Oral Zasocitinib for Long-Term Safety in Active Ulcerative Colitis and Crohn's Disease
Zasocitinib
Colitis+6
+ Colitis, Ulcerative
+ Colonic Diseases
Treatment Study
Summary
Study start date: May 28, 2025
Actual date on which the first participant was enrolled.This study focuses on two serious types of inflammatory bowel diseases (IBD) known as Crohn's Disease and Ulcerative Colitis, which cause inflammation and pain in the intestines. The research aims to examine the long-term safety and effectiveness of a medicine called Zasocitinib (TAK-279) that helps reduce this inflammation. This trial is particularly important for adults with moderate to severe forms of these diseases, as it seeks to offer a potential long-term treatment option that can manage symptoms and improve quality of life. Participants in the study receive oral doses of TAK-279 over a period of up to two years. The study is designed as an extension of earlier trials, allowing those who benefited previously to continue their treatment. Throughout the trial, participants attend 11 clinic visits to monitor the drug's effectiveness and safety. This careful monitoring helps researchers understand the potential risks and benefits of prolonged use of the medication in managing IBD symptoms.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.183 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.From 18 to 76 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
Inclusion Criteria: 1. The participant is willing and able to understand and fully comply with trial procedures and requirements (including digital tools and applications), in the opinion of the investigator. The participant has provided informed consent (that is, in writing, documented via a signed and dated informed consent form \[ICF\]) and any required privacy authorization prior to the initiation of any trial procedures. Disease-Specific Inclusion Criteria: 2. Completion of Week 52 in the parent phase 2 CD and UC trials with valid electronic (e) Diary data for Week 52 (TAK-279-CD-2001 and TAK-279-UC-2001). 3. Clinical or symptomatic responder at parent trial Week 52 as defined below: 1. TAK-279-CD-2001: Clinical response in PRO2 at parent trial Week 52, assessed as \>=30% decrease in average daily very soft or liquid stools and/ or \>=30% decrease in average AP from parent trial baseline. 2. TAK-279-UC-2001: Symptomatic response at parent trial Week 52, assessed as a reduction in partial modified Mayo score (pmMS) of \>=1 points and \>=30% from parent trial baseline; and a decrease from parent trial baseline in the rectal bleeding sub-score of \>=1 point or an absolute rectal bleeding sub-score of \<=1 point. Other General Inclusion Criteria: 4. Participants must meet the contraception recommendations. Exclusion Criteria: 1. Participant considered by the investigator to be unsuitable for the OLE trial due to their trial compliance and medication adherence concerns. 2. Participants with malignancy or dysplasia per endoscopy any time during the parent trial or at the beginning of the OLE. Exclusion Criteria related to Laboratory Investigations: 3. Participants meeting the exclusion criteria related to laboratory investigations as defined in the protocol. Exclusion criteria related to other prohibited concomitant medication: 4. Participants taking oral corticosteroids for CD or UC during parent trial at or after Week 48.
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.2 intervention groups are designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalGroup II
ExperimentalStudy Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 16 locations
Woodholme Gastroenterology Associates
Glen Burnie, United StatesOpen Woodholme Gastroenterology Associates in Google MapsTyler Research Institute, LLC
Tyler, United StatesChongqing General Hospital
Chongqing, ChinaThe First Affiliated Hospital of Sun Yat-sen University
Guangdong, China