Overview

This trial is active, not recruiting.

Condition plaque psoriasis
Treatment secukinumab
Phase phase 3
Sponsor Novartis Pharmaceuticals
Start date January 2015
End date May 2017
Trial size 1580 participants
Trial identifier NCT02409667, CAIN457A3302

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, investigator)
Primary purpose treatment
Arm
(Active Comparator)
570 patients with moderate to severe plaque psoriasis who have reached PASI 90 response after 24 weeks of treatment with secukinumab 300 mg subcutanous (s.c.) every 4 weeks will be treated with Secukinumab 300 mg subcutanous (s.c.) from week 24 until Week 52 every 4 weeks.
secukinumab
Secukinumab 300 mg
(Experimental)
570 patients with moderate to severe plaque psoriasis who have reached PASI 90 response after 24 weeks of treatment with secukinumab 300 mg subcutanous (s.c.) every 4 weeks will be treated with Secukinumab 300 mg subcutanous (s.c.) from week 24 until Week 52 at a longer dosing interval.
secukinumab
Secukinumab 300 mg
(Experimental)
105 patients with moderate to severe plaque psoriasis who have reached PASI 75-90 response after 24 weeks of treatment with secukinumab 300 mg subcutanous (s.c.) every 4 weeks will be treated with Secukinumab 300 mg subcutanous (s.c.) from week 24 until Week 52 at a shorter dosing interval.
secukinumab
Secukinumab 300 mg
(Active Comparator)
105 patients with moderate to severe plaque psoriasis who have reached PASI 75-90 response after 24 weeks of treatment with secukinumab 300 mg subcutanous (s.c.) every 4 weeks will be treated with Secukinumab 300 mg subcutanous (s.c.) from week 24 until Week 52 every 4 weeks.
secukinumab
Secukinumab 300 mg

Primary Outcomes

Measure
Psoriasis Area and Severity Index 90 response rate (PASI 90)
time frame: Week 24 to Week 52

Secondary Outcomes

Measure
Psoriasis Area and Severity Index 75 response rate (PASI 75)
time frame: Week 24 to Week 52

Eligibility Criteria

Male or female participants of any age.

Main Inclusion Criteria: 1. Chronic plaque-type psoriasis diagnosed for at least 6 months prior to Screening and candidate for systemic therapy. 2. 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: 1. 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. 2. History of hypersensitivity to any of the study drugs or to drugs of similar chemical classes. 3. Forms of psoriasis other than chronic plaque-type (eg, pustular, erythrodermic and guttate psoriasis). 4. Drug-induced psoriasis (ie, new onset or current exacerbation from beta-blockers, calcium channel inhibitors or lithium). 5. Ongoing use of prohibited psoriasis treatments (eg, topical or systemic corticosteroids, ultraviolet (UV) therapy). 6. 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. 7. 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). 8. 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. 9. Active ongoing inflammatory diseases other than psoriasis that might confound the evaluation of the benefit of secukinumab therapy. 10. 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.

Additional Information

Official title Long Term Clear Skin Maintenance Treatment Optimization in Patients With Moderate to Severe Chronic Plaque Psoriasis: A Randomized, Multicenter, Open-label With Blinded-assessment, Comparative, 52 Week Study to Evaluate the Efficacy, Safety and Tolerability of Secukinumab 300 mg s.c.
Trial information was received from ClinicalTrials.gov and was last updated in August 2016.
Information provided to ClinicalTrials.gov by Novartis.