| CTRI Number |
CTRI/2026/02/102948 [Registered on: 04/02/2026] Trial Registered Prospectively |
| Last Modified On: |
02/06/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Other |
|
Public Title of Study
|
This study looks at long-acting medicines (antibodies) to see how well they work by themselves or combined to help people with moderate to severe ulcerative colitis |
|
Scientific Title of Study
|
Phase 2 Platform Trial to Assess the Efficacy and Safety of Long-acting Antibodies as Single Agents and in Combinations for Moderately to Severely Active Ulcerative Colitis |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| 2025-521242-26 |
EudraCT |
| IND Number: 174249 |
Other |
| SPY123-201 Version 1.2, 04-Jun-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
|
| Spyre Therapeutics, Inc. 221 Crescent St Building 23, Suite 105 Waltham, MA 02453 USA |
|
|
Primary Sponsor
|
| Name |
Spyre Therapeutics, Inc. |
| Address |
221 Crescent St Building 23, Suite 105 Waltham, MA 02453 USA |
| Type of Sponsor |
Pharmaceutical industry-Global |
|
Details of Secondary Sponsor
Modification(s)
|
| Name |
Address |
| PSI CRO PHARMA India Private Limited |
2nd Floor, Doddamane Building 19/1, Vittal Mallya Road, BENGALURU Bangalore KARNATAKA 560001 India |
|
|
Countries of Recruitment
|
Argentina
Australia
Austria
Belgium
Bosnia and Herzegovina
Brazil
Bulgaria
Canada
Chile
China
Croatia
Czech Republic
France
Georgia
Germany
Greece
Hungary
India
Israel
Italy
Japan
Jordan
Kazakhstan
Lithuania
Mexico
Poland
Romania
Serbia
Slovakia
Spain
Switzerland
Taiwan
Turkey
Ukraine
United States of America
Republic of Korea
Republic of Moldova |
Sites of Study
Modification(s)
|
| No of Sites = 9 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Vineet Ahuja |
All India Institute of Medical Sciences |
Room No. A713, 7th floor, Department of gastroenterology, New Rajkumari OPD Building, Ansari Nagar-110029
New Delhi
DELHI |
9810707170
vineet.aiims@gmail.com |
| Dr Rupa Banerjee |
Asian Institute of Gastroenterology |
PI OPD Cabin, 6th Floor, IBD Center, Tower A, Plot No 2/3, Mindspace Rd, P Janardhan Reddy Nagar, Gachibowli- 500032
Hyderabad
TELANGANA |
9849287530
rupabanerjee.aig@gmail.com |
| Dr Siddharth Srivastava |
Govind Ballabh Pant Institute of Postgraduate Medical Education and Research |
Room No.203,239, 2nd floor Department of gastroenterology Academic block, 1 Jawahar Lal Nehru Marg-110002
New Delhi
DELHI |
9718599215
docsiddharth1@gmail.com |
| Dr Abraham Koshy |
Lakeshore Hospital and Research Centre Ltd |
PI OPD cabin, 2nd Floor, Gastroenterology, New Block, 24/477, Maradu,
Nettoor, Kochi-682040,
Ernakulam
KERALA |
9495093420
koshyabe@yahoo.com |
| Dr Mukesh Kalla |
S. R. Kalla Memorial Gastro & General Hospital |
Room No.78-79, Main Building,Basement Dhuleshwar Garden, Behind HSBC Bank, Sardar Patel Marg, C-Scheme Jaipur-302001
Jaipur
RAJASTHAN |
9829050622
drmkalla@rediffmail.com |
| Dr Chetan Mehta |
Shree Giriraj Hospital |
Ground floor, 27-Navjyot Park Corner, 150 Feet Ring Road-360005
Rajkot
GUJARAT |
9825077472
mehtacn@hotmail.com |
| Dr Rajiv Mehta |
SIDS Hospital and Research Centre A Unit of SIDS Healthcare Private Limited |
PI OPD Cabin, 1st Floor, Department of gastroenterology, OPD block Off Ring Road, Near Shell Petrol Pump, Sosyo Circle Lane - 395002
Surat
GUJARAT |
9879863510
rmgastro@yahoo.com |
| Dr Dawesh Prakash Yadav |
Sir Sunderlal Hospital Banaras Hindu University |
PI OPD Cabin, Ground Floor, CSSB Building, Department of gastroenterology, Varanasi-221005
Varanasi
UTTAR PRADESH |
8130856563
devesh.thedoc@gmail.com |
| Dr Gaurav Kumar Gupta |
SMS Superspeciality Hospital |
Room No. 3,4,8 & 9, Ground floor, Department of Gastroenterology, Super Specialty building, Vivekananda Marg, C-Scheme- 302004
Jaipur
RAJASTHAN |
9214027938
drgauravsms@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 9 |
| Name of Committee |
Approval Status |
| Institute Ethics Committee, All India institute of Medical Sciences |
Approved |
| Institutional Ethics Committee for Clinical Trials(IEC-CT), Institute of Medical Sciences, Banaras Hindu University, Varanasi. |
Submittted/Under Review |
| Institutional Ethics Committee MAMC |
Approved |
| Institutional Ethics Committee, Asian Institute of Gastroenterology |
Approved |
| Lakeshore Ethics Committee |
Approved |
| S.R. Kalla Memorial Ethical Committee For Human Research |
Approved |
| Shree Giriraj Hospital Research Ethics Committee |
Approved |
| SURAT INSTITUTE OF DIGESTIVE SCIENCE ETHICS COMMITTEE |
Approved |
| The Ethics Committee, S.M.S Medical college and Attached Hospitals |
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 |
| Comparator Agent |
Matching Placebo |
Intravenous /Subcutaneous administration
approximately 48 weeks
|
| Intervention |
SPY001-001 |
(150mg/ml) Intravenous administration approximately 48 weeks |
| Intervention |
SPY001-001 |
(180mg/ml) Subcutaneous administration
approximately 48 weeks
|
| Intervention |
SPY002-091 |
(200mg/ml) Intravenous /Subcutaneous administration
approximately 48 weeks
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
64.00 Year(s) |
| Gender |
Both |
| Details |
1. Adult participants must have had a diagnosis of UC for greater than or equal to 3 months before Day 1 confirmed by endoscopy and histology either previously or during Screening. If documentation of confirmatory endoscopy or histology is not available for review, additional biopsies during screening endoscopy may be performed and sent to a local histology laboratory for histologic assessment documenting findings consistent with UC. On histology, any mention of UC, chronic inflammation, or equivalent is considered adequate.
2. Active UC with disease extent of greater than or equal to 15 cm from the anal verge, as confirmed by Screening endoscopy, with the exception of up to approximately 15 percentage of the total population permitted to have only proctitis (less than15 cm from the anal verge).
3. Moderately to severely active disease as defined by a modified Mayo score of 5 to 9, rectal bleeding subscore of greater than or equal to 1, and Mayo endoscopic subscore greater than or equal to 2.
4. History of corticosteroid dependence, OR inadequate response,1 OR loss of response, 2 OR intolerance to 1 of the following:
a. conventional therapy only (oral locally acting or systemic corticosteroids, or immunosuppressants) (target of approximately 40 percentage – 60 percentage of the planned sample size) OR
b. approved advanced therapies, ie anti-TNF, anti-alpha4beta7, anti-IL-12 or IL-23, anti-IL-23, JAK inhibitors, or S1P receptor antagonists), as defined in the full protocol (target of approximately 40 percentage to 60 percentage of the planned sample size).
5. Participants taking oral corticosteroids (up to 20 mg per day prednisone or equivalent, 9 mg per day budesonide, or 5 mg per day beclomethasone) must be on a stable dose for greater than or equal to 2 weeks prior to Day 1 and be willing to stay on the same dose during the ITP (for Part A participants), or through Week 6 and initiate taper at Week 6 (for Part B participants). |
|
| ExclusionCriteria |
| Details |
1. Failed (inadequate, lack, or loss of response or intolerance to) 4 or more approved or investigational advanced therapy classes (anti-TNF, anti-alpha4beta7, anti-IL-12 or IL-23, anti-IL-23, JAK inhibitors, and S1P receptor antagonists) at the approved labeled dose or higher, if applicable.
2. Failed (inadequate response, loss of response, or intolerance to) 2 or more of the following classes (whether drug is approved or investigational) at an approved labeled dose or higher, if applicable:
– anti-alpha4beta7 (eg, vedolizumab),
– anti-TL1A, or
– anti-IL-23 (eg, mirikizumab, guselkumab, risankizumab)
|
|
|
Method of Generating Random Sequence
|
Stratified randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
PART A: To assess the effects of intervention on
histologic disease activity following 12 weeks of treatment
PART B: To assess the efficacy of intervention in inducing
clinical remission following 12 weeks of treatment |
PART A: Change in RHI from baseline at Week 12
PART B: Clinical remission at Week 12 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| PART A: To assess the efficacy of intervention in inducing clinical remission following 12 weeks of treatment |
Clinical remission at Week 12 |
PART A: To assess the efficacy of intervention in inducing
endoscopic improvement following 12 weeks of
treatment |
Endoscopic improvement at Week 12 |
| PART B: To assess the efficacy of intervention in inducing endoscopic improvement following 12 weeks of treatment |
Endoscopic improvement at Week 12 |
PART B: To assess the efficacy of intervention in inducing
clinical response following 12 weeks of treatment |
Clinical response at Week 12 |
PART B: To assess the efficacy of intervention in inducing
histologic improvement following 12 weeks of
treatment |
Histologic improvement at Week 12 |
PART B: To assess the efficacy of intervention in inducing
HEMI following 12 weeks of treatment |
HEMI at Week 12 |
PART B: To assess the efficacy of
intervention in achieving
clinical remission at the end of MTP |
Clinical remission at Week 48 |
|
|
Target Sample Size
|
Total Sample Size="645"
Sample Size from India="35"
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)
|
15/04/2026 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
01/07/2025 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="10"
Days="7" |
|
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
|
This is a Phase 2 multi-center, double-blind, randomized,
open-label (Part A) and placebo-controlled (Part B) proof-of-concept platform
study in participants with moderately to severely active UC. In Part A of
the study, which is open-label, 3 interventions are currently planned to be
evaluated as monotherapies. The purpose of Part A is to generate
preliminary proof-of-concept safety and efficacy data in initial cohorts of
participants with UC for each monotherapy intervention, to enable modifications
as needed in Part B (eg, sample size), confirm intervention specific treatment
features, and further inform subsequent Part B cohorts. In Part B of the study, which is placebo-controlled, the
treatment arms will consist of monoclonal -controlled proof-of-concept efficacy
and safety data to inform further development of each intervention. The duration of individual participation will be up to
approximately 97 weeks, and treatment duration will be up to approximately 48
weeks
The main objectives of the study is to assess the effects of intervention on histologic
disease activity, clinical remission, endoscopic improvement, clinical disease
activity, pharmacokinetics, anti-drug antibodies at week 12 for both part A and
B. The total sample size for PART A and Part B combined is approximately 645 globally and 35 patients from India. |