Judging the Efficacy of Secukinumab in Patients With Psoriasis Using AutoiNjector: a Clinical Trial Evaluating Treatment Results (JUNCTURE)
This study has been completed.
Sponsor:
Novartis Pharmaceuticals
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01636687
First received: July 6, 2012
Last updated: February 12, 2013
Last verified: February 2013
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Purpose
The purpose of this study is to demonstrate efficacy of autoinjector administered secukinumab at Week 12 based on PASI and IGA response rates versus placebo in subjects with moderate to severe chronic plaque-type psoriasis.
| Condition | Intervention | Phase |
|---|---|---|
|
Plaque-type Psoriasis |
Drug: Secukinumab 150mg Drug: Secukinumab 300mg Drug: Placebo |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study 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 in Autoinjectors to Demonstrate Efficacy After Twelve Weeks of Treatment, and to Assess the Safety, Tolerability, Usability and Long-term Efficacy in Subjects With Chronic Plaque-type Psoriasis |
Resource links provided by NLM:
Further study details as provided by Novartis:
Primary Outcome Measures:
- Psoriasis Area and Severity Index (PASI) 75 score and Investigators' Global Assessment (IGA) with 0 or 1 response [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]Measures Efficacy of autoinjector administered secukinumab in subjects with moderate to severe chronic plaque-type psoriasis
Secondary Outcome Measures:
- Self-administered Self-Injection Assessment Questionnaire (SIAQ) and investigator / site staff observation [ Time Frame: Week 0- Week 48 ] [ Designated as safety issue: Yes ]Outcome Measure Description: To measure Subjects usability (ability to follow instructions for use and potential use-related hazards) and satisfaction with the secukinumab autoinjector.
- Psoriasis Area and Severity Index (PASI) 50 / 75 / 90 / 100 and IGA 0 or 1 response [ Time Frame: up to Week 12, and over time up to Week 52 ] [ Designated as safety issue: No ]Measures Efficacy of secukinumab on moderate to severe chronic plaque-type psoriasis
- Clinical safety and tolerability of secukinumab [ Time Frame: up to Week 12, and over time up to Week 52 ] [ Designated as safety issue: Yes ]Outcome Measure Description: to investigate the clinical safety and tolerability of secukinumab as assessed by vital signs, clinical laboratory values, ECGs and AE monitoring
- Efficacy of secukinumab with respects to the EQ-5D score [ Time Frame: up to Week 12, and over time up to Week 52 ] [ Designated as safety issue: No ]Outcome Measure Description: to assess the efficacy of secukinumab in subjects with moderate to severe chronic plaque-type psoriasis with respect to EQ-5D score.
- Efficacy of secukinumab with respects to the DLQI [ Time Frame: up to Week 12, and over time up to Week 52 ] [ Designated as safety issue: No ]Outcome Measure Description: to investigate the effects of secukinumab in subjects with moderate to severe chronic plaque-type psoriasis with respect to DLQI
- Efficacy of secukinumab with respects to DLQI 0 or 1 [ Time Frame: up to Week 12, and over time up to Week 52 ] [ Designated as safety issue: No ]Outcome Measure Description: to investigate the effects of secukinumab with respect to DLQI 0 or 1 achievement.
- Secukinumab immunogenicity [ Time Frame: up to Week 12, and over time up to Week 52 ] [ Designated as safety issue: No ]Outcome Measure Description: to investigate the development of immunogenicity against secukinumab
| Enrollment: | 182 |
| Study Start Date: | September 2012 |
| Primary Completion Date: | January 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Secukinumab 150mg
Secukinumab 150mg (1 injection per dose) and placebo to secukinumab 150mg (1 injection per dose)
|
Drug: Secukinumab 150mg
Secukinumab 150mg (1 injection per dose) and placebo to secukinumab 150mg (1 injection per dose)
|
| Experimental: Secukinumab 300mg |
Drug: Secukinumab 300mg
Secukinumab 300mg (2 injections per dose)
|
|
Placebo Comparator: Placebo
placebo to secukinumab 150mg (2 injections per dose)
|
Drug: Placebo
placebo to secukinumab 150mg
|
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. Other protocol-defined inclusion/exclusion criteria may apply
- Other protocol-defined inclusion/exclusion criteria may apply.
Contacts and Locations
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More Information
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| Responsible Party: | Novartis ( Novartis Pharmaceuticals ) |
| ClinicalTrials.gov Identifier: | NCT01636687 History of Changes |
| Other Study ID Numbers: | CAIN457A2309, 2012-002609-22 |
| Study First Received: | July 6, 2012 |
| Last Updated: | February 12, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Novartis:
|
Psoriasis Moderate to Severe Plaque-type Psoriasis |
Additional relevant MeSH terms:
|
Psoriasis Skin Diseases, Papulosquamous Skin Diseases |
ClinicalTrials.gov processed this record on June 18, 2013