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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06380907




Registration number
NCT06380907
Ethics application status
Date submitted
15/11/2022
Date registered
24/04/2024

Titles & IDs
Public title
A Phase 2 Study of ZL-1102 in Patients With Chronic Plaque Psoriasis
Scientific 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
Secondary ID [1] 0 0
ZL-1102-002
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Plaque Psoriasis 0 0
Condition category
Condition code
Skin 0 0 0 0
Dermatological conditions
Skin 0 0 0 0
Other skin conditions

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - ZL-1102 1% w/w gel BID for 16 weeks
Treatment: Drugs - ZL-1102 3% w/w gel BID for 16 weeks
Treatment: Drugs - ZL-1102 3% w/w gel QD for 16 weeks
Treatment: Drugs - Placebo ZL-1102 0% w/w gel BID for 16 weeks
Treatment: Drugs - Placebo ZL-1102 0% w/w gel QD for 16 weeks

Active comparator: Arm 1 - ZL-1102

Active comparator: Arm 2 - ZL-1102

Active comparator: Arm 3 - ZL-1102

Placebo comparator: Arm 4 - Vehicle

Placebo comparator: Arm 5 - Vehicle


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

1% w/w gel BID for 16 weeks

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

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

Treatment: Drugs: Placebo ZL-1102 0% w/w gel BID for 16 weeks
Vehicle 0% w/w gel BID for 16 weeks

Treatment: Drugs: Placebo ZL-1102 0% w/w gel QD for 16 weeks
Vehicle 0% w/w gel QD for 16 weeks
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Efficacy of different doses of ZL-1102 compared to Vehicle at Week 16.
Timepoint [1] 0 0
16 weeks
Secondary outcome [1] 0 0
The proportion of patients achieving IGA treatment success.
Timepoint [1] 0 0
20 Weeks
Secondary outcome [2] 0 0
The proportion of patients achieving IGA score of 0 or 1.
Timepoint [2] 0 0
20 Weeks
Secondary outcome [3] 0 0
The percent change from baseline in mPASI score.
Timepoint [3] 0 0
20 Weeks
Secondary outcome [4] 0 0
The proportion of patients achieving mPASI 75 at Week 2, 4, 8, 12, and 20.
Timepoint [4] 0 0
20 Weeks
Secondary outcome [5] 0 0
The proportion of patients achieving mPASI 50/90/100 at Weeks 2, 4, 8, 12, 16, and 20.
Timepoint [5] 0 0
20 Weeks
Secondary outcome [6] 0 0
Time to achieve mPASI 50/75/90.
Timepoint [6] 0 0
20 Weeks
Secondary outcome [7] 0 0
Time to achieve IGA score of 0 or 1.
Timepoint [7] 0 0
20 Weeks
Secondary outcome [8] 0 0
Time to achieve 1- or 2-point improvement in IGA.
Timepoint [8] 0 0
20 Weeks
Secondary outcome [9] 0 0
Incidence of Treatment Related Adverse Events through Week 20.
Timepoint [9] 0 0
20 Weeks
Secondary outcome [10] 0 0
Mean local tolerability scores (LTS)
Timepoint [10] 0 0
20 Weeks
Secondary outcome [11] 0 0
Serum concentration of ZL-1102.
Timepoint [11] 0 0
16 Weeks
Secondary outcome [12] 0 0
Anti-drug antibody (ADA) of ZL-1102.
Timepoint [12] 0 0
16 Weeks

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
22/05/2024
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/03/2026
Actual
Sample size
Target
250
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,QLD,VIC
Recruitment hospital [1] 0 0
Zai Lab Site 5013 - Phillip
Recruitment hospital [2] 0 0
Zai Lab Site 5021 - Kogarah
Recruitment hospital [3] 0 0
Zai Lab Site 5016 - Kotara
Recruitment hospital [4] 0 0
Zai Lab Site 5020 - Birtinya
Recruitment hospital [5] 0 0
Zai Lab Site 5019 - Coorparoo
Recruitment hospital [6] 0 0
Zai Lab Site 5017 - Woolloongabba
Recruitment hospital [7] 0 0
Zai Lab Site 5014 - Carlton
Recruitment hospital [8] 0 0
Zai Lab Site 5002 - Melbourne E.
Recruitment hospital [9] 0 0
Zai Lab Site 5015 - Melbourne
Recruitment hospital [10] 0 0
Zai Lab Site 5018 - Parkville
Recruitment postcode(s) [1] 0 0
2606 - Phillip
Recruitment postcode(s) [2] 0 0
2217 - Kogarah
Recruitment postcode(s) [3] 0 0
2289 - Kotara
Recruitment postcode(s) [4] 0 0
4375 - Birtinya
Recruitment postcode(s) [5] 0 0
4151 - Coorparoo
Recruitment postcode(s) [6] 0 0
4102 - Woolloongabba
Recruitment postcode(s) [7] 0 0
3053 - Carlton
Recruitment postcode(s) [8] 0 0
3002 - Melbourne E.
Recruitment postcode(s) [9] 0 0
3124 - Melbourne
Recruitment postcode(s) [10] 0 0
3050 - Parkville

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Zai Lab (Hong Kong), Ltd.
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
Zai Lab (US) LLC
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Zai Lab 1102-002 Study Team
Address 0 0
Country 0 0
Phone 0 0
857-971-3465
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT06380907