Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT04898348




Registration number
NCT04898348
Ethics application status
Date submitted
13/05/2021
Date registered
24/05/2021
Date last updated
2/08/2023

Titles & IDs
Public title
A Study to Investigate Efficacy and Safety of KBL697 in Patients With Mild to Moderate Active Ulcerative Colitis
Scientific 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
Secondary ID [1] 0 0
KBL-CURE-2020-03
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Ulcerative Colitis 0 0
Condition category
Condition code
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders
Oral and Gastrointestinal 0 0 0 0
Inflammatory bowel disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - KBL697
Treatment: Drugs - Placebo

Placebo Comparator: Placebo - 3 capsules twice a day dosing of Placebo

Experimental: KBL697 - 3 capsules twice a day dosing of KBL697


Treatment: Drugs: KBL697
3 capsules twice a day dosing of KBL697

Treatment: Drugs: Placebo
3 capsules twice a day dosing of Placebo
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Proportion of Patients with Clinical Remission
Timepoint [1] 0 0
Week 8
Secondary outcome [1] 0 0
Change from baseline in Partial Mayo Score
Timepoint [1] 0 0
Week 8
Secondary outcome [2] 0 0
Portion of patients with Endoscopic subscore change
Timepoint [2] 0 0
Week 8
Secondary outcome [3] 0 0
Change from baseline in C-reactive Protein
Timepoint [3] 0 0
Week 8
Secondary outcome [4] 0 0
Change from baseline in Fecal Calprotectin
Timepoint [4] 0 0
Week 8
Secondary outcome [5] 0 0
Changes from baseline in Inflammatory Bowel Disease Questionnaire score
Timepoint [5] 0 0
Week 8
Secondary outcome [6] 0 0
Change from baseline in Histologic Disease Activity
Timepoint [6] 0 0
Week 8
Secondary outcome [7] 0 0
Safety measure through incidence of treatment-emergent adverse events (TEAEs)
Timepoint [7] 0 0
Week 12

Eligibility
Key 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
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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 design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Withdrawn
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
14/01/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
28/07/2023
Sample size
Target
Accrual to date
Final
0
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
The Royal Melbourne Hospital - Melbourne
Recruitment postcode(s) [1] 0 0
3002 - Melbourne

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
KoBioLabs
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT04898348
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT04898348