Overview Study details Eligibility Things to know Research Study plan

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Overview Study details Eligibility Things to know Research Study plan

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

PHASE2TERMINATED

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 details:

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.

Eligibility criteria

Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.

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.

Eligibility

Age eligible for study : NA

Healthy volunteers accepted : No

Gender eligible for study: ALL

Things to know

Study dates

Study start:

Primary completion:

Study completion finish:

Study type

TREATMENT

Phase

PHASE2

Study ID

NCT06380907

Intervention or treatment

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

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

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

DRUG: Placebo ZL-1102 0% w/w gel BID for 16 weeks

DRUG: Placebo ZL-1102 0% w/w gel QD for 16 weeks

Conditions

Plaque Psoriasis

Condition: Plaque Psoriasis
DRUG: ZL-1102 1% w/w gel BID for 16 weeks and other drugs
Phillip, Australian Capital Territory, Australia and more
Sponsor: Zai Lab (Hong Kong), Ltd.

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Are you running this trial?

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Research sites nearby

Closest Location:

Zai Lab Site 5013

Select from list below to view details:

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

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Who is running the clinical trial?

ZL(KL

Zai Lab (Hong Kong), Ltd.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Participant Group/Arm	Intervention/Treatment
ACTIVE_COMPARATOR: Arm 1 ZL-1102	Drug: ZL-1102 1% w/w gel BID for 16 weeks
ACTIVE_COMPARATOR: Arm 2 ZL-1102	Drug: ZL-1102 3% w/w gel BID for 16 weeks
ACTIVE_COMPARATOR: Arm 3 ZL-1102	Drug: ZL-1102 3% w/w gel QD for 16 weeks
PLACEBO_COMPARATOR: Arm 4 Vehicle	Drug: Placebo ZL-1102 0% w/w gel BID for 16 weeks
PLACEBO_COMPARATOR: Arm 5 Vehicle	Drug: Placebo ZL-1102 0% w/w gel QD for 16 weeks

What is the study measuring?

Primary Outcome

Measure	Description	Time Frame
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 Outcome

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

Are you running this trial?If you're a clinic or sponsor, you can claim this study.

Claim this trial

References

Clinical Trials Gov: A Phase 2 Study of ZL-1102 in Patients With Chronic Plaque Psoriasis

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