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

Plaque Psoriasis Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06380907
• Other study ID #: ZL-1102-002
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: June 2024
• Est. completion date: March 2026

Study information

• Verified date: April 2024
• Source: Zai Lab (Hong Kong), Ltd.
• Contact: Zai Lab 1102-002 Study Team
• Phone: 857-971-3465
• Email: Study-ZL-1102-002[@]zailaboratory.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 250
• Est. completion date: March 2026
• Est. primary completion date: February 28, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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:

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

Related Conditions & MeSH terms

• Plaque Psoriasis
• Psoriasis

Intervention

Drug:
• 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

Locations

Country	Name	City	State
Australia	Zai Lab Site 5014	Carlton	Victoria
Australia	Zai Lab Site 5016	Kotara	New South Wales
Australia	Zai Lab Site 5015	Melbourne	Victoria
Australia	Zai Lab Site 5002	Melbourne E.	Victoria
Australia	Zai Lab Site 5013	Phillip	Australian Capital Territory
Australia	Zai Lab Site 5017	Woolloongabba	Queensland

Sponsors (2)

Lead Sponsor	Collaborator
Zai Lab (Hong Kong), Ltd.	Zai Lab (US) LLC

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	16 weeks
Secondary	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.	20 Weeks
Secondary	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	20 Weeks
Secondary	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.	20 Weeks
Secondary	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.	20 Weeks
Secondary	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.	20 Weeks
Secondary	Time to achieve mPASI 50/75/90.	The time to achieve mPASI 50/75/90 through week 20.	20 Weeks
Secondary	Time to achieve IGA score of 0 or 1.	Time to achieve IGA score of 0 or 1 through Week 20.	20 Weeks
Secondary	Time to achieve 1- or 2-point improvement in IGA.	Time to achieve 1- or 2-point improvement in IGA score through Week 20.	20 Weeks
Secondary	Incidence of Treatment Related Adverse Events through Week 20.	Number of patients with treatment related adverse events through week 20.	20 Weeks
Secondary	Mean local tolerability scores (LTS)	Mean local tolerability scores at Weeks 2, 4,8, 12,16, and 20	20 Weeks
Secondary	Serum concentration of ZL-1102.	Serum concentration of ZL-1102.	16 Weeks
Secondary	Anti-drug antibody (ADA) of ZL-1102.	Incidence, prevalence, and titers of ADA of ZL-1102 in this study	16 Weeks