This is Phase 3, Randomized, Placebo-controlled study to demonstrate superiority of CT-P13 over Placebo SC in Patients With Moderately to Severely Active Crohns Disease which is an inflammatory bowel disease (IBD)

Phase 3

Active, not recruiting

• Conditions: Crohns disease, unspecified,

• Registration Number: CTRI/2019/10/021825
• Lead Sponsor: CELLTRION Inc

Brief Summary

This is a randomized, placebo-controlled, double-blind, multicenter, parallel-group, Phase 3 study, designed to evaluate the efficacy, PK, PD, and safety of CT-P13 SC as maintenance therapy in patients with moderately to severely active CD who have had an inadequate response to conventional therapy.

Approximately 600 patients with moderately to severely active CD will be enrolled in the open-label Induction Phase.

It is estimated that at least 360 patients (240 in CT-P13 SC arm and 120 in Placebo SC arm) will enter the double-blind Maintenance Phase. The Maintenance Phase treatment will continue up to Week 54 and the subsequent open-label Extension Phase treatment will continue up to Week 102. In the open-label Extension Phase, all patients will receive CT-P13 SC.

The duration of the study will be up to 112 weeks, which includes Screening (up to 6 weeks) and Treatment Period (up to the last dosing visit of study drug at Week 102) followed by End-of-Study (EOS) Visit (after 4 weeks off dose period).

Detailed Description

Not available

Study Timeline

• Study Start: 2020-06-02
• Last Update Posted: 2024-04-14

Recruitment & Eligibility

• Status: Closed to Recruitment of Participants
• Sex: All
• Target Recruitment: 600

Inclusion Criteria

• Inclusion Criteria: Patient is male or female aged 18 to 75 years, inclusive.
• Patient who has moderately to severely active CD with a score on the CDAI of 220 to 450 points.

Exclusion Criteria

Exclusion Criteria: Patient who has previously received either a TNFalpha inhibitor or biological agent within 5 half-lives Patient who has previously demonstrated inadequate response or intolerance to TNFalpha inhibitors for the treatment of CD.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Clinical remission defined by CDAI score	Clinical remission [Time Frame: Week 54]

Secondary Outcome Measures

Name	Time	Method
Secondary Objective	The secondary objective of this study is to evaluate additional efficacy, PK, PD, and overall safety including immunogenicity.

Trial Locations

Locations (7)

Asian Institute of Gastroenterology; 🇮🇳 Hyderabad, TELANGANA, India

B.J. Government Medical College and Sassoon General Hospitals; 🇮🇳 Pune, MAHARASHTRA, India

Nirmal Hospitals; 🇮🇳 Surat, GUJARAT, India

Seth Gordhandas Sunderdas Medical College And King Edward Memorial (KEM) Hospital; 🇮🇳 (Suburban), MAHARASHTRA, India

Shree Giriraj Multispeciality Hospital; 🇮🇳 Rajkot, GUJARAT, India

Victoria Hospital; 🇮🇳 Bangalore, KARNATAKA, India

Yashoda Hospitals; 🇮🇳 Hyderabad, TELANGANA, India

Asian Institute of Gastroenterology

🇮🇳Hyderabad, TELANGANA, India

Dr Rupa Banerjee

Principal investigator

919849287530

dr_rupa_banerjee@hotmail.com