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

Psoriasis Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05645627
• Other study ID #: CIBI112A301
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: February 10, 2023
• Est. completion date: April 10, 2025

Study information

• Verified date: April 2023
• Source: Innovent Biologics (Suzhou) Co. Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 500
• Est. completion date: April 10, 2025
• Est. primary completion date: September 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Psoriasis

Intervention

Drug:
• IBI112
IBI112 by subcutaneous injection through week 16 ,and then will receive Dose 3 IBI112 by subcutaneous injection through week 48
• placebo /IBI112
placebo by subcutaneous injection cross over IBI112 by subcutaneous injection at week 16 through week 48
• IBI112
IBI112 by subcutaneous injection through week 16 ,and then will receive Dose 3 IBI112 by subcutaneous injection through week 48

Locations

Country	Name	City	State
China	Shanghai Skin Disease Hospital	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Innovent Biologics (Suzhou) Co. Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Week 16
Primary	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	Week 16
Secondary	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	Week 16
Secondary	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	Week 16
Secondary	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	Week 16
Secondary	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	Week 16
Secondary	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	Week 52
Secondary	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	Week 52
Secondary	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	Week 52
Secondary	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	Week 52
Secondary	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	Week 52
Secondary	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	Week 52