A Study of Guselkumab Therapy in Participants With Moderately to Severely Active Ulcerative Colitis

Phase 3

Active, not recruiting

Conditions: Ulcerative colitis, unspecified,

Registration Number: CTRI/2023/05/052724

Lead Sponsor: Johnson and Johnson Private Limited

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.

Detailed Description: Not available

Recruitment & Eligibility

Status: Closed to Recruitment of Participants

Sex: All

Target Recruitment: 399

Inclusion Criteria

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, TNFÎ± antagonists, vedolizumab, ozanimod, or approved JAK inhibitors).

Exclusion Criteria

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.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Proportion of subjects achieving Clinical remission	at week 12

Secondary Outcome Measures

Name	Time	Method
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 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 Histologic-endoscopic mucosal improvement	at week 12

Trial Locations

Locations (8): Asian Institute of Gastroenterology
🇮🇳
Hyderabad, TELANGANA, India
Fortis Memorial Research Institute
🇮🇳
Gurgaon, HARYANA, India
Government Medical College Trivandrum
🇮🇳
Thiruvananthapuram, KERALA, India
Indira Gandhi Institute Of Medical Sciences
🇮🇳
Patna, BIHAR, India
Kasturba Medical College and Hospital
🇮🇳
Udupi, KARNATAKA, India
P.D Hinduja National Hospital and Medical Research Center
🇮🇳
Mumbai, MAHARASHTRA, India
Postgraduate Institute of Medical Education and Research
🇮🇳
Chandigarh, CHANDIGARH, India
SIDS Hospital and Research Centre
🇮🇳
Surat, GUJARAT, India
Asian Institute of Gastroenterology
🇮🇳Hyderabad, TELANGANA, India
Dr Rupa Banerjee
Principal investigator
9849287530
rupabanerjee.aig@gmail.com