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A Study to Evaluate IBI112 in the Treatment of Subjects With Moderate to Severe Plaque Psoriasis

Primary Purpose

Psoriasis

Status
Active
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
IBI112 dose 2
IBI112 dose 4
IBI112 dose 1
IBI112 dose 3
placebo
Sponsored by
Innovent Biologics (Suzhou) Co. Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Psoriasis

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion criteria

  • Diagnosis of plaque-type psoriasis with or without psoriatic arthritis for at least 6 months prior to first administration of any study agent
  • Must be a candidate for phototherapy or systemic treatment for psoriasis (either new to treatment or having had previous treatment) Exclusion criteria
  • History of or current signs or symptoms of severe, progressive, or uncontrolled renal, hepatic, hematological, gastrointestinal, endocrine, pulmonary, cardiac, neurologic, cerebral, or psychiatric disease
  • Participant has history of erythrodermic psoriasis, generalized or localized pustular psoriasis, medication-induced or medication-exacerbated psoriasis, or new onset guttate psoriasis
  • Has received any therapeutic agent directly targeted to IL-12, IL-17, or IL-23within 6 months of the first administration of study agent
  • Has received any therapeutic agent directly targeted toTNF-a within 3 months of the first administration of study agent
  • Has received any conventional therapeutic agent within 1 months of the first administration of study agent
  • Has received any topic therapeutic agent within 2 weeks of the first administration of study agent

Sites / Locations

  • PeKing University People's Hostpital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Experimental

Experimental

Experimental

Placebo Comparator

Arm Label

IBI112 dose 1

IBI112 dose 4

IBI112 dose 2

IBI112 dose 3

Placebo

Arm Description

Participants will receive IBI112 dose 1 subcutaneous injection(SC)

Participants will receive IBI112 dose 4 subcutaneous injection(SC)

Participants will receive IBI112 dose 2 subcutaneous injection(SC)

Participants will receive IBI112 dose 3 subcutaneous injection(SC)

Participants will receive placebo subcutaneous injection(SC)

Outcomes

Primary Outcome Measures

Percentage of patients achieving Psoriasis Area and severity index(PASI) 90 at week 16
PASI 90 is defined as at least a 90% reduction in PASI relative to baseline

Secondary Outcome Measures

Percentage of patients achieving Psoriasis Area and severity index(PASI) 75 at week 16
PASI 75 is defined as at least a 75% reduction in PASI relative to baseline
Percentage of patients achieving Psoriasis Area and severity index(PASI) 100 at week 16
PASI 100 is defined as at least a 100% reduction in PASI relative to baseline
Percentage of patients with Physician Global Assessment(PGA) Score of Cleared(0) or Minimal(1) at week 16
PGA of psoriasis is used to determine the participant's psoriasis lesions overall at a given time point.PGA score ranges from 0-4,0=cleared, 1= minimal ,2=mild, 3= moderate, 4= marked, 5= severe
Percentage of patients with Physician Global Assessment(PGA) Score of Cleared(0) at week 16
PGA of psoriasis is used to determine the participant's psoriasis lesions overall at a given time point.PGA score ranges from 0-4,0=cleared, 1= minimal ,2=mild, 3= moderate, 4= marked, 5= severe
Change from Baseline in Dermatology life quality index(DLQI) at week 16
The DLQI is a 10-item questionnaire that measures the impact of skin disease on participant's quality of life
Percentage of patients achieving Psoriasis Area and severity index(PASI) 90 at week 52
PASI 90 is defined as at least a 90% reduction in PASI relative to baseline
Percentage of patients achieving Psoriasis Area and severity index(PASI) 100 at week 52
PASI 100 is defined as at least a 100% reduction in PASI relative to baseline
Percentage of patients achieving Psoriasis Area and severity index(PASI) 75 at week 52
PASI 75 is defined as at least a 75% reduction in PASI relative to baseline
Percentage of patients with Physician Global Assessment(PGA) Score of Cleared(0) or Minimal(1) at week 52
PGA of psoriasis is used to determine the participant's psoriasis lesions overall at a given time point.PGA score ranges from 0-4,0=cleared, 1= minimal ,2=mild, 3= moderate, 4= marked, 5= severe
Percentage of patients with Physician Global Assessment(PGA) Score of Cleared(0) at week 52
PGA of psoriasis is used to determine the participant's psoriasis lesions overall at a given time point.PGA score ranges from 0-4,0=cleared, 1= minimal ,2=mild, 3= moderate, 4= marked, 5= severe
Change from Baseline in Dermatology life quality index(DLQI) at week 52
The DLQI is a 10-item questionnaire that measures the impact of skin disease on participant's quality of life

Full Information

First Posted
August 5, 2021
Last Updated
January 20, 2023
Sponsor
Innovent Biologics (Suzhou) Co. Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT05003531
Brief Title
A Study to Evaluate IBI112 in the Treatment of Subjects With Moderate to Severe Plaque Psoriasis
Official Title
A Phase II Multicenter, Randomized, Double-blind, Parallel, Placebo-controlled Trial to Evaluate the Efficacy and Safety of IBI112 in Different Dose Regimens for the Treatment of Subjects With Moderate-to-severe Plaque Psoriasis
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
September 23, 2021 (Actual)
Primary Completion Date
April 30, 2022 (Actual)
Study Completion Date
September 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Innovent Biologics (Suzhou) Co. Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to evaluate the efficacy and safety of IBI112 administered in different dose regimens for the treatment of patients with plaque psoriasis

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psoriasis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
250 (Actual)

8. Arms, Groups, and Interventions

Arm Title
IBI112 dose 1
Arm Type
Experimental
Arm Description
Participants will receive IBI112 dose 1 subcutaneous injection(SC)
Arm Title
IBI112 dose 4
Arm Type
Experimental
Arm Description
Participants will receive IBI112 dose 4 subcutaneous injection(SC)
Arm Title
IBI112 dose 2
Arm Type
Experimental
Arm Description
Participants will receive IBI112 dose 2 subcutaneous injection(SC)
Arm Title
IBI112 dose 3
Arm Type
Experimental
Arm Description
Participants will receive IBI112 dose 3 subcutaneous injection(SC)
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Participants will receive placebo subcutaneous injection(SC)
Intervention Type
Drug
Intervention Name(s)
IBI112 dose 2
Intervention Description
Participants will receive placebo or dose 2 IBI112 SC
Intervention Type
Drug
Intervention Name(s)
IBI112 dose 4
Intervention Description
Participants will receive placebo or dose 4 IBI112 SC
Intervention Type
Drug
Intervention Name(s)
IBI112 dose 1
Intervention Description
Participants will receive placebo or dose 1 IBI112 SC
Intervention Type
Drug
Intervention Name(s)
IBI112 dose 3
Intervention Description
Participants will receive placebo or dose 3 IBI112 SC
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
Participants will receive placebo SC
Primary Outcome Measure Information:
Title
Percentage of patients achieving Psoriasis Area and severity index(PASI) 90 at week 16
Description
PASI 90 is defined as at least a 90% reduction in PASI relative to baseline
Time Frame
Week 16
Secondary Outcome Measure Information:
Title
Percentage of patients achieving Psoriasis Area and severity index(PASI) 75 at week 16
Description
PASI 75 is defined as at least a 75% reduction in PASI relative to baseline
Time Frame
Week 16
Title
Percentage of patients achieving Psoriasis Area and severity index(PASI) 100 at week 16
Description
PASI 100 is defined as at least a 100% reduction in PASI relative to baseline
Time Frame
Week 16
Title
Percentage of patients with Physician Global Assessment(PGA) Score of Cleared(0) or Minimal(1) at week 16
Description
PGA of psoriasis is used to determine the participant's psoriasis lesions overall at a given time point.PGA score ranges from 0-4,0=cleared, 1= minimal ,2=mild, 3= moderate, 4= marked, 5= severe
Time Frame
Week 16
Title
Percentage of patients with Physician Global Assessment(PGA) Score of Cleared(0) at week 16
Description
PGA of psoriasis is used to determine the participant's psoriasis lesions overall at a given time point.PGA score ranges from 0-4,0=cleared, 1= minimal ,2=mild, 3= moderate, 4= marked, 5= severe
Time Frame
Week 16
Title
Change from Baseline in Dermatology life quality index(DLQI) at week 16
Description
The DLQI is a 10-item questionnaire that measures the impact of skin disease on participant's quality of life
Time Frame
Week 16
Title
Percentage of patients achieving Psoriasis Area and severity index(PASI) 90 at week 52
Description
PASI 90 is defined as at least a 90% reduction in PASI relative to baseline
Time Frame
Week 52
Title
Percentage of patients achieving Psoriasis Area and severity index(PASI) 100 at week 52
Description
PASI 100 is defined as at least a 100% reduction in PASI relative to baseline
Time Frame
Week 52
Title
Percentage of patients achieving Psoriasis Area and severity index(PASI) 75 at week 52
Description
PASI 75 is defined as at least a 75% reduction in PASI relative to baseline
Time Frame
Week 52
Title
Percentage of patients with Physician Global Assessment(PGA) Score of Cleared(0) or Minimal(1) at week 52
Description
PGA of psoriasis is used to determine the participant's psoriasis lesions overall at a given time point.PGA score ranges from 0-4,0=cleared, 1= minimal ,2=mild, 3= moderate, 4= marked, 5= severe
Time Frame
Week 52
Title
Percentage of patients with Physician Global Assessment(PGA) Score of Cleared(0) at week 52
Description
PGA of psoriasis is used to determine the participant's psoriasis lesions overall at a given time point.PGA score ranges from 0-4,0=cleared, 1= minimal ,2=mild, 3= moderate, 4= marked, 5= severe
Time Frame
Week 52
Title
Change from Baseline in Dermatology life quality index(DLQI) at week 52
Description
The DLQI is a 10-item questionnaire that measures the impact of skin disease on participant's quality of life
Time Frame
Week 52

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria Diagnosis of plaque-type psoriasis with or without psoriatic arthritis for at least 6 months prior to first administration of any study agent Must be a candidate for phototherapy or systemic treatment for psoriasis (either new to treatment or having had previous treatment) Exclusion criteria History of or current signs or symptoms of severe, progressive, or uncontrolled renal, hepatic, hematological, gastrointestinal, endocrine, pulmonary, cardiac, neurologic, cerebral, or psychiatric disease Participant has history of erythrodermic psoriasis, generalized or localized pustular psoriasis, medication-induced or medication-exacerbated psoriasis, or new onset guttate psoriasis Has received any therapeutic agent directly targeted to IL-12, IL-17, or IL-23within 6 months of the first administration of study agent Has received any therapeutic agent directly targeted toTNF-a within 3 months of the first administration of study agent Has received any conventional therapeutic agent within 1 months of the first administration of study agent Has received any topic therapeutic agent within 2 weeks of the first administration of study agent
Facility Information:
Facility Name
PeKing University People's Hostpital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100044
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

A Study to Evaluate IBI112 in the Treatment of Subjects With Moderate to Severe Plaque Psoriasis

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