FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2023/05/052724 [Registered on: 16/05/2023] Trial Registered Prospectively
Last Modified On: 05/09/2023
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 of Guselkumab Therapy in Participants With Moderately to Severely Active Ulcerative Colitis 
Scientific Title of Study   A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Efficacy and Safety of Guselkumab Subcutaneous Induction Therapy in Participants with Moderately to Severely Active Ulcerative Colitis Phase 3 Study to Evaluate the Efficacy and Safety of Guselkumab Subcutaneous Induction Therapy in Participants with Moderately to Severely Active Ulcerative Colitis 
Trial Acronym  ASTRO 
Secondary IDs if Any  
Secondary ID  Identifier 
2022-000365-41  EudraCT 
CNTO1959UCO3004 Version: Amendment 2 dated 16 Aug 2022  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Sanish Davis  
Designation  R and D Director GCO India 
Affiliation  Janssen Pharmaceutical Companies of Johnson and Johnson Pvt Ltd 
Address  8th Floor, Global clinical trials, Johnson and Johnson Private Limited
Arena Space, Jogeshwari(East)
Mumbai
MAHARASHTRA
400060
India 
Phone    
Fax    
Email  sdavis20@its.jnj.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Sanish Davis  
Designation  R and D Director GCO India 
Affiliation  Janssen Pharmaceutical Companies of Johnson and Johnson Pvt Ltd 
Address  8th Floor, Global clinical trials, Johnson and Johnson Private Limited
Arena Space, Jogeshwari(East)
Mumbai
MAHARASHTRA
400060
India 
Phone    
Fax    
Email  sdavis20@its.jnj.com  
 
Details of Contact Person
Public Query  
Name  Dr Sanish Davis  
Designation  R and D Director GCO India 
Affiliation  Janssen Pharmaceutical Companies of Johnson and Johnson Pvt Ltd 
Address  8th Floor, Global clinical trials, Johnson and Johnson Private Limited
Arena Space, Jogeshwari(East)
Mumbai
MAHARASHTRA
400060
India 
Phone    
Fax    
Email  sdavis20@its.jnj.com  
 
Source of Monetary or Material Support  
Johnson and Johnson Private Limited, Arena Space Jogeshwari East, Mumbai-400060 MAHARASHTRA. 
 
Primary Sponsor  
Name  Johnson and Johnson Private Limited  
Address  L. B. S. Marg, Mulund (West) Maharashtra (India) – 400080 
Type of Sponsor  Pharmaceutical industry-Global 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     Australia
Belgium
Brazil
Bulgaria
Canada
China
Czech Republic
France
Germany
Hungary
India
Israel
Italy
Mexico
New Zealand
Poland
Spain
Taiwan
Turkey
United States of America  
Sites of Study  
No of Sites = 8  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Rupa Banerjee  Asian Institute of Gastroenterology  6-3- 661,Somajiguda, Hyderabad- 500082, Andhra Pradesh
Hyderabad
TELANGANA 		 9849287530

rupabanerjee.aig@gmail.com 
Dr Gourdas Choudhuri   Fortis Memorial Research Institute  Sector - 44, Opposite HUDA City Centre, Gurugram, Haryana-122002
Gurgaon
HARYANA 		 911244962200
911244962222
gourdas.choudhuri@fortishealthcare.com 
Dr Krishnadas Devadas  Government Medical College Trivandrum  Government Medical College, Department of Medical Gastroenterology, Medical College P O, Thiruvananthapuram, Kerala, 695011
Thiruvananthapuram
KERALA 		 9847111824

kdas40@gmail.com 
Dr Vishwa Mohan Dayal  Indira Gandhi Institute Of Medical Sciences  Bailey Rd, Sheikhpura, Patna, Bihar-800014
Patna
BIHAR 		 0612229631

vmdayal@gmail.com 
Dr Ganesh Pai  Kasturba Medical College and Hospital  Kasturba Hospital, Department of Gastroenterology, Kasturba Medical College and Hospital, Manipal-576104, Karnataka
Udupi
KARNATAKA 		 9945376424
8202571934
cgpai@yahoo.co.in 
Dr Devendra Desai  P.D Hinduja National Hospital and Medical Research Center  914,9tH Floor , SI Building P.D Hinduja National Hospital and Medical research center Veer Sarkar Marg, Mahim Mumbai Maharashtra - 400016
Mumbai
MAHARASHTRA 		 9322596152

dr_ddesai@hindujahospital.com 
Dr Usha Dutta  Postgraduate Institute of Medical Education and Research  F-block, ground floor, Nehru Hospital, Postgraduate Institute of Medical Education and Research, Sector-160012
Chandigarh
CHANDIGARH 		 1722756610
1722744401
ushadutta@gmail.com 
Dr Mehta Rajiv Manhar  SIDS Hospital and Research Centre  JJ Empire and Tapi Villa building, Vijay Nagar Gate No-3, Besides Nirman Bhavan, Opposite Gandhi College, Majura Gate, Ring Road, Surat-395002, Gujarat
Surat
GUJARAT 		 9879863510

rmgastro@yahoo.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 8  
Name of Committee  Approval Status 
HUMAN ETHICS COMMITTEE of Government Medical College  Approved 
Institutional Ethics Committee of Fortis Memorial Research Institute  Approved 
Institutional Ethics Committee of Asian Institute of Gastroenterology  Approved 
Institutional Ethics Committee of Indira Gandhi Institute Of Medical Sciences  Approved 
Institutional Ethics Committee of P.D Hinduja National Hospital and Medical research center  Approved 
Institutional Ethics Committee of Postgraduate Institute of Medical Education and Research  Submittted/Under Review 
MAHE Ethics Committee  Approved 
Surat Institute of digestive sciences Ethics committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Approved/Obtained 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K519||Ulcerative colitis, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Guselkumab  Guselkumab SC 400 mg (2 active autoinjectors) at Weeks 0, 4, and 8 followed by guselkumab 100 mg from Week 16 every 8 week. 
Intervention  Guselkumab  Guselkumab SC 400 mg (2 active autoinjectors) at Weeks 0, 4, and 8 followed by guselkumab 200 mg q4w SC from Week 12 to every 4 week 
Comparator Agent  Placebo  Placebo SC (2 placebo autoinjectors) at Weeks 0, 4, and 8 followed by placebo q4w SC from Week 12 to every 4 week 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  -Documented diagnosis of ulcerative colitis (UC) for at least 3 months prior to baseline
-Moderately to severely active UC as assessed by the modified mayo score
-Demonstraed inadequate response to or intolerance of conventional (ie,6-MP, AZA, or corticosteroids) or advanced therapy (ADT; ie, TNFα antagonists, vedolizumab, ozanimod, or approved JAK inhibitors). 
 
ExclusionCriteria 
Details  -Extent of inflammatory disease limited to the rectum
-Participants with current diagnosis of indeterminate colitis, microscopic colitis, ischemic colitis, or crohns disease(CD)
-Has a history of, or ongoing, chronic or recurrent infectious disease
-Currently has a malignancy or a history of malignancy within 5 years before screening (with the exception of nonmelanoma skin cancer or cervical carcinoma in situ that has been treated with no evidence of recurrence within 12 months of first dose of study intervention)
-Has severe extensive colitis as defined in the protocol 
 
Method of Generating Random Sequence   Permuted block randomization, variable 
Method of Concealment   Centralized 
Blinding/Masking   Double Blind Double Dummy 
Primary Outcome  
Outcome  TimePoints 
Proportion of subjects achieving Clinical remission  at week 12 
 
Secondary Outcome  
Outcome  TimePoints 
Proportion of subjects achieving Symptomatic remission  at week 12 and at week 24 
Proportion of subjects achieving Endoscopic improvement  at week 12 and at week 24 
Proportion of subjects achieving Clinical response  at week 12 and at week 24 
Proportion of subjects achieving Clinical Remission  at week 24 
Proportion of subjects achieving Histologic-endoscopic mucosal improvement  at week 12 
 
Target Sample Size   Total Sample Size="399"
Sample Size from India="30" 
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)   31/05/2023 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  07/10/2022 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="4"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Closed to Recruitment of Participants 
Recruitment Status of Trial (India)  Closed to Recruitment of Participants 
Publication Details   NA 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary   Despite the availability of advanced therapies, many patients either inadequately respond (ie, primary nonresponse) or lose their initial response (ie, secondary nonresponse) to treatment. Guselkumab is a fully human immunoglobulin G1 lambda monoclonal antibody that binds to the p19 protein subunit of human IL-23 with high specificity and affinity. In addition, SC administration has become an attractive alternative to more invasive, expensive, and time-consuming intravenous infusions. Considering the benefit from  anti-IL-23 therapy and SC induction dosing, the aim of this study is to evaluate the efficacy, safety, and PK/PD profile of Guselkumab SC induction compared to placebo in participants with moderately to severely active UC. 
Close