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

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

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

Study Overview

• Status: Completed
• Conditions: Psoriasis
• Intervention / Treatment: Drug: IBI112 dose 1; Drug: IBI112 dose 4; Drug: IBI112 dose 2; Drug: IBI112 dose 3; Drug: placebo

• Study Type: Interventional
• Enrollment (Actual): 250
• Phase: Phase 2

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100044
      • PeKing University People's Hostpital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: IBI112 dose 1; Participants will receive IBI112 dose 1 subcutaneous injection(SC)	Drug: IBI112 dose 1; Participants will receive placebo or dose 1 IBI112 SC
Experimental: IBI112 dose 4; Participants will receive IBI112 dose 4 subcutaneous injection(SC)	Drug: IBI112 dose 4; Participants will receive placebo or dose 4 IBI112 SC
Experimental: IBI112 dose 2; Participants will receive IBI112 dose 2 subcutaneous injection(SC)	Drug: IBI112 dose 2; Participants will receive placebo or dose 2 IBI112 SC
Experimental: IBI112 dose 3; Participants will receive IBI112 dose 3 subcutaneous injection(SC)	Drug: IBI112 dose 3; Participants will receive placebo or dose 3 IBI112 SC
Placebo Comparator: Placebo; Participants will receive placebo subcutaneous injection(SC)	Drug: placebo; Participants will receive placebo SC

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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
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
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	Week 16
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	Week 16
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	Week 52
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	Week 52

Collaborators and Investigators

• Sponsor: Innovent Biologics (Suzhou) Co. Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): September 23, 2021
• Primary Completion (Actual): March 25, 2022
• Study Completion (Actual): January 17, 2023

Study Registration Dates

• First Submitted: August 5, 2021
• First Submitted That Met QC Criteria: August 5, 2021
• First Posted (Actual): August 12, 2021

Study Record Updates

• Last Update Posted (Actual): January 25, 2024
• Last Update Submitted That Met QC Criteria: January 23, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Skin Diseases, Papulosquamous; Psoriasis
• Other Study ID Numbers: CIBI112A201

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No