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Trial details imported from ClinicalTrials.gov

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




Registration number
NCT04898348
Ethics application status
Date submitted
13/05/2021
Date registered
24/05/2021

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
Trial website
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

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT04898348