Trial · NCT01646177
A Study in Participants With Moderate to Severe Psoriasis (UNCOVER-3)
NCT01646177, Phase 3, Completed, Eli Lilly and Company; results first posted 2016-10-21
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study in Participants With Moderate to Severe Psoriasis (UNCOVER-3). Trials, record NCT01646177. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01646177
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study in Participants With Moderate to Severe Psoriasis (UNCOVER-3)
- NCT number
- NCT01646177
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 1,346 participants, actual
- Lead sponsor
- Eli Lilly and Company
- Conditions
- Psoriasis
- Interventions
- Placebo, 50 mg etanercept, 80 mg ixekizumab
- First posted
- 2012-07-20
- Last updated
- 2020-07-28
- Results first posted
- 2016-10-21
Source ClinicalTrials.gov
Registered outcomes18
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | 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) | Week 12 | 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. |
| Primary | 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) | Week 12 | 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 | Number of Participants Achieving an sPGA (0) (Efficacy of Ixekizumab in Participants With Moderate to Severe Chronic Plaque Psoriasis. Measure: sPGA) | Week 12 | 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. |
| Secondary | Number of Participants Achieving ≥90% (PASI 90) Improvement (Efficacy of Ixekizumab in Participants With Moderate to Severe Chronic Plaque Psoriasis. Measure: PASI) | Week 12 | 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. |
| Secondary | Number of Participants Achieving 100% (PASI 100) Improvement (Efficacy of Ixekizumab in Participants With Moderate to Severe Chronic Plaque Psoriasis. Measure: PASI) | Week 12 | 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. |
| Secondary | Number of Participants Achieving an Itch Numeric Rating Scale (NRS) ≥4 Point Reduction [Quality of Life and Outcome Assessments. Measures: Patient Reported Outcomes (PRO)] | Week 12 | 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. |
| Secondary | Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score | Baseline, Week 12 | 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. |
| Secondary | Change From Baseline in Nail Psoriasis Severity Index (NAPSI) Score | Baseline, Week 12 | 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. |
| Secondary | Percent of Body Surface Area (BSA) Involvement of Psoriasis | Week 12 | 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. |
| Secondary | Change From Baseline in Psoriasis Scalp Severity Index (PSSI) Score | Baseline, Week 12 | 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. |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 registered outcomesOutcomes18
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | 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) | Week 12 | All randomized participants. Participants who did not meet clinical response criteria or have missing data at Week 12 will be considered non-responders for the Non-Responder Imputation (NRI) analysis. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | 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) | Week 12 | All randomized participants. Participants who did not meet clinical response criteria or have missing data at Week 12 will be considered non-responders for the Non-Responder Imputation (NRI) analysis. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants Achieving an sPGA (0) (Efficacy of Ixekizumab in Participants With Moderate to Severe Chronic Plaque Psoriasis. Measure: sPGA) | Week 12 | All randomized participants. Participants who did not meet clinical response criteria or have missing data at Week 12 will be considered non-responders for the Non-Responder Imputation (NRI) analysis. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants Achieving ≥90% (PASI 90) Improvement (Efficacy of Ixekizumab in Participants With Moderate to Severe Chronic Plaque Psoriasis. Measure: PASI) | Week 12 | All randomized participants. Participants who did not meet clinical response criteria or have missing data at Week 12 will be considered non-responders for the Non-Responder Imputation (NRI) analysis. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants Achieving 100% (PASI 100) Improvement (Efficacy of Ixekizumab in Participants With Moderate to Severe Chronic Plaque Psoriasis. Measure: PASI) | Week 12 | All randomized participants. Participants who did not meet clinical response criteria or have missing data at Week 12 will be considered non-responders for the Non-Responder Imputation (NRI) analysis. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants Achieving an Itch Numeric Rating Scale (NRS) ≥4 Point Reduction [Quality of Life and Outcome Assessments. Measures: Patient Reported Outcomes (PRO)] | Week 12 | All randomized participants and had an Itch NRS score \>=4 at baseline. Participants who did not meet clinical response criteria or have missing data at Week 12 will be considered non-responders for the NRI analysis. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score | Baseline, Week 12 | All randomized participants and had at least one post-dose measurement of DLQI. | Units on a Scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Nail Psoriasis Severity Index (NAPSI) Score | Baseline, Week 12 | All randomized participants and had fingernail involvement at baseline and had at least one post-dose measurement of NAPSI. | Units on a Scale | LEAST_SQUARES_MEAN |
| SECONDARY | Percent of Body Surface Area (BSA) Involvement of Psoriasis | Week 12 | All randomized participants and had at least one post-dose measurement of BSA. | Percent | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Psoriasis Scalp Severity Index (PSSI) Score | Baseline, Week 12 | All randomized participants and had scalp psoriasis at baseline and had at least one post-dose measurement of PSSI. | Units on a Scale | LEAST_SQUARES_MEAN |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 outcomesResults by group88
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| 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) | Placebo | 13 | Participants | ||
| 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) | 50 mg Etanercept | 159 | Participants | ||
| 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) | 80 mg Ixekizumab Dosing Regimen 2 (Q4W) | 291 | Participants | ||
| 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) | 80 mg Ixekizumab Dosing Regimen 1 (Q2W) | 310 | Participants | ||
| 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) | Placebo | 14 | Participants | ||
| 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) | 50 mg Etanercept | 204 | Participants | ||
| 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) | 80 mg Ixekizumab Dosing Regimen 2 (Q4W) | 325 | Participants | ||
| 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) | 80 mg Ixekizumab Dosing Regimen 1 (Q2W) | 336 | Participants | ||
| Number of Participants Achieving an sPGA (0) (Efficacy of Ixekizumab in Participants With Moderate to Severe Chronic Plaque Psoriasis. Measure: sPGA) | Placebo | 0 | Participants | ||
| Number of Participants Achieving an sPGA (0) (Efficacy of Ixekizumab in Participants With Moderate to Severe Chronic Plaque Psoriasis. Measure: sPGA) | 50 mg Etanercept | 33 | Participants |
1 to 10 of 88Source ClinicalTrials.gov
See all 88 results by groupParticipant flow144
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Blinded Induction Dosing (Week 0-12) | STARTED | Placebo | 193 | |
| Blinded Induction Dosing (Week 0-12) | STARTED | 50 mg Etanercept (ETN) | 382 | |
| Blinded Induction Dosing (Week 0-12) | STARTED | 80 mg Ixekizumab Dosing Regimen 2 (Q4W) | 386 | |
| Blinded Induction Dosing (Week 0-12) | STARTED | 80 mg Ixekizumab Dosing Regimen 1 (Q2W) | 385 | |
| Blinded Induction Dosing (Week 0-12) | STARTED | PBO/IXE80Q4W | 0 | |
| Blinded Induction Dosing (Week 0-12) | STARTED | ETN/IXE80Q4W | 0 | |
| Blinded Induction Dosing (Week 0-12) | STARTED | IXE80Q4W/IXE80Q4W | 0 | |
| Blinded Induction Dosing (Week 0-12) | STARTED | IXE80Q2W/IXE80Q4W | 0 | |
| Blinded Induction Dosing (Week 0-12) | STARTED | PBO Follow-Up Period | 0 | |
| Blinded Induction Dosing (Week 0-12) | STARTED | ETN Follow-Up Period | 0 |
1 to 10 of 144Source ClinicalTrials.gov
See all 144 participant flowAdverse events3,924
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 | 2 | 193 | 2 |
| other | Diarrhoea | Gastrointestinal disorders | 50 mg Etanercept | 6 | 382 | 6 |
| other | Diarrhoea | Gastrointestinal disorders | 80 mg Ixekizumab Dosing Regimen 2 (Q4W) | 3 | 382 | 7 |
| other | Diarrhoea | Gastrointestinal disorders | 80 mg Ixekizumab Dosing Regimen 1 (Q2W) | 11 | 384 | 12 |
| other | Diarrhoea | Gastrointestinal disorders | PBO/IXE80Q4W Long-Term Extension | 10 | 183 | 12 |
| other | Diarrhoea | Gastrointestinal disorders | ETN/IXE80Q4W Long-Term Extension | 27 | 369 | 29 |
| other | Diarrhoea | Gastrointestinal disorders | IXE80Q4W/IXE80Q4W Long-Term Extension | 14 | 360 | 18 |
| other | Diarrhoea | Gastrointestinal disorders | IXE80Q2W/IXE80Q4W Long-Term Extension | 25 | 362 | 32 |
| other | Diarrhoea | Gastrointestinal disorders | PBO Follow-Up Period | 0 | 157 | 0 |
| other | Diarrhoea | Gastrointestinal disorders | ETN Follow-Up Period | 0 | 309 | 0 |
1 to 10 of 3,924Source ClinicalTrials.gov
See all 3,924 adverse eventsAdverse event totals36
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo | ||
| Total, all-cause mortality | 50 mg Etanercept | ||
| Total, all-cause mortality | 80 mg Ixekizumab Dosing Regimen 2 (Q4W) | ||
| Total, all-cause mortality | 80 mg Ixekizumab Dosing Regimen 1 (Q2W) | ||
| Total, all-cause mortality | PBO/IXE80Q4W Long-Term Extension | ||
| Total, all-cause mortality | ETN/IXE80Q4W Long-Term Extension | ||
| Total, all-cause mortality | IXE80Q4W/IXE80Q4W Long-Term Extension | ||
| Total, all-cause mortality | IXE80Q2W/IXE80Q4W Long-Term Extension | ||
| Total, all-cause mortality | PBO Follow-Up Period | ||
| Total, all-cause mortality | ETN Follow-Up Period |
1 to 10 of 36Source ClinicalTrials.gov
See all 36 adverse event totalsPapers13
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.
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