| CTRI Number |
CTRI/2020/10/028507 [Registered on: 21/10/2020] Trial Registered Prospectively |
| Last Modified On: |
22/08/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Phase 3 clinical study designed to evaluate the efficacy and safety in patients. |
|
Scientific Title of Study
|
A Phase 3, Multicenter, Randomized, Double-Blind, Placebo- and Active-
Controlled, Treat-Through Study to Evaluate the Efficacy and Safety of Mirikizumab in
Patients with Moderately to Severely Active Crohns Disease |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NCT03926130 |
ClinicalTrials.gov |
| Protocol number I6T-MC-AMAM(a) Version No1 dated 08/Apr/2020 |
DCGI |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Modification(s)
|
| Name |
Dr Manish Mistry |
| Designation |
Medical Director |
| Affiliation |
Eli Lilly and Company (India) Pvt. Ltd. |
| Address |
Plot No - 92, Sec - 32, Institutional Area, Gurgaon HARYANA-122001 India
Gurgaon
HARYANA
122001
India |
| Phone |
9820234897 |
| Fax |
|
| Email |
manish.mistry@lilly.com |
|
Details of Contact Person
Scientific Query
Modification(s)
|
| Name |
Dr Manish Mistry |
| Designation |
Medical Director |
| Affiliation |
Eli Lilly and Company (India) Pvt. Ltd. |
| Address |
Plot No - 92, Sec - 32, Institutional Area, Gurgaon HARYANA-122001 India
Gurgaon
HARYANA
122001
India |
| Phone |
9820234897 |
| Fax |
|
| Email |
manish.mistry@lilly.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rajeev Sharan Shrivastava |
| Designation |
Associate Director |
| Affiliation |
Eli Lilly and Company (India) Pvt. Ltd. |
| Address |
Plot No - 92, Sec - 32, Institutional Area, Gurgaon - 122001
Gurgaon
HARYANA
122001
India |
| Phone |
01244753000 |
| Fax |
|
| Email |
shrivastava_rajeev_sharan@lilly.com |
|
|
Source of Monetary or Material Support
|
| Eli Lilly and Company (India) PVT LTD, Plot No. 92, Sector-32, Gurgaon, Haryana - 122001 |
|
|
Primary Sponsor
|
| Name |
Eli Lilly and Company India Pvt Ltd |
| Address |
Eli Lilly and Company (India) PVT LTD, Plot No. 92, Sector-32, Gurgaon, Haryana - 122001 |
| Type of Sponsor |
Pharmaceutical industry-Global |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
Argentina
Australia
Austria
Belgium
Brazil
Canada
China
Croatia
Czech Republic
Denmark
France
Germany
Hungary
India
Italy
Latvia
Lithuania
Mexico
Netherlands
Poland
Republic of Korea
Romania
Serbia
Slovakia
Spain
United Kingdom
Israel
Japan
Sweden
Switzerland
Turkey
Ukraine
United States of America
Russian Federation |
Sites of Study
Modification(s)
|
| No of Sites = 14 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Sharad Malhotra |
Aakash Healthcare Superspeciality Hospital |
Road No. 201 Sector 3 Dwarka New Delhi 110075, New delhi, 110075 India
New Delhi
DELHI |
9810161287
sharaddoctor@gmail.com |
| Dr Vineet Ahuja |
All India Institute of Medical Sciences (AIIMS) |
Ansari Nagar, New Delhi, Delhi 110029 India
New Delhi
DELHI |
011-26588500
vineet.aiims@gmail.com |
| Dr Ganesh Subramanian |
Apollo Speciality Hospital |
No 320, Padma Complex, Anna Salai, Chennai - 600035
Chennai
TAMIL NADU |
9841098434
gastroganesh@gmail.com |
| Dr Rupa Banerjee |
Asia Institute of Gastroenterology |
Beside Ramky Towers, Gachibowlo, Hyderabad, Telangana - 500032
Hyderabad
TELANGANA |
914042444222
dr_rupa_banerjee@hotmail.com |
| Dr Ajit Sood |
Dayanand Medical College & Hospital |
Tagore Nagar, Civil Lines, Ludhiana, Punjab 141001 India
Ludhiana
PUNJAB |
9815400718
ajitsood10@gmail.com |
| Dr Porika Shravan Kumar |
Gandhi Hospital |
6-1-34, Musheerabad, Secunderabad, Andhra Pradesh 500003 India
Hyderabad
TELANGANA |
9848011080
shravangastro@gmail.com |
| Dr Saumin Shah |
Gujarat Hospital - Gastro and Vascular Centre |
Opposite ShriRam Petrol Pump, Anand Mahal Road, Adajan, Surat, Gujarat 395009 India
Surat
GUJARAT |
02612782020
dr.sauminpshah@gmail.com |
| Dr Ashish Kumar Sethi |
International Gastro Institute |
7th floor, Isha hospital, B/H Atlantis,
Sarabhai Road, Vadodara - 390007,Gujarat, India
Vadodara
GUJARAT |
9825040703
drashishsethi@hotmail.com |
| Dr Shrikant Vasantrao Mukewar |
Midas institute of Gastroenterology |
Midas Multispeciality Hospital Pvt. Ltd. Midas Heights, 07, Central Bazaar Road, Ramdas Peth, Nagpur - 440010, Maharashtra.
Nagpur
MAHARASHTRA |
7720033280
shrikant_mukewar@yahoo.com |
| Dr Jayanta Samanta |
Post Graduate Institute of Medical Education and Research |
Chandigarh - 160012
India
Chandigarh
CHANDIGARH |
9855319529
dj_samanta@yahoo.co.in |
| Dr Nitin V Pai |
Ruby Hall Clinic |
40, Sassoon Road, Pune, Maharashtra 411001 India
Pune
MAHARASHTRA |
9822008682
drnitinpai@gmail.com |
| Dr Pankaj Kumar Shrimal |
S. R. Kalla Memorial Gastro and General Hospital |
78-79, Dhuleshwar Garden, Behind HSBC Bank, Sardar Patel Marg, C-Scheme, Jaipur, Rajasthan 302001 India
Jaipur
RAJASTHAN |
0141-5112042
drpankajkalla@gmail.com |
| Dr Naresh Kumar Bansal |
Sir Gangaram Hospital |
Sir Ganga Ram Hospital, Rajinder Nagar, New Delhi, Delhi 110060
New Delhi
DELHI |
011-66173891
drnbansal@ymail.com |
| Dr B Ravi Shankar |
Yashoda Hospitals |
Behind Hari Hara kala Bhawan, Alexander Road, Secunderabad, Telangana 500003 India
Hyderabad
TELANGANA |
09391075600
b_ravishankar@yahoo.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 14 |
| Name of Committee |
Approval Status |
| Aakash Healthcare Superspeciality Hospital, Institutional Ethics Committee |
Approved |
| Drug Trial Ethics Committee, Dayanand Medical College and Hospital |
Approved |
| Ethics Committee, AIIMS Ethics Committee |
Approved |
| Ethics Committee- Isha Hospital |
Approved |
| Institutional Ethics Committee - PGIMER |
Approved |
| Institutional Ethics Committee Asian Institute of Gastroenterology |
Approved |
| Institutional Ethics Committee Multispeciality |
Approved |
| Institutional Ethics Committee Poona Medical Research Foundation |
Approved |
| Institutional Ethics Committee, Gandhi Medical College |
Approved |
| Institutional Ethics Committee- clinical studies |
Approved |
| S. R. Kalla Memorial Ethics Committee for Human Research |
Approved |
| Sir Ganga Ram Hospital Ethics Committee |
Approved |
| Unity Hospital Ethics Committee |
Approved |
| Yashoda Academy of Medical Education & Research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K500||Crohns disease of small intestine, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Mirikizumab |
dose A IV, followed by dose B SC. The total duration of the combined treatment periods is up to 52 weeks. |
| Comparator Agent |
Placebo |
placebo to match mirikizumab and placebo to match ustekinumab (IV and SC).
The total duration of the combined treatment periods is up to 52 weeks. |
| Comparator Agent |
Ustekinumab |
6 mg/kg IV, then 90 mg SC every 8 weeks.
The total duration of the combined treatment periods is up to 52 weeks. |
|
|
Inclusion Criteria
|
| Age From |
15.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1. Diagnosis of CD for at least 3 months prior to baseline.
2. Confirmed diagnosis of moderate to severe CD as assessed by SF, AP score, and SES-CD
3. Demonstrated intolerance, loss of response or inadequate response to conventional or to biologic therapy for CD
4. If female, subject must meet the contraception recommendations |
|
| ExclusionCriteria |
| Details |
1. Have a current diagnosis of ulcerative colitis, inflammatory bowel disease-unclassified (IBD-U) (formerly known as indeterminate colitis) or short bowel syndrome
2. Currently have or are suspected to have an abscess. Recent cutaneous and perianal abscesses are not exclusionary if drained, adequately treated and resolved at least 3 weeks prior to baseline or 8 weeks prior to baseline for intra-abdominal abscesses, provided that there is no anticipated need for any further surgery
3. Have a stoma, ileoanal pouch or ostomy
4. Have had a bowel resection within 6 months, or any kind of intra-abdominal or extra abdominal surgery within 3 months of baseline
5. Have ever received any monoclonal antibodies binding IL-23 |
|
|
Method of Generating Random Sequence
|
Stratified randomization |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Percentage of Participants Achieving Endoscopic Response
Percentage of Participants Achieving Clinical Remission |
Week 52 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Percentage of Participants Achieving Endoscopic Remission.
Percentage of Participants Achieving Clinical Remission or Endoscopic Remission who were Corticosteroid Free.
|
Week 52 |
| Percentage of Participants Achieving Clinical Remission |
Week 12 |
Percentage of Participants Achieving Clinical Remission.
|
Week 52 |
Change from Baseline in C-Reactive Protein.
Change from Baseline in Fecal Calprotectin. |
Baseline, Week 52 |
Percentage of Participants with Extraintestinal Manifestations (EIMs) of Crohns Disease.
Percentage of Participants with Fistulae Response. |
Week 52 |
| Pharmacokinetics (PK): Area Under the Concentration Time Curve (AUC) of Mirikizumab |
Baseline through Week 52 |
| Change from Baseline in Health Related Quality of Life |
Baseline, Week 52 |
|
|
Target Sample Size
|
Total Sample Size="1100"
Sample Size from India="55"
Final Enrollment numbers achieved (Total)= "1158"
Final Enrollment numbers achieved (India)="26" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
27/10/2020 |
| Date of Study Completion (India) |
02/10/2023 |
| Date of First Enrollment (Global) |
23/07/2019 |
| Date of Study Completion (Global) |
02/10/2023 |
|
Estimated Duration of Trial
|
Years="2"
Months="8"
Days="24" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
The reason for this study is to see if the study drug mirikizumab is safe and effective in participants with moderately to severely active Crohn’s disease. |