| CTRI Number |
CTRI/2024/02/062456 [Registered on: 08/02/2024] Trial Registered Prospectively |
| Last Modified On: |
16/07/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
A study to evaluate the efficacy and safety of ZYIL1
oral capsules for the treatment of patients with mild to
moderately active Ulcerative Colitis resistant or
intolerant to oral aminosalicylates |
|
Scientific Title of Study
|
A randomised, double blind, parallel, interventional
phase IIa proof of concept trial to evaluate the efficacy
and safety of ZYIL1 for the treatment of patients with
mild to moderately active Ulcerative Colitis resistant or
intolerant to oral aminosalicylates |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| ZYIL1.23.001,Ver 02,Dated 09 May 2023 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Kevinkumar Kansagra |
| Designation |
Sr. General Manager |
| Affiliation |
Zydus Research Centre |
| Address |
Survey No. 396/403, Sarkhej-Bavla National Highway
No. 8A Moraiya
Ahmadabad
GUJARAT
382213
India |
| Phone |
02717665555 |
| Fax |
|
| Email |
kevinkumarkansagra@zyduslife.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Suchi Shah |
| Designation |
Senior Scientist |
| Affiliation |
Zydus Research Centre |
| Address |
Survey No. 396/403, Sarkhej-Bavla National Highway
No. 8A Moraiya
Ahmadabad
GUJARAT
382213
India |
| Phone |
02717665555 |
| Fax |
|
| Email |
Suchi.Shah@zyduslife.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Suchi Shah |
| Designation |
Senior Scientist |
| Affiliation |
Zydus Research Centre |
| Address |
Survey No. 396/403, Sarkhej-Bavla National Highway
No. 8A Moraiya
Ahmadabad
GUJARAT
382213
India |
| Phone |
02717665555 |
| Fax |
|
| Email |
Suchi.Shah@zyduslife.com |
|
|
Source of Monetary or Material Support
|
| Zydus Lifesciences Ltd., Zydus Research Centre, Survey No. 396/403,Sarkhej-Bavla National Highway No.8A Moraiya, Ahmedabad 382213, India |
|
|
Primary Sponsor
|
| Name |
Zydus Lifesciences Limited |
| Address |
Zydus Research Centre, Survey No. 396/403, Sarkhej-BavlaNational Highway No.8A Moraiya, Ahmedabad 382213, India |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 10 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Ashish Sethi |
Isha Hospital |
7th Floor, International Gastro Institute, B/H. Atlantis, Sarabhai Road, Vadodara, Gujarat- 390007
Vadodara
GUJARAT |
9825040703
drashishsethi@hotmail.com |
| Dr Vineet Ahuja |
AIIMS |
Ansari Nagar, New Delhi- 110029, India
New Delhi
DELHI |
9810707170
26588647
vineet.aiims@gmail.com |
| Dr Nitin Borse |
Apex Wellness Hospital |
"Survey No. 799, Plot No. 187,
Behind Prakash Petrol Pump, Govind Nagar,
Nashik- 422009, Maharashtra"
Nashik
MAHARASHTRA |
9822011684
nitinborse@hotmail.com |
| Dr Manish Bhatnagar |
ICON Hospital |
B/S. Kalyan Pushti Haveli, Opp. Alpha One Mall Exit, Near Vastrapur Lake, Vastrapur, Ahmedabad- 380015, Gujarat, India
Ahmadabad
GUJARAT |
9825085059
bhatnagarclinic@yahoo.com |
| Dr Samir Patil |
KIMS Kingsway Hospitals |
44, Parwana Bhawan, Kingsway, Nagpur, Maharashtra-440001
Nagpur
MAHARASHTRA |
8928686680
samirpatil@gmail.com |
| Dr Kaivan Shah |
Navneet Memorial Hospital "SUSHRUSHA" |
"Opp. Sardar Patel Seva Samaj Hall,
In the Lane Opp. Tele Exchange,
Navrangpura, Ahmedabad- 380006"
Ahmadabad
GUJARAT |
9833622433
drkaivanshah12@gmail.com |
| Dr Parth Shah |
Sheth Vadilal Sarabhai General Hospital & Sheth Chinai Maternity Hospital |
Ellis Bridge, Ahmedabad - 380006, Gujarat, India
Ahmadabad
GUJARAT |
9924939099
doctorparthshah@gmail.com |
| Dr Soham Doshi |
Shree Siddhivinayak Maternity & Nursing Home |
Unity Campus, Opp. KTHM College, Gangapur Road, Nashik, Maharashtra- 422002
Nashik
MAHARASHTRA |
9004680924
drsohamdoshi2022@gmail.com |
| Dr Siddhartha Ramakrishna Balakrishnan |
SRM Institutes For Medical Science (SIMS) |
No.1, jawaharlal Nehru Salai, Vadapalani, Chennai, Tamil Nadu- 600026
Chennai
TAMIL NADU |
9994614890
drramakrishna.bs@simshospitals.com |
| Dr Rakesh Kumar Adi |
Yashoda Hospitals |
"Behind Hari Hara Kora Bhavan,
SP Road, Secunderabad - 500003, Telangana"
Hyderabad
TELANGANA |
9985004650
rakeshkumaradi@yahoo.in |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 10 |
| Name of Committee |
Approval Status |
| "Apex Wellness Ethics Committee- AWEC Apex Wellness Hospital, 799, Plot No 187, Behind Prakash Petrol Pump, Govind Nagar, Nashik, Maharashtra - 422009" |
Approved |
| "Ethics Committee Isha Hospital ISHA HOSPITAL Behind Atlantis, OPP. Vadodara Central Sarabhai Campus, Subhanpura Vadodara Vadodara Gujarat - 390007 India" |
Approved |
| "Ethics Committee of Navneet Memorial Hospital, Navneet Memorial Hospital, Opp. Sardar Patel Seva Samaj Hall, Navrangpura Ahmedabad Gujarat – 380006, India" |
Approved |
| "Institute Ethics Committee All India Institute of Medical Sciences Old OT Block, Room No. 102, AIIMS Hospital Ansari Nagar, New Delhi-29 New Delhi South Delhi Delhi - 110029 India" |
Approved |
| "Institutional Ethics Committee Aatman Hospital Aatman Hospital 5, Anveshan Row House, Opp Umiya Mata Mandir Bopal-Ghuma Main Road, Bopal Ahmedabad Ahmedabad Gujarat - 380058 India" |
Approved |
| "Institutional Ethics Committee SRM Institutes for Medical Science (SIMS) No 1, Jawaharlal Nehru Salai, Vadapalani Chennai, Tamil Nadu - 600026 India" |
Approved |
| "Kingsway Hospitals Ethics Committee Kingsway Hospitals, 44, Parwana Bhawan, Kingsway, Nagpur, Maharashtra - 440001 " |
Approved |
| "Shree Siddhivinayak Hospital Ethics Committee Shree Siddhivinayak Maternity and Nursing Home, Unity Campus, 2nd Floor, Opposite K.T.H.M, College, Gangapur Road, Nashik, Maharashtra - 422002 " |
Approved |
| "Shrey Hospital Institutional Ethics Committee Shrey Hospital Private Limited, 270/B/5 Near AMCO Bank, Stadium Circle, Navrangpura, Ahmedabad, Gujarat - 380009 " |
Approved |
| "Yashoda Academy of Medical Education and Research Yashoda Hospitals, Behind Hari Hara kala Bhawan SP Road Secunderabad, Hyderabad, Telangana - 500003 India" |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K519||Ulcerative colitis, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Arm 1 |
Dose:- ZYIL1 25 mg + Placebo 50 mg
Route:- Oral
Duration: 12 week |
| Intervention |
Arm 2 |
Dose:- ZYIL1 50 mg + Placebo 25 mg
Route:- Oral
Duration: 12 week |
| Comparator Agent |
Not Applicable |
Not Applicable |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
1) Male and female patients aged 18 to 75 years, both inclusive.
2) Have had ulcerative colitis (UC) diagnosed at least 3 months prior to screening. The
diagnosis of UC must be confirmed by endoscopic and histologic evidence.
3) Mild to Moderate active disease defined as total score of at least 4 on the mMS,
endoscopy subscore of at least 2 and a rectal bleeding sub-score of at least 1.
4) Demonstrated an inadequate response to, loss of response to, or intolerance to any of
the Oral aminosalicylates (e.g., mesalamine, sulfasalazine, olsalazine, balsalazide)
â—‹ Signs and symptoms of persistently active disease, in the opinion of the
investigator, during a current or prior course of at least 4 weeks of treatment with 2.4
g/day mesalamine, 4 g/day sulfasalazine, 1 g/day olsalazine, or 6.75 g/day
balsalazide.
5)Men and women of childbearing potential must agree to use adequate birth control
measures during the study. Acceptable methods of birth control in this study include:
surgical sterilization, intrauterine device, oral contraceptive, contraceptive patch, long
acting injectable contraceptive, partner’s vasectomy, double-barrier method (condom
or diaphragm with spermicide) or abstinence for at least 4 weeks prior to study drug
administration, during study participation and for 30 days after their last dose of study
drug.
6) All patients aged 45 years or over must have had a colonoscopy to screen for
adenomatous polyps within 5 years of screening or must have had a colonoscopy at
screening to assess for polyps.
|
|
| ExclusionCriteria |
| Details |
1)Diagnosis of Crohn’s disease or indeterminate colitis or the presence or history of a
fistula consistent with Crohn’s disease.
2)Have positive stool culture for pathogens (O+P, bacteria) or positive test for C.
difficile at screening. If C. difficile is positive, the patient may be treated and retested.
3)Patients who have an evidence of pathogenic bowel infection.
4) History of recurrent or chronic infection (e.g., hepatitis B or C, syphilis, TB).
5) Laboratory test positive for HBsAg, HCV or HIV at screening. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
To assess the efficacy of ZYIL1 for
induction of clinical remission in participants with mild to
moderate active UC. |
Baseline to Week 6 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To assess the overall safety and
tolerability of ZYIL1 |
Baseline to End of study |
|
|
Target Sample Size
|
Total Sample Size="24"
Sample Size from India="24"
Final Enrollment numbers achieved (Total)= "24"
Final Enrollment numbers achieved (India)="24" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
20/02/2024 |
| Date of Study Completion (India) |
28/11/2024 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
ZYIL1 capsules 25 mg / 50 mg for oral administration twice daily for 12 weeks for active ulcerative colitis for patients not responding to mesalamine. It is a proof of concept study to evaluate efficacy of ZYIL1 with 25 and 50 mg dose to select most efficacious and safe dose. |