Psoriatic PlaquePhase 2NCT04911751
A Study to Investigate Efficacy and Safety of KBL697 in Patients with Moderate Plaque Type Psoriasis
A Phase 2 study testing KBL697 in people with Psoriatic Plaque, run by KoBioLabs at 10 sites in 2 countries.
Trial summary
The study is designed to investigate efficacy and safety of KBL697 in patients with Moderate Plaque Type Psoriasis. KBL697 has been developed as a potential new treatment for Psoriatic Plaque. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Psoriatic Plaque
- What is being tested?
- KBL697
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 10 sitesin 2 countries
- Study dates
- 8 Nov 2021to 7 Oct 2024
- 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
- Male or female, aged 18 to 75 years (inclusive)
- Have a diagnosis of plaque type psoriasis for ≥ 6 months
- Must have chronic plaque type psoriasis of moderate severity
- All subjects must agree and commit to the use of a reliable contraceptive regimen.
Who cannot join
- Current diagnosis of forms of psoriasis other than chronic plaque type only
- Drug-induced psoriasis
- Other inflammatory skin disease that may confound the evaluation of plaque psoriasis
- Failed 2 or more systemic treatments for plaque psoriasis
- Medicinal shampoos that contain tar and/or salicylic acid within 2 weeks prior to Baseline Visit
Trial locations and contacts
10 sites in 2 countries.
10 sites in 2 countries
United States6 sites
Louisiana Dermatology Associates - Dermatology
Baton Rouge, Louisiana, 70809
Total Skin and Beauty Dermatology Center
Birmingham, Alabama, 35205
Revival Research Institute
Doral, Florida, 33122
Indago Research and Health Center
Hialeah, Florida, 33012
Southern California Dermatology, Inc
Santa Ana, California, 92701
Clinical Science Institute
Santa Monica, California, 90404
Australia4 sites
Sinclair Dermatology
East Melbourne, Victoria, 3002
Premier Specialist
Kogarah, New South Wales, 2217
Westmead Hospital
Westmead, New South Wales, 2145
Veracity Clinical Trials Ltd
Woolloongabba, Queensland, 4102
About this study
Official title: A Phase 2, Double-Blind, Randomized, Placebo-Controlled, Study to Evaluate the Efficacy and Safety of KBL697 in Patients with Moderate Plaque Type Psoriasis
The study is designed to investigate efficacy and safety of KBL697 in patients with Moderate Plaque Type Psoriasis. KBL697 has been developed as a potential new treatment for Psoriatic Plaque.
- Conditions
- Psoriatic Plaque
- Being tested
- KBL697
- Keywords
- microbiome, KBL697, Plaque psoriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KBL697Drug
1 capsule BID of KBL697 or Placebo
KBL697Drug
5 capsules BID of KBL697 or Placebo
| Study group | Role | What they receive |
|---|---|---|
| Low dose group | Experimental | 39 subjects for low dose group. 26 subjects on KBL697, 13 subjects on placebo. Receives: Drug: KBL697 |
| High dose group | Experimental | 39 subjects for high dose group. 26 subjects on KBL697, 13 subjects on placebo. Receives: Drug: KBL697 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Psoriasis Area and Severity Index (PASI)
Change from Baseline in PASI score
Measured: Baseline to Week 12
Secondary outcomes (7)
Psoriasis Area and Severity Index (PASI)
Change from Baseline in PASI score
Measured: Baseline to Weeks 2, 4 and 8
Psoriasis Area and Severity Index (PASI) -50
Percent of patients who achieved PASI-50
Measured: Baseline to Week 12
Psoriasis Area and Severity Index (PASI) -75
Percent of patients who achieved PASI-75
Measured: Baseline to Week 12
Physician's Global Assessment (PGA)
Change from Baseline in PGA score
Measured: Baseline to Weeks 4, 8 and 12
Physician's Global Assessment (PGA)
Percent of patients who achieve PGA score of 0 or 1
Measured: Week 12
Psoriasis-Affected Body Surface Area (BSA)
Change from Baseline in Psoriasis-Affected BSA
Measured: Baseline to Weeks 4, 8 and 12
Safety measure through incidence of treatment-emergent adverse events (TEAEs)
The number of patients experiencing TEAEs and number of individual TEAEs will be summarized among treatment arms, by system organ class (SOC) and PT. TEAEs will also be summarized among treatment arms, by severity and by relationship to study drug.
Measured: Baseline to Week 16
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2021
- Study start8 Nov 2021
- Primary completion8 Nov 2023
- Study completion7 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Psoriatic PlaqueStudies 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- KoBioLabs
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ira Thorla, Principal investigator, Louisiana Dermatology AssociatesJose Cardona, Principal investigator, Indago Research and Health CenterJennifer Soung, Principal investigator, Southern California Dermatology, IncJames Krell, Principal investigator, Total Skin and Beauty Dermatology CenterPaul Yamauchi, Principal investigator, Clinical Science InstituteIvette Espinosa-Fernandez, Principal investigator, Revival Research InstituteAnnika Smith, Principal investigator, Westmead HospitalDeirdre Murrell, Principal investigator, Premier Specialist
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04911751
- Sponsor's protocol ID
- KBL-CURE-2020-02
- Status last verified
- Jan 2025
- First submitted
- 9 May 2021
- Last updated
- 7 Jan 2025
- 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 7 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Double-Blind, Randomized, Placebo-Controlled, Study to Evaluate the Efficacy and Safety of KBL697 in Patients with Moderate Plaque Type Psoriasis
- ClinicalTrials.gov ID
- NCT04911751
- Acronym / sponsor ID
- KBL-CURE-2020-02
- Conditions
- Psoriatic Plaque
- Keywords
- microbiome, KBL697, Plaque psoriasis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- KoBioLabsIndustry (pharma, biotech, devices)
- Study start
- 8 Nov 2021 (actual)
- Primary completion
- 8 Nov 2023 (actual)
- Study completion
- 7 Oct 2024 (actual)
- First posted
- 3 Jun 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 Moderate Plaque Type Psoriasis. KBL697 has been developed as a potential new treatment for Psoriatic Plaque.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Low dose group | Experimental | Drug: KBL69739 subjects for low dose group. 26 subjects on KBL697, 13 subjects on placebo. |
| High dose group | Experimental | Drug: KBL69739 subjects for high dose group. 26 subjects on KBL697, 13 subjects on placebo. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male or female, aged 18 to 75 years (inclusive)
- Have a diagnosis of plaque type psoriasis for ≥ 6 months
- Must have chronic plaque type psoriasis of moderate severity
- All subjects must agree and commit to the use of a reliable contraceptive regimen.
Key exclusion criteria (5 listed)
- Current diagnosis of forms of psoriasis other than chronic plaque type only
- Drug-induced psoriasis
- Other inflammatory skin disease that may confound the evaluation of plaque psoriasis
- Failed 2 or more systemic treatments for plaque psoriasis
- Medicinal shampoos that contain tar and/or salicylic acid within 2 weeks prior to Baseline Visit
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 |
|---|---|---|
| KBL6971 capsule BID of KBL697 or Placebo | Drug | Low dose group |
| KBL6975 capsules BID of KBL697 or Placebo | Drug | High dose group |
Primary outcome
Psoriasis Area and Severity Index (PASI)
Time frame: Baseline to Week 12
Change from Baseline in PASI score
7 secondary outcomes
Psoriasis Area and Severity Index (PASI)
Time frame: Baseline to Weeks 2, 4 and 8
Psoriasis Area and Severity Index (PASI) -50
Time frame: Baseline to Week 12
Psoriasis Area and Severity Index (PASI) -75
Time frame: Baseline to Week 12
Physician's Global Assessment (PGA)
Time frame: Baseline to Weeks 4, 8 and 12
Physician's Global Assessment (PGA)
Time frame: Week 12
Psoriasis-Affected Body Surface Area (BSA)
Time frame: Baseline to Weeks 4, 8 and 12
Safety measure through incidence of treatment-emergent adverse events (TEAEs)
Time frame: Baseline to Week 16
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2025.
- 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.
Ira Thorla principal investigator
Louisiana Dermatology Associates
Jose Cardona principal investigator
Indago Research and Health Center
Jennifer Soung principal investigator
Southern California Dermatology, Inc
10 sites in 2 countries: 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 Psoriatic Plaque, run by KoBioLabs at 10 sites in 2 countries.
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 4 inclusion and 5 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: finished, as of the sponsor's last update on 7 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in United States, 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. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Psoriasis Area and Severity Index (PASI) (time frame: Baseline to Week 12). 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 7 Jan 2025.