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Judging the Efficacy of Secukinumab in Patients With Psoriasis Using AutoiNjector: a Clinical Trial Evaluating Treatment Results (JUNCTURE)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01636687
First received: July 6, 2012
Last updated: June 19, 2014
Last verified: June 2014

July 6, 2012
June 19, 2014
October 2012
March 2017   (final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT01636687 on ClinicalTrials.gov Archive Site
  • 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
  • PASI 50 / 75 / 90 / 100 and IGA 0 or 1 response, after Week 52 [ Time Frame: after Week 52 ] [ Designated as safety issue: No ]
    To assess the long term efficacy of secukinumab on moderate to severe chronic plaque-type psoriasis with respect to PASI 50 / 75 / 90 / 100 and IGA 0 or 1 response, after Week 52
  • PASI score and IGA mod 2011 score after Week 52 [ Time Frame: after Week 52 ] [ Designated as safety issue: No ]
    To assess the long term efficacy of secukinumab on moderate to severe chronic plaque-type psoriasis with respect to PASI score and IGA mod 2011 score after Week 52
  • Long term clinical safety and tolerability of secukinumab [ Time Frame: after Week 52 ] [ Designated as safety issue: Yes ]
    To investigate the clinical safety and tolerability of secukinumab as assessed by vital signs, clinical laboratory variables, ECGs, and adverse events monitoring after Week 52
  • 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
Not Provided
Not Provided
 
Judging the Efficacy of Secukinumab in Patients With Psoriasis Using AutoiNjector: a Clinical Trial Evaluating Treatment Results (JUNCTURE)
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

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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Plaque-type Psoriasis
  • Drug: Placebo
    2 injections of placebo to secukinumab 150mg per dose
  • Drug: Secukinumab 150mg
    Secukinumab 150mg: 1 injection of 150 mg secukinumab and 1 injection of placebo to secukinumab 150mg per dose. After Week 52 database lock, study is open label so only 1 injection of secukinumab 150mg per dose will be administered
  • Drug: Secukinumab 300mg
    Secukinumab 300mg (2 injections of 150mg secukinumab per dose)
  • Experimental: Placebo
    Subjects who were at placebo at Week 52 cannot continue in the extension treatment period
    Intervention: Drug: Placebo
  • Experimental: Secukinumab 150 mg
    After the data base lock of week 52 data has been performed, subjects will receive secukinumab 150 mg treatment as open label for the remainder of the extension treatment period
    Intervention: Drug: Secukinumab 150mg
  • Experimental: Secukinumab 300 mg
    After the data base lock of week 52 data has been performed, subjects will receive secukinumab 300 mg treatment as open label for the remainder of the extension treatment period
    Intervention: Drug: Secukinumab 300mg
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
182
March 2017
March 2017   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Canada,   Estonia,   France,   Germany
 
NCT01636687
CAIN457A2309, 2012-002609-22
Yes
Novartis ( Novartis Pharmaceuticals )
Novartis Pharmaceuticals
Not Provided
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
Novartis
June 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP