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

Phase 2

Completed

• Conditions: Psoriasis
• Interventions: Drug: IBI112 dose 4; Drug: IBI112 dose 3; Drug: IBI112 dose 1; Drug: IBI112 dose 2; Drug: placebo

• Registration Number: NCT05003531
• Lead Sponsor: Innovent Biologics (Suzhou) Co. Ltd.

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-08-05
• Study First Submitted QC: 2021-08-05
• Study First Posted: 2021-08-12
• Study Start: 2021-09-23
• Primary Completion: 2022-03-25
• Study Completion: 2023-01-17
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-23
• Last Update Posted: 2024-01-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 250

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
IBI112 dose 4	IBI112 dose 4	Participants will receive IBI112 dose 4 subcutaneous injection(SC)
IBI112 dose 3	IBI112 dose 3	Participants will receive IBI112 dose 3 subcutaneous injection(SC)
IBI112 dose 1	IBI112 dose 1	Participants will receive IBI112 dose 1 subcutaneous injection(SC)
IBI112 dose 2	IBI112 dose 2	Participants will receive IBI112 dose 2 subcutaneous injection(SC)
Placebo	placebo	Participants will receive placebo subcutaneous injection(SC)

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Percentage of patients achieving Psoriasis Area and severity index(PASI) 75 at week 52	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 16	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 achieving Psoriasis Area and severity index(PASI) 90 at week 52	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) 75 at week 16	Week 16	PASI 75 is defined as at least a 75% reduction in PASI relative to baseline
Change from Baseline in Dermatology life quality index(DLQI) at week 16	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) 100 at week 52	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) 100 at week 16	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 52	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 16	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 52	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	Week 52	The DLQI is a 10-item questionnaire that measures the impact of skin disease on participant's quality of life

Trial Locations

Locations (1)

PeKing University People's Hostpital; 🇨🇳 Beijing, Beijing, China