Trial · NCT01474512
Outcomes17
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 17 of 17
Download this page as JSON| 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 |
| SECONDARY | Change From Baseline in All Scores of the Work Productivity Activity Impairment Questionnaire-Psoriasis (WPAI-PSO) Quality of Life and Outcome Assessments. Measures: Participant Reported Outcomes (PRO) | Baseline, Week 12 | ITT Population: all randomized participants analyzed according to the treatment to which they are assigned, and had results at specified time points, last observation carried forward (LOCF). | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Quick Inventory of Depressive Symptomatology-Self Reported 16 Items (QIDS-SR16) | Baseline, Week 12 | ITT Population: all randomized participants analyzed according to the treatment to which they are assigned, and had results at the specified time points, LOCF. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Medical Outcomes Study 36-item Short Form Health Survey (SF-36) and Physical Component Summary (PCS) and Mental Component Summary (MCS) | Baseline, Week 12 | ITT Population: all randomized participants analyzed according to the treatment to which they are assigned; and with results at the specified time points, LOCF. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Patient's Global Assessment of Disease Severity (PatGA) | Baseline, Week 12 | ITT Population: all randomized participants analyzed according to the treatment to which they are assigned; and with at least 1 post-baseline PatGA measurement. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Percentage of Participants Achieving Palmoplantar PASI (PPASI) of ≥50% (PPASI50), ≥75% (PPASI75), or 100% (PPASI100) Improvement | Week 12 | ITT Population: all randomized participants analyzed according to the treatment to which they are assigned; and who had palmoplantar Ps at baseline. | percentage of participants | NUMBER |
| SECONDARY | Pharmacokinetics (PK): Trough Concentration at Steady State (Ctrough ss) | Weeks 12: Day 84 and Week 24: Day 168 | ITT Population: all randomized participants analyzed according to the treatment to which they are assigned; and who had Ctrough ss results at specified time points where the concentration met the definition of being a trough concentration. | micrograms/milliliter (µg/mL) | GEOMETRIC_MEAN |
| SECONDARY | Percentage of Participants With Anti-ixekizumab Antibodies | Baseline through Week 12 | All randomized participants who received at least 1 dose of study drug and had evaluable data. | percentage of participants | NUMBER |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
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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