NCT06380907

Recruiting

Phase 2

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

Zai Lab (Hong Kong), Ltd.10 sites in 1 country250 target enrollmentMay 22, 2024

InterventionsZL-1102 1% w/w gel BID for 16 weeks ZL-1102 3% w/w gel BID for 16 weeks ZL-1102 3% w/w gel QD for 16 weeks Placebo ZL-1102 0% w/w gel BID for 16 weeks Placebo ZL-1102 0% w/w gel QD for 16 weeks

DrugsZL-1102 1% w/w gel BID for 16 weeks ZL-1102 3% w/w gel BID for 16 weeks ZL-1102 3% w/w gel QD for 16 weeks Placebo ZL-1102 0% w/w gel BID for 16 weeks Placebo ZL-1102 0% w/w gel QD for 16 weeks

Overview

Phase: Phase 2
Intervention: ZL-1102 1% w/w gel BID for 16 weeks
Conditions: Plaque Psoriasis
Sponsor: Zai Lab (Hong Kong), Ltd.
Enrollment: 250
Locations: 10
Primary Endpoint: Efficacy of different doses of ZL-1102 compared to Vehicle at Week 16.
Status: Recruiting
Last Updated: last year

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief 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

Detailed Description

This is a randomized, double-blind, vehicle-controlled, dose-ranging, phase 2 study of ZL-1102 in patients with chronic plaque psoriasis. Approximately 250 patients will be randomized at a ratio of 1:1:1:1:1 to 5 treatment arms for 16 weeks of treatment.

Registry

clinicaltrials.gov

Start Date

May 22, 2024

End Date

March 2026

Last Updated

last year

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Zai Lab (Hong Kong), Ltd.

Responsible Party

Sponsor

Eligibility Criteria

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.
•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.

Arms & Interventions

Arm 1

ZL-1102

Intervention: ZL-1102 1% w/w gel BID for 16 weeks

Arm 2

ZL-1102

Intervention: ZL-1102 3% w/w gel BID for 16 weeks

Arm 3

ZL-1102

Intervention: ZL-1102 3% w/w gel QD for 16 weeks

Arm 4

Vehicle

Intervention: Placebo ZL-1102 0% w/w gel BID for 16 weeks

Arm 5

Vehicle

Intervention: Placebo ZL-1102 0% w/w gel QD for 16 weeks

Outcomes

Primary Outcomes

Efficacy of different doses of ZL-1102 compared to Vehicle at Week 16.

Time Frame: 16 weeks

The proportion of patients achieving mPASI 75 (at least a 75% reduction in mPASI score from baseline) at Week 16.

Secondary Outcomes

Time to achieve IGA score of 0 or 1.(20 Weeks)
The proportion of patients achieving IGA score of 0 or 1.(20 Weeks)
The proportion of patients achieving mPASI 50/90/100 at Weeks 2, 4, 8, 12, 16, and 20.(20 Weeks)
Mean local tolerability scores (LTS)(20 Weeks)
Serum concentration of ZL-1102.(16 Weeks)
Time to achieve 1- or 2-point improvement in IGA.(20 Weeks)
Anti-drug antibody (ADA) of ZL-1102.(16 Weeks)
The percent change from baseline in mPASI score.(20 Weeks)
The proportion of patients achieving mPASI 75 at Week 2, 4, 8, 12, and 20.(20 Weeks)
The proportion of patients achieving IGA treatment success.(20 Weeks)
Time to achieve mPASI 50/75/90.(20 Weeks)
Incidence of Treatment Related Adverse Events through Week 20.(20 Weeks)