NCT04911751CompletedPhase 2
A Phase 2, Double-Blind, Randomized, Placebo-Controlled, Study to Evaluate the Efficacy and Safety of KBL697 in Patients with Moderate Plaque Type Psoriasis
KoBioLabs10 sites in 2 countries80 target enrollmentStarted: November 8, 2021Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Enrollment
- 80
- Locations
- 10
- Primary Endpoint
- Psoriasis Area and Severity Index (PASI)
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Low dose group
Experimental
39 subjects for low dose group. 26 subjects on KBL697, 13 subjects on placebo.
Intervention: KBL697 (Drug)
High dose group
Experimental
39 subjects for high dose group. 26 subjects on KBL697, 13 subjects on placebo.
Intervention: KBL697 (Drug)
Outcomes
Primary Outcomes
Psoriasis Area and Severity Index (PASI)
Time Frame: Baseline to Week 12
Change from Baseline in PASI score
Secondary Outcomes
- Psoriasis Area and Severity Index (PASI)(Baseline to Weeks 2, 4 and 8)
- Psoriasis Area and Severity Index (PASI) -75(Baseline to Week 12)
- Psoriasis Area and Severity Index (PASI) -50(Baseline to Week 12)
- Psoriasis-Affected Body Surface Area (BSA)(Baseline to Weeks 4, 8 and 12)
- Safety measure through incidence of treatment-emergent adverse events (TEAEs)(Baseline to Week 16)
- Physician's Global Assessment (PGA)(Week 12)
Investigators
Study Sites (10)
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