| CTRI Number |
CTRI/2025/12/099316 [Registered on: 17/12/2025] Trial Registered Prospectively |
| Last Modified On: |
16/12/2025 |
| 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 Phase 2 Study to Evaluate Therapies for Inflammatory Bowel Disease |
|
Scientific Title of Study
|
A Phase 2, Multicenter, Platform Study to Evaluate the Safety, Efficacy, Pharmacokinetics, and Pharmacodynamics with Multiple Therapies in Participants With Active Crohns Disease or Active Ulcerative Colitis |
| Trial Acronym |
ASCEND-IBD |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| 2025-522001-38 |
EudraCT |
| IND Number: 177071 |
Other |
| MT-100-201 Version 2.0, Final, 12 June 2025 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Radhika Bobba |
| Designation |
Regional Director, India and Far East |
| Affiliation |
PSI CRO PHARMA India Private Limited |
| Address |
PSI CRO PHARMA India Private Limited 2nd Floor, Doddamane Building 19/1, Vittal Mallya Road, BENGALURU
Bangalore
KARNATAKA
560001
India |
| Phone |
9844058849 |
| Fax |
|
| Email |
radhika.bobba@psi-cro.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Radhika Bobba |
| Designation |
Regional Director, India and Far East |
| Affiliation |
PSI CRO PHARMA India Private Limited |
| Address |
PSI CRO PHARMA India Private Limited 2nd Floor, Doddamane Building 19/1, Vittal Mallya Road, BENGALURU
Bangalore
KARNATAKA
560001
India |
| Phone |
9844058849 |
| Fax |
|
| Email |
radhika.bobba@psi-cro.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Radhika Bobba |
| Designation |
Regional Director, India and Far East |
| Affiliation |
PSI CRO PHARMA India Private Limited |
| Address |
PSI CRO PHARMA India Private Limited 2nd Floor, Doddamane Building 19/1, Vittal Mallya Road, BENGALURU
Bangalore
KARNATAKA
560001
India |
| Phone |
9844058849 |
| Fax |
|
| Email |
radhika.bobba@psi-cro.com |
|
|
Source of Monetary or Material Support
|
| Mirador Therapeutics, Inc
4902 Headquarters Point, Suite 300 San Diego, California 92121 USA
|
|
|
Primary Sponsor
|
| Name |
Mirador Therapeutics, Inc |
| Address |
4902 Headquarters Point, Suite 300 San Diego, California 92121 USA
|
| Type of Sponsor |
Pharmaceutical industry-Global |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| PSI CRO PHARMA India Private Limited |
PSI CRO PHARMA India Private Limited 2nd Floor, Doddamane Building 19/1, Vittal Mallya Road, BENGALURU
Bangalore
KARNATAKA
560001
India |
|
|
Countries of Recruitment
|
Belgium
Australia
Brazil
Bulgaria
Canada
Croatia
Czech Republic
Georgia
Germany
India
Israel
Italy
Jordan
Poland
Serbia
Slovakia
Ukraine
United States of America
Republic of Moldova |
|
Sites of Study
|
| No of Sites = 6 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Vineet Ahuja |
All India Institute of Medical Sciences |
Room No. 125, 1st floor, Department of Gastroenterology and Human Nutrition Unit, Ansari Nagar East, Gautam Nagar, 110029
New Delhi
DELHI |
9810707170
91-11-26588500
vineet.aiims@gmail.com |
| Dr Shravan Kumar P |
Gandhi Medical College and Hospital |
Room No. 01, Dept of Gastroenterology, Super Specialty Division 6-1-34, Musheerabad, Secunderabad, 500048
Hyderabad
TELANGANA |
9848011080
040 4884 9999
shravangastro@gmail.com |
| Dr Mukesh Kalla |
S.R Kalla Memorial Gastro and General Hospital |
Room No.: N/A, 4th floor, Research Department, Department of Gastroenterology, 78-79 Dhuleshwar Garden, Behind HSBC Bank, Sardar Patel Marg, C-Scheme, 302006
Jaipur
RAJASTHAN |
9829050622
917023006666
drmkalla@rediffmail.com |
| Dr Rajiv Mehta |
SIDS Hospital and Research Centre |
Room No.: N/A, Ground Floor, Clinical Research Dept. Department of Gastroenterology A unit of SIDS health care private limited, Off ring road, Near shell petrol pump, Ring road-sosyo circle lane, 395002
Surat
GUJARAT |
9879863510
080 3707 1478
rmgastro@yahoo.com |
| Dr Mukesh Jain |
SMS Medical College & Attached Hospitals |
Room No. 217, Department of Gastroenterology, Vivekananda Marg, C-Scheme, 302004
Jaipur
RAJASTHAN |
9414323607
91 141 2563743
drmukeshjaingastro@gmail.com |
| Dr Vinay B N |
Victoria Hospital |
Room No. 372B (PMSSY 3rd Floor), Department of Surgical Gastroenterology & Liver Transplantation, Medical College and Research Institute K R Road, Fort, 560002
Bangalore
KARNATAKA |
9972121844
080 3569 4356
vinaybndoc@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 6 |
| Name of Committee |
Approval Status |
| Ethics Committee of SMS Medical College and Attached Hospital |
Submittted/Under Review |
| Institute Ethics Committee All India Institute of Medical Sciences |
Not Applicable |
| Institutional Ethics Committee Gandhi Medical college and Hospital |
Not Applicable |
| Institutional Ethics Committee, Bangalore Medical College & Research |
Submittted/Under Review |
| S.R. Kalla Memorial Ethical Committee for Human Research |
Approved |
| Surat Institute of digestive sciences EC |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K519||Ulcerative colitis, unspecified, (2) ICD-10 Condition: K509||Crohns disease, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
MT-501 |
MT-501 tablets will be administered daily for up to 13 weeks |
| Comparator Agent |
Placebo |
Placebo tablets will be administered daily for up to 13 weeks |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Inclusion Criteria Crohns Disease
a. Diagnosis of Crohn s Disease as confirmed by endoscopy and histopathology
b. Moderately to severely active CD as defined by Clinical Disease Activity Index and Simple Endoscopic Score
c. Meets drug stabilization requirements
Inclusion Criteria Ulcerative Colitis
a. Diagnosis of Ulcerative Colitis as confirmed by endoscopy and histopathology
b. Moderately to severely active UC as defined by a 3 component MMCS
c Meets drug stabilization requirements
|
|
| ExclusionCriteria |
| Details |
Exclusion Criteria Crohns Disease
a. Diagnosis of indeterminate colitis
b. Suspected or diagnosed intra-abdominal or perianal abscess at Screening
c. Previous small bowel resection with combined resected length of greater than 100 cm or previous colonic resection of greater than 2 segments
d. CD isolated to the stomach duodenum jejunum or perianal region without colonic and or ileal involvement
Exclusion Criteria Ulcerative Colitis
a. Current evidence or within recent history (within last 6 months) of fulminant colitis, toxic megacolon, or bowel perforation
b. Current stoma or impending need for colostomy or ileostomy
c. Received IV corticosteroids within 14 days prior to Screening or during the Screening Phase
d. Previous total proctocolectomy or subtotal colectomy |
|
|
Method of Generating Random Sequence
|
Stratified block randomization |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Double Blind Double Dummy |
|
Primary Outcome
|
| Outcome |
TimePoints |
a. Assess the proportion of participants reporting treatment emergent adverse events, serious adverse events, adverse events leading to discontinuation, and markedly abnormal laboratory values
b. Assess the Proportion of Participants with Endoscopic Response as assessed by SES CD score.
c. Assess the Proportion of Participants Endoscopic Improvement as assessed by MES.
d. Assess the Proportion of Participants with Clinical Remission as assessed by CDAI score.
e. Assess the Proportion of Participants with Clinical Remission by endoscopy, rectal bleeding and stool frequency |
a. Time Frame Up to 13 weeks
b. Time Frame 13 weeks.
c. Time Frame 12 weeks
d. Time Frame 13 weeks
e. Time Frame 12 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
a. Assess the Proportion of Participants with Clinical Remission as assessed by CDAI score.
b. Assess the Proportion of Participants with Clinical Remission by endoscopy rectal bleeding and stool frequency.
c. Assess the Proportion of Participants with Symptomatic remission as assessed by patient reported outcomes
d. Assess the Proportion of Participants with Clinical Response as assessed by CDAI score.
e. Assess the Proportion of Participants with Clinical Response as assessed by MMCS.
f. Assess the Proportion of Participants with Endoscopic and Clinical Response by SES CD and clinical response as assessed by CDAI score.
g. Assess the Proportion of Participants with Histologic Response as assessed by the RHI.
h. Assess the Proportion of Participants with Histologic Remission as assessed by the RHI.
i. Assess the Proportion of Participants with Histologic Endoscopic Mucosal Improvement as assessed by the Geboes score and MES.
|
a. Time Frame: 13 weeks
b. Time Frame: 12 weeks
c. Time Frame: Up to 13 weeks
d. Time Frame: 13 weeks
e. Time Frame: 12 weeks
f. Time Frame: 13 weeks
g. Time Frame: 12 weeks
h. Time Frame: 12 weeks
i. Time Frame: 12 weeks
|
j. Characterize the Change in Endoscopy as assessed by SES CD.
k. Characterize the Change in Endoscopy Score as assessed by MES.
l. Characterize the Change in Histology Score assessed by GHAS and RHI.
m. Characterize the Change in Histology Score as assessed by Geobes, RHI and NHI
n. Assess the Pharmacokinetics of Investigational Drug |
j. Time Frame: 13 weeks
k. Time Frame: 12 weeks
l. Time Frame: 13 weeks
m. Time Frame: 12 weeks
n. Time Frame: Up to 13 weeks
|
|
|
Target Sample Size
|
Total Sample Size="210"
Sample Size from India="10"
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 2 |
|
Date of First Enrollment (India)
|
30/05/2026 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
17/07/2025 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="2"
Days="15" |
|
Recruitment Status of Trial (Global)
|
Open to Recruitment |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
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
|
A Phase 2, Multi-Center, Platform Study to Evaluate the Safety, Efficacy, Pharmacokinetics, and Pharmacodynamics with Multiple Therapies in Participants with Active Crohn’s Disease or Active Ulcerative Colitis (ASCEND-IBD). |