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

Study Overview
=================
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.

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

Conditions
-----------------
Ulcerative Colitis

Intervention / Treatment
-----------------
* Drug: KBL697
* Drug: Placebo


Participation Criteria
=================
Eligibility 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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>3 capsules twice a day dosing of Placebo | Drug: Placebo<br>* 3 capsules twice a day dosing of Placebo<br>|
| Experimental: KBL697<br>3 capsules twice a day dosing of KBL697 | Drug: KBL697<br>* 3 capsules twice a day dosing of KBL697<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of Patients with Clinical Remission | Proportion of Patients with Clinical Remission at Week 8 | Week 8 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Portion of patients with Endoscopic subscore change | Portion of patients with endoscopic subscore decrease to ≥ 1 at Week 8 | Week 8 | 
| Change from baseline in C-reactive Protein | Change from baseline in concentration of C-reactive Protein | Week 8 | 
| Change from baseline in Fecal Calprotectin | Change from baseline in concentration of fecal Calprotectin | Week 8 | 
| 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 | 
| Change from baseline in Histologic Disease Activity | Change from baseline in histologic disease activity measured by Geboes score | Week 8 | 
| 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
microbiome, KBL697, Inflammatory Bowel Disease