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

NCT06380907 | Recruiting Phase 2

• 1 other identifier: ZL-1102-002
• Study Type: interventional
• Target: 250
• Locations: 1 country
• Sites: 10

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

Conditions

Plaque Psoriasis

Outcome Measures

Primary Outcomes (1)

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

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

  16 weeks

Secondary Outcomes (12)

• The proportion of patients achieving IGA treatment success.

  20 Weeks

• The proportion of patients achieving IGA score of 0 or 1.

  20 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 mPASI 50/90/100 at Weeks 2, 4, 8, 12, 16, and 20.

  20 Weeks

Study Arms (5)

Arm 1

ACTIVE COMPARATOR

ZL-1102

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

Arm 2

ACTIVE COMPARATOR

ZL-1102

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

Arm 3

ACTIVE COMPARATOR

ZL-1102

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

Arm 4

PLACEBO COMPARATOR

Vehicle

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

Arm 5

PLACEBO COMPARATOR

Vehicle

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

Interventions

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

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

Arm 1

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

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

Arm 2

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

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

Arm 3

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

Vehicle 0% w/w gel BID for 16 weeks

Arm 4

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

Vehicle 0% w/w gel QD for 16 weeks

Arm 5

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Zai Lab (Hong Kong), Ltd.: lead
• Zai Lab (US) LLC: collaborator

Study Sites (10)

Zai Lab Site 5013

Phillip, Australian Capital Territory, 2606, Australia

RECRUITING

Zai Lab Site 5021

Kogarah, New South Wales, 2217, Australia

RECRUITING

Zai Lab Site 5016

Kotara, New South Wales, 2289, Australia

RECRUITING

Zai Lab Site 5020

Birtinya, Queensland, 4375, Australia

RECRUITING

Zai Lab Site 5019

Coorparoo, Queensland, 4151, Australia

RECRUITING

Zai Lab Site 5017

Woolloongabba, Queensland, 4102, Australia

RECRUITING

Zai Lab Site 5014

Carlton, Victoria, 3053, Australia

RECRUITING

Zai Lab Site 5015

Melbourne, Victoria, 3124, Australia

RECRUITING

Zai Lab Site 5002

Melbourne E., Victoria, 3002, Australia

RECRUITING

Zai Lab Site 5018

Parkville, Victoria, 3050, Australia

RECRUITING

Central Study Contacts

Zai Lab 1102-002 Study Team

CONTACT

857-971-3465; Study-ZL-1102-002@zailaboratory.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 15, 2022
• First Posted: April 24, 2024
• Study Start: May 22, 2024
• Primary Completion: February 28, 2026
• Study Completion: March 1, 2026
• Last Updated: November 5, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

AU (10)