Trials Sponsors Conditions Drugs Pricing

Conditions

Plaque Psoriasis

Outcome Measures

Primary Outcomes (1)

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 Outcomes (12)

The proportion of patients achieving IGA treatment success.
20 Weeks
The proportion of patients achieving IGA score of 0 or 1.
20 Weeks
The percent change from baseline in mPASI score.
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.
20 Weeks
+7 more secondary outcomes

Study Arms (5)

Arm 1

ACTIVE COMPARATOR

ZL-1102

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

Arm 2

ACTIVE COMPARATOR

ZL-1102

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

Arm 3

ACTIVE COMPARATOR

ZL-1102

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

Interventions

ZL-1102 1% w/w gel BID for 16 weeksDrug

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

Arm 1

ZL-1102 3% w/w gel BID for 16 weeksDrug

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

Arm 2

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

Sponsors & Collaborators

Zai Lab (Hong Kong), Ltd.
Industrylead
Zai Lab (US) LLC
Industrycollaborator

Study Sites (10)

Zai Lab Site 5013

Phillip, Australian Capital Territory, 2606, Australia

Zai Lab Site 5021

Kogarah, New South Wales, 2217, Australia

Zai Lab Site 5016

Kotara, New South Wales, 2289, Australia

Zai Lab Site 5020

Birtinya, Queensland, 4375, Australia

Zai Lab Site 5019

Coorparoo, Queensland, 4151, Australia

Zai Lab Site 5017

Woolloongabba, Queensland, 4102, Australia

Zai Lab Site 5014

Carlton, Victoria, 3053, Australia

Enrollment

65 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: phase 2
Allocation: RANDOMIZED
Masking: QUADRUPLE
Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose: TREATMENT
Intervention Model: PARALLEL
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

November 15, 2022

First Posted

April 24, 2024

Study Start

May 22, 2024

Actual (reported)

Study Stopped

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

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (12)

Study Arms (5)

Arm 1

Arm 2

Arm 3

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (10)

Enrollment

Study Design

Study Record Dates

Arm 4

Arm 5

You may not qualify if:

Data Sharing

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (12)

Study Arms (5)

Arm 1

Arm 2

Arm 3

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (10)

Enrollment

Study Design

Study Record Dates

Arm 4

Arm 5

You may not qualify if:

Data Sharing

Source record

Locations