A Study to Investigate Efficacy and Safety of KBL697 in P... | NCT04898348

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

NCT04898348

Sponsor

KoBioLabs

Status

Withdrawn

Last Update Posted

Aug 2, 2023Actual

Enrollment

0Actual

Phase

Phase 2

Conditions

Ulcerative Colitis

Interventions

KBL697
Placebo

Countries

Australia

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2022

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

No patients recruited

Expanded Access Info

Start Date

Jan 14, 2022Actual

Primary Completion Date

Jul 28, 2023Actual

Completion Date

Jul 28, 2023Actual

First Submitted Date

May 13, 2021

First Submission Date that Met QC Criteria

May 18, 2021

First Posted Date

May 24, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 31, 2023

Last Update Posted Date

Aug 2, 2023Actual

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Placebo	Placebo Comparator	3 capsules twice a day dosing of Placebo	Drug: Placebo
KBL697	Experimental	3 capsules twice a day dosing of KBL697	Drug: KBL697

Interventions

Name	Type	Description	Arm Group Labels	Other Names
KBL697	Drug	3 capsules twice a day dosing of KBL697	KBL697
Placebo

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

ID	Term
D003093	Colitis, Ulcerative
D015212	Inflammatory Bowel Diseases

ID	Term
D003092	Colitis
D005759	Gastroenteritis
D005767	Gastrointestinal Diseases
D004066	Digestive System Diseases