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

Innovent Biologics (Suzhou) Co. Ltd.500 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

500

Conditions

Psoriasis

Interventions

IBI112DRUG

IBI112 by subcutaneous injection through week 16 ,and then will receive Dose 3 IBI112 by subcutaneous injection through week 48

placebo /IBI112DRUG

placebo by subcutaneous injection cross over IBI112 by subcutaneous injection at week 16 through week 48

IBI112DRUG

IBI112 by subcutaneous injection through week 16 ,and then will receive Dose 3 IBI112 by subcutaneous injection through week 48

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Locations (1)

Shanghai Skin Disease Hospital

Shanghai, Shanghai 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

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

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 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

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

Data from ClinicalTrials.gov

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