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

NCT04898348 | Withdrawn Phase 2 FDA Drug

• 1 other identifier: KBL-CURE-2020-03
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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

Keywords

microbiome; KBL697; Inflammatory Bowel Disease

Outcome Measures

Primary Outcomes (1)

• Proportion of Patients with Clinical Remission

  Proportion of Patients with Clinical Remission at Week 8

  Week 8

Secondary Outcomes (7)

• Change from baseline in Partial Mayo Score

  Week 8

• Portion of patients with Endoscopic subscore change

  Week 8

• Change from baseline in C-reactive Protein

  Week 8

• Change from baseline in Fecal Calprotectin

  Week 8

• Changes from baseline in Inflammatory Bowel Disease Questionnaire score

  Week 8

Study Arms (2)

Placebo

PLACEBO COMPARATOR

3 capsules twice a day dosing of Placebo

Drug: Placebo

KBL697

EXPERIMENTAL

3 capsules twice a day dosing of KBL697

Drug: KBL697

Interventions

KBL697 DRUG

3 capsules twice a day dosing of KBL697

KBL697

Placebo DRUG

3 capsules twice a day dosing of Placebo

Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• KoBioLabs: lead

Study Sites (1)

The Royal Melbourne Hospital

Melbourne, Victoria, 3002, Australia

Location

MeSH Terms

Conditions

Colitis, Ulcerative; Inflammatory Bowel Diseases

Condition Hierarchy (Ancestors)

Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Colonic Diseases; Intestinal Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 13, 2021
• First Posted: May 24, 2021
• Study Start: January 14, 2022
• Primary Completion: July 28, 2023
• Study Completion: July 28, 2023
• Last Updated: August 2, 2023

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)