Phase 3
Completed N=12
A Study of the Early Activity of Ixekizumab (LY2439821) in Moderate-to-Severe Psoriasis
Source: ClinicalTrials.gov NCT02387801 ↗Enrolled (actual)
12
Serious AEs
0.0%
Results posted
Oct 2016
Primary outcomePrimary: Time to at Least a 1 Point Improvement on the Patient's Global Assessment of Disease Severity (PatGA) Score — 5.0; 6.0 Days
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
Summary
To detect onset of activity of ixekizumab in participants with moderate-to-severe plaque psoriasis and to document the same using sequential photographic images.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Time to at Least a 1 Point Improvement on the Patient's Global Assessment of Disease Severity (PatGA) Score |
5.0; 6.0 | — |
| SECONDARY Mean Change From Baseline on Itch Numeric Rating Scale (NRS) Score |
-6.2; -6.6 | — |
| SECONDARY Mean Change From Baseline on the Dermatology Life Quality Index (DLQI) |
-13.4; -14.3 | — |
| SECONDARY Mean Change From Baseline in Percent Body Surface Area (%BSA) |
-26.1; -28.0 | — |
| SECONDARY Mean Change From Baseline on the Psoriasis Area and Severity Index (PASI) |
-22.00; -22.72 | — |
| SECONDARY Time to at Least a 2 Point Improvement on the PatGA Score |
10.0; 13.5 | — |
Eligibility Criteria
Inclusion Criteria
- Present with chronic moderate-to-severe plaque psoriasis based on a confirmed (by a dermatologist) diagnosis of chronic plaque psoriasis for at least 6 months prior to baseline
- Active psoriatic skin lesions of plaque psoriasis (Ps)
- Are a candidate for phototherapy and/or systemic therapy
- Men must agree to use a reliable method of birth control or remain abstinent during the study and for at least 12 weeks after stopping treatment
- Women must agree to use reliable birth control or remain abstinent during the study and for at least 12 weeks after stopping treatment
Exclusion Criteria
- Are unable to commit to the photography schedule for the duration of the study
- Have participated in any study with interleukin 17 (IL-17) or (IL-23) antagonists, including ixekizumab
- Serious disorder or illness other than psoriasis
- Serious infection within the last 3 months
- Breastfeeding or nursing (lactating) women
Data sourced from ClinicalTrials.gov (NCT02387801). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.