Back to results

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

Primary Purpose

Ulcerative Colitis

Status

Withdrawn

Phase

Phase 2

Locations

Australia

Study Type

Interventional

Intervention

KBL697

Placebo

About this trial

This is an interventional treatment trial for Ulcerative Colitis focused on measuring microbiome, KBL697, Inflammatory Bowel Disease

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

The Royal Melbourne Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Placebo

KBL697

Arm Description

3 capsules twice a day dosing of Placebo

3 capsules twice a day dosing of KBL697

Outcomes

Primary Outcome Measures

Proportion of Patients with Clinical Remission

Proportion of Patients with Clinical Remission at Week 8

Secondary Outcome Measures

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

Portion of patients with Endoscopic subscore change

Portion of patients with endoscopic subscore decrease to ≥ 1 at Week 8

Change from baseline in C-reactive Protein

Change from baseline in concentration of C-reactive Protein

Change from baseline in Fecal Calprotectin

Change from baseline in concentration of fecal Calprotectin

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

Change from baseline in Histologic Disease Activity

Change from baseline in histologic disease activity measured by Geboes score

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.

Full Information

NCT ID

NCT04898348

First Posted

May 13, 2021

Last Updated

July 31, 2023

Sponsor

KoBioLabs

1. Study Identification

Unique Protocol Identification Number

NCT04898348

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2022

Overall Recruitment Status

Withdrawn

Why Stopped

No patients recruited

Study Start Date

January 14, 2022 (Actual)

Primary Completion Date

July 28, 2023 (Actual)

Study Completion Date

July 28, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

KoBioLabs

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Ulcerative Colitis

Keywords

microbiome, KBL697, Inflammatory Bowel Disease

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

3 capsules twice a day dosing of Placebo

Arm Title

KBL697

Arm Type

Experimental

Arm Description

3 capsules twice a day dosing of KBL697

Intervention Type

Drug

Intervention Name(s)

KBL697

Intervention Description

3 capsules twice a day dosing of KBL697

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

3 capsules twice a day dosing of Placebo

Primary Outcome Measure Information:

Title

Proportion of Patients with Clinical Remission

Description

Proportion of Patients with Clinical Remission at Week 8

Time Frame

Week 8

Secondary Outcome Measure Information:

Title

Change from baseline in Partial Mayo Score

Description

Change from baseline in Partial Mayo Score at Week 8 Minimum value: 0, Maximum value: 9, higher score mean a worse outcome

Time Frame

Week 8

Title

Portion of patients with Endoscopic subscore change

Description

Portion of patients with endoscopic subscore decrease to ≥ 1 at Week 8

Time Frame

Week 8

Title

Change from baseline in C-reactive Protein

Description

Change from baseline in concentration of C-reactive Protein

Time Frame

Week 8

Title

Change from baseline in Fecal Calprotectin

Description

Change from baseline in concentration of fecal Calprotectin

Time Frame

Week 8

Title

Changes from baseline in Inflammatory Bowel Disease Questionnaire score

Description

Changes from baseline in Inflammatory Bowel Disease Questionnaire score Minimum value: 0, Maximum value: 224, higher score mean a worse outcome

Time Frame

Week 8

Title

Change from baseline in Histologic Disease Activity

Description

Change from baseline in histologic disease activity measured by Geboes score

Time Frame

Week 8

Title

Safety measure through incidence of treatment-emergent adverse events (TEAEs)

Description

Time Frame

Week 12

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

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

Facility Information:

Facility Name

The Royal Melbourne Hospital

City

Melbourne

State/Province

Victoria

ZIP/Postal Code

3002

Country

Australia

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

We'll reach out to this number within 24 hrs