Clinical trial NCT04911751: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Psoriatic Plaque
Keywords: microbiome
KBL697
Plaque psoriasis
Lead sponsor: KoBioLabs
Sponsor class: INDUSTRY
First posted: 2021-06-03
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Psoriasis Area and Severity Index (PASI)
timeFrame: Baseline to Week 12
Secondary outcomes:
measure: Psoriasis Area and Severity Index (PASI)
timeFrame: Baseline to Weeks 2, 4 and 8
measure: Psoriasis Area and Severity Index (PASI) -50
timeFrame: Baseline to Week 12
measure: Psoriasis Area and Severity Index (PASI) -75
timeFrame: Baseline to Week 12
measure: Physician's Global Assessment (PGA)
timeFrame: Baseline to Weeks 4, 8 and 12
measure: Physician's Global Assessment (PGA)
timeFrame: Week 12
measure: Psoriasis-Affected Body Surface Area (BSA)
timeFrame: Baseline to Weeks 4, 8 and 12
measure: Safety measure through incidence of treatment-emergent adverse events (TEAEs)
timeFrame: Baseline to Week 16
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Total Skin and Beauty Dermatology Center
state: Alabama
city: Santa Ana
country: United States
facility: Southern California Dermatology, Inc
state: California
city: Santa Monica
country: United States
facility: Clinical Science Institute
state: California
city: Doral
country: United States
facility: Revival Research Institute
state: Florida
city: Hialeah
country: United States
facility: Indago Research and Health Center
state: Florida
city: Baton Rouge
country: United States
facility: Louisiana Dermatology Associates - Dermatology
state: Louisiana
city: Kogarah
country: Australia
facility: Premier Specialist
state: New South Wales
city: Westmead
country: Australia
facility: Westmead Hospital
state: New South Wales
city: Woolloongabba
country: Australia
facility: Veracity Clinical Trials Ltd
state: Queensland
city: East Melbourne
country: Australia
facility: Sinclair Dermatology
state: Victoria
Study officials:
affiliation: Louisiana Dermatology Associates
name: Ira Thorla
role: PRINCIPAL_INVESTIGATOR
affiliation: Indago Research and Health Center
name: Jose Cardona
role: PRINCIPAL_INVESTIGATOR
affiliation: Southern California Dermatology, Inc
name: Jennifer Soung
role: PRINCIPAL_INVESTIGATOR
affiliation: Total Skin and Beauty Dermatology Center
name: James Krell
role: PRINCIPAL_INVESTIGATOR
affiliation: Clinical Science Institute
name: Paul Yamauchi
role: PRINCIPAL_INVESTIGATOR
affiliation: Revival Research Institute
name: Ivette Espinosa-Fernandez
role: PRINCIPAL_INVESTIGATOR
affiliation: Westmead Hospital
name: Annika Smith
role: PRINCIPAL_INVESTIGATOR
affiliation: Premier Specialist
name: Deirdre Murrell
role: PRINCIPAL_INVESTIGATOR
affiliation: Veracity Clinical Trials Ltd
name: Lynda Spelman
role: PRINCIPAL_INVESTIGATOR
affiliation: Sinclair Dermatology
name: Samantha Eisman
role: PRINCIPAL_INVESTIGATOR
References: