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

Phase 3

Completed

• Conditions: Psoriasis
• Interventions: Drug: placebo /IBI112; Drug: IBI112

• Registration Number: NCT05645627
• Lead Sponsor: Innovent Biologics (Suzhou) Co. Ltd.

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-12-01
• Study First Submitted QC: 2022-12-01
• Study First Posted: 2022-12-09
• Study Start: 2023-02-10
• Primary Completion: 2023-08-09
• Study Completion: 2024-08-01
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-28
• Last Update Posted: 2024-10-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 500

Inclusion Criteria

1. Diagnosis of plaque-type psoriasis with or without psoriatic arthritis for at least 6 months prior to first administration of any study agent
2. Must be a candidate for phototherapy or systemic treatment for psoriasis (either new to treatment or having had previous treatment)

Exclusion Criteria

1. History of or current signs or symptoms of severe, progressive, or uncontrolled renal, hepatic, hematological, gastrointestinal, endocrine, pulmonary, cardiac, neurologic, cerebral, or psychiatric disease
2. Participant has history of erythrodermic psoriasis, generalized or localized pustular psoriasis, medication-induced or medication-exacerbated psoriasis, or new onset guttate psoriasis
3. Has received any therapeutic agent directly targeted to IL-17within 6 months of the first administration of study agent
4. Has received any therapeutic agent directly targeted toTNF-a within 3 months of the first administration of study agent
5. Has received any conventional therapeutic agent within 1 months of the first administration of study agent
6. Has received any topic therapeutic agent within 2 weeks of the first administration of study agent

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 1	placebo /IBI112	Participants receive placebo through week 16,placebo participants will cross over to receive IBI112 through week 48
Group 2	IBI112	Participants receive Dose 1 IBI112 through week 16 ,and then will receive Dose 2 IBI112 through week 48
Group 3	IBI112	Participants receive Dose 1 IBI112 through week 16 ,and then will receive Dose 3 IBI112 through week 48

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
Percentage of patients achieving an static Physician's Global Assessment (sPGA) Score of Cleared (0) or Minimal (1) at Week 16	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

Name	Time	Method
Percentage of patients achieving an static Physician's Global Assessment (sPGA) Score of Cleared (0) at Week 16	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 52	Week 52	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) 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) 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 an static Physician's Global Assessment (sPGA) Score of Cleared (0) at Week 52	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) 100 at week 16	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) or Minimal (1) at Week 52	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	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	Week 52	PASI 100 is defined as at least a 100% reduction in PASI relative to baseline

Trial Locations

Locations (1)

Shanghai Skin Disease Hospital; 🇨🇳 Shanghai, Shanghai, China