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

Ulcerative Colitis Clinical Trial

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04898348
• Other study ID #: KBL-CURE-2020-03
• Status: Withdrawn
• Phase: Phase 2
• Start date: January 14, 2022
• Est. completion date: July 28, 2023

Study information

• Verified date: September 2022
• Source: KoBioLabs
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: July 28, 2023
• Est. primary completion date: July 28, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Colitis
• Colitis, Ulcerative
• Ulcer
• Ulcerative Colitis

Intervention

Drug:
• KBL697
3 capsules twice a day dosing of KBL697
• Placebo
3 capsules twice a day dosing of Placebo

Locations

Country	Name	City	State
Australia	The Royal Melbourne Hospital	Melbourne	Victoria

Sponsors (1)

Lead Sponsor	Collaborator
KoBioLabs

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of Patients with Clinical Remission	Proportion of Patients with Clinical Remission at Week 8	Week 8
Secondary	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
Secondary	Portion of patients with Endoscopic subscore change	Portion of patients with endoscopic subscore decrease to = 1 at Week 8	Week 8
Secondary	Change from baseline in C-reactive Protein	Change from baseline in concentration of C-reactive Protein	Week 8
Secondary	Change from baseline in Fecal Calprotectin	Change from baseline in concentration of fecal Calprotectin	Week 8
Secondary	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
Secondary	Change from baseline in Histologic Disease Activity	Change from baseline in histologic disease activity measured by Geboes score	Week 8
Secondary	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