Ulcerative Colitis
Conditions
Keywords
microbiome, KBL697, Inflammatory Bowel Disease
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.
Interventions
DRUGKBL697
3 capsules twice a day dosing of KBL697
DRUGPlacebo
3 capsules twice a day dosing of Placebo
Sponsors
KoBioLabs
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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 *
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of Patients with Clinical Remission | Week 8 | Proportion of Patients with Clinical Remission at Week 8 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Portion of patients with Endoscopic subscore change | Week 8 | Portion of patients with endoscopic subscore decrease to ≥ 1 at Week 8 |
| Change from baseline in C-reactive Protein | Week 8 | Change from baseline in concentration of C-reactive Protein |
| Change from baseline in Fecal Calprotectin | Week 8 | Change from baseline in concentration of fecal Calprotectin |
| Change from baseline in Partial Mayo Score | Week 8 | Change from baseline in Partial Mayo Score at Week 8 Minimum value: 0, Maximum value: 9, higher score mean a worse outcome |
| Change from baseline in Histologic Disease Activity | Week 8 | Change from baseline in histologic disease activity measured by Geboes score |
| Safety measure through incidence of treatment-emergent adverse events (TEAEs) | Week 12 | 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. |
| Changes from baseline in Inflammatory Bowel Disease Questionnaire score | Week 8 | Changes from baseline in Inflammatory Bowel Disease Questionnaire score Minimum value: 0, Maximum value: 224, higher score mean a worse outcome |
Countries
Australia
Outcome results
None listed