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

• Register: EUCTR
• Last refreshed on: 10 April 2017
• Main ID: EUCTR2013-003434-32-BG
• Date of registration: 20/03/2014
• Prospective Registration: Yes
• Primary sponsor: Novartis Pharma Services AG
• Public title: A long-term study of the efficacy and safety of secukinumab compared with ustekinumab in adult subjects with moderate to severe plaque 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) - Efficacy of secukinumab compared to ustekinumab in patients with plaque-type psoriasis
• Date of first enrolment: 17/04/2014
• Target sample size: 640
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2013-003434-32
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: yes Placebo: no Other: no Number of treatment arms in the trial: 2
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): no

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: Medical Depart. (Desislava Uzunova)
• Affiliation: Novartis Pharma Services AG

• Name: Medical Depart. (Desislava Uzunova)
• Affiliation: Novartis Pharma Services AG

Key inclusion & exclusion 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:
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.


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]

Plaque psoriasis
MedDRA version: 19.0 Level: LLT Classification code 10050576 Term: Psoriasis vulgaris System Organ Class: 100000004858

Intervention(s)

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 Sponsor code: AIN457
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 150-
Pharmaceutical form of the placebo: Solution for injection in pre-filled syringe
Route of administration of the placebo: Subcutaneous use

Trade Name: Stelara
Product Name: ustekinumab
Pharmaceutical Form: Solution for injection in pre-filled syringe
INN or Proposed INN: ustekinumab
CAS Number: 815610-63-0
Other descriptive name: USTEKINUMAB
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 45-

Primary Outcome(s)

Primary end point(s): Proportion of PASI 90 responders

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

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

Timepoint(s) of evaluation of this end point: Week 16

Secondary Outcome(s)

Secondary end point(s): Speed of onset
PASI 90 Response status

Timepoint(s) of evaluation of this end point: week 4
week 52

Secondary ID(s)

2013-003434-32-NL

CAIN457A2317

Source(s) of Monetary Support

Novartis Pharma Services AG