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

Last updated: November 1, 2024
Sponsor: Zai Lab (Hong Kong), Ltd.
Overall Status: Active - Recruiting

Phase

2

Condition

Warts

Skin Wounds

Psoriasis And Psoriatic Disorders

Treatment

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

ZL-1102

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

Clinical Study ID

NCT06380907
ZL-1102-002
  • Ages > 18
  • All Genders

Study 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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Adults ≥ 18 years of age.

  2. Willing and able to provide signed and dated informed consent prior to anystudy-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 determinedby Investigator via medical records or in medical history obtained from the patient,is currently eligible for topical treatment and meets all the following criteria atscreening and baseline:

  4. IGA ≥ 2 (5 score system)

  5. Affected BSA 3%-15% (excluding head)

  6. Agree not to have prolonged sun exposure (e.g., recreational) during the studyperiod. Tanning bed use or use of other light-emitting diodes (LEDs) is not allowed.

Exclusion

Exclusion Criteria:

  1. Other types of psoriasis dominant other than plaque psoriasis (e.g., psoriaticarthritis, 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 significantlaboratory abnormality that would prevent study participation or place the patientat significant risk, as determined by the Investigator.

  3. Known or suspected:

  4. Severe renal insufficiency or hepatic insufficiency.

  5. History of severe depression or suicidal ideation or behavior within 2 yearsprior to screening.

  6. Positive for any of the following tests at screening:

  7. Human immunodeficiency virus (HIV): HIV antibody

  8. Hepatitis B virus (HBV): hepatitis B surface antigen (HBsAg)/hepatitis B coreantibody (HBcAb)/HBV DNA

  9. Hepatitis C virus (HCV): HCV RNA

  10. Patients with active tuberculosis (TB) or untreated latent TB per local guidelines.

  11. History of and/or concurrent condition of inflammatory bowel disease (IBD) (ulcerative colitis and Crohn's disease), or signs/symptoms of IBD at screeningthat, in the opinion of the Investigator, pose an unacceptable risk to the patientif participating in the study.

  12. History of and/or concurrent condition of serious hypersensitivity (anaphylacticshock or anaphylactoid reaction) to IL-17 antibodies and any human or humanizedbiological agents.

  13. Patients who have a history of malignancy unless deemed cured by adequate treatmentwith no evidence of recurrence for ≥ 3 years before the initiation of studytreatment.

  14. Patients with a history of chronic alcohol or drug abuse within 6 months of theinitiation of study treatment, as determined by the Investigator.

  15. Prior exposure to ZL-1102.

  16. Patients who have received a live vaccine within 6 weeks prior to dosing on Day 1.

  17. Females who are pregnant, wishing to become pregnant during the study, or arebreastfeeding

Study Design

Total Participants: 250
Treatment Group(s): 7
Primary Treatment: ZL-1102 3% w/w gel BID for 16 weeks
Phase: 2
Study Start date:
May 22, 2024
Estimated Completion Date:
March 31, 2026

Study 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.

Connect with a study center

  • Zai Lab Site 5013

    Phillip, Australian Capital Territory 2606
    Australia

    Active - Recruiting

  • Zai Lab Site 5021

    Kogarah, New South Wales 2217
    Australia

    Active - Recruiting

  • Zai Lab Site 5016

    Kotara, New South Wales 2289
    Australia

    Active - Recruiting

  • Zai Lab Site 5020

    Birtinya, Queensland 4375
    Australia

    Active - Recruiting

  • Zai Lab Site 5019

    Coorparoo, Queensland 4151
    Australia

    Active - Recruiting

  • Zai Lab Site 5017

    Woolloongabba, Queensland 4102
    Australia

    Active - Recruiting

  • Zai Lab Site 5015

    Camberwell, Victoria 3124
    Australia

    Site Not Available

  • Zai Lab Site 5014

    Carlton, Victoria 3053
    Australia

    Active - Recruiting

  • Zai Lab Site 5015

    Melbourne, Victoria 3124
    Australia

    Active - Recruiting

  • Zai Lab Site 5002

    Melbourne E., Victoria 3002
    Australia

    Active - Recruiting

  • Zai Lab Site 5018

    Parkville, Victoria 3050
    Australia

    Active - Recruiting

  • Zai Lab Site 7006

    Surrey, British Columbia V3R6A7
    Canada

    Site Not Available

  • Zai Lab Site 7017

    Fredericton, New Brunswick E3B1G9
    Canada

    Site Not Available

  • Zai Lab Site 7009

    Barrie, Ontario L4M7G1
    Canada

    Site Not Available

  • Zai Lab Site 7002

    Hamilton, Ontario L8N1Y2
    Canada

    Site Not Available

  • Zai Lab Site 7007

    London, Ontario N6H5L5
    Canada

    Site Not Available

  • Zai Lab Site 7004

    Oakville, Ontario L6J7W5
    Canada

    Site Not Available

  • Zai Lab Site 7005

    Ottawa, Ontario K2C3N2
    Canada

    Site Not Available

  • Zai Lab Site 7003

    Peterborough, Ontario K9J5K2
    Canada

    Site Not Available

  • Zai Lab Site 7001

    Toronto, Ontario M3H5Y8
    Canada

    Site Not Available

  • Zai Lab Site 7010

    Waterloo, Ontario N2J1C4
    Canada

    Site Not Available

  • Zai Lab Site 7008

    Windsor, Ontario N8W1E6
    Canada

    Site Not Available

  • Zai Lab Site 7016

    Montréal, Quebec H2X2V1
    Canada

    Site Not Available

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.