Back to resultsA Study to Evaluate IBI112 in the Treatment of Psoriasis With Moderate to Severe Plaque Psoriasis
Primary Purpose
Psoriasis
Status
Active
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
IBI112
placebo /IBI112
IBI112
Sponsored by
About this trial
This is an interventional treatment trial for Psoriasis
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-17within 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
- Shanghai Skin Disease Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Placebo Comparator
Experimental
Experimental
Arm Label
Group 1
Group 2
Group 3
Arm Description
Participants receive placebo through week 16,placebo participants will cross over to receive IBI112 through week 48
Participants receive Dose 1 IBI112 through week 16 ,and then will receive Dose 2 IBI112 through week 48
Participants receive Dose 1 IBI112 through week 16 ,and then will receive Dose 3 IBI112 through week 48
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
Percentage of patients achieving an static Physician's Global Assessment (sPGA) Score of Cleared (0) or Minimal (1) at Week 16
sPGA of psoriasis is used to determine the participant's psoriasis lesions overall at a given time point. sPGA score ranges from 0-4,0=cleared, 1= minimal ,2=mild, 3= moderate, 4= marked, 5= severe
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 achieving an static Physician's Global Assessment (sPGA) Score of Cleared (0) at Week 16
sPGA of psoriasis is used to determine the participant's psoriasis lesions overall at a given time point. sPGA 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 an static Physician's Global Assessment (sPGA) Score of Cleared (0) or Minimal (1) at Week 52
sPGA of psoriasis is used to determine the participant's psoriasis lesions overall at a given time point. sPGA score ranges from 0-4,0=cleared, 1= minimal ,2=mild, 3= moderate, 4= marked, 5= severe
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 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 an static Physician's Global Assessment (sPGA) Score of Cleared (0) at Week 52
sPGA of psoriasis is used to determine the participant's psoriasis lesions overall at a given time point. sPGA 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
NCT ID
NCT05645627
First Posted
December 1, 2022
Last Updated
April 11, 2023
Sponsor
Innovent Biologics (Suzhou) Co. Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT05645627
Brief Title
A Study to Evaluate IBI112 in the Treatment of Psoriasis With Moderate to Severe Plaque Psoriasis
Official Title
A Phase Ⅲ, Multicenter, Randomized, Double-blind, 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
April 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
February 10, 2023 (Actual)
Primary Completion Date
September 30, 2023 (Anticipated)
Study Completion Date
April 10, 2025 (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 in the treatment of participants with moderate to severe plaque-type 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 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
500 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Group 1
Arm Type
Placebo Comparator
Arm Description
Participants receive placebo through week 16,placebo participants will cross over to receive IBI112 through week 48
Arm Title
Group 2
Arm Type
Experimental
Arm Description
Participants receive Dose 1 IBI112 through week 16 ,and then will receive Dose 2 IBI112 through week 48
Arm Title
Group 3
Arm Type
Experimental
Arm Description
Participants receive Dose 1 IBI112 through week 16 ,and then will receive Dose 3 IBI112 through week 48
Intervention Type
Drug
Intervention Name(s)
IBI112
Intervention Description
IBI112 by subcutaneous injection through week 16 ,and then will receive Dose 3 IBI112 by subcutaneous injection through week 48
Intervention Type
Drug
Intervention Name(s)
placebo /IBI112
Intervention Description
placebo by subcutaneous injection cross over IBI112 by subcutaneous injection at week 16 through week 48
Intervention Type
Drug
Intervention Name(s)
IBI112
Intervention Description
IBI112 by subcutaneous injection through week 16 ,and then will receive Dose 3 IBI112 by subcutaneous injection through week 48
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
Title
Percentage of patients achieving an static Physician's Global Assessment (sPGA) Score of Cleared (0) or Minimal (1) at Week 16
Description
sPGA of psoriasis is used to determine the participant's psoriasis lesions overall at a given time point. sPGA score ranges from 0-4,0=cleared, 1= minimal ,2=mild, 3= moderate, 4= marked, 5= severe
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 achieving an static Physician's Global Assessment (sPGA) Score of Cleared (0) at Week 16
Description
sPGA of psoriasis is used to determine the participant's psoriasis lesions overall at a given time point. sPGA 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 an static Physician's Global Assessment (sPGA) Score of Cleared (0) or Minimal (1) at Week 52
Description
sPGA of psoriasis is used to determine the participant's psoriasis lesions overall at a given time point. sPGA 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 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 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 an static Physician's Global Assessment (sPGA) Score of Cleared (0) at Week 52
Description
sPGA of psoriasis is used to determine the participant's psoriasis lesions overall at a given time point. sPGA 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-17within 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
Shanghai Skin Disease Hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200443
Country
China
12. IPD Sharing Statement
Learn more about this trial
A Study to Evaluate IBI112 in the Treatment of Psoriasis With Moderate to Severe Plaque Psoriasis
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