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

January 5, 2025 updated by: KoBioLabs

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
80

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Psoriasis Area and Severity Index (PASI)
Time Frame: Baseline to Week 12
Change from Baseline in PASI score
Baseline to Week 12

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Psoriasis Area and Severity Index (PASI)
Time Frame: Baseline to Weeks 2, 4 and 8
Change from Baseline in PASI score
Baseline to Weeks 2, 4 and 8
Psoriasis Area and Severity Index (PASI) -50
Time Frame: Baseline to Week 12
Percent of patients who achieved PASI-50
Baseline to Week 12
Psoriasis Area and Severity Index (PASI) -75
Time Frame: Baseline to Week 12
Percent of patients who achieved PASI-75
Baseline to Week 12
Physician's Global Assessment (PGA)
Time Frame: Baseline to Weeks 4, 8 and 12
Change from Baseline in PGA score
Baseline to Weeks 4, 8 and 12
Physician's Global Assessment (PGA)
Time Frame: Week 12
Percent of patients who achieve PGA score of 0 or 1
Week 12
Psoriasis-Affected Body Surface Area (BSA)
Time Frame: Baseline to Weeks 4, 8 and 12
Change from Baseline in Psoriasis-Affected BSA
Baseline to Weeks 4, 8 and 12
Safety measure through incidence of treatment-emergent adverse events (TEAEs)
Time Frame: Baseline to Week 16
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
KoBioLabs

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 8, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 8, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 7, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 9, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 27, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 3, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 5, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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