Phase 3
N=43
Efficacy and Safety of Intravenous and Subcutaneous Secukinumab in Moderate to Severe Chronic Plaque-type Psoriasis
Plaque-type Psoriasis
Bottom Line
View on ClinicalTrials.gov: NCT01412944 ↗Enrolled (actual)
43
Serious AEs
1.1%
Results posted
Mar 2015
Primary outcome: Primary: Percentage of Participants (Who Achieved a Partial Response Defined as ≥ 50% But < 75% Improvement in Psoriasis Area and Severity Index (PASI) After 12 Weeks of Treatment in Study AIN457A2304) With 75% Improvement From Baseline in PASI — 66.7; 90.5 Percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- secukinumab 150mg (Drug); secukinumab 10mg/kg i.v. regimen (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 a Partial Response Defined as ≥ 50% But < 75% Improvement in Psoriasis Area and Severity Index (PASI) After 12 Weeks of Treatment in Study AIN457A2304) With 75% Improvement From Baseline in PASI |
66.7; 90.5 | — |
| PRIMARY Percentage of Participants (Who Achieved a Partial Response Defined as ≥ 50% But < 75% Improvement in PASI After 12 Weeks of Treatment in Study AIN457A2304) With Investigator's Global Assessment Model 2011 (IGA Mod 2011) 0 or 1 Response |
66.7; 33.3 | — |
| SECONDARY Percentage of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response |
9.5; 9.5; 19.0; 47.6; 85.7; 100.0 | — |
| SECONDARY Mean Percent Change From Baseline in PASI Scores |
-65.427; -74.824; -69.804; -83.063; -75.422; -90.980 | — |
| SECONDARY Percentage of Participants in Each IGA Mod 2011 Score Category |
0.0; 0.0; 9.5; 9.5; 57.1; 66.7 | — |
| SECONDARY Percentage of Participants Who Achieved Dermatology Life Quality Index (DLQI) of 0 or 1 |
0.0; 4.8; 25.0; 75.0; 40.0; 70.0 | — |
| SECONDARY Mean Percent Change From Baseline in Dermatology Life Quality Index (DLQI) Scores |
-67.1; -82.4; -68.7; -74.8; -66.9; -63.2 | — |
| SECONDARY Mean Percent Change From Baseline in EuroQOL 5-Dimension Health Status Questionnaire (EQ-5D) Health State Assessment (From 0 to 100) |
71.0; 73.1; 76.9; 57.5; 74.6; 45.3 | — |
| SECONDARY Number of Participants Who Developed Anti-secukinumab Antibodies |
0; 0 | — |
| SECONDARY Relationship Between Response to AIN457 and Failed Response to Previous Biologic Psoriasis Therapy |
— | — |
Summary
The study will assess the safety and efficacy of intravenous (10mg/kg) and subcutaneous (300mg) secukinumab in moderate to severe chronic plaque-type psoriasis who are partial responders to secukinumab.
Eligibility Criteria
Inclusion criteria
- Written Informed Consent must be obtained before any assessment is performed,
- Subject must be able to understand and communicate with the investigator and comply with the requirements of the study.
- Subjects must have participated in the study CAIN457A2304 and have achieved a partial response after twelve weeks of treatment with no major protocol deviations.
A partial response is defined as having achieved ≥ PASI 50 but < 75 response.
Exclusion criteria
- Pregnant women or lactating women
- Forms of psoriasis other than chronic plaque -type
- Ongoing use of prohibited psoriasis treatments
- Ongoing use of other non-psoriasis prohibited treatments
- Previous exposure to any biologic drug directly targeting IL-17 or the IL-17 receptor, except secukinumab in study CAIN457A2304
- Active ongoing inflammation diseases other than psoriasis that might confound the evaluation of the benefits of secukinumab therapy
- UV therapy or excessive exposure to sunlight
Data sourced from ClinicalTrials.gov (NCT01412944). 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.