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

NCT ID: NCT04898348

Last Updated: 2023-08-02

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE2
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-01-14
• Study Completion Date: 2023-07-28

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 colitis.

Conditions

Ulcerative Colitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Placebo

3 capsules twice a day dosing of Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

3 capsules twice a day dosing of Placebo

KBL697

3 capsules twice a day dosing of KBL697

Group Type: EXPERIMENTAL

KBL697

Intervention Type: DRUG

3 capsules twice a day dosing of KBL697

Interventions

KBL697

3 capsules twice a day dosing of KBL697

Intervention Type: DRUG

Placebo

3 capsules twice a day dosing of Placebo

Intervention Type: DRUG

Eligibility 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 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

KoBioLabs

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

The Royal Melbourne Hospital

Melbourne, Victoria, Australia

Countries

Australia

Other Identifiers

KBL-CURE-2020-03

Identifier Type: -

Identifier Source: org_study_id