Trial · NCT01474512
A Phase 3 Study in Participants With Moderate to Severe Psoriasis
NCT01474512, Phase 3, Completed, Eli Lilly and Company; results first posted 2016-05-27
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Phase 3 Study in Participants With Moderate to Severe Psoriasis. Trials, record NCT01474512. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01474512
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Phase 3 Study in Participants With Moderate to Severe Psoriasis
- NCT number
- NCT01474512
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 1,296 participants, actual
- Lead sponsor
- Eli Lilly and Company
- Conditions
- Psoriasis
- Interventions
- 80 mg Ixekizumab Dosing Regimens 1, 2, and 3, Placebo
- First posted
- 2011-11-18
- Last updated
- 2019-10-03
- Results first posted
- 2016-05-27
Source ClinicalTrials.gov
Registered outcomes17
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants With Static Physician Global Assessment (sPGA) of 0 or 1 (Efficacy of Ixekizumab in Participants With Moderate to Severe Plaque Ps Measure: sPGA) | Week 12 | 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. Participants Ps were 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. |
| Primary | Percentage of Participants Achieving ≥75% Improvement in Ps Area and Severity Index (PASI75) (Efficacy of Ixekizumab in Participants With Moderate to Severe Plaque Psoriasis Measure: PASI) | Week 12 | 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 | Percentage of Participants Achieving an sPGA of 0 (Efficacy of Ixekizumab in Participants With Moderate to Severe Plaque Ps Measure: sPGA) | Week 12 | 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. Participants Ps were assessed as 0 (clear), 1 (minimal), 2 (mild), 3 (moderate), 4 (severe), or 5 (very severe). |
| Secondary | Percentage of Participants Achieving PASI 90% (PASI90) or 100% (PASI100) (Efficacy of Ixekizumab in Participants With Moderate to Severe Plaque Ps Measure: PASI) | Week 12 | 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 or PASI100 were defined as having an improvement of ≥90% or of 100% respectively in PASI scores compared to baseline. |
| Secondary | Percentage of Participants Maintaining sPGA 0 or 1 After Re-Randomization at Start of Maintenance Dosing Period | Week 60 | 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. Participants Ps were assessed as 0 (clear), 1 (minimal), 2 (mild), 3 (moderate), 4 (severe), or 5 (very severe). |
| Secondary | Percentage of Participants With Itch Numeric Rating Scale (Itch NRS) Score ≥4 Point Reduction From Baseline | Baseline, Week 12 | The Itch NRS is a participant-administered, 11-point horizontal scale anchored at 0 (no itch) and 10 (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. |
| Secondary | Change From Baseline in Dermatology-Specific Quality of Life Index (DLQI) Score | Baseline, Week 12 | 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 unanswered ("not relevant") responses were scored as "0." Total scores range from 0 to 30, with higher score indicating greater quality of life is 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). |
| Secondary | Change From Baseline in Nail Psoriasis Severity Index (NAPSI) | Baseline, Week 12 | The NAPSI is a numeric, reproducible, objective tool for evaluation of fingernail Ps. This scale is used to evaluate the severity of fingernail bed Ps and fingernail matrix Ps 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 Ps 0 (none) to 4 (Ps in 4 quadrants of the fingernail) and fingernail matrix Ps 0 (none) to 4 (Ps in 4 quadrants of the matrix), depending on the presence (score of 1) or absence (score of 0) of any of the features of fingernail bed or matrix Ps 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, then the sum of all fingernails equals the total NAPSI score with a range from 0 to 80 with higher scores indicating more severe psoriasis. LS mean change from baseline was calculated using MMRM. |
| Secondary | Percent of Body Surface Area (BSA) Involvement of Ps | Week 12 | BSA is a physician rating of the percentage of involvement of Ps for each participant. BSA is assessed on a continuous scale from 0% (no involvement) to 100% (full involvement), where 1% corresponds to the size of the participants hand (includes the palm, fingers and thumb). Total BSA is the sum of handprints from the affected areas. LS mean change from baseline was calculated using MMRM. |
| Secondary | Change From Baseline in Psoriasis Scalp Severity Index (PSSI) | Baseline, Week 12 | 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 to 72, with lower scores indicating less severity. LS mean change from baseline was calculated using MMRM. |
1 to 10 of 17Source ClinicalTrials.gov
See all 17 registered outcomesOutcomes17
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants With Static Physician Global Assessment (sPGA) of 0 or 1 (Efficacy of Ixekizumab in Participants With Moderate to Severe Plaque Ps Measure: sPGA) | Week 12 | Intent to Treat (ITT) Population: all randomized participants analyzed according to the treatment to which they were assigned. Participants who did not meet the clinical response criteria or had missing data at Week 12 were considered non-responders for Non-Responder Imputation (NRI) analysis. | percentage of participants | NUMBER |
| PRIMARY | Percentage of Participants Achieving ≥75% Improvement in Ps Area and Severity Index (PASI75) (Efficacy of Ixekizumab in Participants With Moderate to Severe Plaque Psoriasis Measure: PASI) | Week 12 | ITT Population: all randomized participants analyzed according to the treatment to which they were assigned. Participants who did not meet the clinical response criteria or had missing data at Week 12 were considered non-responders for NRI analysis. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Achieving an sPGA of 0 (Efficacy of Ixekizumab in Participants With Moderate to Severe Plaque Ps Measure: sPGA) | Week 12 | ITT Population: all randomized participants analyzed according to the treatment to which they are assigned. Participants who did not meet the clinical response criteria or had missing data at Week 12 were considered non-responders for NRI analysis. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Achieving PASI 90% (PASI90) or 100% (PASI100) (Efficacy of Ixekizumab in Participants With Moderate to Severe Plaque Ps Measure: PASI) | Week 12 | ITT Population: all randomized participants analyzed according to the treatment to which they are assigned. Participants who did not meet the clinical response criteria or had missing data at Week 12 were considered non-responders for NRI analysis. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Maintaining sPGA 0 or 1 After Re-Randomization at Start of Maintenance Dosing Period | Week 60 | Maintenance Period Primary Population (MPPP): all randomized participants from Period 2 who achieved sPGA (0, 1), were re-randomized at Week 12 and who received at least 1 dose of study treatment Period 3. Participants did not meet the clinical response criteria or had missing data at Week 12 were considered non-responders for NRI analysis. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Itch Numeric Rating Scale (Itch NRS) Score ≥4 Point Reduction From Baseline | Baseline, Week 12 | ITT Population: all randomized participants analyzed according to the treatment to which they are assigned; and had an Itch NRS score ≥4 at baseline. Participants who did not meet the clinical response criteria or had missing data at Week 12 were considered non-responders for NRI analysis. | percentage of participants | NUMBER |
| SECONDARY | Change From Baseline in Dermatology-Specific Quality of Life Index (DLQI) Score | Baseline, Week 12 | ITT Population: all randomized participants analyzed according to the treatment to which they are assigned; and who had at least 1 post-baseline DLQI measurement. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Nail Psoriasis Severity Index (NAPSI) | Baseline, Week 12 | ITT Population: all randomized participants analyzed according to the treatment to which they are assigned; and had fingernail Ps at baseline. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Percent of Body Surface Area (BSA) Involvement of Ps | Week 12 | ITT Population: all randomized participants analyzed according to the treatment to which they are assigned; and had at least 1 post-baseline BSA measurement. | percentage of body surface | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Psoriasis Scalp Severity Index (PSSI) | Baseline, Week 12 | ITT Population: all randomized participants analyzed according to the treatment to which they are assigned; and had scalp Ps at baseline. | units on a scale | LEAST_SQUARES_MEAN |
1 to 10 of 17Source ClinicalTrials.gov
See all 17 outcomesResults by group77
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Participants With Static Physician Global Assessment (sPGA) of 0 or 1 (Efficacy of Ixekizumab in Participants With Moderate to Severe Plaque Ps Measure: sPGA) | Placebo | 3.2 | percentage of participants | ||
| Percentage of Participants With Static Physician Global Assessment (sPGA) of 0 or 1 (Efficacy of Ixekizumab in Participants With Moderate to Severe Plaque Ps Measure: sPGA) | Ixe Q4W | 76.4 | percentage of participants | ||
| Percentage of Participants With Static Physician Global Assessment (sPGA) of 0 or 1 (Efficacy of Ixekizumab in Participants With Moderate to Severe Plaque Ps Measure: sPGA) | Ixe Q2W | 81.8 | percentage of participants | ||
| Percentage of Participants Achieving ≥75% Improvement in Ps Area and Severity Index (PASI75) (Efficacy of Ixekizumab in Participants With Moderate to Severe Plaque Psoriasis Measure: PASI) | Placebo | 3.9 | percentage of participants | ||
| Percentage of Participants Achieving ≥75% Improvement in Ps Area and Severity Index (PASI75) (Efficacy of Ixekizumab in Participants With Moderate to Severe Plaque Psoriasis Measure: PASI) | Ixe Q4W | 82.6 | percentage of participants | ||
| Percentage of Participants Achieving ≥75% Improvement in Ps Area and Severity Index (PASI75) (Efficacy of Ixekizumab in Participants With Moderate to Severe Plaque Psoriasis Measure: PASI) | Ixe Q2W | 89.1 | percentage of participants | ||
| Percentage of Participants Achieving an sPGA of 0 (Efficacy of Ixekizumab in Participants With Moderate to Severe Plaque Ps Measure: sPGA) | Placebo | 0.0 | percentage of participants | ||
| Percentage of Participants Achieving an sPGA of 0 (Efficacy of Ixekizumab in Participants With Moderate to Severe Plaque Ps Measure: sPGA) | Ixe Q4W | 34.5 | percentage of participants | ||
| Percentage of Participants Achieving an sPGA of 0 (Efficacy of Ixekizumab in Participants With Moderate to Severe Plaque Ps Measure: sPGA) | Ixe Q2W | 37.0 | percentage of participants | ||
| Percentage of Participants Achieving PASI 90% (PASI90) or 100% (PASI100) (Efficacy of Ixekizumab in Participants With Moderate to Severe Plaque Ps Measure: PASI) | Placebo | PASI90 | 0.5 | percentage of participants |
1 to 10 of 77Source ClinicalTrials.gov
See all 77 results by groupParticipant flow288
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Induction Period | STARTED | Placebo- Induction Period | 431 | |
| Induction Period | STARTED | Ixe Q4W - Induction Period | 432 | |
| Induction Period | STARTED | Ixe Q2W - Induction Period | 433 | |
| Induction Period | STARTED | Ixe/Placebo- Maintenance Period Primary Pop | 0 | |
| Induction Period | STARTED | Ixe/Ixe Q12W - Maintenance Period Primary Pop | 0 | |
| Induction Period | STARTED | Ixe/Ixe Q4W - Maintenance Period Primary Pop | 0 | |
| Induction Period | STARTED | Placebo Resp/Placebo - Maintenance Period Secondary Pop | 0 | |
| Induction Period | STARTED | Placebo Non-Resp/Ixe Q4W - Maintenance Period Secondary Pop | 0 | |
| Induction Period | STARTED | Ixe Q4W Non-Resp/Ixe Q4W- Maintenance Period Secondary Pop | 0 | |
| Induction Period | STARTED | Q2W Non-Resp/Q4W - Maintenance Period Secondary Pop | 0 |
1 to 10 of 288Source ClinicalTrials.gov
See all 288 participant flowAdverse events4,788
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 | Diarrhoea | Gastrointestinal disorders | Placebo - Induction Period | 4 | 431 | 5 |
| other | Diarrhoea | Gastrointestinal disorders | Ixe Q4W - Induction Period | 10 | 432 | 11 |
| other | Diarrhoea | Gastrointestinal disorders | Ixe Q2W - Induction Period | 9 | 433 | 11 |
| other | Diarrhoea | Gastrointestinal disorders | Ixe/Placebo- Maintenance Period Primary Pop | 8 | 226 | 8 |
| other | Diarrhoea | Gastrointestinal disorders | Ixe/Ixe Q12W - Maintenance Period Primary Pop | 4 | 227 | 4 |
| other | Diarrhoea | Gastrointestinal disorders | Ixe/Ixe Q4W - Maintenance Period Primary Pop | 8 | 229 | 8 |
| other | Diarrhoea | Gastrointestinal disorders | Placebo Resp/Placebo - Maintenance Period Secondary Pop | 0 | 16 | 0 |
| other | Diarrhoea | Gastrointestinal disorders | Placebo Non-Resp/Ixe Q4W - Maintenance Period Secondary Pop | 22 | 391 | 29 |
| other | Diarrhoea | Gastrointestinal disorders | Ixe Q4W Non-Resp/Ixe Q4W - Maintenance Period Secondary Pop | 1 | 78 | 1 |
| other | Diarrhoea | Gastrointestinal disorders | Q2W Non-Resp/Q4W - Maintenance Period Secondary Pop | 2 | 62 | 2 |
1 to 10 of 4,788Source ClinicalTrials.gov
See all 4,788 adverse eventsAdverse event totals54
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo - Induction Period | ||
| Total, all-cause mortality | Ixe Q4W - Induction Period | ||
| Total, all-cause mortality | Ixe Q2W - Induction Period | ||
| Total, all-cause mortality | Ixe/Placebo- Maintenance Period Primary Pop | ||
| Total, all-cause mortality | Ixe/Ixe Q12W - Maintenance Period Primary Pop | ||
| Total, all-cause mortality | Ixe/Ixe Q4W - Maintenance Period Primary Pop | ||
| Total, all-cause mortality | Placebo Resp/Placebo - Maintenance Period Secondary Pop | ||
| Total, all-cause mortality | Placebo Non-Resp/Ixe Q4W - Maintenance Period Secondary Pop | ||
| Total, all-cause mortality | Ixe Q4W Non-Resp/Ixe Q4W - Maintenance Period Secondary Pop | ||
| Total, all-cause mortality | Q2W Non-Resp/Q4W - Maintenance Period Secondary Pop |
1 to 10 of 54Source ClinicalTrials.gov
See all 54 adverse event totalsPapers6
The papers the trial lists on ClinicalTrials.gov.
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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GET https://conductscience.org/api/trials/v1/NCT01474512/results?page=2