| CTRI Number |
CTRI/2020/01/022606 [Registered on: 06/01/2020] Trial Registered Prospectively |
| Last Modified On: |
20/10/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
A study to assess the performance and safety of Etrasimod in the treatment of patients with moderately to severely active Ulcerative Colitis |
|
Scientific Title of Study
|
A Phase 3, Randomized, Double-Blind, Placebo-Controlled, 12-Week Study to Assess the Efficacy and Safety of Etrasimod in Subjects with Moderately to Severely Active Ulcerative Colitis |
| Trial Acronym |
|
Secondary IDs if Any
Modification(s)
|
| Secondary ID |
Identifier |
| APD334-302 Amendment 2, dated 07 Feb 2020 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
|
| Designation |
|
| Affiliation |
|
| Address |
|
| Phone |
|
| Fax |
|
| Email |
|
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Details of Contact Person
Scientific Query
|
| Name |
Suneela Thatte |
| Designation |
Head India Local Solutions Director Early Clinical Development |
| Affiliation |
IQVIA RDS (India) Private Limited |
| Address |
IQVIA RDS (India) Private Limited Natraj by Rustomjee 6th Floor 194
MV Road Near Western Express Highway Metro Station Andheri
East Mumbai 400069
Mumbai
MAHARASHTRA
400069
India |
| Phone |
|
| Fax |
|
| Email |
suneela.thatte@quintiles.com |
|
Details of Contact Person
Public Query
|
| Name |
Suneela Thatte |
| Designation |
Head India Local Solutions Director Early Clinical Development |
| Affiliation |
IQVIA RDS (India) Private Limited |
| Address |
IQVIA RDS (India) Private Limited Natraj by Rustomjee 6th Floor 194
MV Road Near Western Express Highway Metro Station Andheri
East Mumbai 400069
Mumbai
MAHARASHTRA
400069
India |
| Phone |
|
| Fax |
|
| Email |
suneela.thatte@quintiles.com |
|
|
Source of Monetary or Material Support
|
| Arena Pharmaceuticals, Inc. 6154 Nancy Ridge Drive, San Diego, CA 92121, USA |
|
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Primary Sponsor
|
| Name |
Arena Pharmaceuticals Inc |
| Address |
6154 Nancy Ridge Drive, San Diego, CA 92121, USA |
| Type of Sponsor |
Pharmaceutical industry-Global |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| IQVIA RDSIndia Pvt Ltd |
2nd Floor, Etamin Block, Prestige Technology
Park II Sarjapur-Marathahalli Outer Ring Road,
Bangalore-560103 Karnataka |
|
|
Countries of Recruitment
|
Argentina
Australia
Austria
Belarus
Belgium
Brazil
Bulgaria
Canada
Chile
China
Colombia
Croatia
Czech Republic
Denmark
Egypt
Estonia
France
Georgia
Germany
Hungary
India
Israel
Italy
Japan
Latvia
Lebanon
Lithuania
Mexico
Netherlands
Poland
Portugal
Republic of Korea
Republic of Moldova
Romania
Russian Federation
Serbia
Slovakia
South Africa
Spain
Switzerland
Taiwan
Thailand
Turkey
Ukraine
United Kingdom
United States of America |
Sites of Study
Modification(s)
|
| No of Sites = 11 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Vineet Ahuja |
All India Institute of Medical Sciences |
Gastroenterology Sri Aurobindo Marg
Ansari Nagar Ansari
Nagar East New Delhi
Delhi 110029
New Delhi
DELHI
New Delhi
DELHI |
9810707170
vineet.aiims@gmail.co |
| Dr Rupa Banerjee |
Asian Institute of Gastroenterology |
IBD center 6th Floor H No 6 3 661
Somajiguda Hyderabad
Telangana 500082
India
Hyderabad
TELANGANA |
914023378888
dr_rupa_banerjee@hotmail.com |
| Dr G N Ramesh |
Aster DM Healthcare Ltd |
Gastroenterology Aster Medcity Aster DM
Healthcare Ltd
Kuttisahib Road Near
Kothad bridge South
Chittoor PO Cheranallor
Kochi 682027
Thiruvananthapuram
KERALA
Thiruvananthapuram
KERALA |
04846699999
drganesh.ramesh@asterhospital.com |
| Dr Gourdas Choudhuri |
Fortis Memorial Research Institute |
Gastroenterology Clinical Research Room, 2nd floor Sec-44 Opp-Huda City
Centre Metro Station
Gurgaon 122002
Gurgaon
HARYANA |
01244962200
gourdas.choudhuri@fortishealthcare.com |
| Dr Sudhir Gupta |
Government Medical College |
Gastroenterology 3rd floor Hanuman Nagar Ajni
Road Medical Chowk
Ajni Nagpur
Maharashtra 440003
India
Nagpur
MAHARASHTRA |
07122744671
sudhirjgupta@gmail.com |
| Dr Nitin Pai |
Grant Medical Foundation Ruby Hall Clinic |
Gastroenterology
Division: Ground floor
Room number: 1
Survey No 40 B S
Dhole Patil Road,
Sasoon Road Pune 411001
Pune
MAHARASHTRA |
02066455582
drnitinpai@gmail.com |
| Dr Shrikant Mukewar |
Midas multispecialty hospital |
Gastroenterology
Division: 4th floor
Midas Heights 7 Central
Bazar Road
Ramdaspeth Nagpur
440010.
Nagpur
MAHARASHTRA |
07122430511
shrikant_mukewar@yahoo.com |
| Dr Saumin P Shah |
Nirmal Hospital Pvt Ltd |
Gastroenterology Clinical Research Department, 5th Floor Nirmal Hospital Pvt
Ltd., Ring Road, Surat
– 395002.
Surat
GUJARAT |
02612333999
dr.sauminpshah@gmail.com |
| DrVinay Kumar |
Post Graduate Department of Medicine GSVM medical College |
Medicine,Ground floor Post Graduate
Department of Medicine
GSVM medical College
Swaroop Nagar Kanpur
208002
Kanpur Nagar
UTTAR PRADESH |
05122535483
dr.vinayschan@gmail.com |
| DrMukesh Kalla |
SR Kalla Memorial Gastro & General |
Clinical Research Department, 1st Floor 78 79 Dhuleshwar
Garden S P Marg
Behind HSBC Bank C
Scheme Jaipur
Rajasthan 302001
Jaipur
RAJASTHAN |
01412378001
drmkalla@rediffmail.com |
| Dr Mehta Rajiv Manhar |
Surat Institute of Digestive Sciences |
Gastroenterology Vijay Nagar Gate No-3
Besides Nirman
Bhavan Opposite
Gandhi College Majura
Gate Ring Road Surat
395002
Surat
GUJARAT |
912612800000
gmgastro@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 11 |
| Name of Committee |
Approval Status |
| Ethics Committee All India Institute of Medical Sciences, Sri Aurobindo Marg, Ansari Nagar, Ansari Nagar East, New Delhi, Delhi 110029 |
Submittted/Under Review |
| Ethics Committee GSVM medical College Swaroop Nagar Kanpur 208002 |
Submittted/Under Review |
| Institutional Ethics Committee Asian Institute of Gastroenterology 6-3-661 Somajiguda Hyderabad Hyderabad Telangana |
Submittted/Under Review |
| Institutional Ethics Committee Fortis Memorial Research Institute, Sec-44, Opp-Huda City Centre Metro Station, Gurgaon - 122002 |
Approved |
| Institutional Ethics Committee Heights, 7, Central Bazar Road, Ramdaspeth, Nagpur – 440010. |
Approved |
| Institutional Ethics Committee Poona Medical Research Foundation Ruby Hall Clinic, Survey No 40, B S Dhole Patil Road, Sasoon Road, Pune – 411001. |
Approved |
| Institutional Ethics Committee,GMC,Nagpur |
Submittted/Under Review |
| Institutional ethics Committee,Kuttisahib Road,Near Kothad bridge, South Chittoor P.O, Cheranallor, Kochi – 682027. |
Approved |
| Nirmal Hospital Pvt Ltd Ethics Committee Ring Road, Surat – 395002. |
Approved |
| SR Kalla Memorial Ethical Committee for Human Research, 78-79, Dhuleshwar Garden, S P Marg, Behind HSBC Bank, C-Scheme, Jaipur – 302001. |
Approved |
| Surat Institute of Digestive Sciences Ethics Committee, Surat Institute of Digestive Sciences, Vijay Nagar Gate No-3, Besides Nirman Bhavan, Opposite Gandhi College, Majura Gate,Ring road, Surat – 395002 |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Ulcerative Colitis |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Etrasimod |
2-mg Film Coated Tablet, Oral,
once daily, up to 52 weeks of
treatment |
| Comparator Agent |
The placebo product is Placebo
Matching tablet |
oral, once daily, up to 52 weeks
of treatment |
|
|
Inclusion Criteria
|
| Age From |
16.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Diagnosed with ulcerative colitis (UC) ≥ 3 months prior to screening
Active UC confirmed by endoscopy
|
|
| ExclusionCriteria |
| Details |
Severe extensive colitis
Diagnosis of Crohns disease or indeterminate colitis or the presence
or history of a fistula consistent with CD
Diagnosis of microscopic colitis ischemic colitis or infectious colitis |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Proportion of Participants With Clinical
Remission Assessed by Mayo Component Sub
scores Time Frame Week 12 |
Proportion of Participants With Clinical
Remission Assessed by Mayo Component Sub
scores Time Frame Week 12 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Proportion of Participants Achieving Endoscopic
Improvement Assessed by Mayo Component
Sub scores Time Frame Week 52
Proportion of Participants Achieving Endoscopic
Improvement Assessed by Mayo Component
Sub scores Time Frame Week 12 |
Proportion of participants With Clinical
Remission Assessed by Mayo Component Sub
scores and no Corticosteroid use for ? 12 Weeks
Time Frame: Week 52
Proportion of Participants With Mucosal Healing
Assessed by Geboes Index Scores Time Frame
Week 52
Proportion of Participants With Mucosal Healing
Assessed by Geboes Index Scores Time Frame
Week 12
Proportion of Participants With Clinical
Remission Assessed by Mayo Component Sub
scores Time Frame Week 12 and Week 52 |
|
|
Target Sample Size
|
Total Sample Size="372"
Sample Size from India="50"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 3 |
Date of First Enrollment (India)
Modification(s)
|
20/02/2021 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
13/06/2019 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="2"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Open to Recruitment |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
The purpose of this study is to determine whether etrasimod is a safe and effective treatment for moderately to severely active ulcerative colitis. Eligible subjects will be randomized to receive either etrasimod or matching placebo once daily in a double-blind fashion for up to 52 weeks of treatment.
|