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WithdrawnNCT04898348Updated Aug 2, 2023

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

A Phase 2 interventional study of KBL697 and Placebo in Ulcerative Colitis, sponsored by KoBioLabs. Withdrawn at 1 site in Australia. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2023-08-02.

Sponsored by KoBioLabs · Phase 2, Interventional, and Treatment

Why this study was withdrawn
No patients recruited
Phase
Phase 2
Study type
Interventional
Enrollment
0
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Ulcerative Colitis

Keywords

  • microbiome
  • KBL697
  • Inflammatory Bowel Disease
03

In context

Colitis

1,073 studies on the registry are indexed under Colitis; 131 are open to participants now.

Browse Colitis studies →

Lead sponsor

KoBioLabs is the lead sponsor of 4 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts 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

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
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
0 participants (actual)

Study arms

  • Placebo comparator
    Placebo

    3 capsules twice a day dosing of Placebo

    Drug: Placebo

  • Experimental
    KBL697

    3 capsules twice a day dosing of KBL697

    Drug: KBL697

Interventions

  • DrugKBL697

    3 capsules twice a day dosing of KBL697

  • DrugPlacebo

    3 capsules twice a day dosing of Placebo

06

What researchers measure

Primary outcomes

  1. Proportion of Patients with Clinical Remission

    Proportion of Patients with Clinical Remission at Week 8

    Time frame: Week 8

Secondary outcomes

  1. 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

    Time frame: Week 8

  2. Portion of patients with Endoscopic subscore change

    Portion of patients with endoscopic subscore decrease to ≥ 1 at Week 8

    Time frame: Week 8

  3. Change from baseline in C-reactive Protein

    Change from baseline in concentration of C-reactive Protein

    Time frame: Week 8

  4. Change from baseline in Fecal Calprotectin

    Change from baseline in concentration of fecal Calprotectin

    Time frame: Week 8

  5. 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

    Time frame: Week 8

  6. Change from baseline in Histologic Disease Activity

    Change from baseline in histologic disease activity measured by Geboes score

    Time frame: Week 8

  7. 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.

    Time frame: Week 12

07

Study locations

1 site
  • The Royal Melbourne Hospital
    Melbourne, Victoria 3002, Australia
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 2, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04898348
Lead sponsor
KoBioLabs
Responsible party
Sponsor
First posted
May 24, 2021
Start date
Jan 14, 2022
Primary completion
Jul 28, 2023
Completion
Jul 28, 2023
Last update
Aug 2, 2023

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Sep 2022. You cannot join it, but the record below documents what was studied.

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