CTRI/2011/09/002026 [Registered on: 29/09/2011] Trial Registered Prospectively
Last Modified On:
01/03/2013
Post Graduate Thesis
No
Type of Trial
Interventional
Type of Study
Biological
Study Design
Randomized, Parallel Group, Active Controlled Trial
Public Title of Study
Safety and Efficacy of Secukinumab Compared to Etanercept in Subjects With Moderate to Severe, Chronic Plaque-Type Psoriasis (FIXTURE)
Scientific Title of Study
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
Trial Acronym
FIXTURE
Secondary IDs if Any
Secondary ID
Identifier
CAIN457A2303
Protocol Number
NCT01358578
ClinicalTrials.gov
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Name
Murugananthan K
Designation
Head-Clinical Development
Affiliation
Address
Novartis Healthcare Private Limited,
Medical Department,
Sandoz House,
Shiv Sagar Estate,
Dr. Annie Besant Road,
Worli, Mumbai
Mumbai MAHARASHTRA 400018 India
Phone
022-24958545
Fax
Email
murugananthan.k@novartis.com
Details of Contact Person Scientific Query
Name
Murugananthan K
Designation
HCD
Affiliation
Address
Novartis Healthcare Private Limited,
Medical Department,
Sandoz House,
Shiv Sagar Estate,
Dr. Annie Besant Road,
Worli, Mumbai
Mumbai MAHARASHTRA 400018 India
Phone
022-24958545
Fax
Email
murugananthan.k@novartis.com
Details of Contact Person Public Query
Name
Murugananthan K
Designation
HCD
Affiliation
Address
Novartis Healthcare Private Limited,
Medical Department,
Sandoz House,
Shiv Sagar Estate,
Dr. Annie Besant Road,
Worli, Mumbai
Hindu Colony, Lane no 3,Near Bhagini Samaj, Dadar (east) mumbai - 400018 Mumbai MAHARASHTRA
912224143895 912224124039 sapleclinic@gmail.com
Dr D V S Pratap
Durgabai Deshmukh hospital & Research Centre
Durgabai Deshmukh hospital & Research Centre, Research Room, 1st floor, OP block, University road, Vidyanagar, Hyderabad - 500044 Hyderabad ANDHRA PRADESH
919848031921
pratap_dvs@yahoo.co.in
Dr Ramesh Bhat
Father Muller Medical College Hospital
Father muller road, Kankanady, Mangalore - 575002 Bangalore KARNATAKA
919845084224 918242238261 rameshderma@yahoo.com
Dr M G Gopal
Kempegowda Institute of Medical Sciences
Kempegowda Institute of Medical Sciences, Skin Department of Skin, No: 10, KIMS hospital, KR Road, VV Puram, Bangalore - 560004 Bangalore KARNATAKA
919845010455
gopalamg@yahoo.co.in
Dr B V Rama Chandra
King George Hospital
Department of Dermatology,Near Collectorate,Maharanipet,
Visakhapatnam-530002.
Visakhapatnam ANDHRA PRADESH
919849121737 918912568650 bvrderma@gmail.com
Dr Rachita Dhurat
Lokmanya Tilak Municipal Medical College & General Hospital
Lokmanya Tilak Municipal Medical College & General Hospital, Department of Dermatology, First Floor , College Building,Sion, , Mumbai , Maharashtra -400022 Mumbai MAHARASHTRA
Ethics Committe-Lokmanya Tilak Municipal Medical College
Approved
Ethics Committtee, BMCRI
Approved
Father Muller Institutional Ethics Committee, Father Muller Medical College Hospital
Approved
Hyderabad Central Ethics Committee, Hyderabad, Dr D V S Pratap
Approved
Independent Ethics committee Nagpur, Dr Sushil Pande
Approved
Instituional Ethics Committee,D.Y.Patil Medical college and Hospital & research centre
Approved
Institutional Ethics Committee, King George Hospital
Approved
KIMS Ethics committee, KIMS
Approved
Osmania Medical college ethics committe, Osmania Medical College
Approved
Regulatory Clearance Status from DCGI
Status
Approved/Obtained
Health Condition / Problems Studied
Health Type
Condition
Patients
Chronic Plaque Psoriasis,
Intervention / Comparator Agent
Type
Name
Details
Comparator Agent
Etanercept -50mg
etanercept 50 mg twice per week given sub-cutaneously for 51 weeks
Comparator Agent
Placebo group
matching with Secukinumab 150mg
Intervention
Secukinumab 150 mg and secukinumab placebo
secukinumab 150 mg (one s.c. injection of the
150 mg dose + one s.c. injection of secukinumab placebo) administered till 48 weeks.
secukinumab placebo (two s.c. injections per dose) administered at Weeks 13, 14 and
15.
Intervention
secukinumab 300 mg and secukinumab placebo
secukinumab 300 mg (two s.c. injections of the
150 mg dose) administered sub cutaneously till 48weeks.
secukinumab placebo- (two sub cutaneous injections per dose) administered at
Weeks 13, 14, and 15.
Inclusion Criteria
Age From
18.00 Year(s)
Age To
99.00 Year(s)
Gender
Both
Details
Patients with Behçets disease and with a history of recurrent uveitis in a least one eye.
Documented evidence of Greater than22 recurrent exacerbations of either intermediate uveitis, posterior uveitis or panuveitis in the study eye within the past 6 months (this could include the current exacerbation for patients having an acute exacerbation at screening). Exacerbations fulfilling the study inclusion criteria must have one or more of the following recorded in the patients patients medical record for each recurrent exacerbation:
Greater than 2 plus vitreous haze with less than 2plus anterior chamber cell grade (intermediate or posterior uveitis) or Greater than22 plus vitreous haze with Greater than22 plus anterior chamber cell grade (panuveitis)
presence of retinal infiltrates or vasculitis or hemorrhages
documented Greater than210 ETDRS letter or 2 line Snellen decrease in visual acuity attributed to ocular inflammation secondary to the recurrent exacerbation of Behçets disease.
• Requirement for either of the following immunosuppressive therapies for at least 3 of the past 6 months for the treatment of or to prevent an exacerbation of ocular inflammation related to Behçets disease:
Prednisone or equivalent Greater than210 mg daily
The need for at least Greater than21 periocular injection or Greater than21 intravitreal corticosteroid injection in the study eye within the past 6 months (the last injection must have not been given within 6 weeks of screening)
Treatment with cyclosporine, tacrolimus, azathioprine, mycophenolate mofetil, mycophenolic acid or methotrexate either as monotherapy or in combination with or without steroids. (Patients treated at any time with chlorambucil or cyclophosphamide are not eligible for the study.)
Patients not meeting the above specified criteria for immunomodulatory therapies are eligible for enrollment if they are intolerant to systemic immunomodulatory therapy as determined by the study investigator.
ExclusionCriteria
Details
Subjects with infectious uveitis, uveitis due to other causes than Behçets disease, or uveitis of unknown etiology.
Less severe (i.e. anterior) uveitis associated with Behçets disease.
Ocular treatments
Treatment with intravitreal anti-VEGF agents administered to the study eye within 3 months prior to study screening.
Treatment with any injected or implantable corticosteroid releasing device (i.e., flucinolone acetonide implant, Retisert®) in the study eye within the last 3 years.
Intraocular surgery or laser photocoagulation in the study eye within the last 6 weeks prior to screening except for a diagnostic vitreous or aqueous tap with a small-gauge needle
Systemic conditions or treatments
Treatment with any live or live-attenuated vaccine (including vaccine for varicella-zoster virus or measles) within 2 months prior to screening.
Any systemic biologic therapy (e.g. interferon, infliximab, daclizumab, etanercept, or adalimumab) given intravenously or subcutaneously within 3 months prior to screening and no prior treatment with AIN457.
Any prior treatment with systemic alkylating agents (cyclophosphamide, chlorambucil).
Chest X-ray or MRI with evidence of ongoing infectious or malignant process, obtained
within 3 months prior to screening, and evaluated by a qualified physician
Method of Generating Random Sequence
Computer generated randomization
Method of Concealment
Other
Blinding/Masking
Double Blind Double Dummy
Primary Outcome
Outcome
TimePoints
• Efficacy of secukinumab compared to placebo in subjects with moderate to severe chronic plaque-type psoriasis Measure: PASI (psoriasis area and severity index) and IGA (investigators global assessment)
Time Frame: 12 wks
Secondary Outcome
Outcome
TimePoints
1.To determine if AIN457 can reduce the need for standard-of-care immuno
suppressivemedications(ISM) in patients requiring systemic immunosuppression to treat/prevent posterior segment uveitis secondary to Behçets disease as measured by the ISM score
1.Time Frame: 24 weeks
Target Sample Size
Total Sample Size="1264" Sample Size from India="120" Final Enrollment numbers achieved (Total)= "" Final Enrollment numbers achieved (India)=""
Individual Participant Data (IPD) Sharing Statement
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Brief Summary
Purpose of the study:
This study will assess the safety and efficacy of secukinumab compared to placebo and etanercept in patients that have moderate to severe, chronic, plaque-type psoriasis.