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

Study Purpose

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 Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years - 75 Years
Gender All
More Inclusion & Exclusion 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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT04898348
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 2
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

KoBioLabs
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

N/A
Principal Investigator Affiliation N/A
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Recruiting
Countries Australia
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Ulcerative Colitis
Arms & Interventions

Arms

Placebo Comparator: Placebo

3 capsules twice a day dosing of Placebo

Experimental: KBL697

3 capsules twice a day dosing of KBL697

Interventions

Drug: - KBL697

3 capsules twice a day dosing of KBL697

Drug: - Placebo

3 capsules twice a day dosing of Placebo

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

The Royal Melbourne Hospital, Melbourne, Victoria, Australia

Status

Recruiting

Address

The Royal Melbourne Hospital

Melbourne, Victoria, 3002

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