Efficacy of Secukinumab Compared to Ustekinumab in Patients With Plaque-type Psoriasis

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT02074982
• Date of registration: 27/02/2014
• Prospective Registration: No
• Primary sponsor: Novartis Pharmaceuticals
• Public title: Efficacy of Secukinumab Compared to Ustekinumab in Patients With Plaque-type Psoriasis
• Scientific title: A 52-week, Multicenter, Randomized, Double-blind Study of Subcutaneous Secukinumab to Demonstrate Efficacy as Assessed by Psoriasis Area and Severity Index at 16 Weeks of Treatment Compared to Ustekinumab and to Assess Long-term Safety, Tolerability and Efficacy in Subjects With Moderate to Severe Plaque Psoriasis (CLEAR)
• Date of first enrolment: February 26, 2014
• Target sample size: 676
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02074982
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 3

Countries of recruitment

Australia, Austria, Belgium, Bulgaria, Canada, Denmark, Estonia, France, Germany, Greece, Guatemala, Hungary, Israel, Italy, Korea, Republic of, Netherlands, Norway, Portugal, Slovakia, Spain, Switzerland, Taiwan, Turkey, United Kingdom, United States

Contacts

• Name: Novartis Pharmaceuticals
• Affiliation: Novartis Pharmaceuticals

Key inclusion & exclusion criteria

Inclusion Criteria:

- patients with moderate to severe plaque type psoriasis for at least 6 months before
randomization

- patients eligible for systemic therapy with inadequately controlled psoriasis

Exclusion Criteria:

- forms of sporiasis other than plaque type psoriasis

- previous exposure to secukinumab, ustekinumab, or other biologic drugs targeting
(IL)-17A or IL-17RA

Other protocol-defined inclusion/exclusion criteria may apply



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Chronic Plaque Type Psoriasis

Intervention(s)

Drug: ustekinumab 45/90 mg

Drug: placebo secukinumab

Drug: AIN457 300 mg

Primary Outcome(s)

Percentage of Participants With Moderate to Severe Plaque Psoriasis Who Achieved Psoriasis Area and Severity Index (PASI) 90 at Week 16 [Time Frame: Week 16]

Secondary Outcome(s)

Speed of Onset Based on the Percentage of Participents Achieving PASI 75 at Week 4 [Time Frame: Week 4]

Percentage of Participants With Moderate to Severe Plaque Psoriasis Who Achieved Psoriasis Area and Severity Index (PASI) 90 at Week 52 [Time Frame: Week 52]

Secondary ID(s)

CAIN457A2317

2013-003434-32

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 21/07/2017
• URL: https://clinicaltrials.gov/ct2/show/results/NCT02074982