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

Innovent Biologics (Suzhou) Co. Ltd.250 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

250

Conditions

Psoriasis

Interventions

IBI112 dose 2DRUG

Participants will receive placebo or dose 2 IBI112 SC

IBI112 dose 4DRUG

Participants will receive placebo or dose 4 IBI112 SC

IBI112 dose 1DRUG

Participants will receive placebo or dose 1 IBI112 SC

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Locations (1)

PeKing University People's Hostpital

Beijing, Beijing Municipality, China

Outcomes

Primary Outcomes

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

Time frame: Week 16

Secondary Outcomes

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

Time frame: 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

Time frame: Week 16

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

Time frame: 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

Time frame: 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

Time frame: Week 16

Percentage of patients achieving Psoriasis Area and severity index(PASI) 90 at week 52

Data from ClinicalTrials.gov

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