A Study to Investigate Efficacy and Safety of KBL697 in Patients With Mild to Moderate Active Ulcerative Colitis
- Registration Number
- NCT04898348
- Lead Sponsor
- KoBioLabs
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
- 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
- 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
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo 3 capsules twice a day dosing of Placebo KBL697 KBL697 3 capsules twice a day dosing of KBL697
- Primary Outcome Measures
Name Time Method Proportion of Patients with Clinical Remission Week 8 Proportion of Patients with Clinical Remission at Week 8
- Secondary Outcome Measures
Name Time Method Change from baseline in C-reactive Protein Week 8 Change from baseline in concentration of C-reactive Protein
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
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 Fecal Calprotectin Week 8 Change from baseline in concentration of fecal Calprotectin
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
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.
Trial Locations
- Locations (1)
The Royal Melbourne Hospital
🇦🇺Melbourne, Victoria, Australia