Status:
WITHDRAWN
A Study to Investigate Efficacy and Safety of KBL697 in Patients With Mild to Moderate Active Ulcerative Colitis
Lead Sponsor:
KoBioLabs
Conditions:
Ulcerative Colitis
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
The study is designed to investigate efficacy and safety of KBL697 in patients with mild to moderate active ulcerative colitis. KBL697 has been developed as a potential new treatment for ulcerative co...
Eligibility Criteria
Inclusion
- Patient has an established diagnosis of ulcerative colitis for at least 3 months prior to Screening
- Patient has active mild to moderate ulcerative colitis at Visit 2
- Patient is taking at least one of the following oral medication: 5-ASA, Corticosteroids, Immunomodulators
Exclusion
- Patient has a possible or confirmed diagnosis of Crohn's Disease or other forms of inflammatory bowel disorders
- Patient has a persistent fever of ≥ 38.3°C
- Patient has current signs or symptoms of infection
- Patient has any immunosuppressant condition
- Patient has a known malignancy within 5 years prior to Screening
- Patient who has a medical history of drug abuse or alcohol abuse
- Patient who, in the opinion of the Investigator, has a clinically significant co-morbid disease
- Patient has hepatic failure
- Patient is pregnant or plans a pregnancy within the study period
- Patient has no previous history of treatment for ulcerative colitis (treatment-naïve patient)
- Patient has ongoing or failed treatment for ulcerative colitis with calcineurin inhibitor
- Patient has received biologic medication
- Patient has received antibiotics within 4 weeks prior to Visit 2
- Patient is unable to stop previous antibiotics treatment during study period
- Patient has received probiotics within 2 weeks prior to Visit 2
- Patient with history of major surgery in any region of the gastrointestinal tract
- Patient has received any investigational product or participated in another clinical trial
- Patient has a stool culture or other examination positive for an enteric pathogen
- Patient tests positive for CMV by PCR test at Screening
- Patient tests positive for HIV at Screening
- Exclusion criteria based on results of Hepatitis B at Screening
- Exclusion criteria based on results of Hepatitis C at Screening
Key Trial Info
Start Date :
January 14 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 28 2023
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04898348
Start Date
January 14 2022
End Date
July 28 2023
Last Update
August 2 2023
Active Locations (1)
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1
The Royal Melbourne Hospital
Melbourne, Victoria, Australia, 3002