| CTRI Number |
CTRI/2012/02/002424 [Registered on: 15/02/2012] Trial Registered Prospectively |
| Last Modified On: |
07/12/2015 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Study to assess the Safety, Tolerability, and Long term Efficacy of Secukinumab drug in patients with Moderate to severe Chronic plaque-type Poriasis. |
|
Scientific Title of Study
|
A Randomized, Double-blind, Double Dummy, Multicenter Study to Assess the Safety, Tolerability and Long-term Efficacy of Intravenous (10mg/kg) and Subcutaneous (300mg) Secukinumab in Subjects With Moderate to Severe Chronic Plaque-type Psoriasis Who Are Partial Responders to Secukinumab |
| Trial Acronym |
STATURE |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| CAIN457A2307-Version 00-Dated: 22-July-2011 |
Protocol Number |
| NCT01412944 |
ClinicalTrials.gov |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Murugananthan K |
| Designation |
Head-Clinical Development |
| Affiliation |
Novartis Healthcare Private Limited |
| Address |
Novartis Healthcare Private Limited,
Medical Department,
Sandoz House,
Shiv Sagar Estate,
Dr. Annie Besant Road,
Worli, Mumbai – 400 018
Maharashtra
Mumbai
MAHARASHTRA
400 018
India |
| Phone |
022-24958545 |
| Fax |
|
| Email |
murugananthan.k@novartis.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Murugananthan K |
| Designation |
Head-Clinical Development |
| Affiliation |
Novartis Healthcare Private Limited |
| Address |
Novartis Healthcare Private Limited,
Medical Department,
Sandoz House,
Shiv Sagar Estate,
Dr. Annie Besant Road,
Worli, Mumbai – 400 018
Maharashtra
Mumbai
MAHARASHTRA
400 018
India |
| Phone |
022-24958545 |
| Fax |
|
| Email |
murugananthan.k@novartis.com |
|
Details of Contact Person
Public Query
|
| Name |
Murugananthan K |
| Designation |
Head-Clinical Development |
| Affiliation |
Novartis Healthcare Private Limited |
| Address |
Novartis Healthcare Private Limited,
Medical Department,
Sandoz House,
Shiv Sagar Estate,
Dr. Annie Besant Road,
Worli, Mumbai – 400 018
Maharashtra
Mumbai
MAHARASHTRA
400 018
India |
| Phone |
022-24958545 |
| Fax |
|
| Email |
murugananthan.k@novartis.com |
|
|
Source of Monetary or Material Support
|
| Novartis Pharma AG, Basel, Switzerland |
|
|
Primary Sponsor
|
| Name |
Novartis Healthcare Pvt Ltd |
| Address |
Medical Dept, Sandoz house, Shiv Sagar Estate, Dr. Annie Besant Road, Worli, Mumbai-400018 |
| Type of Sponsor |
Pharmaceutical industry-Global |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
Austria
Canada
Czech Republic
India
Japan
Poland
Slovakia
Switzerland
Taiwan
United States of America
Viet Nam |
|
Sites of Study
|
| No of Sites = 9 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Narendra Shetty |
A J Institute of Medical Sciences |
N.H. 17,Kuntikana, , Mangalore, Karnataka, 575004
Bangalore
KARNATAKA
Bangalore
KARNATAKA |
919945613123
91-8242225541
drnarendrashetty@yahoo.com |
| Dr Vikrant Saoji |
Dr. Vikrant Saoji Skin Clinic |
27 Ramdaspeth, Central Bazar Road, Navprabhat Chamber, Opp. Tarun Bharat, Ramdaspeth - Nagpur-440010
Nagpur
MAHARASHTRA
Nagpur
MAHARASHTRA |
9822697892
vikrantsaoji@hotmail.com |
| Dr Mahendra Kura |
Grant Medical college and JJ Hospital |
OPD-42, 2nd Floor, OPD building, JJ Hospital, Byculla, Mumbai-400008
Mumbai
MAHARASHTRA
Mumbai
MAHARASHTRA |
9322593511
02223735599
drkura@gmail.com |
| Dr T K Sumathy |
M.S. Ramaiah Memorial Hospital |
Sr. Prof & HOD, Dept of Dermatology, Ms Ramaiya Medical College, MSRIT Post, New BEL Road, Bangalore, Karnataka 560054
Bangalore
KARNATAKA
Bangalore
KARNATAKA |
080-22183009
91-8040528402
tksumathy@gmail.com |
| Dr A S Kumar |
Owaisi Hospital and research centre |
D M R L X Road Santosh Nagar P O,Kanchan Bagh, Hyderabad, 500058
Hyderabad
ANDHRA PRADESH
Hyderabad
ANDHRA PRADESH |
04065942565
04024340144
dr_askumar@yahoo.com |
| Dr Rizwan Haq |
Radiance skin clinic |
Opp sardar muslim library, Behind Sardar Bus stop, Tekdi road sadar, Nagpur
Nagpur
MAHARASHTRA
Nagpur
MAHARASHTRA |
07123210803
07122551957
drrizwanhaq@yahoo.co.in |
| Dr Shyamal Balki |
Shree Hospital & critical care, |
799, Omnagar, Sakkardara, Mrchi Bazar, Umred Road, Nagpur-9, Maharashtra, India
Nagpur
MAHARASHTRA
Nagpur
MAHARASHTRA |
9226212512
07122740371
shyamalbalki@gmail.com |
| Dr Milind Borkar |
Skin Clinic |
Second Floor, Sadoday Pride, opp archraj tower sardar, nagpur-440001
Nagpur
MAHARASHTRA
Nagpur
MAHARASHTRA |
9422108764
drmilindborkar@rediffmail.com |
| Dr Suneel Vartak |
Skin Clinic |
Flat No. 111-112, Rajan Complex, Dattamandir Chowk, Nasikroad, Nasik-422 101, Maharashtra, India
Nashik
MAHARASHTRA
Nashik
MAHARASHTRA |
919423971385
912532458568
suneel.vartak@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 9 |
| Name of Committee |
Approval Status |
| AJIMS Ethics Committee,A J Institute of Medical Sciences |
Approved |
| Centre for Liver research and diagnostics, Dr. A S Kumar,Hyderabad |
Submittted/Under Review |
| Ethical Review Board, M S Ramaiah Memorial Hospital |
Approved |
| Ethics Committee, Grant Medical college and JJ Hospital |
Submittted/Under Review |
| Global Health Concern Ethics Committee, Dr. Milind Borkar, Nagpur |
Approved |
| Global Health Concern Ethics Committee, Dr. Rizwan Haq, Nagpur |
Approved |
| Independent Ethics committee,Dr. Vikrant Saoji, Nagpur |
Approved |
| Midicity Independent ethics committee,Dr. Shyamal Balki, Nagpur |
Approved |
| North Maharashtra Ethics Committee,Skin Clinic |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Plaque-type Psoriasis
, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
| Intervention |
secukinumab 10mg/kg i.v. regimen |
Each subject to receive an i.v. infusion of
secukinumab solution at randomization and at Weeks
2 and 4, plus two s.c. injections of secukinumab placebo in 1 mL of diluent, at randomization
and at Week 4 till week 11th. |
| Intervention |
secukinumab 300mg |
Each Subject will recieve secukinumab 150mg(2 injections per dose)s.c. injections both at randomization and at Week 4plus an i.v. infusion of
100 mL of normal saline in an infusion bag at randomization and at Weeks 2 and 4. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
1.Informed consent must be obtained before any assessment is performed, where a relevant and legal representative will also sign the informed study consent according to local laws and regulations.
2.Subject must be able to understand and communicate with the investigator and comply with the requirements of the study.
3.Subjects must be participated in the study CAIN457A2304 and have achieved a partial response after twelve weeks of treatment with no major protocol deviations.
4.A partial response is defined as having achieved PASI 50 not 75 response. |
|
| ExclusionCriteria |
| Details |
1. Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female
after conception and until the termination of gestation, confirmed by a positive urine test.
2. Women of child-bearing potential, defined as all women physiologically capable of
becoming pregnant, unwilling to use effective contraception during the study and for 16
weeks after stopping treatment.
3. Forms of psoriasis other than chronic plaque-type (e.g., pustular, erythrodermic and guttate
psoriasis).
4.Ongoing use of prohibited psoriasis treatments (e.g., topical or systemic corticosteroids, UV
therapy). Ongoing use of other non-psoriasis prohibited treatments.
5.Previous exposure to any biologic drug directly targeting IL-17 or the IL-17 receptor, except secukinumab in study CAIN457A2304
6. Active ongoing inflammatory diseases other than psoriasis that might confound the evaluation
of the benefit of secukinumab therapy. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Double Blind Double Dummy |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Efficacy of intravenous administration of secukinumab compared with subcutaneous administration secukinumab with respect to both PASI 75 and IGA 0 or 1 response |
8 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Efficacy of a higher dose of secukinumab than administered in CAIN457A2304 in achieving PASI 75 or IGA 0 or 1 response over time
2.Efficacy of secukinumab treatment regimens in subjects with respect to PASI 50/75/90/100 response and IGA 0 or 1 response overtime
3.Efficacy treatment regimens with secukinumab with respect to PASI score and IGA mod 2011 score over time.
|
1.Week 40
2.Week 40
3.Week 40
|
|
|
Target Sample Size
|
Total Sample Size="140"
Sample Size from India="50"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
27/04/2012 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
15/11/2011 |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="8"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
No publications provided
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Purpose of the Study:
The study will assess the safety and efficacy of intravenous (10mg/kg) and subcutaneous (300mg) secukinumab in moderate to severe chronic plaque-type psoriasis who are partial responders to secukinumab.
FPFV for India: 27-Apr-2012
Enrollment Target for India: 50 |