ASCEND-IBDSafety and Efficacy of Multiple Therapies in Active Crohn's Disease and Ulcerative Colitis
MT-501
+ MT-201
Colitis+6
+ Colitis, Ulcerative
+ Colonic Diseases
Treatment Study
Summary
Study start date: June 26, 2025
Actual date on which the first participant was enrolled.This study is designed to explore the effectiveness and safety of new treatments for people with moderately to severely active Crohn's Disease or Ulcerative Colitis. These are chronic conditions that cause inflammation in the digestive tract, leading to symptoms like abdominal pain and diarrhea. The study aims to find out how well these experimental therapies work, how safe they are, and how they interact with the body. Finding better treatments is important because current options may not be effective for everyone and can have significant side effects. Participants in the study will receive either oral or injectable experimental treatments. The study will carefully monitor how the participants' bodies process these treatments and the effects they have on the disease. Researchers will look at various factors to determine how the treatments influence the disease's activity and the participants' overall well-being. While the aim is to find more effective and safer options, all new treatments can have potential risks, which will be closely monitored throughout the study.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.140 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 80 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-Crohn's Disease: * Diagnosis of Crohn's Disease (CD), as confirmed by endoscopy and histopathology * Moderately to severely active CD as defined by Clinical Disease Activity Index (CDAI) and Simple Endoscopic Score (SES-CD) * Meets drug stabilization requirements Inclusion Criteria-Ulcerative Colitis: * Diagnosis of Ulcerative Colitis (UC), as confirmed by endoscopy and histopathology * Moderately to severely active UC as defined by a 3-component MMCS * Meets drug stabilization requirements Exclusion Criteria-Crohn's Disease: * Diagnosis of indeterminate colitis * Suspected or diagnosed intra-abdominal or perianal abscess at Screening * Previous small bowel resection with combined resected length of \> 100 cm or previous colonic resection of \> 2 segments * CD isolated to the stomach, duodenum, jejunum, or perianal region, without colonic and/or ileal involvement Exclusion Criteria-Ulcerative Colitis: * Current evidence or within recent history (within last 6 months) of fulminant colitis, toxic megacolon, or bowel perforation * Current stoma or impending need for colostomy or ileostomy * Received IV corticosteroids within 14 days prior to Screening or during the Screening Phase * Previous total proctocolectomy or subtotal colectomy
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.3 intervention groups are designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalGroup II
ExperimentalGroup III
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 66 locations
Mirador Therapeutics Selected Site
Birmingham, United StatesOpen Mirador Therapeutics Selected Site in Google MapsMirador Therapeutics Selected Site
Scottsdale, United StatesMirador Therapeutics Selected Site
Sun City, United StatesMirador Therapeutics Selected Site
Little Rock, United States