A long-term study of the efficacy and safety of secukinumab compared with ustekinumab in adult subjects with moderate to severe plaque psoriasis

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) - Efficacy of secukinumab compared to ustekinumab in patients with plaque-type psoriasis

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2013-003434-32-NL

Enrollment

640

Registered

2013-12-06

Start date

2014-01-30

Completion date

Unknown

Last updated

2016-10-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Plaque psoriasis MedDRA version: 18.0 Level: LLT Classification code 10050576 Term: Psoriasis vulgaris System Organ Class: 100000004858

Interventions

Trade Name: Cosentyx Product Name: Secukinumab Product Code: AIN457 Pharmaceutical Form: Solution for injection in pre-filled syringe INN or Proposed INN: SECUKINUMAB CAS Number: 1229022-83-6 Current

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Patients with moderate to severe plaque type psoriasis for at least 6 months before randomization 2. Patients eligible for systemic therapy with inadequately controlled psoriasis Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 576 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 64

Exclusion criteria

Exclusion criteria: 1. Forms of psoriasis other than plaque type psoriasis 2. Previous exposure secukinumab, ustekinumab, or other biologic drugs targeting (IL)-17A or IL-17RA Other protocol-defined inclusion/exclusion criteria may apply.

Design outcomes

Primary

Measure	Time frame
Main Objective: To demonstrate the superiority of secukinumab compared to ustekinumab in subjects with moderate to severe plaque psoriasis based on the proportion of PASI 90 responders at Week 16;Secondary Objective: To demonstrate the superiority of secukinumab versus ustekinumab as to the speed of onset To demonstrate the superiority of secukinumab versus ustekinumab based on the proportion of PASI 90 responders ;Primary end point(s): Proportion of PASI 90 responders;Timepoint(s) of evaluation of this end point: Week 16	—

Measure

Time frame

Main Objective: To demonstrate the superiority of secukinumab compared to ustekinumab in subjects with moderate to severe plaque psoriasis based on the proportion of PASI 90 responders at Week 16;Secondary Objective: To demonstrate the superiority of secukinumab versus ustekinumab as to the speed of onset To demonstrate the superiority of secukinumab versus ustekinumab based on the proportion of PASI 90 responders ;Primary end point(s): Proportion of PASI 90 responders;Timepoint(s) of evaluation of this end point: Week 16

—

Secondary

Measure	Time frame
Secondary end point(s): Speed of onset PASI 90 Response status ;Timepoint(s) of evaluation of this end point: week 4 week 52	—

Countries

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

Public ContactClinical Trial Information Desk

Novartis Pharma Services AG

clinicaltrial.enquiries@novartis.com+4161324 1111

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026