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

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-11-08

Study Completion Date

2024-10-07

Brief Summary

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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.

Detailed Description

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Conditions

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Psoriatic Plaque

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Low dose group

39 subjects for low dose group. 26 subjects on KBL697, 13 subjects on placebo.

Group Type EXPERIMENTAL

KBL697

Intervention Type DRUG

1 capsule BID of KBL697 or Placebo

High dose group

39 subjects for high dose group. 26 subjects on KBL697, 13 subjects on placebo.

Group Type EXPERIMENTAL

KBL697

Intervention Type DRUG

5 capsules BID of KBL697 or Placebo

Interventions

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KBL697

1 capsule BID of KBL697 or Placebo

Intervention Type DRUG

KBL697

5 capsules BID of KBL697 or Placebo

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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KoBioLabs

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

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

Site Status

Southern California Dermatology, Inc

Santa Ana, California, United States

Site Status

Clinical Science Institute

Santa Monica, California, United States

Site Status

Revival Research Institute

Doral, Florida, United States

Site Status

Indago Research and Health Center

Hialeah, Florida, United States

Site Status

Louisiana Dermatology Associates - Dermatology

Baton Rouge, Louisiana, United States

Site Status

Premier Specialist

Kogarah, New South Wales, Australia

Site Status

Westmead Hospital

Westmead, New South Wales, Australia

Site Status

Veracity Clinical Trials Ltd

Woolloongabba, Queensland, Australia

Site Status

Sinclair Dermatology

East Melbourne, Victoria, Australia

Site Status

Countries

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United States Australia

Other Identifiers

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KBL-CURE-2020-02

Identifier Type: -

Identifier Source: org_study_id

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