Ulcerative ColitisPhase 2NCT04898348
A Study to Investigate Efficacy and Safety of KBL697 in Patients With Mild to Moderate Active Ulcerative Colitis
A Phase 2 study testing KBL697 in people with Ulcerative Colitis, run by KoBioLabs at 1 site in Australia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Ulcerative Colitis
- What is being tested?
- KBL697
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteAustralia
- Study dates
- 14 Jan 2022to 28 Jul 2023
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 22Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
- Conditions
- Ulcerative Colitis
- Being tested
- KBL697, Placebo
- Keywords
- microbiome, KBL697, Inflammatory Bowel Disease
- Medical subject headings
- Colitis, Ulcerative, Inflammatory Bowel Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KBL697Drug
3 capsules twice a day dosing of KBL697
PlaceboDrug
3 capsules twice a day dosing of Placebo
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | 3 capsules twice a day dosing of Placebo Receives: Drug: Placebo |
| KBL697 | Experimental | 3 capsules twice a day dosing of KBL697 Receives: Drug: KBL697 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of Patients with Clinical Remission
Proportion of Patients with Clinical Remission at Week 8
Measured: Week 8
Secondary outcomes (7)
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
Measured: Week 8
Portion of patients with Endoscopic subscore change
Portion of patients with endoscopic subscore decrease to ≥ 1 at Week 8
Measured: Week 8
Change from baseline in C-reactive Protein
Change from baseline in concentration of C-reactive Protein
Measured: Week 8
Change from baseline in Fecal Calprotectin
Change from baseline in concentration of fecal Calprotectin
Measured: 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
Measured: Week 8
Change from baseline in Histologic Disease Activity
Change from baseline in histologic disease activity measured by Geboes score
Measured: 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.
Measured: Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2021
- Study start14 Jan 2022
- Primary completion28 Jul 2023
- Study completion28 Jul 2023
Why it stopped: No patients recruited
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ulcerative ColitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- KoBioLabs
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04898348
- Sponsor's protocol ID
- KBL-CURE-2020-03
- Status last verified
- Sep 2022
- First submitted
- 13 May 2021
- Last updated
- 2 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04898348
- Acronym / sponsor ID
- KBL-CURE-2020-03
- Conditions
- Ulcerative Colitis
- Keywords
- microbiome, KBL697, Inflammatory Bowel Disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: No patients recruited
- Enrolment
- 0 participants (actual)
- Lead sponsor
- KoBioLabsIndustry (pharma, biotech, devices)
- Study start
- 14 Jan 2022 (actual)
- Primary completion
- 28 Jul 2023 (actual)
- Study completion
- 28 Jul 2023 (actual)
- First posted
- 24 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: Placebo3 capsules twice a day dosing of Placebo |
| KBL697 | Experimental | Drug: KBL6973 capsules twice a day dosing of KBL697 |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (22 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| KBL6973 capsules twice a day dosing of KBL697 | Drug | KBL697 |
| Placebo3 capsules twice a day dosing of Placebo | Drug | Placebo |
Primary outcome
Proportion of Patients with Clinical Remission
Time frame: Week 8
Proportion of Patients with Clinical Remission at Week 8
7 secondary outcomes
Change from baseline in Partial Mayo Score
Time frame: Week 8
Portion of patients with Endoscopic subscore change
Time frame: Week 8
Change from baseline in C-reactive Protein
Time frame: Week 8
Change from baseline in Fecal Calprotectin
Time frame: Week 8
Changes from baseline in Inflammatory Bowel Disease Questionnaire score
Time frame: Week 8
Change from baseline in Histologic Disease Activity
Time frame: Week 8
Safety measure through incidence of treatment-emergent adverse events (TEAEs)
Time frame: Week 12
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing KBL697 in people with Ulcerative Colitis, run by KoBioLabs at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 2 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of Patients with Clinical Remission (time frame: Week 8). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Aug 2023.