Phase 3
Completed N=177
First Study of Secukinumab in Pre-filled Syringes in Subjects With Chronic Plaque-type Psoriasis: Response at 12 Weeks
Moderate to Severe Plaque-type Psoriasis
Source: ClinicalTrials.gov NCT01555125 ↗
Enrolled (actual)
177
Serious AEs
7.1%
Results posted
Aug 2018
Primary outcomePrimary: Efficacy of Secukinumab Compared to Placebo in Subjects With Moderate to Severe Chronic Plaque-type Psoriasis at Week 12 Measure: PASI 75 (Psoriasis Area and Severity Index) Response. — 69.5; 75.9; 0 Percentage of participants — p=<0.0001
◆ Published Evidence
Established
38citations · ~10 / year
Effect of Secukinumab on Traditional Cardiovascular Risk Factors and Inflammatory Biomarkers: Post Hoc Analyses of Pooled Data Across Three Indications.
Summary
The purpose of this study is to demonstrate efficacy of secukinumab at Week 12 based on PASI and IGA response rates versus placebo in subjects with moderate to severe chronic plaque-type psoriasis.
Linked Publications (5)
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Effect of Secukinumab on Traditional Cardiovascular Risk Factors and Inflammatory Biomarkers: Post Hoc Analyses of Pooled Data Across Three Indications.
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Efficacy of Secukinumab for Moderate-to-Severe Head and Neck Psoriasis Over 52 Weeks: Pooled Analysis of Four Phase 3 Studies.
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Correlation Between Change in Psoriasis Area and Severity Index and Dermatology Life Quality Index in Patients with Psoriasis: Pooled Analysis from Four Phase 3 Clinical Trials of Secukinumab.
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Efficacy of Secukinumab on Moderate-to-severe Plaque Psoriasis Affecting Different Body Regions: a Pooled Analysis of Four Phase 3 Studies.
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Secukinumab in Pediatric Patients with Plaque Psoriasis: Pooled Safety Analysis from Two Phase 3 Randomized Clinical Trials.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Efficacy of Secukinumab Compared to Placebo in Subjects With Moderate to Severe Chronic Plaque-type Psoriasis at Week 12 Measure: PASI 75 (Psoriasis Area and Severity Index) Response. |
69.5; 75.9; 0 | <0.0001 sig |
| PRIMARY Efficacy of Secukinumab Compared to Placebo in Subjects With Moderate to Severe Chronic Plaque-type Psoriasis Measure:IGA (Investigator's Global Assessment) With a 0 or 1 Response at Week 12 |
52.5; 69; 0 | <0.0001 sig |
| SECONDARY Absolute Change From Baseline in Self Injection Assessment Questionnaire (SIAQ) Domain Scores at Week 12 |
1.07; 0.85; 0.57; 1.10; 1.08; 1.26 | — |
| SECONDARY Absolute Change From Baseline in Self-Injection Assessment Questionnaire (SIAQ) Domain Scores at Week 48 |
0.93; 1.01; 0.63; 0.76; 1.63; 1.24 | — |
| SECONDARY Number of Subjects With Potential Use Related Hazards at Week 1 |
0; 0; 0; 0; 0; 1 | — |
| SECONDARY Percentage of Subjects With Successful Self Administration of Study Drug at Week 1 |
100; 100; 100 | — |
| SECONDARY Percent of Responders With Psoriasis Area and Severity Index (PASI) Equal to or Greater Than 50, PASI 75, PASI 90, PASI 100, (Induction) With Non-responder Imputation |
86.4; 87.9; 5.1; 45.8; 60.3; 0 | — |
| SECONDARY Percent of Responders With Psoriasis Area and Severity Index (PASI) Equal to or Greater Than 50, PASI 75, PASI 90, PASI 100, (Maintenance; Observed Data) |
71.4; 84.6; 72.0; 96.0; 89.8; 96.2 | — |
| SECONDARY Percent of Responders With Investigator's Global Assessment (IGA) Mod 2011 Score of 0 or 1, (Maintenance; Observed Data) |
51; 71.2; 72; 92 | — |
| SECONDARY Absolute Change From Baseline for PASI Score at Week 12, (Induction) |
-16.33; -17.90; 0.50 | — |
| SECONDARY Absolute Change From Baseline for PASI Score Over Time up to Week 52, (Maintenance; Observed Data) |
-16.9; -18.7; -15.2; -20 | — |
| SECONDARY Number of Participants in Each Investigator's Global Assessment (IGA) Mod 2011 Category at Week 12, (Induction) |
6; 26; 0; 26; 17; 0 | — |
| SECONDARY Percentage of Participants in Each Investigator's Global Assessment (IGA) Mod 2011 Category Over Time up to Week 52, (Maintenance; Observed Data) |
36.7; 48.1; 52; 44; 14.3; 23.1 | — |
| SECONDARY Change From Baseline in EQ-5D at Week 12 (Induction) |
12.1; 11.2; 0.8 | — |
| SECONDARY Change From Baseline in EuroQOL 5-Dimension Health Status Questionnaire (EQ-5D) Over Time up to Week 52, (Maintenance) |
11.4; 13.5; 12.2; 19.7 | — |
| SECONDARY Median Percentage Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score, (Induction) |
-78.6; -85.0; -16.7 | — |
| SECONDARY Median Percentage Change From Baseline in Dermatology Life Quality Index (DLQI) Score Over Time up to Week 52, (Maintenance) |
-71.4; -90.5; -91.7; -97.2 | — |
| SECONDARY Percentage of Participants Achieving a DLQI Score of 0 or 1 at Week 12, (Induction) |
54.4; 54.7; 7.4 | — |
| SECONDARY Percentage of Participants Achieving a DLQI Score of 0 or 1 Over Time up to Week 52, (Maintenance) |
48.3; 62.5; 62.1; 76.9 | — |
| SECONDARY Number of Responders With PASI Equal to or Greater Than 50, PASI 75, PASI 90, PASI 100 After Week 52 |
26; 25; 9; 17; 27; 32 | — |
| SECONDARY Absolute Change From Baseline for PASI Score After Week 52, (Observed Data) |
-18; -18.7; -14.7; -19.4 | — |
| SECONDARY Number of Participants in Each IGA Mod 2011 Category After Week 52 (Observed Data) |
7; 15; 7; 7; 3; 4 | — |
| SECONDARY Number of Participants Developing Treatment Emergent Anti-secukinumab Antibodies, Immunogenicity |
3; 0; 0; 0; 0 | — |
Eligibility Criteria
Inclusion criteria
- Moderate and severe plaque-type psoriasis diagnosed for at least 6 months.
- Severity of psoriasis disease meeting all of the following three criteria:
Psoriasis Area and Severity Index (PASI) score of 12 or greater, Investigator's Global Assessment (IGA) score of 3 or greater, Total body surface area (BSA) affected of 10% or greater.
-Inadequate control by prior use of topical treatment, phototherapy and/or systemic therapy.
Exclusion criteria
- Current forms of psoriasis other than chronic plaque-type psoriasis (for example, pustular, erythrodermic, guttate).
- Current drug-induced psoriasis.
- Previous use of secukinumab or any drug that targets IL-17 or IL-17 receptor.
- Significant medical problems such as uncontrolled hypertension, congestive heart failure or a condition that significantly immunocompromises the subject.
- Hematological abnormalities.
- History of an ongoing, chronic or recurrent infectious disease, or evidence of untreated tuberculosis.
- History of lymphoproliferative disease or history of malignancy of any organ system within the past 5 years.
- Pregnant or nursing (lactating) women. Other protocol-defined inclusion/exclusion criteria may apply
Data sourced from ClinicalTrials.gov (NCT01555125) 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.