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

Psoriatic Plaque Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04911751
• Other study ID #: KBL-CURE-2020-02
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: November 8, 2021
• Est. completion date: March 26, 2024

Study information

• Verified date: September 2022
• Source: KoBioLabs
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 80
• Est. completion date: March 26, 2024
• Est. primary completion date: November 18, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Psoriasis
• Psoriatic Plaque

Intervention

Drug:
• KBL697
1 capsule BID of KBL697 or Placebo
• KBL697
5 capsules BID of KBL697 or Placebo

Locations

Country	Name	City	State
Australia	Sinclair Dermatology	East Melbourne	Victoria
Australia	Premier Specialist	Kogarah	New South Wales
Australia	Westmead Hospital	Westmead	New South Wales
Australia	Veracity Clinical Trials Ltd	Woolloongabba	Queensland
United States	Louisiana Dermatology Associates - Dermatology	Baton Rouge	Louisiana
United States	Total Skin and Beauty Dermatology Center	Birmingham	Alabama
United States	Revival Research Institute	Doral	Florida
United States	Indago Research and Health Center	Hialeah	Florida
United States	Southern California Dermatology, Inc	Santa Ana	California
United States	Clinical Science Institute	Santa Monica	California

Sponsors (1)

Lead Sponsor	Collaborator
KoBioLabs

Countries where clinical trial is conducted

United States,  Australia, 

Outcome

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