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NCT01597245 · ClinicalTrials.gov registry record · Phase 3
A Phase 3 Study in Participants With Moderate to Severe Psoriasis (UNCOVER-2)
A Phase 3 study of Psoriasis, sponsored by Eli Lilly and Company.
- Completed
- Registry status
- Phase 3
- Development phase
- 1,224
- Enrollment target
- 20
- Study locations
NCT01597245: Completed Phase 3 study of Psoriasis, sponsored by Eli Lilly and Company.
NCT01597245 is a Phase 3 study of Psoriasis that has completed, run by Eli Lilly and Company. The registered enrollment target is 1,224 participants, above the 479-participant average among 125 other Psoriasis trials with a reported enrollment target (156% higher). The trial reports 20 study locations across 13 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01597245, a Phase 3 study of Psoriasis, has completed, sponsored by Eli Lilly and Company.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 1,224 participants
- Enrollment target
- 20
- Study locations
Study Summary
This study will assess the safety and efficacy of ixekizumab (LY2439821) compared to etanercept and placebo in participants with moderate to severe chronic plaque psoriasis.
Primary Outcome
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.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG 80 mg ixekizumab Dosing Regimen
- DRUG 50 mg etanercept
Study Locations (20)
Florida
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. - Boca Raton
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. - DeLand
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. - Jacksonville
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. - Tampa
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. - West Palm Beach
Arizona
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. - Phoenix
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. - Scottsdale
California
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. - Riverside
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. - San Diego
Georgia
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. - Alpharetta
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. - Atlanta
Arkansas
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. - Little Rock
Colorado
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. - Denver
Connecticut
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. - Farmington
District of Columbia
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. - Washington D.C.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,224 participants |
| Start Date | 2012-05-18 |
| Est. Completion | 2019-06-18 |
| Phase | Phase 3 |
What the finished NCT01597245 record still lists
NCT01597245 is an interventional study that assigns participants to a tested intervention. Its 1,224 participants enrollment target places it among the larger protocols in the corpus, above the 479-participant average among 125 other Psoriasis trials with a reported enrollment target (156% higher).
The record links to 1 condition, with Psoriasis appearing as the primary indexed condition, and to 3 interventions - of which Placebo is the first listed.
NCT01597245 names 20 study sites across 13 states, led by Florida, Arizona, California.
Frequently Asked Questions
What is clinical trial NCT01597245 about?
NCT01597245 is a clinical study titled "A Phase 3 Study in Participants With Moderate to Severe Psoriasis (UNCOVER-2)". This study will assess the safety and efficacy of ixekizumab (LY2439821) compared to etanercept and placebo in participants with moderate to severe chronic plaque psoriasis.
What is the current status of trial NCT01597245?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,224 participants. The study started on 2012-05-18. Estimated completion is 2019-06-18.
What conditions does trial NCT01597245 study?
This clinical trial studies the following conditions: Psoriasis.
What interventions are being tested in trial NCT01597245?
The interventions under investigation include: Placebo (DRUG), 80 mg ixekizumab Dosing Regimen (DRUG), 50 mg etanercept (DRUG).
Who is sponsoring clinical trial NCT01597245?
This trial is sponsored by Eli Lilly and Company, which has 1,341 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01597245 being conducted?
This trial has 20 study locations across Arizona, Arkansas, California, Colorado, Connecticut. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Psoriasis
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01597245's enrollment target sits among peer trials
1,224 9th of 125 higher than 117 of 125 other Psoriasis trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Psoriasis trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
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ACTIVE NOT RECRUITING · Phase 3
-
A Study of Subcutaneous Risankizumab Injection for Pediatric Participants With Moderate to Severe Plaque Psoriasis to Assess Change in Disease Symptoms
COMPLETED · Phase 3
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