A Study to Investigate Efficacy and Safety of KBL697 in Patients with Moderate Plaque Type Psoriasis

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.

Study Overview

• Status: Completed
• Conditions: Psoriatic Plaque
• Intervention / Treatment: Drug: KBL697; Drug: KBL697

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Phase 2

Contacts and Locations

Study Locations

• Australia
  • New South Wales
    • Kogarah, New South Wales, Australia, 2217
      • Premier Specialist
    • Westmead, New South Wales, Australia, 2145
      • Westmead Hospital
  • Queensland
    • Woolloongabba, Queensland, Australia, 4102
      • Veracity Clinical Trials Ltd
  • Victoria
    • East Melbourne, Victoria, Australia, 3002
      • Sinclair Dermatology
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35205
      • Total Skin And Beauty Dermatology Center
  • California
    • Santa Ana, California, United States, 92701
      • Southern California Dermatology, Inc
    • Santa Monica, California, United States, 90404
      • Clinical Science Institute
  • Florida
    • Doral, Florida, United States, 33122
      • Revival Research Institute
    • Hialeah, Florida, United States, 33012
      • Indago Research and Health Center
  • Louisiana
    • Baton Rouge, Louisiana, United States, 70809
      • Louisiana Dermatology Associates - Dermatology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 71 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Low dose group; 39 subjects for low dose group. 26 subjects on KBL697, 13 subjects on placebo.	Drug: KBL697; 1 capsule BID of KBL697 or Placebo; Drug: KBL697; 5 capsules BID of KBL697 or Placebo
Experimental: High dose group; 39 subjects for high dose group. 26 subjects on KBL697, 13 subjects on placebo.	Drug: KBL697; 1 capsule BID of KBL697 or Placebo; Drug: KBL697; 5 capsules BID of KBL697 or Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Psoriasis Area and Severity Index (PASI)	Change from Baseline in PASI score	Baseline to Week 12

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Psoriasis Area and Severity Index (PASI)	Change from Baseline in PASI score	Baseline to Weeks 2, 4 and 8
Psoriasis Area and Severity Index (PASI) -50	Percent of patients who achieved PASI-50	Baseline to Week 12
Psoriasis Area and Severity Index (PASI) -75	Percent of patients who achieved PASI-75	Baseline to Week 12
Physician's Global Assessment (PGA)	Change from Baseline in PGA score	Baseline to Weeks 4, 8 and 12
Physician's Global Assessment (PGA)	Percent of patients who achieve PGA score of 0 or 1	Week 12
Psoriasis-Affected Body Surface Area (BSA)	Change from Baseline in Psoriasis-Affected BSA	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.	Baseline to Week 16

Collaborators and Investigators

• Sponsor: KoBioLabs
• Investigators: Principal Investigator: Ira Thorla, Louisiana Dermatology Associates; Principal Investigator: Jose Cardona, Indago Research and Health Center; Principal Investigator: Jennifer Soung, Southern California Dermatology, Inc; Principal Investigator: James Krell, Total Skin And Beauty Dermatology Center; Principal Investigator: Paul Yamauchi, Clinical Science Institute; Principal Investigator: Ivette Espinosa-Fernandez, Revival Research Institute; Principal Investigator: Annika Smith, Westmead Hospital; Principal Investigator: Deirdre Murrell, Premier Specialist; Principal Investigator: Lynda Spelman, Veracity Clinical Trials Ltd; Principal Investigator: Samantha Eisman, Sinclair Dermatology

Study record dates

Study Major Dates

• Study Start (Actual): November 8, 2021
• Primary Completion (Actual): November 8, 2023
• Study Completion (Actual): October 7, 2024

Study Registration Dates

• First Submitted: May 9, 2021
• First Submitted That Met QC Criteria: May 27, 2021
• First Posted (Actual): June 3, 2021

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 5, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Keywords: microbiome; Plaque psoriasis; KBL697
• Additional Relevant MeSH Terms: Skin Diseases, Papulosquamous; Skin Diseases; Psoriasis
• Other Study ID Numbers: KBL-CURE-2020-02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No