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TerminatedNCT06380907Updated Aug 10, 2026

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

A Phase 2 interventional study of ZL-1102 1% w/w gel BID for 16 weeks and ZL-1102 3% w/w gel BID for 16 weeks in Plaque Psoriasis, sponsored by Zai Lab (Hong Kong), Ltd.. Terminated at 10 sites in Australia. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-10.

Sponsored by Zai Lab (Hong Kong), Ltd. · Phase 2, Interventional, and Treatment

Why this study was terminated
Sponsor decision
Phase
Phase 2
Study type
Interventional
Enrollment
65
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

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

Read the 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.

02

Conditions studied

  • Plaque Psoriasis
03

In context

Lead sponsor

Zai Lab (Hong Kong), Ltd. is the lead sponsor of 4 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
65 participants (actual)

Study arms

  • Active comparator
    Arm 1

    ZL-1102

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

  • Active comparator
    Arm 2

    ZL-1102

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

  • Active comparator
    Arm 3

    ZL-1102

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

  • Placebo comparator
    Arm 4

    Vehicle

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

  • Placebo comparator
    Arm 5

    Vehicle

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

Interventions

  • DrugZL-1102 1% w/w gel BID for 16 weeks

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

  • DrugZL-1102 3% w/w gel BID for 16 weeks

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

  • DrugZL-1102 3% w/w gel QD for 16 weeks

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

  • DrugPlacebo ZL-1102 0% w/w gel BID for 16 weeks

    Vehicle 0% w/w gel BID for 16 weeks

  • DrugPlacebo ZL-1102 0% w/w gel QD for 16 weeks

    Vehicle 0% w/w gel QD for 16 weeks

06

What researchers measure

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.

    Time frame: 16 weeks

Secondary outcomes

  1. The proportion of patients achieving IGA treatment success.

    The proportion of patients achieving IGA treatment success, defined as an IGA score of 0 or 1 with at least a 2-point improvement from baseline at Weeks 2, 4, 8, 12, 16,and 20.

    Time frame: 20 Weeks

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

    The proportion of patients achieving an IGA score of 0 or 1 at Weeks 2, 4, 8, 12, 16, and 20

    Time frame: 20 Weeks

  3. The percent change from baseline in mPASI score.

    The percent change from baseline in mPASI score at Weeks 2, 4, 8, 12, 16, and 20.

    Time frame: 20 Weeks

  4. The proportion of patients achieving mPASI 75 at Week 2, 4, 8, 12, and 20.

    The proportion of patients achieving mPASI 75 at Week 2, 4, 8, 12, and 20.

    Time frame: 20 Weeks

  5. The proportion of patients achieving mPASI 50/90/100 at Weeks 2, 4, 8, 12, 16, and 20.

    The proportion of patients achieving mPASII 50/90/100 at Weeks 2, 4, 8, 12,16, and 20.

    Time frame: 20 Weeks

  6. Time to achieve mPASI 50/75/90.

    The time to achieve mPASI 50/75/90 through week 20.

    Time frame: 20 Weeks

  7. Time to achieve IGA score of 0 or 1.

    Time to achieve IGA score of 0 or 1 through Week 20.

    Time frame: 20 Weeks

  8. Time to achieve 1- or 2-point improvement in IGA.

    Time to achieve 1- or 2-point improvement in IGA score through Week 20.

    Time frame: 20 Weeks

  9. Incidence of Treatment Related Adverse Events through Week 20.

    Number of patients with treatment related adverse events through week 20.

    Time frame: 20 Weeks

  10. Mean local tolerability scores (LTS)

    Mean local tolerability scores at Weeks 2, 4,8, 12,16, and 20

    Time frame: 20 Weeks

  11. Serum concentration of ZL-1102.

    Serum concentration of ZL-1102.

    Time frame: 16 Weeks

  12. Anti-drug antibody (ADA) of ZL-1102.

    Incidence, prevalence, and titers of ADA of ZL-1102 in this study

    Time frame: 16 Weeks

07

Study locations

10 sites
  • Zai Lab Site 5013
    Phillip, Australian Capital Territory 2606, Australia
  • Zai Lab Site 5021
    Kogarah, New South Wales 2217, Australia
  • Zai Lab Site 5016
    Kotara, New South Wales 2289, Australia
  • Zai Lab Site 5020
    Birtinya, Queensland 4375, Australia
  • Zai Lab Site 5019
    Coorparoo, Queensland 4151, Australia
  • Zai Lab Site 5017
    Woolloongabba, Queensland 4102, Australia
  • Zai Lab Site 5014
    Carlton, Victoria 3053, Australia
  • Zai Lab Site 5015
    Melbourne, Victoria 3124, Australia
  • Zai Lab Site 5002
    Melbourne E., Victoria 3002, Australia
  • Zai Lab Site 5018
    Parkville, Victoria 3050, Australia
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 10, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06380907
Lead sponsor
Zai Lab (Hong Kong), Ltd.
Collaborators
Zai Lab (US) LLC
Responsible party
Sponsor
First posted
Apr 24, 2024
Start date
May 22, 2024
Primary completion
Dec 16, 2025
Completion
Dec 16, 2025
Last update
Aug 10, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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