A Study to Investigate Efficacy and Safety of KBL697 in Patients With Mild to Moderate Active Ulcerative Colitis

• Status: Not yet recruiting
• Trial end date: 2022-09-01
• Target enrollment: 0
• Participant gender: All

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 colitis.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: KoBioLabs
• Treatments: Vancomycin

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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 has a known allergy or intolerance to vancomycin

• Patient has any contraindication for use of vancomycin

• 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