Testing ZL-1102 for treating chronic plaque psoriasis

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

This study is testing a new gel called ZL-1102 to see if it can help people with chronic plaque psoriasis feel better over 16 weeks.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 250 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Zai Lab (Hong Kong), Ltd. (Industry-sponsored)
• Locations: 10 sites (Phillip, Australian Capital Territory and 9 other locations)
• Trial ID: NCT06380907 on ClinicalTrials.gov

What this trial studies

This phase 2 study evaluates the efficacy and safety of ZL-1102, a topical gel, in patients with chronic plaque psoriasis. Approximately 250 participants will be randomly assigned to one of five treatment groups, receiving different doses of ZL-1102 or a placebo for 16 weeks. The study is designed to be double-blind and vehicle-controlled, ensuring that neither the participants nor the researchers know who is receiving the active treatment versus the placebo. The primary goal is to assess how well the different doses work in reducing the symptoms of psoriasis.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with a clinical diagnosis of plaque psoriasis for at least 6 months and a body surface area affected between 3% and 15%.

Not a fit: Patients with other types of psoriasis or those whose lesions are not suitable for topical treatment will not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new effective option for patients suffering from chronic plaque psoriasis.

How similar studies have performed: Other studies have shown promise with similar topical treatments for psoriasis, indicating a potential for success with this approach.

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

Where this trial is running

Phillip, Australian Capital Territory and 9 other locations

• Zai Lab Site 5013 — Phillip, Australian Capital Territory, Australia (Recruiting)
• Zai Lab Site 5021 — Kogarah, New South Wales, Australia (Recruiting)
• Zai Lab Site 5016 — Kotara, New South Wales, Australia (Recruiting)
• Zai Lab Site 5020 — Birtinya, Queensland, Australia (Recruiting)
• Zai Lab Site 5019 — Coorparoo, Queensland, Australia (Recruiting)
• Zai Lab Site 5017 — Woolloongabba, Queensland, Australia (Recruiting)
• Zai Lab Site 5014 — Carlton, Victoria, Australia (Recruiting)
• Zai Lab Site 5015 — Melbourne, Victoria, Australia (Recruiting)
• Zai Lab Site 5002 — Melbourne E., Victoria, Australia (Recruiting)
• Zai Lab Site 5018 — Parkville, Victoria, Australia (Recruiting)

Study contacts

• Study coordinator: Zai Lab 1102-002 Study Team

Conditions Plaque Psoriasis