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A Randomized, Double-Blind, Vehicle-Controlled, Multicenter, Dose-Ranging Phase 2 Study to Evaluate Different Doses of ZL-1102 Topical Gel in Chronic Plaque Psoriasis
Led by Zai Lab (Hong Kong), Ltd. · Updated on 2024-11-05
250
Participants Needed
10
Research Sites
N/A
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
Researchers are evaluating the safety and effectiveness of different doses of ZL-1102 topical gel in treating adults with chronic plaque psoriasis. This phase 2 study is randomized, double-blind, and vehicle-controlled, involving around 250 participants to compare multiple doses of ZL-1102 against a placebo gel over 16 weeks. Participants will be assigned to one of five groups receiving either ZL-1102 gel at varying doses and frequencies or a matching placebo gel. The treatments include ZL-1102 1% gel applied twice daily, ZL-1102 3% gel applied once or twice daily, or placebo gel applied once or twice daily. The treatment period lasts for 16 weeks, followed by assessments. During the study, participants will undergo regular evaluations including assessments of psoriasis severity using tools like IGA and mPASI scores. Researchers will monitor treatment efficacy, skin tolerability, serum drug levels, and potential side effects through week 20. Participants will be followed closely to measure improvements and adverse events, ensuring comprehensive safety monitoring throughout the study duration.
CONDITIONS
Brief 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 or older
- Able and willing to provide signed informed consent and comply with study procedures
- Clinical diagnosis of psoriasis vulgaris for at least 6 months
- Investigator's Global Assessment (IGA) score of 2 or higher on a 5-point scale
- Affected body surface area between 3% and 15%, excluding the head
- Agree to avoid prolonged sun exposure, tanning beds, or LED devices during the study period
You will not qualify if you...
- Presence of psoriasis types other than plaque psoriasis or lesions not eligible for topical treatment
- Serious medical or psychiatric conditions or significant lab abnormalities preventing participation
- Severe renal or hepatic insufficiency
- History of severe depression or suicidal behavior within 2 years
- Positive tests for HIV, hepatitis B, or hepatitis C at screening
- Active tuberculosis or untreated latent tuberculosis
- History or signs of inflammatory bowel disease posing unacceptable risk
- History of serious allergic reactions to IL-17 antibodies or related agents
- History of malignancy unless cured with no recurrence for at least 3 years
- History of chronic alcohol or drug abuse within 6 months
- Prior exposure to ZL-1102
- Receipt of live vaccine within 6 weeks before dosing
- Females who are pregnant, breastfeeding, or planning pregnancy during the study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 16 weeks
Participants receive different doses of ZL-1102 topical gel or placebo for chronic plaque psoriasis.
Visits occur regularly during the 16 weeks of treatment
Duration - 4 weeks after treatment
Participants are monitored for treatment efficacy, safety, and tolerability after completing treatment.
Visits up to Week 20 for assessments
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
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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