Phase 3
Completed N=543
Study of Efficacy and Safety of Secukinumab in Subjects With Moderate to Severe Chronic Plaque-type Psoriasis
Source: ClinicalTrials.gov NCT03066609 ↗Enrolled (actual)
543
Serious AEs
3.3%
Results posted
Dec 2019
Primary outcomePrimary: Psoriasis Area and Severity Index (PASI) 75 (Multiple Imputation) — 112; 254; 6 Participants — p=<0.0001
◆ Published Evidence
Established
46citations · ~8 / year
Secukinumab demonstrates high efficacy and a favorable safety profile over 52 weeks in Chinese patients with moderate to severe plaque psoriasis.
Summary
The purpose of this study was to determine if secukinumab is effective and safe in the treatment of plaque type psoriasis
Linked Publications
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Secukinumab demonstrates high efficacy and a favorable safety profile over 52 weeks in Chinese patients with moderate to severe plaque psoriasis.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Psoriasis Area and Severity Index (PASI) 75 (Multiple Imputation) |
112; 254; 6 | <0.0001 sig |
| PRIMARY Investigator's Global Assessment (IGA) Mod 2011 0/1 (Multiple Imputation) |
92; 214; 4 | <0.0001 sig |
| SECONDARY Psoriasis Area and Severity Index (PASI) 90 (Multiple Imputation) |
85; 210; 2 | <0.0001 sig |
| SECONDARY Efficacy of Secukinumab in Maintaining PASI 75 Response at Week 52 in Subjects Who Were PASI 75 Responders at Week 12 (Multiple Imputation) |
94; 235 | — |
| SECONDARY Efficacy of Secukinumab in Maintaining IGA Mod 2011 0 or 1 Response at Week 52 in Subjects Who Were IGA Mod 2011 0 or 1 Responders at Week 12 (Multiple Imputation) |
65; 162 | — |
| SECONDARY PASI 50/75/90/100 and IGA Mod 2011 0 or 1 Response Over Time (Multiple Imputation) |
0; 1; 0; 0; 5; 25 | — |
| SECONDARY American Collage of Rheumatology (ACR) Response 20/50/70 |
4; 13; 0; 0; 3; 12 | — |
| SECONDARY Time to PASI 75 Response up to Week 12 |
57; 55 | — |
Eligibility Criteria
Inclusion Criteria
- Subjects must give a written, signed and dated informed consent.
- Men or women at least 18 years of age at time of screening.
- Chronic plaque-type psoriasis present for at least 6 months and diagnosed before Baseline.
- Moderate to severe psoriasis as defined at Baseline by:
- PASI score of 12 or greater, and
- IGA mod 2011 score of 3 or greater (based on a static scale of 0 - 4), and
- Body Surface Area (BSA) affected by plaque-type psoriasis of 10% or greater.
- Candidate for systemic therapy. This is defined as a subject having moderate to severe chronic plaque-type psoriasis that is inadequately controlled by
- topical treatment and/or,
- phototherapy and/or,
- previous systemic therapy.
Exclusion Criteria
- Forms of psoriasis other than chronic plaque-type (e.g., pustular, erythrodermic and guttate psoriasis) at Screening or Baseline.
- Drug-induced psoriasis.
- Ongoing use of prohibited treatments.
- Previous exposure to secukinumab (AIN457) or any other biologic drug directly targeting IL-17 or the IL-17 receptor.
- Use of other investigational drugs at the time of enrollment, or within 5 half-lives of enrollment, or within 30 days until the expected pharmacodynamic effect has returned to baseline, whichever is longer; or longer if required by local regulations.
- Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test.
Data sourced from ClinicalTrials.gov (NCT03066609) 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.