Phase 3 Psoriasis Trial, Completed NCT02718898 Sponsor: Eli Lilly and Company Condition: Psoriasis
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Trial results

AI generated results summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

According to the results reported on ClinicalTrials.gov, this trial (NCT02718898) looked at a medicine called ixekizumab (given as an 80mg injection every two weeks) compared to a placebo (a dummy treatment with no active ingredient) in people with genital psoriasis. A total of 149 people started the blinded portion of the trial — 74 received placebo and 75 received ixekizumab. The trial then moved into an open-label phase (where everyone knew what treatment was being given) and a follow-up period. The main thing being measured was how many participants' genital psoriasis was rated by a doctor as either "clear" or "minimal" by the end of the blinded treatment period. The reported data shows that, for the primary measure — a doctor's rating of genital psoriasis as "clear" or "minimal" — 55 out of 75 participants in the ixekizumab group reached that rating, compared to 6 out of 74 in the placebo group. For the secondary measures, the reported data shows: 55 ixekizumab participants versus 2 placebo participants had their overall body psoriasis rated "clear" or "minimal"; 37 versus 5 reported at least a 3-point improvement in genital itch on a 0–10 scale; 29 versus 9 reported their sexual activity was "never" or "rarely" limited by their genital psoriasis; and 23 versus 9 reported they "never" or "rarely" avoided sexual activity because of it. For quality of life (measured on a 0–30 scale where higher scores mean worse quality of life), the ixekizumab group reported an average decrease of 9.7 points from their starting score, while the placebo group reported an average decrease of 1.4 points. It is important to note that these numbers describe what was measured and counted in this specific group of trial participants — they do not tell us about longer-term outcomes, and the trial design changed across its different phases. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

These are the results as reported to ClinicalTrials.gov, not medical advice. Verify independently with the trial site and discuss what they mean for you with your doctor.

Phase 3 Psoriasis Trial, Completed

NCT02718898
Completed Phase 3 🇦🇺 Australian site

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • You have been diagnosed with chronic plaque psoriasis for at least 6 months before the study starts.
  • You have moderate-to-severe psoriasis in the genital area at the time of screening and at the start of the study.
  • You also have plaque psoriasis somewhere on your body outside of the genital area at the time of screening and at the start of the study.
  • You have already tried at least one cream, ointment, or other topical (applied to skin) treatment for psoriasis in the genital area, and it either did not work or you could not tolerate it.
  • You agree to use a reliable form of birth control, which can include not having sex, throughout the study and for at least 12 weeks after your last dose of the study drug.

Who may not be able to join:

  • You have a type of psoriasis other than plaque psoriasis, such as pustular, erythrodermic, or guttate psoriasis.
  • Your psoriasis was caused by a medication you have taken.
  • You have recently received certain psoriasis treatments (the waiting period varies depending on the treatment, ranging from 4 weeks to up to 12 months — confirm with trial site).
  • You have ever been treated with ixekizumab, secukinumab, brodalumab, or a similar type of medication.
  • You are unable to avoid excessive sun exposure or tanning beds for at least 4 weeks before the study starts and during the study.
  • You are currently taking part in another clinical trial that involves an experimental treatment.
  • You have a serious illness or medical condition other than plaque psoriasis.
  • You have had or currently have a cancer diagnosis within the past 5 years before the study starts.
  • You have had a serious infection in the last 3 months.
  • You have received a live vaccine in the 3 months before the study starts, or plan to receive one during the study.
  • You have received a BCG vaccination (a vaccine typically given for tuberculosis) within the past year.
  • You are currently pregnant or breastfeeding.

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 28 July 2026
Phase 3: approximately ~65% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

Contact this trial

Principal Investigator: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), Eli Lilly and Company

Australian sites

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., Adelaide,
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., Carlton,
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., Darlinghurst,
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., Woolloongabba,

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

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Trial details

Status
Completed
Phase
Phase 3
Registry
ClinicalTrials.gov
Start date
1 April 2016
Est. completion
22 February 2017

Where this trial is recruiting

🇦🇺 Australia 🇦🇹 Austria 🇧🇪 Belgium 🇨🇦 Canada 🇳🇱 Netherlands Puerto Rico Turkey (Türkiye) 🇺🇸 United States

4 site(s) in Australia. Confirm current status and contact details directly with the trial site.

Primary endpoints

Number of Participants Achieving Static Physician Global Assessment (sPGA) of Genitalia (0,1)

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 28 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov