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Monoclonal Antibodies
ZL-1102 Gel for Psoriasis
Phase 2
Recruiting
Research Sponsored by Zai Lab (Hong Kong), Ltd.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Must not have
Positive for any of the following tests at screening: Human immunodeficiency virus (HIV): HIV antibody, Hepatitis B virus (HBV): hepatitis B surface antigen (HBsAg)/hepatitis B core antibody (HBcAb)/HBV DNA, Hepatitis C virus (HCV): HCV RNA, Patients with active tuberculosis (TB) or untreated latent TB per local guidelines, 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, 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, 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, Patients with a history of chronic alcohol or drug abuse within 6 months of the initiation of study treatment, as determined by the Investigator, Prior exposure to ZL-1102, Patients who have received a live vaccine within 6 weeks prior to dosing on Day 1, Females who are pregnant, wishing to become pregnant during the study, or are breastfeeding
Other types of psoriasis dominant other than plaque psoriasis (e.g., pustular, erythrodermic, guttate, palmar, plantar, scalp or nail disease) or the lesion is not eligible for topical treatment only
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 20 weeks
Summary
This trial will test different doses of a topical gel called ZL-1102 to see how well it works and how safe it is for treating chronic plaque psoriasis.
Who is the study for?
This trial is for individuals with chronic plaque psoriasis. Participants should have a stable disease state and be willing to apply the study gel as directed throughout the trial period. Specific details about who can join are not provided, but typically participants must meet certain health criteria.
What is being tested?
The study is testing ZL-1102, a topical gel designed to treat plaque psoriasis by targeting IL-17A, which is involved in inflammation. Patients will be randomly assigned to receive different doses of ZL-1102 or a placebo without knowing which one they're getting.
What are the potential side effects?
Potential side effects are not listed, but since ZL-1102 targets the immune system, it may cause skin reactions at the application site or affect immune responses. The exact side effects will be monitored and recorded during the trial.
Eligibility Criteria
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
My psoriasis is not mainly plaque type or can't be treated with just creams.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 20 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~20 weeks
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Efficacy of different doses of ZL-1102 compared to Vehicle at Week 16.
Secondary study objectives
Anti-drug antibody (ADA) of ZL-1102.
Incidence of Treatment Related Adverse Events through Week 20.
Mean local tolerability scores (LTS)
+9 moreTrial Design
5Treatment groups
Active Control
Placebo Group
Group I: Arm 1Active Control1 Intervention
ZL-1102
Group II: Arm 2Active Control1 Intervention
ZL-1102
Group III: Arm 3Active Control1 Intervention
ZL-1102
Group IV: Arm 4Placebo Group1 Intervention
Vehicle
Group V: Arm 5Placebo Group1 Intervention
Vehicle
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Who is running the clinical trial?
Zai Lab (Hong Kong), Ltd.Lead Sponsor
3 Previous Clinical Trials
184 Total Patients Enrolled
Zai Lab (US) LLCIndustry Sponsor
1 Previous Clinical Trials
112 Total Patients Enrolled