A Phase 2 Study of ZL-1102 in Patients With Chronic Plaque Psoriasis

Launched by ZAI LAB (HONG KONG), LTD. · Apr 23, 2024

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ClinConnect Summary

This clinical trial is studying a new treatment called ZL-1102, which is a topical gel designed for adults with chronic plaque psoriasis, a common skin condition that causes red, scaly patches. The goal of the study is to see how effective and safe different doses of this gel are compared to a placebo (an inactive substance) in helping improve psoriasis symptoms. The trial is currently looking for participants aged 18 and older who have had psoriasis for at least six months and have a certain level of severity in their skin condition.

If you or someone you know qualifies for this study, you can expect to apply the gel daily and attend regular check-ins with the research team to monitor your progress. Participants will need to agree to avoid prolonged sun exposure and certain activities during the study. It's important to note that not everyone can participate; for instance, those with different types of psoriasis, serious health issues, or a recent history of specific medical conditions may be excluded. This study aims to provide valuable information about ZL-1102's potential as a new option for managing psoriasis.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Adults ≥ 18 years of age.
• • 2. 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
• 3. 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:
• • 1. IGA ≥ 2 (5 score system)
• • 2. Affected BSA 3%-15% (excluding head)
• • 4. 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:
• • 1. 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.
• • 2. 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.
• 3. Known or suspected:
• • 1. Severe renal insufficiency or hepatic insufficiency.
• • 2. History of severe depression or suicidal ideation or behavior within 2 years prior to screening.
• 4. Positive for any of the following tests at screening:
• • 1. Human immunodeficiency virus (HIV): HIV antibody
• • 2. Hepatitis B virus (HBV): hepatitis B surface antigen (HBsAg)/hepatitis B core antibody (HBcAb)/HBV DNA
• • 3. Hepatitis C virus (HCV): HCV RNA
• • 5. Patients with active tuberculosis (TB) or untreated latent TB per local guidelines.
• • 6. History of and/or concurrent condition of inflammatory bowel disease (IBD) (ulcerative colitis and Crohn's disease), or signs/symptoms of IBD at screening that, in the opinion of the Investigator, pose an unacceptable risk to the patient if participating in the study.
• • 7. History of and/or concurrent condition of serious hypersensitivity (anaphylactic shock or anaphylactoid reaction) to IL-17 antibodies and any human or humanized biological agents.
• • 8. Patients who have a history of malignancy unless deemed cured by adequate treatment with no evidence of recurrence for ≥ 3 years before the initiation of study treatment.
• • 9. Patients with a history of chronic alcohol or drug abuse within 6 months of the initiation of study treatment, as determined by the Investigator.
• • 10. Prior exposure to ZL-1102.
• • 11. Patients who have received a live vaccine within 6 weeks prior to dosing on Day 1.
• • 12. Females who are pregnant, wishing to become pregnant during the study, or are breastfeeding