Efficacy and Safety of Subcutaneous Secukinumab for Moderate to Severe Chronic Plaque-type Psoriasis for up to 1 Year (ERASURE)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01365455
First received: June 1, 2011
Last updated: January 22, 2015
Last verified: January 2015

June 1, 2011
January 22, 2015
June 2011
April 2013   (final data collection date for primary outcome measure)
  • Number of patients who achieve >75 or higher (Psoriasis Area and Severity Index) PASI score [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Measure: PASI score
  • Number of patients who achieve (Investigator's Global Assessment) IGA scor of 0 or 1 [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Number of patients who achieve (Investigator's Global Assessment) IGA scor of 0 or 1 as an indicator of efficacy of efficacy of secukinumab in subjects with moderate to severe chronic plaque-type psoriasis
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
Complete list of historical versions of study NCT01365455 on ClinicalTrials.gov Archive Site
  • Number of patients who achieve >75 or higher. [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
    Number of patients who achieve >75 or higher (Psoriasis Area and Severity Index) PASI score to measure efficacy of secukinumab in subjects with moderate to severe chronic plaque-type psoriasis
  • 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
  • Number of patients with a IGA score of 0 or 1 [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
    Number of patients who achieve (Investigator's Global Assessment) IGA scor of 0 or 1 as an indicator of efficacy of efficacy of secukinumab in subjects with moderate to severe chronic plaque-type psoriasis
  • 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
Not Provided
Not Provided
 
Efficacy and Safety of Subcutaneous Secukinumab for Moderate to Severe Chronic Plaque-type Psoriasis for up to 1 Year
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

This study will assess the safety and efficacy of secukinumab compared to placebo in patients that have moderate to severe, chronic, plaque-type psoriasis.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Moderate to Severe Plaque-type Psoriasis
  • Drug: secukinumab 150 mg
    secukinumab (AIN457) 150mg or 300mg subcutaneous
  • Drug: placebo to secukinumab 150 mg
    Placebo to Match secukinumab (AIN457) 150mg or 300mg subcutaneous
  • Experimental: AIN457 150 mg
    AIN457 secukinumab 150 mg subcutaneous (s.c.) injection plus a placebo secukinumab s.c. injection once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4 and until Week 48, except for Weeks 13, 14, and 15 when they received two s.c. injections of placebo per week
    Interventions:
    • Drug: secukinumab 150 mg
    • Drug: placebo to secukinumab 150 mg
  • Experimental: AIN457 300 mg
    AIN457 secukinumab 300 mg (two s.c. injections of 150 mg) once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4, and until Week 48, except for Weeks 13, 14, and 15 when they received two s.c. injections of placebo per week
    Interventions:
    • Drug: secukinumab 150 mg
    • Drug: placebo to secukinumab 150 mg
  • Placebo Comparator: placebo
    placebo secukinumab (two s.c. injections per dose) once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks (Weeks 4 and 8). Prior to receiving the Week 12 dose, all patients in the placebo group were assigned to the following treatment groups based on their PASI 75 response at Week 12. PASI 75 responders: continued on placebo and received their placebo injections at Weeks 12, 13, 14, 15, and then every 4 weeks starting at Week 16 until Week 48.
    Intervention: Drug: placebo to secukinumab 150 mg
  • Experimental: AIN457 150mg from Placebo
    Patients randomized to AIN457 150mg in Maintenance phase when they were on Placebo in Induction Phase because they were PASI 75 non-responders and received their treatment on Weeks 12, 13, 14, 15, and then every 4 weeks starting at Week 16 until Week 48.
    Interventions:
    • Drug: secukinumab 150 mg
    • Drug: placebo to secukinumab 150 mg
  • Experimental: AIN457 300mg from Placebo
    Patients randomized to AIN457 300mg in Maintenance phase when they were on Placebo in Induction Phase. PASI 75 non-responders and received their treatment on Weeks 12, 13, 14, 15, and then every 4 weeks starting at Week 16 until Week 48.
    Interventions:
    • Drug: secukinumab 150 mg
    • Drug: placebo to secukinumab 150 mg

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
739
April 2013
April 2013   (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.
  • Subjects not willing to limit UV light exposure during the study 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,   Argentina,   Canada,   Colombia,   Estonia,   Iceland,   Israel,   Japan,   Latvia,   Lithuania,   Mexico,   Taiwan
 
NCT01365455
CAIN457A2302, 2010-023512-13
Not Provided
Novartis ( Novartis Pharmaceuticals )
Novartis Pharmaceuticals
Not Provided
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
Study Director: Novartis Pharmceuticals Novartis Pharmaceuticals
Novartis
January 2015

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