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
  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:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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


Enrollment: 739
Study Start Date: June 2011
Study Completion Date: April 2013
Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
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 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
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
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.
Drug: placebo to secukinumab 150 mg
Placebo to Match secukinumab (AIN457) 150mg or 300mg subcutaneous
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.
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 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.
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

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01365455

  Show 88 Study Locations
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
Study Director: Novartis Pharmceuticals Novartis Pharmaceuticals
  More Information

No publications provided by Novartis

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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 22, 2015
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
Skin Diseases, Papulosquamous
Antibodies, Monoclonal
Immunologic Factors
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on March 25, 2015