Study of efficacy and safety of secukinumab 2 mL pre-filled syringe (300 mg) in subjects with moderate to severe plaque psoriasis

• Register: EUCTR
• Last refreshed on: 28 February 2019
• Main ID: EUCTR2015-005170-38-IS
• Date of registration: 24/08/2016
• Prospective Registration: Yes
• Primary sponsor: Novartis Pharma Services AG
• Public title: Study of efficacy and safety of secukinumab 2 mL pre-filled syringe (300 mg) in subjects with moderate to severe plaque psoriasis
• Scientific title: A multicenter, randomized, double-blind, placebo-controlled, 52-weeks study to demonstrate the efficacy, safety and tolerability of subcutaneous secukinumAb injections with 2 mL pre-fiLLed syringes (300 mg) in adUlt subjects with moderate to seveRE plaque psoriasis – ALLURE - ALLURE
• Date of first enrolment: 04/10/2016
• Target sample size: 210
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2015-005170-38
• 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: 3
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): no

Countries of recruitment

Belgium, Canada, Germany, Iceland, Latvia, Poland, Russian Federation, Spain, Turkey, United Kingdom, United States

Contacts

• Name: Medical Information
• Affiliation: Novartis Healthcare A/S

• Name: Medical Information
• Affiliation: Novartis Healthcare A/S

Key inclusion & exclusion criteria

Inclusion criteria:
* Men or women of at least 18 years of age at the time of Screening.
* Moderate to severe chronic plaque-type psoriasis present for at least 6 months and diagnosed before Randomization.
* Candidate for systemic therapy.
* Additional inclusion criteria may apply , please refer to the protocol.
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 189
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 21

Exclusion criteria:
* Forms of psoriasis other than chronic plaque-type (e.g., pustular, erythrodermic and guttate psoriasis)
* Ongoing use of prohibited treatments.
* Previous exposure to secukinumab (AIN457) or any other biologic drug directly targeting IL-17 or the IL-17 receptor.
* Pregnant or nursing (lactating) women
*Additional exclusion criteria may apply , please refer to the protocol.


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

Health Condition(s) or Problem(s) studied

Plaque psoriasis
MedDRA version: 19.0 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: 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
Other descriptive name: SECUKINUMAB
Concentration unit: mg/ml milligram(s)/millilitre
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: 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
Other descriptive name: SECUKINUMAB
Concentration unit: mg/ml milligram(s)/millilitre
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)

Main Objective: To demonstrate the efficacy of secukinumab 300 mg when administered as 2 mL pre-filled syringes in subjects with chronic plaque-type psoriasis with respect to both PASI 75 and IGA mod 2011 0 or 1 response (co-primary endpoint) at Week 12, compared to placebo.

Secondary Objective: • To demonstrate the efficacy of secukinumab 300 mg when administered as 2 mL pre-filled syringes in subjects with chronic plaque-type psoriasis with respect to PASI 90 and PASI 100 at Week 12, compared to placebo.
• To demonstrate the efficacy of secukinumab 300 mg when administered as two 1 mL pre-filled syringes in subjects with chronic plaque-type psoriasis with respect to PASI 100 at Week 12, compared to placebo.

Primary end point(s): PASI 75 and IGA mod 2011 0 or 1 response

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

Secondary Outcome(s)

Secondary end point(s): PASI 90 and PASI 100

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

Secondary ID(s)

2015-005170-38-GB

CAIN457A2323

Source(s) of Monetary Support

Novartis Pharma Services AG

Ethics review

Status: Approved
Approval date:
Contact:

Results

• Results available: Yes
• Date Posted: 23/06/2019
• Date Completed: 08/06/2018
• URL: https://www.clinicaltrialsregister.eu/ctr-search/trial/2015-005170-38/results