Phase 3
Completed N=1,257
A Study Comparing Different Dosing Regimens of Ixekizumab (LY2439821) in Participants With Moderate to Severe Plaque Psoriasis
Source: ClinicalTrials.gov NCT02513550 ↗Enrolled (actual)
1,257
Serious AEs
3.1%
Results posted
Apr 2018
Primary outcomePrimary: Percentage of Participants Achieving Static Physician Global Assessment (sPGA) of (0,1) — 70.6; 72.5; 78.6 Percentage of participants — p==0.005
◆ 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 This can indicate results are unpublished — a known publication-bias signal.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
The main purpose of this study is to evaluate the efficacy of ixekizumab dosing regimens in participants with plaque psoriasis.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Achieving Static Physician Global Assessment (sPGA) of (0,1) |
70.6; 72.5; 78.6 | =0.005 sig |
| PRIMARY Percentage of Participants Achieving 75% Improvement in Psoriasis Area and Severity Index (PASI 75) |
79; 83.7; 85.9 | =0.006 sig |
| SECONDARY Percentage of Participants Achieving sPGA (0) |
44.8; 48.7; 60.1 | — |
| SECONDARY Percentage of Participants Achieving PASI 90 |
65.2; 73.9; 79.5 | — |
| SECONDARY Percentage of Participants Achieving PASI 100 |
43.5; 49.3; 59.7 | — |
| SECONDARY Change From Baseline in PASI |
-18.34; -18.95; -19.41 | — |
| SECONDARY Percent Improvement in PASI |
91.09; 94.24; 96.25 | — |
| SECONDARY Mean Change From Baseline in Percent Body Surface Area (BSA) Involvement |
-23.93; -24.62; -25.01 | — |
| SECONDARY Mean Change From Baseline in Nail Psoriasis Severity Index (NAPSI) Score |
-19.27; -19.87; -20.82 | — |
| SECONDARY Mean Change From Baseline in Psoriasis Scalp Severity Index (PSSI) Score |
-18.35; -18.73; -18.65 | — |
| SECONDARY Mean Change From Baseline in Palmoplantar PASI (PPASI) |
-9.55; -9.37; -9.00 | — |
| SECONDARY Percentage of Participants Achieving an Itch Numeric Rating Scale (Itch NRS) ≥4 Point Reduction From Baseline |
74.0; 72.3; 77.2 | — |
| SECONDARY Percentage of Participants Achieving Dermatology Life Quality Index (DLQI) Total Score of 0 and 1 (DLQI [0,1]) |
66.1; 70.3; 74.0 | — |
| SECONDARY Change From Baseline in DLQI Total Score |
-9.70; -9.97; -10.23 | — |
| SECONDARY Change From Baseline in Itch NRS Score |
-4.90; -5.15; -5.33 | — |
| SECONDARY Change From Baseline in Skin Pain Visual Analog Scale (VAS) |
-35.50; -36.77; -38.07 | — |
| SECONDARY Change From Baseline in European Quality of Life - 5 Dimensions 5 Level (EQ-5D-5L) VAS |
11.93; 12.47; 14.42 | — |
| SECONDARY Pharmacokinetics (PK): Trough Concentration at Steady State (Ctrough,ss) of Ixekizumab |
3.55; 4.03; 2.78; 7.87; 2.72; 2.81 | — |
| SECONDARY Number of Participants With Anti-Ixekizumab Antibodies |
71; 64; 84 | — |
Eligibility Criteria
Inclusion Criteria
- Present with chronic plaque psoriasis for at least 6 months prior to enrollment
- At least 10% BSA of psoriasis at screening and at enrollment
- sPGA score of at least 3 and PASI score of at least 12 at screening and at enrollment
- Candidates for phototherapy and/or systemic therapy
- Participant must agree to use reliable method of birth control during the study; women must continue using birth control for at least 12 weeks after stopping treatment
Exclusion Criteria
- Predominant pattern of pustular, erythrodermic, or guttate forms of psoriasis
- History of drug-induced psoriasis
- Cannot avoid excessive sun exposure or use of tanning booths for at least 4 weeks prior to enrollment and during the study
- Received systemic non-biologic psoriasis therapy or phototherapy within the previous 4 weeks; or had topical psoriasis treatment within the previous 2 weeks prior to enrollment
- Concurrent or recent use of any biologic agent
- Have participated in any study with ixekizumab
- Received a live vaccination within 12 weeks prior to enrollment
- Serious disorder or illness other than psoriasis
- Ongoing or serious infection within the last 12 weeks or evidence of tuberculosis
- Major surgery within 8 weeks of baseline, or will require surgery during the study
- Breastfeeding or nursing (lactating) women
Data sourced from ClinicalTrials.gov (NCT02513550). 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.