Efficacy and Safety of Subcutaneous Secukinumab for Moderate to Severe Chronic Plaque-type Psoriasis assessing different doses and dose regimens

• Register: EUCTR
• Last refreshed on: 12 May 2014
• Main ID: EUCTR2011-000767-27-BG
• Date of registration: 17/08/2011
• Prospective Registration: Yes
• Primary sponsor: Novartis Pharma Services AG
• Public title: Efficacy and Safety of Subcutaneous Secukinumab for Moderate to Severe Chronic Plaque-type Psoriasis assessing different doses and dose regimens
• Scientific title: A randomized, double-blind, multicenter study of subcutaneous secukinumab, assessing Psoriasis Area and Severity Index (PASI) response and maintenance of response in subjects with moderate to severe chronic plaque-type psoriasis on either a fixed dose regimen or on a retreatment at start of relapse regimen
• Date of first enrolment: 03/10/2011
• Target sample size: 918
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2011-000767-27
• 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: no Placebo: no Other: yes Other specify the comparator: between regimens Number of treatment arms in the trial: 4

Countries of recruitment

Austria, Bulgaria, Canada, Czech Republic, Germany, India, Italy, Japan, Peru, Poland, Singapore, Switzerland, Taiwan, United Kingdom, United States, Vietnam

Key inclusion & exclusion criteria

Inclusion criteria:
• Moderate and severe plaque-type psoriasis diagnosed for at least 6 months.
• Severity of disease meeting all of the following three criteria:
o PASI score of 12 or greater,
o Investigator’s Global Assessment (IGA) score of 3 or greater
o Total body surface area (BSA) affected of 10% or greater.
• Inadequate control by prior use of topical treatment, phototherapy and/or systemic therapy.

Other protocol-defined inclusion criteria may apply.

Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 872
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 46

Exclusion criteria:
• Current forms of psoriasis other than chronic plaque-type psoriasis (for example, pustular, erythrodermic, guttate).
• Current drug-induced psoriasis.
• Previous use of secukinumab or any drug that targets IL-17 or IL-17 receptor.
• Significant medical problems such as uncontrolled hypertension, congestive heart failure or a condition that significantly immunocompromises the subject.
• Hematological abnormalities.
• History of an ongoing, chronic or recurrent infectious disease, or evidence of untreated tuberculosis.
• History of lymphoproliferative disease or history of malignancy of any organ system within the past 5 years.
• 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: 14.1 Level: LLT Classification code 10050576 Term: Psoriasis vulgaris System Organ Class: 100000004858

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

Intervention(s)

Product Name: Secukinumab
Product Code: AIN457
Pharmaceutical Form: Powder for solution for injection/infusion
INN or Proposed INN: Secukinumab
Current Sponsor code: AIN457
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 150-
Pharmaceutical form of the placebo: Powder for solution for injection
Route of administration of the placebo: Subcutaneous use

Primary Outcome(s)

Timepoint(s) of evaluation of this end point: Week 40 to Week 52

Main Objective: Efficacy of secukinumab over 52 weeks based on PASI, in two different doses and two treatment regimens (fixed interval vs personalized treatment), in subjects with moderate to severe chronic plaque-type psoriasis

Primary end point(s): PASI 75 response

Secondary Objective: - Efficacy of assessed secukinumab doses and dose regimens over time and up to 52 weeks based on PASI and IGA
- Safety and tolerability of assessed secukinumab doses and dose regimens over time and up to 52 weeks
- Quality of life changes based on patient reported outcomes over time and up to 52 weeks for the assessed secukinumab doses and dose regimens

Secondary Outcome(s)

Secondary end point(s): - PASI and IGA
- Safety and tolerability
- Quality of Life changes

Timepoint(s) of evaluation of this end point: Respectively:
- 52 weeks
- Over time and up to Week 52
- Over time and up to Week 52

Secondary ID(s)

CAIN457A2304

2011-000767-27-GB

Source(s) of Monetary Support

Novartis Pharma AG