Back to resultsA Study to Investigate Efficacy and Safety of KBL697 in Patients With Moderate Plaque Type Psoriasis
Primary Purpose
Psoriatic Plaque
Status
Active
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
KBL697
KBL697
Sponsored by
About this trial
This is an interventional treatment trial for Psoriatic Plaque focused on measuring microbiome, KBL697, Plaque psoriasis
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
Sites / Locations
- Total Skin and Beauty Dermatology Center
- Southern California Dermatology, Inc
- Clinical Science Institute
- Revival Research Institute
- Indago Research and Health Center
- Louisiana Dermatology Associates - Dermatology
- Premier Specialist
- Westmead Hospital
- Veracity Clinical Trials Ltd
- Sinclair Dermatology
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Low dose group
High dose group
Arm Description
39 subjects for low dose group. 26 subjects on KBL697, 13 subjects on placebo.
39 subjects for high dose group. 26 subjects on KBL697, 13 subjects on placebo.
Outcomes
Primary Outcome Measures
Psoriasis Area and Severity Index (PASI)
Change from Baseline in PASI score
Secondary Outcome Measures
Psoriasis Area and Severity Index (PASI)
Change from Baseline in PASI score
Psoriasis Area and Severity Index (PASI) -50
Percent of patients who achieved PASI-50
Psoriasis Area and Severity Index (PASI) -75
Percent of patients who achieved PASI-75
Physician's Global Assessment (PGA)
Change from Baseline in PGA score
Physician's Global Assessment (PGA)
Percent of patients who achieve PGA score of 0 or 1
Psoriasis-Affected Body Surface Area (BSA)
Change from Baseline in Psoriasis-Affected BSA
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04911751
Brief Title
A Study to Investigate Efficacy and Safety of KBL697 in Patients With Moderate Plaque Type Psoriasis
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
Study Type
Interventional
2. Study Status
Record Verification Date
September 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
November 8, 2021 (Actual)
Primary Completion Date
November 18, 2023 (Anticipated)
Study Completion Date
March 26, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
KoBioLabs
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psoriatic Plaque
Keywords
microbiome, KBL697, Plaque psoriasis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
80 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Low dose group
Arm Type
Experimental
Arm Description
39 subjects for low dose group. 26 subjects on KBL697, 13 subjects on placebo.
Arm Title
High dose group
Arm Type
Experimental
Arm Description
39 subjects for high dose group. 26 subjects on KBL697, 13 subjects on placebo.
Intervention Type
Drug
Intervention Name(s)
KBL697
Intervention Description
1 capsule BID of KBL697 or Placebo
Intervention Type
Drug
Intervention Name(s)
KBL697
Intervention Description
5 capsules BID of KBL697 or Placebo
Primary Outcome Measure Information:
Title
Psoriasis Area and Severity Index (PASI)
Description
Change from Baseline in PASI score
Time Frame
Baseline to Week 12
Secondary Outcome Measure Information:
Title
Psoriasis Area and Severity Index (PASI)
Description
Change from Baseline in PASI score
Time Frame
Baseline to Weeks 2, 4 and 8
Title
Psoriasis Area and Severity Index (PASI) -50
Description
Percent of patients who achieved PASI-50
Time Frame
Baseline to Week 12
Title
Psoriasis Area and Severity Index (PASI) -75
Description
Percent of patients who achieved PASI-75
Time Frame
Baseline to Week 12
Title
Physician's Global Assessment (PGA)
Description
Change from Baseline in PGA score
Time Frame
Baseline to Weeks 4, 8 and 12
Title
Physician's Global Assessment (PGA)
Description
Percent of patients who achieve PGA score of 0 or 1
Time Frame
Week 12
Title
Psoriasis-Affected Body Surface Area (BSA)
Description
Change from Baseline in Psoriasis-Affected BSA
Time Frame
Baseline to Weeks 4, 8 and 12
Title
Safety measure through incidence of treatment-emergent adverse events (TEAEs)
Description
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.
Time Frame
Baseline to Week 16
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ira Thorla
Organizational Affiliation
Louisiana Dermatology Associates
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jose Cardona
Organizational Affiliation
Indago Research and Health Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jennifer Soung
Organizational Affiliation
Southern California Dermatology, Inc
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
James Krell
Organizational Affiliation
Total Skin and Beauty Dermatology Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Paul Yamauchi
Organizational Affiliation
Clinical Science Institute
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ivette Espinosa-Fernandez
Organizational Affiliation
Revival Research Institute
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Annika Smith
Organizational Affiliation
Westmead Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Deirdre Murrell
Organizational Affiliation
Premier Specialist
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Lynda Spelman
Organizational Affiliation
Veracity Clinical Trials Ltd
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Samantha Eisman
Organizational Affiliation
Sinclair Dermatology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Total Skin and Beauty Dermatology Center
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35205
Country
United States
Facility Name
Southern California Dermatology, Inc
City
Santa Ana
State/Province
California
ZIP/Postal Code
92701
Country
United States
Facility Name
Clinical Science Institute
City
Santa Monica
State/Province
California
ZIP/Postal Code
90404
Country
United States
Facility Name
Revival Research Institute
City
Doral
State/Province
Florida
ZIP/Postal Code
33122
Country
United States
Facility Name
Indago Research and Health Center
City
Hialeah
State/Province
Florida
ZIP/Postal Code
33012
Country
United States
Facility Name
Louisiana Dermatology Associates - Dermatology
City
Baton Rouge
State/Province
Louisiana
ZIP/Postal Code
70809
Country
United States
Facility Name
Premier Specialist
City
Kogarah
State/Province
New South Wales
ZIP/Postal Code
2217
Country
Australia
Facility Name
Westmead Hospital
City
Westmead
State/Province
New South Wales
ZIP/Postal Code
2145
Country
Australia
Facility Name
Veracity Clinical Trials Ltd
City
Woolloongabba
State/Province
Queensland
ZIP/Postal Code
4102
Country
Australia
Facility Name
Sinclair Dermatology
City
East Melbourne
State/Province
Victoria
ZIP/Postal Code
3002
Country
Australia
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
A Study to Investigate Efficacy and Safety of KBL697 in Patients With Moderate Plaque Type Psoriasis
We'll reach out to this number within 24 hrs