protocolSection identificationModule nctId: NCT06380907, orgStudyIdInfo id: ZL-1102-002, briefTitle: A Phase 2 Study of ZL-1102 in Patients With Chronic Plaque Psoriasis, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06, primaryCompletionDateStruct date: 2026-02-28, completionDateStruct date: 2026-03, studyFirstPostDateStruct date: 2024-04-24, lastUpdatePostDateStruct date: 2024-04-26, sponsorCollaboratorsModule leadSponsor name: Zai Lab (Hong Kong), Ltd., class: INDUSTRY, collaborators name: Zai Lab (US) LLC, descriptionModule briefSummary: 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, conditionsModule conditions: Plaque Psoriasis, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 250, type: ESTIMATED, armsInterventionsModule interventions name: ZL-1102 1% w/w gel BID for 16 weeks, interventions name: ZL-1102 3% w/w gel BID for 16 weeks, interventions name: ZL-1102 3% w/w gel QD for 16 weeks, interventions name: Placebo ZL-1102 0% w/w gel BID for 16 weeks, interventions name: Placebo ZL-1102 0% w/w gel QD for 16 weeks, outcomesModule primaryOutcomes measure: Efficacy of different doses of ZL-1102 compared to Vehicle at Week 16., secondaryOutcomes measure: The proportion of patients achieving IGA treatment success., secondaryOutcomes measure: The proportion of patients achieving IGA score of 0 or 1., secondaryOutcomes measure: The percent change from baseline in mPASI score., secondaryOutcomes measure: The proportion of patients achieving mPASI 75 at Week 2, 4, 8, 12, and 20., secondaryOutcomes measure: The proportion of patients achieving mPASI 50/90/100 at Weeks 2, 4, 8, 12, 16, and 20., secondaryOutcomes measure: Time to achieve mPASI 50/75/90., secondaryOutcomes measure: Time to achieve IGA score of 0 or 1., secondaryOutcomes measure: Time to achieve 1- or 2-point improvement in IGA., secondaryOutcomes measure: Incidence of Treatment Related Adverse Events through Week 20., secondaryOutcomes measure: Mean local tolerability scores (LTS), secondaryOutcomes measure: Serum concentration of ZL-1102., secondaryOutcomes measure: Anti-drug antibody (ADA) of ZL-1102., eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Zai Lab Site 5013, city: Phillip, state: Australian Capital Territory, zip: 2606, country: Australia, geoPoint lat: -31.13333, lon: 150.85, locations facility: Zai Lab Site 5016, city: Kotara, state: New South Wales, zip: 2289, country: Australia, geoPoint lat: -32.95, lon: 151.68333, locations facility: Zai Lab Site 5017, city: Woolloongabba, state: Queensland, zip: 4102, country: Australia, geoPoint lat: -27.48855, lon: 153.03655, locations facility: Zai Lab Site 5014, city: Carlton, state: Victoria, zip: 3053, country: Australia, geoPoint lat: -37.8, lon: 144.96667, locations facility: Zai Lab Site 5002, city: Melbourne E., state: Victoria, country: Australia, geoPoint lat: -37.81667, lon: 144.9879, locations facility: Zai Lab Site 5015, city: Melbourne, state: Victoria, zip: 3124, country: Australia, geoPoint lat: -37.814, lon: 144.96332, hasResults: False