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

A Multicenter, Double-blind, Randomized, Placebo-controlled Study to Evaluate the Efficacy and Safety of KBL697 in Patients With Mild to Moderate Active Ulcerative Colitis

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.

Study Overview

• Status: Withdrawn
• Conditions: Ulcerative Colitis
• Intervention / Treatment: Drug: Placebo; Drug: KBL697

• Study Type: Interventional
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Arial (Jinyoung) Bai; Phone Number: +82 2 8889964; Email: jinyoung.bai@kobiolabs.com

Study Locations

• Australia
  • Victoria
    • Melbourne, Victoria, Australia, 3002
      • The Royal Melbourne Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; 3 capsules twice a day dosing of Placebo	Drug: Placebo; 3 capsules twice a day dosing of Placebo
Experimental: KBL697; 3 capsules twice a day dosing of KBL697	Drug: KBL697; 3 capsules twice a day dosing of KBL697

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of Patients with Clinical Remission	Proportion of Patients with Clinical Remission at Week 8	Week 8

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline in Partial Mayo Score	Change from baseline in Partial Mayo Score at Week 8 Minimum value: 0, Maximum value: 9, higher score mean a worse outcome	Week 8
Portion of patients with Endoscopic subscore change	Portion of patients with endoscopic subscore decrease to ≥ 1 at Week 8	Week 8
Change from baseline in C-reactive Protein	Change from baseline in concentration of C-reactive Protein	Week 8
Change from baseline in Fecal Calprotectin	Change from baseline in concentration of fecal Calprotectin	Week 8
Changes from baseline in Inflammatory Bowel Disease Questionnaire score	Changes from baseline in Inflammatory Bowel Disease Questionnaire score Minimum value: 0, Maximum value: 224, higher score mean a worse outcome	Week 8
Change from baseline in Histologic Disease Activity	Change from baseline in histologic disease activity measured by Geboes score	Week 8
Safety measure through incidence of treatment-emergent adverse events (TEAEs)	Occurrence of TEAEs, treatment-related TEAEs, TEAEs by severity (mild/moderate/severe), serious TEAEs, TEAEs leading to dose adjustment, treatment termination, or death will be summarized by actual treatment groups respectively.	Week 12

Collaborators and Investigators

• Sponsor: KoBioLabs

Study record dates

Study Major Dates

• Study Start (Actual): January 14, 2022
• Primary Completion (Actual): July 28, 2023
• Study Completion (Actual): July 28, 2023

Study Registration Dates

• First Submitted: May 13, 2021
• First Submitted That Met QC Criteria: May 18, 2021
• First Posted (Actual): May 24, 2021

Study Record Updates

• Last Update Posted (Actual): August 2, 2023
• Last Update Submitted That Met QC Criteria: July 31, 2023
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Keywords: Inflammatory Bowel Disease; microbiome; KBL697
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Gastrointestinal Diseases; Gastroenteritis; Colonic Diseases; Intestinal Diseases; Inflammatory Bowel Diseases; Ulcer; Colitis; Colitis, Ulcerative
• Other Study ID Numbers: KBL-CURE-2020-03

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No