Study of efficacy and safety of secukinumab compared to ustekinumab in subjects with plaque psoriasis

• Register: EUCTR
• Last refreshed on: 10 September 2018
• Main ID: EUCTR2015-002898-37-PL
• Date of registration: 25/07/2016
• Prospective Registration: Yes
• Primary sponsor: Novartis Pharma Services AG
• Public title: Study of efficacy and safety of secukinumab compared to ustekinumab in subjects with plaque psoriasis
• Scientific title: A 52-week, multicenter, randomized, double-blind study of secukinumab (300 mg) to demonstrate efficacy as assessed by Psoriasis Area and Severity Index and Investigator’s Global Assessment after 12 weeks of treatment, compared to ustekinumab, and to assess longterm safety, tolerability, and efficacy in subjects with moderate to severe plaque psoriasis (CLARITY)
• Date of first enrolment: 29/09/2016
• Target sample size: 1100
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2015-002898-37
• 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: yes 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

Canada, Czech Republic, Guatemala, Hungary, Iceland, Korea, Republic of, Malaysia, Poland, Slovakia, United States

Contacts

• Name: Punkt informacyjny badania kliniczn
• Affiliation: Novartis Pharma Services AG

• Name: Punkt informacyjny badania kliniczn
• Affiliation: Novartis Pharma Services AG

Key inclusion & exclusion criteria

Inclusion criteria:
1. Subjects must give a written, signed and dated informed consent
2. Men or women must be at least 18 years of age at the time of screening
3. Chronic plaque-type psoriasis present for at least 6 months before randomization
4. Moderate to severe plaque psoriasis as defined at randomization by:
? PASI score of =12 and
? Body Surface Area (BSA) affected by plaque-type psoriasis =10%
and
? IGA mod 2011 =3 (based on a scale of 0–4)
5. Candidate for systemic therapy, defined as having psoriasis
inadequately controlled by:
? Topical treatment (including topical corticosteroids) and/or
? Phototherapy and/or
? Previous systemic therapy

Other protocol-defined inclusion criteria may apply.
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 990
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 110

Exclusion criteria:
1. Forms of psoriasis other than plaque psoriasis
2. Drug-induced psoriasis
3. Ongoing use of prohibited treatments
4. Previous exposure to secukinumab or any other biologic drug directly targeting IL-17A or IL-17RA, or ustekinumab, or any therapies targeting IL-12 or IL-23
5. Use of any other investigational drugs within 5 half-lives of the
investigational treatment before study drug initiation
6. Pregnant or nursing (lactating) women

Other protocol-defined exclusion criteria may apply.


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

Health Condition(s) or Problem(s) studied

Moderate to severe chronic plaque-type psoriasis
MedDRA version: 20.0 Level: LLT Classification code 10050576 Term: Psoriasis vulgaris System Organ Class: 100000004858

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

Intervention(s)

Trade Name: Stelara
Product Name: Stelara
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-

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 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

Primary Outcome(s)

Timepoint(s) of evaluation of this end point: week 12

Main Objective: To demonstrate the superiority of secukinumab compared to ustekinumab in subjects with moderate to severe plaque psoriasis with respect to both PASI 90 and IGA mod 2011 0/1
response at Week 12

Primary end point(s): PASI 90 and IGA mod 2011 0/1 after 12 weeks of treatment

Secondary Objective: To demonstrate the superiority of secukinumab compared to ustekinumab in subjects with moderate to severe plaque psoriasis with respect to:
? PASI 75 response at Week 12
? PASI 75 response at Week 4
? PASI 90 at Week 16
? PASI 100 at Week 16
? IGA mod 2011 0/1 at Week 16
? PASI 100 at Week 12
? PASI 75 at Week 16
? PASI 90 at Week 52
To investigate the clinical safety of secukinumab compared to ustekinumab as assessed by adverse event monitoring, vital signs, and clinical laboratory variables.

Secondary Outcome(s)

Secondary end point(s): PASI 75 after 4, 12 and 16 weeks of treatment
PASI 90 after 16 and 52 weeks of treatment
PASI 100 after 12 and 16 weeks of treatment
IGA mod 2011 0/1 after 16 weeks of treatment

Timepoint(s) of evaluation of this end point: Week 4, Week 12, Week 16, Week 52

Secondary ID(s)

CAIN457A2326

2015-002898-37-HU

Source(s) of Monetary Support

Novartis Pharma Services AG