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

• Conditions: Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]; MedDRA version: 14.0Level: LLTClassification code 10050576Term: Psoriasis vulgarisSystem Organ Class: 10040785 - Skin and subcutaneous tissue disorders; Moderate to severe chronic plaque-type psoriasis

• Registration Number: EUCTR2011-002510-36-SK
• Lead Sponsor: ovartis Pharma Services AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-09-12
• Last Update Posted: 2 May 2016

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 140

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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<br>- Efficacy of secukinumab treatment regimens in subjects with respect to PASI 50/75/90/100 response and IGA 0 or 1 response<br>- Efficacy of treatment regimens with secukinumab with respect to PASI score and IGA mod 2011 score<br>- Safety and tolerability of secukinumab treatment regimens as assessed by vital signs, clinical laboratory variables, ECGs and adverse events monitoring<br>- Effects of treatment regimens with secukinumab with respect to the dermatology life quality index (DLQI) 0 or 1 achievement.;Primary end point(s): PASI 75 and IGA 0 or 1 response;Timepoint(s) of evaluation of this end point: at week 8

Secondary Outcome Measures

Name	Time	Method
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