Trial · NCT02513550
A Study Comparing Different Dosing Regimens of Ixekizumab (LY2439821) in Participants With Moderate to Severe Plaque Psoriasis
NCT02513550, Phase 3, Completed, Eli Lilly and Company; results first posted 2018-04-18
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study Comparing Different Dosing Regimens of Ixekizumab (LY2439821) in Participants With Moderate to Severe Plaque Psoriasis. Trials, record NCT02513550. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02513550
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study Comparing Different Dosing Regimens of Ixekizumab (LY2439821) in Participants With Moderate to Severe Plaque Psoriasis
- NCT number
- NCT02513550
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 1,257 participants, actual
- Lead sponsor
- Eli Lilly and Company
- Conditions
- Plaque Psoriasis
- Interventions
- Ixekizumab, Placebo
- First posted
- 2015-07-31
- Last updated
- 2020-06-17
- Other registries' IDs
- eudract:2015-000190-12
- Results first posted
- 2018-04-18
Source ClinicalTrials.gov
Registered outcomes19
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants Achieving Static Physician Global Assessment (sPGA) of (0,1) | 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. Participants who did not meet the clinical response criteria or had missing data at Week 52 were considered non-responders for Non-Responder Imputation (NRI) analysis. |
| Primary | Percentage of Participants Achieving 75% Improvement in Psoriasis Area and Severity Index (PASI 75) | 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). Participants who did not meet the clinical response criteria or had missing data at Week52 were considered non-responders for NRI analysis. |
| Secondary | Percentage of Participants Achieving sPGA (0) | 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. Participants who did not meet the clinical response criteria or had missing data at Week 52 were considered non-responders for Non-Responder Imputation (NRI) analysis. |
| Secondary | Percentage of Participants Achieving PASI 90 | 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). |
| Secondary | Percentage of Participants Achieving PASI 100 | 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 | Change From Baseline in PASI | 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. |
| Secondary | Percent Improvement in PASI | 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. |
| Secondary | Mean Change From Baseline in Percent Body Surface Area (BSA) Involvement | 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. |
| Secondary | Mean Change From Baseline in Nail Psoriasis Severity Index (NAPSI) Score | 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. |
| Secondary | Mean Change From Baseline in Psoriasis Scalp Severity Index (PSSI) Score | 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. |
1 to 10 of 19Source ClinicalTrials.gov
See all 19 registered outcomesOutcomes19
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants Achieving Static Physician Global Assessment (sPGA) of (0,1) | Week 52 | All randomized participants analyzed according to the treatment to which they were assigned. As pre-specified in the analysis plan, outcome measures will not be reported for the Maximum Extended Enrollment (ME2) arms/groups but only for the main global study arms/groups. | Percentage of participants | NUMBER |
| PRIMARY | Percentage of Participants Achieving 75% Improvement in Psoriasis Area and Severity Index (PASI 75) | Week 52 | All randomized participants analyzed according to the treatment to which they were assigned. As pre-specified in the analysis plan, outcome measures will not be reported for the Maximum Extended Enrollment (ME2) arms/groups but only for the main global study arms/groups. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Achieving sPGA (0) | Week 52 | All randomized participants analyzed according to the treatment to which they were assigned. As pre-specified in the analysis plan, outcome measures will not be reported for the Maximum Extended Enrollment (ME2) arms/groups but only for the main global study arms/groups. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Achieving PASI 90 | Week 52 | All randomized participants analyzed according to the treatment to which they were assigned. As pre-specified in the analysis plan, outcome measures will not be reported for the Maximum Extended Enrollment (ME2) arms/groups but only for the main global study arms/groups. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Achieving PASI 100 | Week 52 | All randomized participants analyzed according to the treatment to which they were assigned. As pre-specified in the analysis plan, outcome measures will not be reported for the Maximum Extended Enrollment (ME2) arms/groups but only for the main global study arms/groups. | Percentage of participants | NUMBER |
| SECONDARY | Change From Baseline in PASI | Baseline, Week 52 | All randomized participants analyzed according to the treatment to which they were assigned and had a baseline and post-baseline measurement for PASI. As pre-specified in the analysis plan, outcome measures will not be reported for the Maximum Extended Enrollment (ME2) arms/groups but only for the main global study arms/groups. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Percent Improvement in PASI | Baseline, Week 52 | All randomized participants analyzed according to the treatment to which they were assigned and had a baseline and post-baseline measurement for PASI. As pre-specified in the analysis plan, outcome measures will not be reported for the Maximum Extended Enrollment (ME2) arms/groups but only for the main global study arms/groups. | Percent change | LEAST_SQUARES_MEAN |
| SECONDARY | Mean Change From Baseline in Percent Body Surface Area (BSA) Involvement | Baseline, Week 52 | All randomized participants analyzed according to the treatment to which they were assigned who had baseline and a post-baseline measurement for BSA affected by Psoriasis. As pre-specified in the analysis plan, outcome measures will not be reported for the Maximum Extended Enrollment (ME2) arms/groups but only for the main global study arms/groups. | Percent Body Surface Affected | LEAST_SQUARES_MEAN |
| SECONDARY | Mean Change From Baseline in Nail Psoriasis Severity Index (NAPSI) Score | Baseline, Week 52 | All randomized participants analyzed according to the treatment to which they were assigned who had baseline fingernail involvement and had a post-baseline measurement. As pre-specified in the analysis plan, outcome measures will not be reported for the Maximum Extended Enrollment (ME2) arms/groups but only for the main global study arms/groups. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Mean Change From Baseline in Psoriasis Scalp Severity Index (PSSI) Score | Baseline, Week 52 | All randomized participants analyzed according to the treatment to which they were assigned and had baseline scalp involvement and had a post-baseline measurement. As pre-specified in the analysis plan, outcome measures will not be reported for the Maximum Extended Enrollment (ME2) arms/groups but only for the main global study arms/groups. | units on a scale | LEAST_SQUARES_MEAN |
1 to 10 of 19Source ClinicalTrials.gov
See all 19 outcomesResults by group74
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Participants Achieving Static Physician Global Assessment (sPGA) of (0,1) | 80 mg Ixekizumab Q4W | 70.6 | Percentage of participants | ||
| Percentage of Participants Achieving Static Physician Global Assessment (sPGA) of (0,1) | 80 mg Ixekizumab Q4W/Q2W | 72.5 | Percentage of participants | ||
| Percentage of Participants Achieving Static Physician Global Assessment (sPGA) of (0,1) | 80 mg Ixekizumab Q2W | 78.6 | Percentage of participants | ||
| Percentage of Participants Achieving 75% Improvement in Psoriasis Area and Severity Index (PASI 75) | 80 mg Ixekizumab Q4W | 79 | Percentage of participants | ||
| Percentage of Participants Achieving 75% Improvement in Psoriasis Area and Severity Index (PASI 75) | 80 mg Ixekizumab Q4W/Q2W | 83.7 | Percentage of participants | ||
| Percentage of Participants Achieving 75% Improvement in Psoriasis Area and Severity Index (PASI 75) | 80 mg Ixekizumab Q2W | 85.9 | Percentage of participants | ||
| Percentage of Participants Achieving sPGA (0) | 80 mg Ixekizumab Q4W | 44.8 | Percentage of participants | ||
| Percentage of Participants Achieving sPGA (0) | 80 mg Ixekizumab Q4W/Q2W | 48.7 | Percentage of participants | ||
| Percentage of Participants Achieving sPGA (0) | 80 mg Ixekizumab Q2W | 60.1 | Percentage of participants | ||
| Percentage of Participants Achieving PASI 90 | 80 mg Ixekizumab Q4W | 65.2 | Percentage of participants |
1 to 10 of 74Source ClinicalTrials.gov
See all 74 results by groupParticipant flow42
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Double Blind Treatment Period | STARTED | 80 mg Ixekizumab Q4W | 310 | |
| Double Blind Treatment Period | STARTED | 80 mg Ixekizumab Q4W/Q2W | 306 | |
| Double Blind Treatment Period | STARTED | 80 mg Ixekizumab Q2W | 611 | |
| Double Blind Treatment Period | STARTED | 80 mg Ixekizumab Q4W Maximum Extended Enrollment Cohort | 9 | |
| Double Blind Treatment Period | STARTED | 80 mg Ixekizumab Q4W/Q2W Maximum Extended Enrollment Cohort | 5 | |
| Double Blind Treatment Period | STARTED | 80 mg Ixekizumab Q2W Maximum Extended Enrollment Cohort | 16 | |
| Double Blind Treatment Period | Received at Least One Dose of Study Drug | 80 mg Ixekizumab Q4W | 310 | |
| Double Blind Treatment Period | Received at Least One Dose of Study Drug | 80 mg Ixekizumab Q4W/Q2W | 306 | |
| Double Blind Treatment Period | Received at Least One Dose of Study Drug | 80 mg Ixekizumab Q2W | 609 | |
| Double Blind Treatment Period | Received at Least One Dose of Study Drug | 80 mg Ixekizumab Q4W Maximum Extended Enrollment Cohort | 9 |
1 to 10 of 42Source ClinicalTrials.gov
See all 42 participant flowAdverse events1,608
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Neutropenia | Blood and lymphatic system disorders | Ixekizumab 80 mg Q4W - Treatment Period | 2 | 310 | 2 |
| other | Neutropenia | Blood and lymphatic system disorders | 80 mg Ixekizumab Q4W/Q2W - Treatment Period | 0 | 306 | 0 |
| other | Neutropenia | Blood and lymphatic system disorders | 80 mg Ixekizumab Q2W - Treatment Period | 1 | 609 | 2 |
| other | Neutropenia | Blood and lymphatic system disorders | 80 mg Ixekizumab Q4W - Post-Treatment Period | 0 | 285 | 0 |
| other | Neutropenia | Blood and lymphatic system disorders | 80 mg Ixekizumab Q4W/Q2W - Post-Treatment Period | 0 | 283 | 0 |
| other | Neutropenia | Blood and lymphatic system disorders | 80 mg Ixekizumab Q2W - Post-Treatment Period | 1 | 559 | 1 |
| other | Neutropenia | Blood and lymphatic system disorders | 80 mg Ixekizumab Q4W - Treatment Period ME2 Cohort | 0 | 9 | 0 |
| other | Neutropenia | Blood and lymphatic system disorders | 80 mg Ixekizumab Q4W/Q2W - Treatment Period ME2 Cohort | 0 | 5 | 0 |
| other | Neutropenia | Blood and lymphatic system disorders | 80 mg Ixekizumab Q2W - Treatment Period ME2 Cohort | 1 | 16 | 1 |
| other | Neutropenia | Blood and lymphatic system disorders | 80 mg Ixekizumab Q4W - Post-Treatment Period ME2 Cohort | 0 | 9 | 0 |
1 to 10 of 1,608Source ClinicalTrials.gov
See all 1,608 adverse eventsAdverse event totals36
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Ixekizumab 80 mg Q4W - Treatment Period | 0 | 310 |
| Total, all-cause mortality | 80 mg Ixekizumab Q4W/Q2W - Treatment Period | 0 | 306 |
| Total, all-cause mortality | 80 mg Ixekizumab Q2W - Treatment Period | 0 | 609 |
| Total, all-cause mortality | 80 mg Ixekizumab Q4W - Post-Treatment Period | 0 | 285 |
| Total, all-cause mortality | 80 mg Ixekizumab Q4W/Q2W - Post-Treatment Period | 0 | 283 |
| Total, all-cause mortality | 80 mg Ixekizumab Q2W - Post-Treatment Period | 0 | 559 |
| Total, all-cause mortality | 80 mg Ixekizumab Q4W - Treatment Period ME2 Cohort | 0 | 9 |
| Total, all-cause mortality | 80 mg Ixekizumab Q4W/Q2W - Treatment Period ME2 Cohort | 0 | 5 |
| Total, all-cause mortality | 80 mg Ixekizumab Q2W - Treatment Period ME2 Cohort | 0 | 16 |
| Total, all-cause mortality | 80 mg Ixekizumab Q4W - Post-Treatment Period ME2 Cohort | 0 | 9 |
1 to 10 of 36Source ClinicalTrials.gov
See all 36 adverse event totalsPapers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
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