A Phase 2 Study of ZL-1102 in Patients With Chronic Plaque Psoriasis
NCT ID: NCT06380907
Last Updated: 2024-11-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
PHASE2
250 participants
INTERVENTIONAL
2024-05-22
2026-03-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
An Phase III Study of Recombinant Anti-IL-17A Humanized Monoclonal Antibody in Chinese Participants With PsO
NCT06299982
A Study to Investigate Efficacy and Safety of KBL697 in Patients with Moderate Plaque Type Psoriasis
NCT04911751
A Clinical Study of SHR-1314 Injection in the Treatment of Moderate to Severe Plaque Psoriasis in Adults
NCT04121143
A Trial Comparing SHR-1139 Injection With Placebo in Patients With Moderate-to-severe Plaque Psoriasis
NCT06875934
Study to Investigate the Safety, Tolerability, Absorption, Distribution, Metabolism, and Elimination of RWJ-445380 Administered to Patients With Plaque Psoriasis
NCT00396422
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Arm 1
ZL-1102
ZL-1102 1% w/w gel BID for 16 weeks
ZL-1102
1% w/w gel BID for 16 weeks
Arm 2
ZL-1102
ZL-1102 3% w/w gel BID for 16 weeks
ZL-1102 3% w/w gel BID for 16 weeks
Arm 3
ZL-1102
ZL-1102 3% w/w gel QD for 16 weeks
ZL-1102 3% w/w gel QD for 16 weeks
Arm 4
Vehicle
Placebo ZL-1102 0% w/w gel BID for 16 weeks
Vehicle 0% w/w gel BID for 16 weeks
Arm 5
Vehicle
Placebo ZL-1102 0% w/w gel QD for 16 weeks
Vehicle 0% w/w gel QD for 16 weeks
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
ZL-1102 1% w/w gel BID for 16 weeks
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 BID for 16 weeks
ZL-1102 3% w/w gel QD for 16 weeks
ZL-1102 3% w/w gel QD for 16 weeks
Placebo ZL-1102 0% w/w gel BID for 16 weeks
Vehicle 0% w/w gel BID for 16 weeks
Placebo ZL-1102 0% w/w gel QD for 16 weeks
Vehicle 0% w/w gel QD for 16 weeks
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
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
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
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Zai Lab (US) LLC
INDUSTRY
Zai Lab (Hong Kong), Ltd.
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Zai Lab Site 5013
Phillip, Australian Capital Territory, Australia
Zai Lab Site 5021
Kogarah, New South Wales, Australia
Zai Lab Site 5016
Kotara, New South Wales, Australia
Zai Lab Site 5020
Birtinya, Queensland, Australia
Zai Lab Site 5019
Coorparoo, Queensland, Australia
Zai Lab Site 5017
Woolloongabba, Queensland, Australia
Zai Lab Site 5014
Carlton, Victoria, Australia
Zai Lab Site 5015
Melbourne, Victoria, Australia
Zai Lab Site 5002
Melbourne E., Victoria, Australia
Zai Lab Site 5018
Parkville, Victoria, Australia
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
ZL-1102-002
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.