Phase 3
Completed N=1,306
Safety and Efficacy of Secukinumab Compared to Etanercept in Subjects With Moderate to Severe, Chronic Plaque-Type Psoriasis
Source: ClinicalTrials.gov NCT01358578 ↗Enrolled (actual)
1,306
Serious AEs
3.5%
Results posted
Sep 2015
Primary outcomePrimary: Efficacy of Secukinumab Compared to Placebo in Subjects With Moderate to Severe Chronic Plaque-type Psoriasis Measure: PASI 75 (Psoriasis Area and Severity Index) . — 219; 249; 16 participants achieving goal
Summary
This study will assess the safety and efficacy of secukinumab compared to placebo and etanercept in patients that have moderate to severe, chronic, plaque-type psoriasis.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Efficacy of Secukinumab Compared to Placebo in Subjects With Moderate to Severe Chronic Plaque-type Psoriasis Measure: PASI 75 (Psoriasis Area and Severity Index) . |
219; 249; 16 | — |
| PRIMARY Efficacy of Secukinumab Compared to Placebo in Subjects With Moderate to Severe Chronic Plaque-type Psoriasis Measure:IGA (Investigator's Global Assessment) Mod 2011 With a 0 or 1 Response at Week 12 |
167; 202; 9 | — |
| SECONDARY Efficacy of Secukinumab Compared to Etanercept and Placebo in Subjects With Moderate to Severe Chronic Plaque-type Psoriasis Measure: PASI 90 at Week 12 |
137; 175; 67; 5 | — |
| SECONDARY Efficacy of Secukinumab Compared to Etanercept in Subjects With Moderate to Severe Chronic Plaque-type Psoriasis Measure: PASI 75 at Week 12 |
219; 249; 142 | — |
| SECONDARY Efficacy of Secukinumab Compared to Etanercept in Subjects With Moderate to Severe Chronic Plaque-type Psoriasis Measure: :IGA (Investigator's Global Assessment) Mod 2011 With a 0 or 1 Response at Week 12 |
167; 202; 88 | — |
| SECONDARY Maintenance of PASI 75 Response at Week 52 for Patients Who Were PASI 75 Responders at Week 12 (Non-responder Imputation) |
180; 210; 103 | — |
| SECONDARY Maintenance of IGA Mod 2011 0 or 1 Response After 52 Weeks of Treatment for Subjects Who Were IGA Mod 2011 0 or 1 Responders After 12 Weeks of Treatment |
113; 161; 50 | — |
| SECONDARY Change in Score From Baseline to Week 12 in Psoriasis Symptom Diary Items Itching, Pain and Scaling in AIN457 vs Placebo |
-4.92; -4.93; -0.54; -4.10; -4.48; -0.33 | — |
| SECONDARY Change From Baseline to Week 12 in Psoriasis Symptom Diary Items Itching, Pain and Scaling in AIN457 vs Etanercept |
-4.92; -4.93; -3.80; -4.10; -4.48; -3.48 | — |
| SECONDARY Number of Participants Developing Anti-secukinumab Antibodies |
2; 3; 0; 0; 0; 6 | — |
Eligibility Criteria
Inclusion Criteria
- Subjects with chronic, plaque-type psoriasis for at least 6 months
- Must have moderate to severe psoriasis based on PASI greater than 12, IGA greater than 3, and greater than 10% body surface area
- Must be inadequately controlled by prior treatments (topicals, phototherapy, and/or systemic therapies)
Exclusion Criteria
- Forms of psoriasis other than chronic, plaque-type (such as pustular, erythrodermic and guttate psoriasis)
- Drug induced psoriasis
- Use of other psoriasis treatments during the study
- Prior use of etanercept
- Prior use of secukinumab or any other drug that target IL-17 (interleukin 17) or the IL-17 receptor
- Pregnant or lactating women; women who do not agree to use contraception during the study and for 16 weeks after stopping treatment
- Significant medical problems such as uncontrolled high blood pressure, congestive heart failure, etc.
- History of an ongoing, chronic or recurrent infection or evidence of tuberculosis
- Allergy to rubber or latex
Other protocol-defined inclusion/exclusion criteria may apply
Data sourced from ClinicalTrials.gov (NCT01358578). 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.