Assessment of the safety and efficacy of intravenous (10mg/kg) and subcutaneous (300mg) secukinumab in moderate to severe chronic plaque-type psoriasis who are partial responders to secukinumab

• Register: EUCTR
• Last refreshed on: 30 September 2013
• Main ID: EUCTR2011-002510-36-DE
• Date of registration: 26/09/2011
• Prospective Registration: Yes
• Primary sponsor: Novartis Pharma Services AG
• Public title: Assessment of the safety and efficacy of intravenous (10mg/kg) and subcutaneous (300mg) secukinumab in moderate to severe chronic plaque-type psoriasis who are partial responders to secukinumab
• Scientific title: A randomized, double-blind, double dummy, multicenter study to assess the safety, tolerability and long-term efficacy of intravenous (10 mg/kg) and subcutaneous (300 mg) secukinumab in subjects with moderate to severe chronic plaque-type psoriasis who are partial responders to secukinumab - Efficacy and safety of i.v and s.c secukinumab in moderate to severe chronic plaque-type psoriasis
• Date of first enrolment: 20/12/2011
• Target sample size: 140
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2011-002510-36
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: yes Single blind: no Double blind: yes Parallel group: yes Cross over: no Other: yes Other trial design description: double dummy If controlled, specify comparator, Other Medicinial Product: no Placebo: no Other: no Number of treatment arms in the trial: 2

Countries of recruitment

Austria, Bulgaria, Canada, Czech Republic, Germany, India, Japan, Poland, Switzerland, Taiwan, United Kingdom, United States

Contacts

• Name: Medizinischer Infoservice
• Affiliation: Novartis Pharma GmbH

• Name: Medizinischer Infoservice
• Affiliation: Novartis Pharma GmbH

Key inclusion & exclusion criteria

Inclusion criteria:
-Written Informed Consent must be obtained before any assessment is performed,
-Subject must be able to understand and communicate with the investigator and comply with the requirements of the study.
-Subjects must have participated in the study CAIN457A2304 and have achieved a partial response after twelve weeks of treatment with no major protocol deviations.
A partial response is defined as having achieved = PASI 50 but < 75 response.

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 132
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 8

Exclusion criteria:
-Pregnant women or lactating women
-Forms of psoriasis other than chronic plaque –type
-Ongoing use of prohibited psoriasis treatments
-Ongoing use of other non-psoriasis prohibited treatments
-Previous exposure to any biologic drug directly targeting IL-17 or the IL-17 receptor, except secukinumab in study CAIN457A2304
-Active ongoing inflammation diseases other than psoriasis that might confound the evaluation of the benefits of secukinumab therapy
-UV therapy or excessive exposure to sunlight



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: 14.0 Level: LLT Classification code 10050576 Term: Psoriasis vulgaris System Organ Class: 10040785 - Skin and subcutaneous tissue disorders

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

Intervention(s)

Product Name: Secukinumab
Product Code: AIN457
Pharmaceutical Form: Powder for solution for 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
Pharmaceutical form of the placebo: Solution for infusion
Route of administration of the placebo: Intravenous use

Primary Outcome(s)

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

Timepoint(s) of evaluation of this end point: at week 8

Main Objective: Efficacy of intravenous administration of secukinumab compared with subcutaneous administration of secukinumab with respect to both PASI 75 and IGA 0 or 1 response

Secondary Objective: - Efficacy of a higher dose of s. c. secukinumab than administered in CAIN457A2304 in achieving PASI 75 or IGA 0 or 1 response
- Efficacy of secukinumab treatment regimens in subjects with respect to PASI 50/75/90/100 response and IGA 0 or 1 response
- Efficacy of treatment regimens with secukinumab with respect to PASI score and IGA mod 2011 score
- Safety and tolerability of secukinumab treatment regimens as assessed by vital signs, clinical laboratory variables, ECGs and adverse events monitoring
- Effects of treatment regimens with secukinumab with respect to the dermatology life quality index (DLQI) 0 or 1 achievement.

Secondary Outcome(s)

Secondary end point(s): Efficacy of a higher dose of s. c. secukinumab than administered in CAIN457A2304 in achieving PASI 75 or IGA 0 or 1 response

Timepoint(s) of evaluation of this end point: over time up to week 40

Secondary ID(s)

CAIN457A2307

2011-002510-36-CZ

Source(s) of Monetary Support

Novartis Pharma AG