Phase 3
N=738
Efficacy and Safety of Subcutaneous Secukinumab for Moderate to Severe Chronic Plaque-type Psoriasis for up to 1 Year
Moderate to Severe Plaque-type Psoriasis
Bottom Line
View on ClinicalTrials.gov: NCT01365455 ↗Enrolled (actual)
738
Serious AEs
4.0%
Results posted
May 2015
Primary outcome: Primary: Percentage of Participants Who Achieved >75 or Higher (Psoriasis Area and Severity Index) PASI Score at 12 Weeks — 71.6; 81.6; 4.5 Percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- secukinumab 150 mg (Drug); placebo to secukinumab 150 mg (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Novartis Pharmaceuticals
- Primary completion
- Apr 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Who Achieved >75 or Higher (Psoriasis Area and Severity Index) PASI Score at 12 Weeks |
71.6; 81.6; 4.5 | — |
| PRIMARY Percentage of Participants Who Achieved (Investigator's Global Assessment) IGA Score of 0 or 1 |
51.2; 65.3; 2.4 | — |
| SECONDARY Percentage of Participants Who Achieved a PASI (Psoriasis Area and Severity Index) Score of 90 or Better at Week 12 |
39.1; 59.2; 1.2 | — |
| SECONDARY Number of Participants That Maintained the Psoriasis Area and Severity Index (PASI) 75 Response at 52 Weeks of Treatment for Participants Who Were PASI 75 Responders at Week 12 |
174; 200; 11; 126; 161; NA | — |
| SECONDARY Number of Participants That Maintained the IGA Mod 2011 0 or 1 Response at 52 Weeks of Treatment for Participants Who Were IGA Mod 2011 0 or 1 Responders at Week 12 |
125; 160; 6; 74; 119; NA | — |
| SECONDARY Change From Baseline to Week 12 in Psoriasis Symptom Diary Items Itching, Pain and Scaling in AIN457 vs Placebo |
-4.86; -545; -0.22; -3.92; -4.59; 0.06 | — |
| SECONDARY Percentage of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response up to 12 Weeks Induction Period |
0.0; 0.0; 0.0; 0.0; 0.0; 0.0 | — |
| SECONDARY Percentage of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response Maintenance Period After Week 12 to Week 52 |
51.6; 66.9; 33.3; 0.9; 1.9; 70.8 | — |
| SECONDARY Mean Percent Change From Baseline in PASI Scores up to Week 12 - Induction Period |
-12.08; -17.50; -3.70; -28.61; -36.51; -5.63 | — |
| SECONDARY Mean Percent Change From Baseline in PASI Scores Maintenance Period After Week 12 to Week 52 |
-83.12; -89.55; -63.10; -21.03; -21.66; -84.47 | — |
| SECONDARY Percentage of Participants in Each IGA Mod 2011 Score Category up to Week 12 - Induction Period |
0.0; 0.0; 0.0; 0.0; 0.0; 0.0 | — |
| SECONDARY Percentage of Participants in Each IGA Mod 2011 Score Category Maintenance Period After Week 12 to Week 52 |
17.6; 38.0; 11.1; 0.0; 0.0; 40.6 | — |
| SECONDARY Time to PASI 75 Response up to 12 Weeks |
57; 57; NA | — |
| SECONDARY Mean Percent Change From Baseline in EuroQOL 5-Dimension Health Status Questionnaire (EQ-5D) Health State Assessment (From 0 to 100) Induction Period |
38.1; 57.1; 6.3; 52.3; 72.7; 6.3 | — |
| SECONDARY Mean Percent Change From Baseline in EuroQOL 5-Dimension Health Status Questionnaire (EQ-5D) Health State Assessment (From 0 to 100) Maintenance Period |
58.5; 76.3; 37.7; -0.1; 3.3; 55.8 | — |
| SECONDARY Percentage Changes in the Dermatology Life Quality Index (DLQI) During Induction Period |
-55.0; -62.5; -5.0; -73.1; -81.5; -8.3 | — |
| SECONDARY Percentage Changes in the Dermatology Life Quality Index (DLQI) During Maintenance Period |
-77.8; -86.4; -58.3; -7.1; -4.4; -83.3 | — |
| SECONDARY Percentage of Participants Who Achieved Dermatology Life Quality Index (DLQI) of 0 or 1 During Induction Period |
17.6; 23.6; 6.4; 39.7; 48.1; 10.0 | — |
| SECONDARY Percentage of Participants Who Achieved Dermatology Life Quality Index (DLQI) of 0 or 1 During Maintenance Period |
46.1; 58.8; 27.8; 10.2; 8.6; 54.7 | — |
| SECONDARY Percentage of Participants Achieving PASI 75, PASI 90 and IGA Mod 2011 0 or 1 Response at Week 12 by Previous Exposure to Biologic Systemic Therapy or Anti-TNF-α Therapy and Failed to Respond to a Previous Biologic or Anti-TNF-α Therapy Psoriasis Therapy |
41.4; 57.9; 4.2; 48.3; 57.9; 12.5 | — |
| SECONDARY Number of Participants Who Developed Anti-secukinumab Antibodies |
2; 0; 0 | — |
Summary
This study will assess the safety and efficacy of secukinumab compared to placebo in patients that have moderate to severe, chronic, plaque-type psoriasis.
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.
- Subjects not willing to limit UV light exposure during the study Other protocol-defined inclusion/exclusion criteria may apply.
Data sourced from ClinicalTrials.gov (NCT01365455). 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.