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

Phase 2

Completed

• Conditions: Psoriatic Plaque
• Interventions: Drug: KBL697

• Registration Number: NCT04911751
• Lead Sponsor: KoBioLabs

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-05-09
• Study First Submitted QC: 2021-05-27
• Study First Posted: 2021-06-03
• Study Start: 2021-11-08
• Primary Completion: 2023-11-08
• Study Completion: 2024-10-07
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-05
• Last Update Posted: 2025-01-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Low dose group	KBL697	39 subjects for low dose group. 26 subjects on KBL697, 13 subjects on placebo.
High dose group	KBL697	39 subjects for high dose group. 26 subjects on KBL697, 13 subjects on placebo.

Primary Outcome Measures

Name	Time	Method
Psoriasis Area and Severity Index (PASI)	Baseline to Week 12	Change from Baseline in PASI score

Secondary Outcome Measures

Name	Time	Method
Psoriasis Area and Severity Index (PASI)	Baseline to Weeks 2, 4 and 8	Change from Baseline in PASI score
Psoriasis Area and Severity Index (PASI) -75	Baseline to Week 12	Percent of patients who achieved PASI-75
Psoriasis Area and Severity Index (PASI) -50	Baseline to Week 12	Percent of patients who achieved PASI-50
Physician's Global Assessment (PGA)	Week 12	Percent of patients who achieve PGA score of 0 or 1
Psoriasis-Affected Body Surface Area (BSA)	Baseline to Weeks 4, 8 and 12	Change from Baseline in Psoriasis-Affected BSA
Safety measure through incidence of treatment-emergent adverse events (TEAEs)	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.

Trial Locations

Locations (10)

Total Skin and Beauty Dermatology Center; 🇺🇸 Birmingham, Alabama, United States

Southern California Dermatology, Inc; 🇺🇸 Santa Ana, California, United States

Clinical Science Institute; 🇺🇸 Santa Monica, California, United States

Revival Research Institute; 🇺🇸 Doral, Florida, United States

Indago Research and Health Center; 🇺🇸 Hialeah, Florida, United States

Louisiana Dermatology Associates - Dermatology; 🇺🇸 Baton Rouge, Louisiana, United States

Premier Specialist; 🇦🇺 Kogarah, New South Wales, Australia

Westmead Hospital; 🇦🇺 Westmead, New South Wales, Australia

Veracity Clinical Trials Ltd; 🇦🇺 Woolloongabba, Queensland, Australia

Sinclair Dermatology; 🇦🇺 East Melbourne, Victoria, Australia