| CTRI Number |
CTRI/2019/10/021825 [Registered on: 31/10/2019] Trial Registered Prospectively |
| Last Modified On: |
14/04/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
This is Phase 3, Randomized, Placebo-controlled study to demonstrate superiority of CT-P13 over Placebo SC in Patients With Moderately to Severely Active Crohns Disease which is an inflammatory bowel disease (IBD) |
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Scientific Title of Study
|
A Randomized, Placebo-Controlled, Double-Blind, Phase 3 Study to Evaluate the Efficacy and Safety of the Subcutaneous Injection of CT-P13 (CT-P13 SC) as Maintenance Therapy in Patients With Moderately to
Severely Active Crohn’s Disease |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| CT-P13 3.8 Protocol Version 2.0 dated 17 May 2019 |
Protocol Number |
| NCT03945019 |
ClinicalTrials.gov |
|
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Details of Principal Investigator or overall Trial Coordinator (multi-center study)
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| Name |
|
| Designation |
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| Affiliation |
|
| Address |
|
| Phone |
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| Fax |
|
| Email |
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Details of Contact Person
Scientific Query
|
| Name |
Rashmi Chitgupi |
| Designation |
Associate Director - Clinical Management |
| Affiliation |
PPD Pharmaceutical Development India Private Limited |
| Address |
PPD Pharmaceutical Development India Private Limited, 101, A Wing, Fulcrum, Hiranandani Business Park,
Sahar Road, Andheri East, Mumbai
Mumbai (Suburban)
MAHARASHTRA
400099
India |
| Phone |
912266022900 |
| Fax |
912266022999 |
| Email |
Rashmi.Chitgupi@ppdi.com |
|
Details of Contact Person
Public Query
|
| Name |
Rashmi Chitgupi |
| Designation |
Associate Director - Clinical Management |
| Affiliation |
PPD Pharmaceutical Development India Private Limited |
| Address |
PPD Pharmaceutical Development India Private Limited, 101, A Wing, Fulcrum, Hiranandani Business Park,
Sahar Road, Andheri East, Mumbai
MAHARASHTRA
400099
India |
| Phone |
912266022900 |
| Fax |
912266022999 |
| Email |
Rashmi.Chitgupi@ppdi.com |
|
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Source of Monetary or Material Support
|
| CELLTRION, Inc. 23 ACADEMY-RO, YEONSU-GU, INCHEON, 22014, SOUTH KOREA |
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Primary Sponsor
|
| Name |
CELLTRION Inc |
| Address |
23 ACADEMY-RO, YEONSU-GU, INCHEON, 22014, SOUTH KOREA |
| Type of Sponsor |
Other [BioPharmaceutical] |
|
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Details of Secondary Sponsor
|
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Countries of Recruitment
|
Austria
Belarus
Brazil
Bulgaria
Chile
Croatia
Czech Republic
France
Germany
Greece
Hungary
India
Ireland
Israel
Italy
Latvia
Mexico
Peru
Poland
Republic of Moldova
Romania
Russian Federation
Serbia
Slovakia
South Africa
Spain
Turkey
Ukraine
United States of America |
Sites of Study
Modification(s)
|
| No of Sites = 7 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Rupa Banerjee |
Asian Institute of Gastroenterology |
Asian Institute of Gastroenterology, 6th Floor, IBD Centre, Plot No 2/3/4/5, Survey No 136, 1, Mindspace Road, Gachibowli,
Hyderabad - 500 032,
Telangana India.
Hyderabad
TELANGANA |
919849287530
dr_rupa_banerjee@hotmail.com |
| Dr Kiran Kumar Jadhav |
B.J. Government Medical College and Sassoon General Hospitals |
B.J. Government Medical College and Sassoon General Hospitals, 1st Floor, Dept of Surgery, Near Pune Railway Station, Sassoon Road, Somwar Peth, Pune - 411001, Maharashtra, India
Pune
MAHARASHTRA |
9823949126
drj.kirankumar@gmail.com |
| Dr Saumin Shah |
Nirmal Hospitals |
Nirmal Hospital Pvt. Ltd, 1st Floor, Adult OPD, Ring Road, Surat – 395002, Gujarat - India
Surat
GUJARAT |
9408042224
dr.sauminpshah@gmail.com |
| Dr Akash Shukla |
Seth Gordhandas Sunderdas Medical College And King Edward Memorial (KEM) Hospital |
Acharya Donde Marg, Parel, Mumbai – 400012. Maharashtra, India
Mumbai (Suburban)
MAHARASHTRA |
919869256376
drakashshukla@yahoo.com |
| Dr Chetan Mehta |
Shree Giriraj Multispeciality Hospital |
Shree Giriraj Multispeciality Hospital, 150 Ft Road, 27 - Navjyot Park Corner, Rajkot - 360 005, Gujarat. India
Rajkot
GUJARAT |
9825077472
mehtacn@hotmail.com |
| Dr Parvesh Kumar Jain |
Victoria Hospital |
Room # 72/A, 2nd Floor, C Block, Bangalore Medical College and Research Institute, Fort,
Bangalore - 560 002. Karnataka, India
Bangalore
KARNATAKA |
9844252189
drjainpravesh1@gmail.com |
| Dr Ravi Shankar Bagepally |
Yashoda Hospitals |
Yashoda Hospital, Department of Gastroenterology, 4th Floor, Behind Hari Hara Kala Bhavan, SP Road,
Secunderabad - 500 003, Telangana, India
Hyderabad
TELANGANA |
9391075600
b_ravishankar@yahoo.com |
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Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 7 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee-l, Seth GS Medical College and KEM Hospital |
Not Applicable |
| ETHICS COMMITTEE - Bangalore Medical College and Research Institute |
Not Applicable |
| INSTITUTIONAL ETHICS COMMITTEE - Yashoda Academy of Medical Education & Research |
Approved |
| INSTITUTIONAL ETHICS COMMITTEE Asian Institute Of Gastroenterology |
Approved |
| INSTITUTIONAL ETHICS COMMITTEE B. J. Medical College & Sassoon General Hospitals |
Approved |
| Nirmal Hospital Pvt Ltd ETHICS COMMITTEE |
Approved |
| Shree Giriraj Hospital Research ETHICS COMMITTEE |
Approved |
|
Regulatory Clearance Status from DCGI
Modification(s)
|
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K509||Crohns disease, unspecified, |
|
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Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
CT-P13 SC (Infliximab) |
Arm 1, CT-P13 SC: from Week 10, CT-P13 SC 120 mg will be administered every 2 weeks via PFS through Week 54.
|
| Comparator Agent |
Placebo SC |
Arm 2, Placebo SC: from Week 10, Placebo SC (matching volume to CT-P13 SC 120 mg) will be administered every 2 weeks via PFS through Week 54. |
|
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Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
Inclusion Criteria:
Patient is male or female aged 18 to 75 years, inclusive.
Patient who has moderately to severely active CD with a score on the CDAI of 220 to 450 points |
|
| ExclusionCriteria |
| Details |
Exclusion Criteria:
Patient who has previously received either a TNFalpha inhibitor or biological agent within 5 half-lives
Patient who has previously demonstrated inadequate response or intolerance to TNFalpha inhibitors for the treatment of CD. |
|
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Method of Generating Random Sequence
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Permuted block randomization, fixed |
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Method of Concealment
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An Open list of random numbers |
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Blinding/Masking
|
Participant and Investigator Blinded |
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Primary Outcome
|
| Outcome |
TimePoints |
| Clinical remission defined by CDAI score |
Clinical remission [Time Frame: Week 54] |
|
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Secondary Outcome
|
| Outcome |
TimePoints |
Secondary Objective
The secondary objective of this study is to evaluate additional efficacy, PK, PD, and overall safety including immunogenicity. |
Week 102 |
|
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Target Sample Size
|
Total Sample Size="600"
Sample Size from India="20"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
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Phase of Trial
|
Phase 3 |
Date of First Enrollment (India)
Modification(s)
|
06/02/2020 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
28/10/2019 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Closed to Recruitment of Participants |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
Publication Details
Modification(s)
|
After completion of the study, the data may be considered for reporting at a scientific meeting or for publication in a scientific journal. In these cases, CELLTRION, Inc. will be responsible for these activities and will work with the investigators to determine how the manuscript is written and edited, the number and order of authors, the publication to which it will be submitted, and other related issues. The Sponsor - CELLTRION, Inc. has final approval authority over all such issues.
Data are the property of CELLTRION, Inc. and cannot be published without prior authorization from CELLTRION, Inc., but data and publication thereof will not be unduly withheld. |
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Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
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Brief Summary
Modification(s)
|
This is a randomized, placebo-controlled, double-blind, multicenter, parallel-group, Phase 3 study, designed to evaluate the efficacy, PK, PD, and safety of CT-P13 SC as maintenance therapy in patients with moderately to severely active CD who have had an inadequate response to conventional therapy. Approximately 600 patients with moderately to severely active CD will be enrolled in the open-label Induction Phase. It is estimated that at least 360 patients (240 in CT-P13 SC arm and 120 in Placebo SC arm) will enter the double-blind Maintenance Phase. The Maintenance Phase treatment will continue up to Week 54 and the subsequent open-label Extension Phase treatment will continue up to Week 102. In the open-label Extension Phase, all patients will receive CT-P13 SC. The duration of the study will be up to 112 weeks, which includes Screening (up to 6 weeks) and Treatment Period (up to the last dosing visit of study drug at Week 102) followed by End-of-Study (EOS) Visit (after 4 weeks off dose period). |