 18, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description:

Lilly provides access to the individual patient data from studies on approved medicines and indications as defined by the sponsor specific information on ClinicalStudyDataRequest.com.

This access is provided in a timely fashion after the primary publication is accepted. Researchers need to have an approved research proposal submitted through ClinicalStudyDataRequest.com. Access to the data will be provided in a secure data sharing environment after signing a data sharing agreement.


Additional relevant MeSH terms:
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases
Ixekizumab
Dermatologic Agents