A Phase 2 Study of ZL-1102 in Patients With Chronic Plaque Psoriasis (NCT06380907) | Clinical Trial Compass
RecruitingPhase 2
A Phase 2 Study of ZL-1102 in Patients With Chronic Plaque Psoriasis
Australia250 participantsStarted 2024-05-22
Plain-language summary
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
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Adults ≥ 18 years of age.
✓. Willing and able to provide signed and dated informed consent prior to any study-related procedures, and willing and able to comply with all study procedures
✓. Clinical diagnosis of psoriasis vulgaris of at least 6 months duration as determined by Investigator via medical records or in medical history obtained from the patient, is currently eligible for topical treatment and meets all the following criteria at screening and baseline:
✓. IGA ≥ 2 (5 score system)
✓. Affected BSA 3%-15% (excluding head)
✓. Agree not to have prolonged sun exposure (e.g., recreational) during the study period. Tanning bed use or use of other light-emitting diodes (LEDs) is not allowed.
Exclusion criteria
✕. Other types of psoriasis dominant other than plaque psoriasis (e.g., psoriatic arthritis, pustular, erythrodermic, guttate, palmar, plantar, scalp or nail disease) or the lesion is not eligible for topical treatment only.
✕. Patients with any serious medical/psychiatric condition or clinically significant laboratory abnormality that would prevent study participation or place the patient at significant risk, as determined by the Investigator.
✕. Known or suspected:
✕. Severe renal insufficiency or hepatic insufficiency.
✕. History of severe depression or suicidal ideation or behavior within 2 years prior to screening.
What they're measuring
1
Efficacy of different doses of ZL-1102 compared to Vehicle at Week 16.