A Study to Investigate Efficacy and Safety of KBL697 in Patients with Moderate Plaque Type Psoriasis
NCT ID: NCT04911751
Last Updated: 2025-01-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
80 participants
INTERVENTIONAL
2021-11-08
2024-10-07
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Low dose group
39 subjects for low dose group. 26 subjects on KBL697, 13 subjects on placebo.
KBL697
1 capsule BID of KBL697 or Placebo
High dose group
39 subjects for high dose group. 26 subjects on KBL697, 13 subjects on placebo.
KBL697
5 capsules BID of KBL697 or Placebo
Interventions
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KBL697
1 capsule BID of KBL697 or Placebo
KBL697
5 capsules BID of KBL697 or Placebo
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
75 Years
ALL
No
Sponsors
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KoBioLabs
INDUSTRY
Responsible Party
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Principal Investigators
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Ira Thorla
Role: PRINCIPAL_INVESTIGATOR
Louisiana Dermatology Associates
Jose Cardona
Role: PRINCIPAL_INVESTIGATOR
Indago Research and Health Center
Jennifer Soung
Role: PRINCIPAL_INVESTIGATOR
Southern California Dermatology, Inc
James Krell
Role: PRINCIPAL_INVESTIGATOR
Total Skin and Beauty Dermatology Center
Paul Yamauchi
Role: PRINCIPAL_INVESTIGATOR
Clinical Science Institute
Ivette Espinosa-Fernandez
Role: PRINCIPAL_INVESTIGATOR
Revival Research Institute
Annika Smith
Role: PRINCIPAL_INVESTIGATOR
Westmead Hospital
Deirdre Murrell
Role: PRINCIPAL_INVESTIGATOR
Premier Specialist
Lynda Spelman
Role: PRINCIPAL_INVESTIGATOR
Veracity Clinical Trials Ltd
Samantha Eisman
Role: PRINCIPAL_INVESTIGATOR
Sinclair Dermatology
Locations
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Total Skin and Beauty Dermatology Center
Birmingham, Alabama, United States
Southern California Dermatology, Inc
Santa Ana, California, United States
Clinical Science Institute
Santa Monica, California, United States
Revival Research Institute
Doral, Florida, United States
Indago Research and Health Center
Hialeah, Florida, United States
Louisiana Dermatology Associates - Dermatology
Baton Rouge, Louisiana, United States
Premier Specialist
Kogarah, New South Wales, Australia
Westmead Hospital
Westmead, New South Wales, Australia
Veracity Clinical Trials Ltd
Woolloongabba, Queensland, Australia
Sinclair Dermatology
East Melbourne, Victoria, Australia
Countries
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Other Identifiers
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KBL-CURE-2020-02
Identifier Type: -
Identifier Source: org_study_id
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