Plaque PsoriasisPhase 2NCT06380907
A Phase 2 Study of ZL-1102 in Patients With Chronic Plaque Psoriasis
A Phase 2 study testing ZL-1102 1% w/w gel BID for 16 weeks, ZL-1102 3% w/w gel BID for 16 weeks and ZL-1102 3% w/w gel QD for 16 weeks in people with Plaque Psoriasis, run by Zai Lab (Hong Kong), Ltd. at 10 sites in Australia.
Trial 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 more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Plaque Psoriasis
- What is being tested?
- ZL-1102 1% w/w gel BID for 16 weeks, ZL-1102 3% w/w gel BID for 16 weeks and ZL-1102 3% w/w gel QD for 16 weeks
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 65 participants
- Where
- 10 sitesAustralia
- Study dates
- 22 May 2024to 16 Dec 2025
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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:
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- 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
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
Australia10 sites
Zai Lab Site 5020
Birtinya, Queensland, 4375
Zai Lab Site 5014
Carlton, Victoria, 3053
Zai Lab Site 5019
Coorparoo, Queensland, 4151
Zai Lab Site 5021
Kogarah, New South Wales, 2217
Zai Lab Site 5016
Kotara, New South Wales, 2289
Zai Lab Site 5015
Melbourne, Victoria, 3124
Zai Lab Site 5002
Melbourne E., Victoria, 3002
Zai Lab Site 5018
Parkville, Victoria, 3050
Zai Lab Site 5013
Phillip, Australian Capital Territory, 2606
Zai Lab Site 5017
Woolloongabba, Queensland, 4102
About this study
Official title: 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
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.
- Conditions
- Plaque Psoriasis
- Being tested
- ZL-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
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ZL-1102 1% w/w gel BID for 16 weeksDrug
ZL-1102
1% w/w gel BID for 16 weeks
ZL-1102 3% w/w gel BID for 16 weeksDrug
ZL-1102 3% w/w gel BID for 16 weeks
ZL-1102 3% w/w gel QD for 16 weeksDrug
ZL-1102 3% w/w gel QD for 16 weeks
Placebo ZL-1102 0% w/w gel BID for 16 weeksDrug
Vehicle 0% w/w gel BID for 16 weeks
Placebo ZL-1102 0% w/w gel QD for 16 weeksDrug
Vehicle 0% w/w gel QD for 16 weeks
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Active comparator | ZL-1102 Receives: Drug: ZL-1102 1% w/w gel BID for 16 weeks |
| Arm 2 | Active comparator | ZL-1102 Receives: Drug: ZL-1102 3% w/w gel BID for 16 weeks |
| Arm 3 | Active comparator | ZL-1102 Receives: Drug: ZL-1102 3% w/w gel QD for 16 weeks |
| Arm 4 | Placebo comparator | Vehicle Receives: Drug: Placebo ZL-1102 0% w/w gel BID for 16 weeks |
| Arm 5 | Placebo comparator | Vehicle Receives: Drug: Placebo ZL-1102 0% w/w gel QD for 16 weeks |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 16 weeks
Secondary outcomes (12)
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.
Measured: 20 Weeks
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
Measured: 20 Weeks
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.
Measured: 20 Weeks
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.
Measured: 20 Weeks
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.
Measured: 20 Weeks
Time to achieve mPASI 50/75/90.
The time to achieve mPASI 50/75/90 through week 20.
Measured: 20 Weeks
Time to achieve IGA score of 0 or 1.
Time to achieve IGA score of 0 or 1 through Week 20.
Measured: 20 Weeks
Time to achieve 1- or 2-point improvement in IGA.
Time to achieve 1- or 2-point improvement in IGA score through Week 20.
Measured: 20 Weeks
Incidence of Treatment Related Adverse Events through Week 20.
Number of patients with treatment related adverse events through week 20.
Measured: 20 Weeks
Mean local tolerability scores (LTS)
Mean local tolerability scores at Weeks 2, 4,8, 12,16, and 20
Measured: 20 Weeks
Serum concentration of ZL-1102.
Serum concentration of ZL-1102.
Measured: 16 Weeks
Anti-drug antibody (ADA) of ZL-1102.
Incidence, prevalence, and titers of ADA of ZL-1102 in this study
Measured: 16 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2024
- Study start22 May 2024
- Primary completion16 Dec 2025
- Study completion16 Dec 2025
Why it stopped: Sponsor decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Plaque PsoriasisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zai Lab (Hong Kong), Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Zai Lab (US) LLC
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06380907
- Sponsor's protocol ID
- ZL-1102-002
- Status last verified
- Aug 2026
- First submitted
- 15 Nov 2022
- Last updated
- 10 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06380907
- Acronym / sponsor ID
- ZL-1102-002
- Conditions
- Plaque Psoriasis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Sponsor decision
- Enrolment
- 65 participants (actual)
- Lead sponsor
- Zai Lab (Hong Kong), Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Zai Lab (US) LLC
- Study start
- 22 May 2024 (actual)
- Primary completion
- 16 Dec 2025 (actual)
- Study completion
- 16 Dec 2025 (actual)
- First posted
- 24 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Active comparator | Drug: ZL-1102 1% w/w gel BID for 16 weeksZL-1102 |
| Arm 2 | Active comparator | Drug: ZL-1102 3% w/w gel BID for 16 weeksZL-1102 |
| Arm 3 | Active comparator | Drug: ZL-1102 3% w/w gel QD for 16 weeksZL-1102 |
| Arm 4 | Placebo comparator | Drug: Placebo ZL-1102 0% w/w gel BID for 16 weeksVehicle |
| Arm 5 | Placebo comparator | Drug: Placebo ZL-1102 0% w/w gel QD for 16 weeksVehicle |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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:
- 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.
Key exclusion criteria (17 listed)
- 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:
- Positive for any of the following tests at screening:
- Patients with active tuberculosis (TB) or untreated latent TB per local guidelines.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ZL-1102 1% w/w gel BID for 16 weeksZL-1102 1% w/w gel BID for 16 weeks | Drug | Arm 1 |
| ZL-1102 3% w/w gel BID for 16 weeksZL-1102 3% w/w gel BID for 16 weeks | Drug | Arm 2 |
| ZL-1102 3% w/w gel QD for 16 weeksZL-1102 3% w/w gel QD for 16 weeks | Drug | Arm 3 |
| Placebo ZL-1102 0% w/w gel BID for 16 weeksVehicle 0% w/w gel BID for 16 weeks | Drug | Arm 4 |
| Placebo ZL-1102 0% w/w gel QD for 16 weeksVehicle 0% w/w gel QD for 16 weeks | Drug | Arm 5 |
Primary outcome
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.
12 secondary outcomes
The proportion of patients achieving IGA treatment success.
Time frame: 20 Weeks
The proportion of patients achieving IGA score of 0 or 1.
Time frame: 20 Weeks
The percent change from baseline in mPASI score.
Time frame: 20 Weeks
The proportion of patients achieving mPASI 75 at Week 2, 4, 8, 12, and 20.
Time frame: 20 Weeks
The proportion of patients achieving mPASI 50/90/100 at Weeks 2, 4, 8, 12, 16, and 20.
Time frame: 20 Weeks
Time to achieve mPASI 50/75/90.
Time frame: 20 Weeks
Time to achieve IGA score of 0 or 1.
Time frame: 20 Weeks
Time to achieve 1- or 2-point improvement in IGA.
Time frame: 20 Weeks
Incidence of Treatment Related Adverse Events through Week 20.
Time frame: 20 Weeks
Mean local tolerability scores (LTS)
Time frame: 20 Weeks
Serum concentration of ZL-1102.
Time frame: 16 Weeks
Anti-drug antibody (ADA) of ZL-1102.
Time frame: 16 Weeks
Results and safety
The study was stopped early (reason given: Sponsor decision). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ZL-1102 1% w/w gel BID for 16 weeks, ZL-1102 3% w/w gel BID for 16 weeks and ZL-1102 3% w/w gel QD for 16 weeks in people with Plaque Psoriasis, run by Zai Lab (Hong Kong), Ltd. at 10 sites in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 10 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Sponsor decision). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy of different doses of ZL-1102 compared to Vehicle at Week 16. (time frame: 16 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Aug 2026.