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A Phase 2 Study of ZL-1102 in Patients With Chronic Plaque Psoriasis
Led by Zai Lab (Hong Kong), Ltd. · Updated on 2024-11-05
250
Participants Needed
10
Research Sites
92 weeks
Total Duration
On this page
Sponsors
Z
Zai Lab (Hong Kong), Ltd.
Lead Sponsor
Z
Zai Lab (US) LLC
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
CONDITIONS
Official Title
A Phase 2 Study of ZL-1102 in Patients With Chronic Plaque Psoriasis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults 18 years of age
- Willing and able to provide signed and dated informed consent and comply with all study procedures
- Clinical diagnosis of psoriasis vulgaris for at least 6 months, currently eligible for topical treatment
- Investigator's Global Assessment (IGA) score 2 (5-point scale)
- Affected body surface area (BSA) between 3% and 15%, excluding the head
- Agree not to have prolonged sun exposure or use tanning beds or other light-emitting devices during the study
You will not qualify if you...
- Other dominant types of psoriasis besides plaque psoriasis, or lesions not eligible for topical treatment only
- Serious medical or psychiatric conditions or significant lab abnormalities that pose risk or prevent participation
- Severe kidney or liver failure
- History of severe depression or suicidal behavior within 2 years prior to screening
- Positive tests for HIV, hepatitis B, or hepatitis C at screening
- Active tuberculosis or untreated latent tuberculosis
- History or current inflammatory bowel disease or related symptoms posing unacceptable risk
- History of serious allergic reactions to IL-17 antibodies or human/humanized biological agents
- History of cancer unless cured with no recurrence for at least 3 years prior to study
- History of chronic alcohol or drug abuse within 6 months prior to study
- Prior exposure to ZL-1102
- Received live vaccine within 6 weeks before dosing
- Females who are pregnant, planning pregnancy, or breastfeeding
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 10 locations
1
Zai Lab Site 5013
Phillip, Australian Capital Territory, Australia, 2606
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2
Zai Lab Site 5021
Kogarah, New South Wales, Australia, 2217
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3
Zai Lab Site 5016
Kotara, New South Wales, Australia, 2289
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4
Zai Lab Site 5020
Birtinya, Queensland, Australia, 4375
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5
Zai Lab Site 5019
Coorparoo, Queensland, Australia, 4151
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6
Zai Lab Site 5017
Woolloongabba, Queensland, Australia, 4102
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7
Zai Lab Site 5014
Carlton, Victoria, Australia, 3053
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8
Zai Lab Site 5015
Melbourne, Victoria, Australia, 3124
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9
Zai Lab Site 5002
Melbourne E., Victoria, Australia, 3002
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10
Zai Lab Site 5018
Parkville, Victoria, Australia, 3050
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Research Team
Z
Zai Lab 1102-002 Study Team
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
5
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