Phase 3
N=1,647
Plaque Psoriasis Efficacy and Safety With Secukinumab
Plaque Psoriasis
Bottom Line
View on ClinicalTrials.gov: NCT02409667 ↗Enrolled (actual)
1,647
Serious AEs
4.1%
Results posted
May 2019
Primary outcome: Primary: Maintenance of PASI 90 Response at Week 52 in Participants With a PASI 90 Response at Week 24 — 552; 496 Participants — p=0.1499
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Secukinumab (Biological)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Novartis Pharmaceuticals
- Primary completion
- Mar 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Maintenance of PASI 90 Response at Week 52 in Participants With a PASI 90 Response at Week 24 |
552; 496 | 0.1499 |
| SECONDARY Key Secondary: PASI 90 Response Rate at Week 52 in Participants With a PASI Response of ≥75 to <90 at Week 24 |
53; 52 | 0.1013 |
| SECONDARY PASI 50, PASI 75, PASI 100 and IGA Mod 2011 0 or 1 Responders at Week 52 in Participants With a PASI 90 Response at Week 24 |
608; 624; 597; 588; 553; 496 | — |
| SECONDARY PASI 50, PASI 75, PASI 100 and IGA Mod 2011 0 or 1 Responders at Week 52 in Participants With a PASI Response of ≥75 to <90 at Week 24 |
98; 88; 74; 80; 53; 52 | — |
| SECONDARY Change From Baseline in PASI in Participants With a PASI 90 Response at Week 24 |
-20.7; -19.9; -20.7; -19.8; -20.6; -19.7 | 0.0489 sig |
| SECONDARY Change From Baseline in PASI in Participants With a PASI Response of ≥75 to <90 at Week 24 |
-16.1; -16.3; -15.9; -16.6; -16.1; -16.6 | 0.1740 |
| SECONDARY Change From Baseline in DLQI in Participants With a PASI 90 Response at Week 24 |
-12.7; -11.4 | 0.0001 sig |
| SECONDARY Change From Baseline in DLQI in Participants With a PASI Response of ≥75 to <90 at Week 24 |
-10.0; -9.72 | 0.0675 |
| SECONDARY Change From Baseline in Work Productivity and Activity Impairment Questionnaire - Psoriasis (WPAI-PSO) Score in Participants With a PASI 90 Response at Week 24 |
-4.70; -1.99; -23.1; -23.0; -24.3; -23.2 | 0.2101 |
| SECONDARY Change From Baseline in WPAI-PSO Score in Participants With a PASI Response of ≥75 to <90 at Week 24 |
-2.36; -3.45; -22.9; -22.1; -23.1; -21.7 | 0.4156 |
| SECONDARY Change From Baseline in Pain, Itching and Scaling Score in Participants With a PASI 90 Response at Week 24 |
-4.56; -4.17; -5.59; -5.20; -6.05; -5.73 | 0.1219 |
| SECONDARY Change From Baseline in Pain, Itching and Scaling Score in Participants With a PASI Response of ≥75 to <90 at Week 24 |
-3.59; -3.68; -4.13; -4.49; -4.66; -5.40 | 0.6457 |
| SECONDARY Change From Baseline in the European Quality of Life - 5 Dimensions (EQ-5D) Visual Analogue Scale (VAS) in Participants With a PASI 90 Response at Week 24 |
24.34; 21.24 | 0.0027 sig |
| SECONDARY Change From Baseline in the EQ-5D VAS in Participants With a PASI Response of ≥75 to <90 at Week 24 |
15.86; 18.92 | 0.2823 |
| SECONDARY Change From Baseline in the EQ-5D Utility Index (Germany, United Kingdom (UK)) in Participants With a PASI 90 Response at Week 24 |
0.17; 0.13; 0.28; 0.22 | 0.0861 |
| SECONDARY Change From Baseline in the EQ-5D Utility Index (Germany, UK) in Participants With a PASI Response of ≥75 to <90 at Week 24 |
0.11; 0.13; 0.18; 0.21 | 0.1852 |
Summary
To demonstrate in the patient pool of PASI 90 responders at Week 24 that secukinumab 300 mg s.c. when administered at a longer dosing interval is non-inferior to secukinumab 300 mg s.c. every 4 weeks treatment with respect to maintaining a PASI 90 response rate at Week 52.
Eligibility Criteria
Main Inclusion Criteria:
- Chronic plaque-type psoriasis diagnosed for at least 6 months prior to Screening and candidate for systemic therapy.
- Moderate to severe psoriasis at Baseline as evidenced by:
- PASI ≥ 10 and
- IGA mod 2011 score of 3 or higher (based on a scale of 0 to 4) and
- BSA affected by plaque-type psoriasis of ≥ 10%.
Main Exclusion Criteria:
- History of exposure to any biologic drug taken for the treatment of chronic plaque psoriasis or any other indication including but not limited to anti-tumor necrosis factor (TNF) alpha, anti interleukin (IL)12/23, or any anti-IL 17A or IL 17A receptor (IL 17AR) antibody.
- History of hypersensitivity to any of the study drugs or to drugs of similar chemical classes.
- Forms of psoriasis other than chronic plaque-type (eg, pustular, erythrodermic and guttate psoriasis).
- Drug-induced psoriasis (ie, new onset or current exacerbation from beta-blockers, calcium channel inhibitors or lithium).
- Ongoing use of prohibited psoriasis treatments (eg, topical or systemic corticosteroids, ultraviolet (UV) therapy).
- Ongoing use of other non-psoriasis prohibited treatments. Washout periods detailed in the protocol have to be adhered to. All other prior non-psoriasis concomitant treatments must be at a stable dose as detailed in the protocol before initiation of study drug.
- 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 human chorionic gonadotropin (hCG) laboratory test (> 5 mIU/mL).
- Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using effective methods of contraception during dosing of study drug and for 16 weeks after stopping study drug.
- Active ongoing inflammatory diseases other than psoriasis that might confound the evaluation of the benefit of secukinumab therapy.
- Underlying condition (including, but not limited to metabolic, hematologic, renal, hepatic, pulmonary, neurologic, endocrine, cardiac, infectious or gastrointestinal conditions) which, in the opinion of the Investigator, significantly immunocompromises the patient and/or places the patient at unacceptable risk for receiving an immunomodulatory therapy.
Data sourced from ClinicalTrials.gov (NCT02409667). 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.