Safety and Efficacy of Secukinumab Compared to Etanercept in Subjects With Moderate to Severe, Chronic Plaque-Type Psoriasis

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT01358578
• Date of registration: 20/05/2011
• Prospective Registration: Yes
• Primary sponsor: Novartis Pharmaceuticals
• Public title: Safety and Efficacy of Secukinumab Compared to Etanercept in Subjects With Moderate to Severe, Chronic Plaque-Type Psoriasis FIXTURE
• Scientific title: A Randomized, Double-blind, Double-dummy, Placebo Controlled, Multicenter Study of Subcutaneous Secukinumab to Demonstrate Efficacy After Twelve Weeks of Treatment, Compared to Placebo and Etanercept, and to Assess the Safety, Tolerability and Long-term Efficacy up to One Year in Subjects With Moderate to Severe Chronic Plaque-type Psoriasis
• Date of first enrolment: June 2011
• Target sample size: 1306
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT01358578
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 3

Countries of recruitment

Argentina, Australia, Belgium, Canada, Colombia, Egypt, Finland, France, Germany, Guatemala, Hungary, Iceland, India, Italy, Korea, Republic of, Philippines, Poland, Romania, Russian Federation, Singapore, Spain, Sweden, Turkey, United Kingdom, United States

Contacts

• Name: Novartis Pharmaceuticals
• Affiliation: Novartis Pharmaceuticals

Key inclusion & exclusion criteria

Inclusion Criteria:

- Subjects with chronic, plaque-type psoriasis for at least 6 months

- Must have moderate to severe psoriasis based on PASI greater than 12, IGA greater than
3, and greater than 10% body surface area

- Must be inadequately controlled by prior treatments (topicals, phototherapy, and/or
systemic therapies)

Exclusion Criteria:

- Forms of psoriasis other than chronic, plaque-type (such as pustular, erythrodermic
and guttate psoriasis)

- Drug induced psoriasis

- Use of other psoriasis treatments during the study

- Prior use of etanercept

- Prior use of secukinumab or any other drug that target IL-17 (interleukin 17) or the
IL-17 receptor

- Pregnant or lactating women; women who do not agree to use contraception during the
study and for 16 weeks after stopping treatment

- Significant medical problems such as uncontrolled high blood pressure, congestive
heart failure, etc.

- History of an ongoing, chronic or recurrent infection or evidence of tuberculosis

- Allergy to rubber or latex

Other protocol-defined inclusion/exclusion criteria may apply



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Chronic Plaque Psoriasis

Intervention(s)

Drug: Placebo

Drug: secukinumab (AIN457)

Drug: etanercept

Primary Outcome(s)

Efficacy of Secukinumab Compared to Placebo in Subjects With Moderate to Severe Chronic Plaque-type Psoriasis Measure: PASI 75 (Psoriasis Area and Severity Index) . [Time Frame: 12 wks]

Efficacy of Secukinumab Compared to Placebo in Subjects With Moderate to Severe Chronic Plaque-type Psoriasis Measure:IGA (Investigator's Global Assessment) Mod 2011 With a 0 or 1 Response at Week 12 [Time Frame: 12 wks]

Secondary Outcome(s)

Efficacy of Secukinumab Compared to Etanercept in Subjects With Moderate to Severe Chronic Plaque-type Psoriasis Measure: PASI 75 at Week 12 [Time Frame: 12 wks]

Number of Participants Developing Anti-secukinumab Antibodies [Time Frame: 60 weeks]

Efficacy of Secukinumab Compared to Etanercept and Placebo in Subjects With Moderate to Severe Chronic Plaque-type Psoriasis Measure: PASI 90 at Week 12 [Time Frame: 12 wks]

Change From Baseline to Week 12 in Psoriasis Symptom Diary Items Itching, Pain and Scaling in AIN457 vs Etanercept [Time Frame: baseline to week 12]

Change in Score From Baseline to Week 12 in Psoriasis Symptom Diary Items Itching, Pain and Scaling in AIN457 vs Placebo [Time Frame: baseline to week 12]

Efficacy of Secukinumab Compared to Etanercept in Subjects With Moderate to Severe Chronic Plaque-type Psoriasis Measure: :IGA (Investigator's Global Assessment) Mod 2011 With a 0 or 1 Response at Week 12 [Time Frame: 12 wks]

Maintenance of IGA Mod 2011 0 or 1 Response After 52 Weeks of Treatment for Subjects Who Were IGA Mod 2011 0 or 1 Responders After 12 Weeks of Treatment [Time Frame: 52 wks]

Maintenance of PASI 75 Response at Week 52 for Patients Who Were PASI 75 Responders at Week 12 (Non-responder Imputation) [Time Frame: 52 wks]

Secondary ID(s)

CAIN457A2303

2010-022228-66

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 23/09/2015
• URL: https://clinicaltrials.gov/ct2/show/results/NCT01358578