Status:
COMPLETED
Efficacy and Safety of Intravenous and Subcutaneous Secukinumab in Moderate to Severe Chronic Plaque-type Psoriasis
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Plaque-type Psoriasis
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The study will assess 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 secukinuma...
Eligibility Criteria
Inclusion
- 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.
- 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
Exclusion
Key Trial Info
Start Date :
December 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2013
Estimated Enrollment :
43 Patients enrolled
Trial Details
Trial ID
NCT01412944
Start Date
December 1 2011
End Date
April 1 2013
Last Update
March 18 2015
Active Locations (27)
Enter a location and click search to find clinical trials sorted by distance.
1
Novartis Investigative Site
Jacksonville, Florida, United States, 32216
2
Novartis Investigative Site
West Palm Beach, Florida, United States, 33409
3
Novartis Investigative Site
Boston, Massachusetts, United States, 02111
4
Novartis Investigative Site
St Louis, Missouri, United States, 63117