Phase 3
Completed N=204
Evaluation of Ixekizumab Using Auto-Injector or Prefilled Syringe in Participants With Moderate to Severe Plaque Psoriasis
Source: ClinicalTrials.gov NCT01777191 ↗Enrolled (actual)
204
Serious AEs
3.0%
Results posted
May 2016
Primary outcomePrimary: Pharmacokinetics (PK): Maximum Serum Concentration (Cmax) by Drug Delivery Device — 15.0; 14.8 micrograms/milliliter (µg/mL)
◆ Published Evidence
Established
41citations · ~5 / year
Phase 3, open-label, randomized study of the pharmacokinetics, efficacy and safety of ixekizumab following subcutaneous administration using a prefilled syringe or an autoinjector in patients with moderate-to-severe plaque psoriasis (UNCOVER-A).
Summary
The purpose of this study is to evaluate the serum concentration of ixekizumab after administration using either prefilled syringe or auto-injector in participants with moderate to severe plaque psoriasis. Treatment period is followed by 40 weeks optional safety extension.
Linked Publications
-
Phase 3, open-label, randomized study of the pharmacokinetics, efficacy and safety of ixekizumab following subcutaneous administration using a prefilled syringe or an autoinjector in patients with moderate-to-severe plaque psoriasis (UNCOVER-A).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Pharmacokinetics (PK): Maximum Serum Concentration (Cmax) by Drug Delivery Device |
15.0; 14.8 | — |
| PRIMARY PK: Area Under the Concentration Time Curve From Time Zero to Last Measured Concentration Value (AUC 0-[Tlast]) by Drug Delivery Device |
157; 154 | — |
| SECONDARY PK: Cmax of Ixekizumab by Site of Injection (Arm, Thigh or Abdomen) |
14.4; 11.5; 12.7; 15.4; 18.5; 17.6 | — |
| SECONDARY PK: AUC 0-tlast by Site of Injection (Arm, Thigh or Abdomen) |
151; 124; 135; 159; 190; 178 | — |
| SECONDARY PK: Cmax by Body Weight |
18.2; 15.1; 11.7 | — |
| SECONDARY PK: AUC 0-tlast by Body Weight |
193; 155; 122 | — |
| SECONDARY Percentage of Participants Achieving a ≥75%, ≥ 90% and 100% Improvement in Psoriasis Area and Severity Index (PASI): Efficacy of Ixekizumab in Participants With Moderate to Severe Plaque Psoriasis. Measure: Psoriasis Area and Severity Index (PASI) |
88.2; 78.4; 76.5; 62.7; 48.0; 42.2 | — |
| SECONDARY Percentage of Participants With a Static Physician Global Assessment (sPGA) (0,1): Efficacy of Ixekizumab in Participants With Moderate to Severe Plaque Psoriasis. Measure: Static Physician Global Assessment (sPGA) |
80.4; 73.5 | — |
| SECONDARY Percentage of Participants With a Static Physician Global Assessment (sPGA) (0) |
51.0; 43.1 | — |
| SECONDARY Percentage of Device Operation Failures |
0; 0.3 | 0.248 |
| SECONDARY Percentage of Participants With Anti-Ixekizumab Antibodies |
11.8; 8.1 | — |
| SECONDARY SQAAQ Item Scores: Quality of Life and Outcome Assessments. Measures: Patient Reported Outcomes (PRO) |
6.6; 6.7; 6.6; 6.8; 6.6; 6.6 | — |
Eligibility Criteria
Inclusion Criteria
- Present with chronic plaque psoriasis based on a confirmed diagnosis of chronic psoriasis vulgaris for at least 6 months prior to randomization
- At least 10% Body Surface Area (BSA) of Psoriasis at screening and at randomization
- Static Physician Global Assessment (sPGA) score of at least 3 AND Psoriasis Area and Severity Index (PASI) score of at least 12 at screening and at randomization
- Candidate for phototherapy and/or systemic therapy
- Men must agree to use a reliable method of birth control during the study
- Women must agree to use birth control or remain abstinent during the study and for at least 12 weeks after stopping treatment
Exclusion Criteria
- Pustular, erythrodermic, and/or guttate forms of psoriasis
- History of drug-induced psoriasis
- Clinically significant flare of psoriasis during the 12 weeks prior to randomization
- Concurrent or recent use of any biologic agent
- Received systemic psoriasis therapy [such as psoralen and ultraviolet A (PUVA) light therapy] or phototherapy within the previous 4 weeks; or had topical psoriasis treatment within the previous 2 weeks prior to randomization
- Cannot avoid excessive sun exposure or use of tanning booths for at least 4 weeks prior to randomization and during the study
- Have participated in any study with interleukin-17 (IL-17) antagonists, including Ixekizumab
- Serious disorder or illness other than plaque psoriasis
- Serious infection within the last 3 months
- Breastfeeding or nursing (lactating) women
Data sourced from ClinicalTrials.gov (NCT01777191) and the linked publication. 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.