Plaque Psoriasis Efficacy and Safety With Secukinumab (OPTIMISE)

Novartis

Status and phase: Completed; Phase 3

Conditions: Plaque Psoriasis

Treatments: Biological: Secukinumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT02409667

CAIN457A3302

Details and patient eligibility

About

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.

Enrollment: 16,487 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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16,487 participants in 4 patient groups

Secukinumab 300mg in PASI 90 responders (every 4 weeks)

Active Comparator group

Description:

Participants with moderate to severe plaque psoriasis who had reached PASI 90 response after 24 weeks of treatment with secukinumab 300 mg subcutanous (s.c.) every 4 weeks were treated with Secukinumab 300 mg subcutanous (s.c.) from week 24 until Week 52 every 4 weeks.

Treatment:

Biological: Secukinumab

Secukinumab 300mg in PASI 90 responders (longer intervals)

Experimental group

Description:

Participants with moderate to severe plaque psoriasis who had reached PASI 90 response after 24 weeks of treatment with secukinumab 300 mg subcutanous (s.c.) every 4 weeks were treated with Secukinumab 300 mg subcutanous (s.c.) from week 24 until Week 52 every 6 weeks.

Treatment:

Biological: Secukinumab

Secukinumab 300mg in PASI 75-90 responders (every 4 weeks)

Experimental group

Description:

Participants with moderate to severe plaque psoriasis who had reached PASI 75 to \<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.

Treatment:

Biological: Secukinumab

Secukinumab 300mg in PASI 75-90 responders (shorter intervals)

Active Comparator group

Description:

Participants with moderate to severe plaque psoriasis who had reached PASI 75 to \<90 response after 24 weeks of treatment with secukinumab 300 mg subcutanous (s.c.) every 4 weeks were treated with Secukinumab 300 mg subcutanous (s.c.) from week 24 until Week 52 every 2 weeks.

Treatment:

Biological: Secukinumab