A Randomized, Double-Blind, Vehicle-Controlled, Multicenter, Dose-Ranging, Phase 2 Study to Evaluate the Efficacy and Safety of Different Doses of ZL-1102 Topical gel (A Human VH IL-17A Antibody Fragment) in the Treatment of Chronic Plaque Psoriasis
This is a randomized, double-blind, vehicle-controlled, dose-ranging, phase 2 study of ZL-1102 in patients with chronic plaque psoriasis. Approximately 250 patients will be randomized at a ratio of 1:1:1:1:1 to 5 treatment arms for 16 weeks of treatment.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
65
ZL-1102 1% w/w gel BID for 16 weeks
ZL-1102 3% w/w gel BID for 16 weeks
ZL-1102 3% w/w gel QD for 16 weeks
Zai Lab Site 5013
Phillip, Australian Capital Territory, Australia
Zai Lab Site 5021
Kogarah, New South Wales, Australia
Zai Lab Site 5016
Kotara, New South Wales, Australia
Zai Lab Site 5020
Efficacy of different doses of ZL-1102 compared to Vehicle at Week 16.
The proportion of patients achieving mPASI 75 (at least a 75% reduction in mPASI score from baseline) at Week 16.
Time frame: 16 weeks
The proportion of patients achieving IGA treatment success.
The proportion of patients achieving IGA treatment success, defined as an IGA score of 0 or 1 with at least a 2-point improvement from baseline at Weeks 2, 4, 8, 12, 16,and 20.
Time frame: 20 Weeks
The proportion of patients achieving IGA score of 0 or 1.
The proportion of patients achieving an IGA score of 0 or 1 at Weeks 2, 4, 8, 12, 16, and 20
Time frame: 20 Weeks
The percent change from baseline in mPASI score.
The percent change from baseline in mPASI score at Weeks 2, 4, 8, 12, 16, and 20.
Time frame: 20 Weeks
The proportion of patients achieving mPASI 75 at Week 2, 4, 8, 12, and 20.
The proportion of patients achieving mPASI 75 at Week 2, 4, 8, 12, and 20.
Time frame: 20 Weeks
The proportion of patients achieving mPASI 50/90/100 at Weeks 2, 4, 8, 12, 16, and 20.
The proportion of patients achieving mPASII 50/90/100 at Weeks 2, 4, 8, 12,16, and 20.
Time frame: 20 Weeks
Time to achieve mPASI 50/75/90.
The time to achieve mPASI 50/75/90 through week 20.
Time frame: 20 Weeks
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Vehicle 0% w/w gel BID for 16 weeks
Vehicle 0% w/w gel QD for 16 weeks
Birtinya, Queensland, Australia
Zai Lab Site 5019
Coorparoo, Queensland, Australia
Zai Lab Site 5017
Woolloongabba, Queensland, Australia
Zai Lab Site 5014
Carlton, Victoria, Australia
Zai Lab Site 5015
Melbourne, Victoria, Australia
Zai Lab Site 5002
Melbourne E., Victoria, Australia
Zai Lab Site 5018
Parkville, Victoria, Australia
Time to achieve IGA score of 0 or 1.
Time to achieve IGA score of 0 or 1 through Week 20.
Time frame: 20 Weeks
Time to achieve 1- or 2-point improvement in IGA.
Time to achieve 1- or 2-point improvement in IGA score through Week 20.
Time frame: 20 Weeks
Incidence of Treatment Related Adverse Events through Week 20.
Number of patients with treatment related adverse events through week 20.
Time frame: 20 Weeks
Mean local tolerability scores (LTS)
Mean local tolerability scores at Weeks 2, 4,8, 12,16, and 20
Time frame: 20 Weeks
Serum concentration of ZL-1102.
Serum concentration of ZL-1102.
Time frame: 16 Weeks
Anti-drug antibody (ADA) of ZL-1102.
Incidence, prevalence, and titers of ADA of ZL-1102 in this study
Time frame: 16 Weeks