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

KoBioLabs

Status and phase: Withdrawn; Phase 2

Conditions: Ulcerative Colitis

Treatments: Drug: Placebo; Drug: KBL697

Study type: Interventional

Funder types: Industry

Identifiers

NCT04898348

KBL-CURE-2020-03

Details and patient eligibility

About

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.

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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
• Exclusion criteria based on results of Hepatitis B at Screening
• Exclusion criteria based on results of Hepatitis C at Screening

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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0 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

3 capsules twice a day dosing of Placebo

Treatment:

Drug: Placebo

KBL697

Experimental group

Description:

3 capsules twice a day dosing of KBL697

Treatment:

Drug: KBL697