- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06380907
A Phase 2 Study of ZL-1102 in Patients With 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
Study Overview
Status
Conditions
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Phase 2
Contacts and Locations
Study Contact
- Name: Zai Lab 1102-002 Study Team
- Phone Number: 857-971-3465
- Email: Study-ZL-1102-002@zailaboratory.com
Study Locations
-
-
Australian Capital Territory
-
Phillip, Australian Capital Territory, Australia, 2606
- Zai Lab Site 5013
-
-
New South Wales
-
Kotara, New South Wales, Australia, 2289
- Zai Lab Site 5016
-
-
Queensland
-
Woolloongabba, Queensland, Australia, 4102
- Zai Lab Site 5017
-
-
Victoria
-
Carlton, Victoria, Australia, 3053
- Zai Lab Site 5014
-
Melbourne, Victoria, Australia, 3124
- Zai Lab Site 5015
-
Melbourne E., Victoria, Australia
- Zai Lab Site 5002
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Arm 1
ZL-1102
|
ZL-1102 1% w/w gel BID for 16 weeks |
Active Comparator: Arm 2
ZL-1102
|
ZL-1102 3% w/w gel BID for 16 weeks
|
Active Comparator: Arm 3
ZL-1102
|
ZL-1102 3% w/w gel QD for 16 weeks
|
Placebo Comparator: Arm 4
Vehicle
|
Vehicle 0% w/w gel BID for 16 weeks
|
Placebo Comparator: Arm 5
Vehicle
|
Vehicle 0% w/w gel QD for 16 weeks
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
16 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The proportion of patients achieving IGA treatment success.
Time Frame: 20 Weeks
|
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.
|
20 Weeks
|
The proportion of patients achieving IGA score of 0 or 1.
Time Frame: 20 Weeks
|
The proportion of patients achieving an IGA score of 0 or 1 at Weeks 2, 4, 8, 12, 16, and 20
|
20 Weeks
|
The percent change from baseline in mPASI score.
Time Frame: 20 Weeks
|
The percent change from baseline in mPASI score at Weeks 2, 4, 8, 12, 16, and 20.
|
20 Weeks
|
Time to achieve IGA score of 0 or 1.
Time Frame: 20 Weeks
|
Time to achieve IGA score of 0 or 1 through Week 20.
|
20 Weeks
|
Time to achieve 1- or 2-point improvement in IGA.
Time Frame: 20 Weeks
|
Time to achieve 1- or 2-point improvement in IGA score through Week 20.
|
20 Weeks
|
Incidence of Treatment Related Adverse Events through Week 20.
Time Frame: 20 Weeks
|
Number of patients with treatment related adverse events through week 20.
|
20 Weeks
|
Serum concentration of ZL-1102.
Time Frame: 16 Weeks
|
Serum concentration of ZL-1102.
|
16 Weeks
|
Anti-drug antibody (ADA) of ZL-1102.
Time Frame: 16 Weeks
|
Incidence, prevalence, and titers of ADA of ZL-1102 in this study
|
16 Weeks
|
Time to achieve mPASI 50/75/90.
Time Frame: 20 Weeks
|
The time to achieve mPASI 50/75/90 through week 20.
|
20 Weeks
|
Mean local tolerability scores (LTS)
Time Frame: 20 Weeks
|
Mean local tolerability scores at Weeks 2, 4,8, 12,16, and 20
|
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 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.
Time Frame: 20 Weeks
|
The proportion of patients achieving mPASII 50/90/100 at Weeks 2, 4, 8, 12,16, and 20.
|
20 Weeks
|
Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ZL-1102-002
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Plaque Psoriasis
-
UCB Biopharma SRLRecruitingModerate Chronic Plaque Psoriasis | Severe Chronic Plaque Psoriasis | Mixed Guttate/Plaque PsoriasisUnited States, Canada, Puerto Rico
-
Idera Pharmaceuticals, Inc.CompletedModerate to Severe Plaque Psoriasis | Actively Extending Plaque PsoriasisUnited States
-
Fresenius Kabi SwissBioSim GmbHMerck KGaA, Darmstadt, GermanyCompletedPsoriasis | Moderate to Severe Plaque Psoriasis | Plaque Type PsoriasisUnited States, Canada, Czechia, Hungary, Russian Federation, Bulgaria, Mexico, United Kingdom, Poland, Germany, Estonia, France
-
UCB Biopharma SRLCompletedModerate to Severe Plaque Psoriasis | Chronic Plaque PsoriasisUnited States, Australia, Canada, Germany, Hungary, Korea, Republic of, Poland, Russian Federation, Taiwan
-
UCB Biopharma SRLCompletedModerate to Severe Chronic Plaque Psoriasis | Chronic Plaque PsoriasisUnited States, Australia, Belgium, Canada, Germany, Hungary, Italy, Japan, Korea, Republic of, Poland, Russian Federation, Taiwan, United Kingdom
-
UCB Biopharma SRLCompletedModerate to Severe Chronic Plaque Psoriasis | Chronic Plaque PsoriasisUnited States, Australia, Belgium, Canada, France, Germany, Netherlands, Poland, Spain, Turkey, United Kingdom
-
Biocon Biologics Inc.MEDA Pharma GmbH & Co. KG; Mylan Inc.; IQVIA Pvt. LtdCompletedHulio Interchangeability to Humira®, Comparing Pharmacokinetics, Efficacy, Safety and ImmunogenicityModerate Chronic Plaque Psoriasis | Severe Chronic Plaque PsoriasisBulgaria, Czechia, Estonia, Poland
-
UCB Biopharma SRLCompletedModerate to Severe Chronic Plaque Psoriasis | Chronic Plaque PsoriasisUnited States, Canada
-
UCB Biopharma SRLActive, not recruitingModerate to Severe Chronic Plaque Psoriasis | Chronic Plaque PsoriasisChina
-
AmgenCompletedPsoriasis-Type Psoriasis | Plaque-Type PsoriasisUnited States
Clinical Trials on ZL-1102 1% w/w gel BID for 16 weeks
-
South Valley UniversityNot yet recruiting