Clinical trial NCT04898348: A Study to Investigate Efficacy and Safety of KBL697 in Patients With Mild to Moderate Active 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
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Ulcerative Colitis
Keywords: microbiome
KBL697
Inflammatory Bowel Disease
Lead sponsor: KoBioLabs
Sponsor class: INDUSTRY
First posted: 2021-05-24
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Proportion of Patients with Clinical Remission
timeFrame: Week 8
Secondary outcomes:
measure: Change from baseline in Partial Mayo Score
timeFrame: Week 8
measure: Portion of patients with Endoscopic subscore change
timeFrame: Week 8
measure: Change from baseline in C-reactive Protein
timeFrame: Week 8
measure: Change from baseline in Fecal Calprotectin
timeFrame: Week 8
measure: Changes from baseline in Inflammatory Bowel Disease Questionnaire score
timeFrame: Week 8
measure: Change from baseline in Histologic Disease Activity
timeFrame: Week 8
measure: Safety measure through incidence of treatment-emergent adverse events (TEAEs)
timeFrame: Week 12
Other outcomes:
Locations:
city: Melbourne
country: Australia
facility: The Royal Melbourne Hospital
state: Victoria
Study officials:
References: