| CTRI Number |
CTRI/2011/12/002201 [Registered on: 05/12/2011] Trial Registered Prospectively |
| Last Modified On: |
01/03/2013 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Biological |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Dose Finding Study for Secukinumab(AIN457) in Moderate to Severe Chronic Plaque-type Psoriasis |
|
Scientific Title of Study
|
A Randomized, Double-blind, Multicenter Study of Subcutaneous Secukinumab, Assessing Psoriasis Area and Severity Index (PASI) Response and Maintenance of Response in Subjects With Moderate to Severe Chronic Plaque-type Psoriasis on Either a Fixed Dose Regimen or on a Retreatment at Start of Relapse Regimen |
| Trial Acronym |
SCULPTURE |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| CAIN457A2304 |
Protocol Number |
| NCT01406938 |
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 A. B. road, Worli Mumbai |
| Type of Sponsor |
Pharmaceutical industry-Global |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
Austria
Bulgaria
Canada
Czech Republic
France
Germany
India
Italy
Japan
Poland
Singapore
Slovakia
Switzerland
United Kingdom
United States of America
Viet Nam |
|
Sites of Study
|
| No of Sites = 10 |
| 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 |
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 |
9822697892
vikrantsaoji@hotmail.com |
| Dr Geetha Kiran |
Gandhi Hospital |
Department of Dermatology,6-1-34, Musheerabad, Secunderabad-500037
Hyderabad
ANDHRA PRADESH |
919440430777
geetakirana@gmail.com |
| Dr Mahendra Kura |
Grant Medical college and JJ Hospital |
OPD-42, 2nd Floor, OPD building, JJ Hospital, Byculla, Mumbai-400008
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 |
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 |
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 |
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 |
9226212512
07122740371
shyamalbalki@gmail.com |
| Dr Milind Borkar |
Skin Clinic |
Second Floor, Sadoday Pride, opp archraj tower sardar, nagpur-440001
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 |
919423971385
912532458568
suneel.vartak@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 10 |
| Name of Committee |
Approval Status |
| AJ Ethics Committee,A J Institute of Medical Sciences |
Approved |
| Ethical Review Board, MS Ramaiah Medical College |
Approved |
| Global Health Concern Ethics Committee,Radiance skin clinic, Nagpur |
Approved |
| Global Health Concern Ethics Committee,Skin Clinic |
Approved |
| Independent Ethics committee,Dr. Vikrant Saoji, Nagpur |
Approved |
| Institutional Ethics Committee, Deccan College of Medical Sciences and Allied hospitals |
Approved |
| Institutional Ethics Committee, Grant Medical college and JJ Hospital |
Approved |
| Institutional Ethics Committee,Gandhi Medical College |
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 |
| Intervention |
Experimental:(fixed interval treatment):Secukinumab 150 mg |
secukinumab 150 mg (1 injection per dose) and placebo to secukinumab 150 mg (1 injection per dose)
1 sub-cutaneous secukinumab 150mg injection plus 1sub-cutaneous placebo injection from Visit1 to Visit17.
At start of relapse- 1sc secukinumab 150mg injection plus 1sc placebo injection.
OR- 2sc Placebo secukinumab injection. |
| Comparator Agent |
N/A |
N/A |
| Intervention |
secukinumab 150 mg: Experimental (personalized therapy: active treatment given only if disease relapses)
|
Intervention: Drug: If disease relapses patient is treated with secukinumab 150 mg. If disease does not relapse patient is treated with placebo |
| Intervention |
secukinumab 300 mg
Intervention: Drug: If disease relapses patient is treated with secukinumab 150 mg. If disease does not relapse patient is treated with placebo |
2 sub-cutaneous secukinumab 150mg injection from Visit2 to Visit17.
At start of relapse- 2 sc secukinumab 150 mg injection
OR- 2 Sc placebo secukinumab injection. |
| Intervention |
secukinumab 300 mg if disease relapses: Experimental (personalized therapy: active treatment given only if disease relapses)
|
Intervention: Biological: If disease relapses patient is treated with secukinumab 300 mg. If disease does not relapse patient is treated with placebo. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Moderate and severe plaque-type psoriasis diagnosed for at least 6 months.
Severity of disease meeting all of the following three criteria:
PASI score of 12 or greater,
Investigators Global Assessment (IGA) score of 3 or greater
Total body surface area (BSA) affected of 10 percent or greater.
Inadequate control by prior use of topical treatment, phototherapy and or systemic therapy.
|
|
| ExclusionCriteria |
| Details |
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.
Other protocol-defined inclusion or exclusion criteria may apply.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| • Proportion of subjects who maintain Psoriasis Area and Severity Index 75 (PASI 75) response relative to baseline after having achieved PASI 75 response after 12 weeks of treatment with secukinumab |
• Proportion of subjects who maintain Psoriasis Area and Severity Index 75 (PASI 75) response relative to baseline after having achieved PASI 75 response after 12 weeks of treatment with secukinumab |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| • Proportion of subjects who achieve PASI 50/75/90/100 response or Investigators Global Assessment (IGA) 0 or 1 response relative to baseline after 12 weeks and after 52 weeks of treatment with secukinumab |
12 and 52 weeks |
|
|
Target Sample Size
|
Total Sample Size="918"
Sample Size from India="95"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
20/12/2011 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
16/08/2011 |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="2"
Months="5"
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
|
Brief Summary:
Purpose of the study: This study will assess the safety and efficacy of two different doses and two different dose regimens of subcutaneous secukinumab in patients that have moderate to severe, chronic, plaque-type psoriasis.
FPFV for India:20-Dec-2011
Enrollment Target for India:95 |