Efficacy and Safety of Subcutaneous Secukinumab for Moderate to Severe Chronic Plaque-type Psoriasis for up to 1 Year (ERASURE)
This study is ongoing, but not recruiting participants.
Sponsor:
Novartis Pharmaceuticals
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01365455
First received: June 1, 2011
Last updated: January 15, 2013
Last verified: January 2013
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Purpose
This study will assess the safety and efficacy of secukinumab compared to placebo in patients that have moderate to severe, chronic, plaque-type psoriasis.
| Condition | Intervention | Phase |
|---|---|---|
|
Moderate to Severe Plaque-type Psoriasis |
Drug: secukinumab 150 mg Drug: placebo to secukinumab 150 mg |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | A Randomized, Double-blind, Placebo Controlled, Multicenter Study of Subcutaneous Secukinumab to Demonstrate Efficacy After Twelve Weeks of Treatment, and to Assess the Safety, Tolerability and Long-term Efficacy up to One Year in Subjects With Moderate to Severe Chronic Plaque-type Psoriasis |
Resource links provided by NLM:
Genetics Home Reference related topics:
psoriatic arthritis
MedlinePlus related topics:
Psoriasis
U.S. FDA Resources
Further study details as provided by Novartis:
Primary Outcome Measures:
- Efficacy of secukinumab in subjects with moderate to severe chronic plaque-type psoriasis [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]Measure: PASI and IGA
Secondary Outcome Measures:
- Efficacy of secukinumab in subjects with moderate to severe chronic plaque-type psoriasis [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]Measure: PASI and IGA
- Clinical safety and tolerability of secukinumab [ Time Frame: 12 and 52 weeks ] [ Designated as safety issue: Yes ]Measure: vital signs, clinical laboratory variables, ECGs, adverse events
- Quality of life assessments [ Time Frame: 12 and 52 weeks ] [ Designated as safety issue: No ]Measure: Patient reported outcome questionnaires
| Estimated Enrollment: | 720 |
| Study Start Date: | June 2011 |
| Estimated Study Completion Date: | March 2013 |
| Estimated Primary Completion Date: | March 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: secukinumab 150 mg
secukinumab 150 mg (1 injection per dose) and placebo to secukinumab 150 mg (1 injection per dose)
|
Drug: secukinumab 150 mg
secukinumab 150 mg (1 injection per dose) and placebo to secukinumab 150 mg (1 injection per dose)
|
|
Experimental: secukinumab 300 mg
secukinumab 150 mg (2 injections per dose)
|
Drug: secukinumab 150 mg
secukinumab 150 mg (2 injections per dose)
|
|
Placebo Comparator: placebo
placebo to secukinumab 150 mg (2 injections per dose)
|
Drug: placebo to secukinumab 150 mg
placebo to secukinumab 150 mg (2 injections per dose)
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion criteria:
- Moderate and severe plaque-type psoriasis diagnosed for at least 6 months.
- Severity of psoriasis disease meeting all of the following three criteria:
- Psoriasis Area and Severity Index (PASI) score of 12 or greater,
- Investigator's Global Assessment (IGA) score of 3 or greater,
- Total body surface area (BSA) affected of 10% or greater.
- Inadequate control by prior use of topical treatment, phototherapy and/or systemic therapy.
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.
- Subjects not willing to limit UV light exposure during the study Other protocol-defined inclusion/exclusion criteria may apply.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01365455
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Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
| Study Director: | Novartis Pharmaceuticals | Novartis Pharmaceuticals |
More Information
No publications provided
| Responsible Party: | Novartis ( Novartis Pharmaceuticals ) |
| ClinicalTrials.gov Identifier: | NCT01365455 History of Changes |
| Other Study ID Numbers: | CAIN457A2302, 2010-023512-13 |
| Study First Received: | June 1, 2011 |
| Last Updated: | January 15, 2013 |
| Health Authority: | United States: Food and Drug Administration Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica Canada: Health Canada Colombia: INVIMA Instituto Nacional de Vigilancia de Medicamentos y Alimentos Estonia: The State Agency of Medicine Iceland: Icelandic Medicines Control Agency Israel: Ministry of Health Japan: Ministry of Health, Labor and Welfare Latvia: State Agency of Medicines Lithuania: State Medicine Control Agency - Ministry of Health Mexico: Federal Commission for Sanitary Risks Protection Panama: Ministry of Health Peru: Ministry of Health Russia: Ministry of Health of the Russian Federation Taiwan: Department of Health |
Keywords provided by Novartis:
|
Psoriasis plaque plaque-type psoriasis IL-17 blocker subcutaneous |
psoriatic arthritis injection AIN457 AIN457A secukinumab |
Additional relevant MeSH terms:
|
Psoriasis Skin Diseases, Papulosquamous Skin Diseases |
ClinicalTrials.gov processed this record on May 19, 2013