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

Innovent Biologics

Status and phase: Completed; Phase 2

Conditions: Psoriasis

Treatments: Drug: IBI112 dose 2; Drug: IBI112 dose 3; Drug: placebo; Drug: IBI112 dose 4; Drug: IBI112 dose 1

Study type: Interventional

Funder types: Industry

Identifiers

NCT05003531

CIBI112A201

Details and patient eligibility

About

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

Enrollment: 250 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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250 participants in 5 patient groups, including a placebo group

IBI112 dose 1

Experimental group

Description:

Participants will receive IBI112 dose 1 subcutaneous injection(SC)

Treatment:

Drug: IBI112 dose 1

IBI112 dose 4

Experimental group

Description:

Participants will receive IBI112 dose 4 subcutaneous injection(SC)

Treatment:

Drug: IBI112 dose 4

IBI112 dose 2

Experimental group

Description:

Participants will receive IBI112 dose 2 subcutaneous injection(SC)

Treatment:

Drug: IBI112 dose 2

IBI112 dose 3

Experimental group

Description:

Participants will receive IBI112 dose 3 subcutaneous injection(SC)

Treatment:

Drug: IBI112 dose 3

Placebo

Placebo Comparator group

Description:

Participants will receive placebo subcutaneous injection(SC)

Treatment:

Drug: placebo