A Study to Evaluate Efficacy and Safety of IBI112 in Adolescent Participants With Moderate to Severe Plaque Psoriasis

Innovent Biopharmaceutical Technology (Hangzhou) Co., LTD.

Status and phase: Enrolling; Phase 3

Conditions: Psoriasis

Treatments: Drug: IBI112; Drug: placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT07265284

CIBI112A304

Details and patient eligibility

About

The purpose of this study is to evaluate the efficacy and safety of IBI112 in the treatment of adolescent participants with moderate to severe plaque-type psoriasis.

Enrollment: 104 estimated patients

Sex: All

Ages: 12 to 18 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

Males or females aged 12 to 18 years; Diagnosed with plaque psoriasis and a history of psoriasis ≥6 months; suitable for phototherapy and/or systemic treatment for psoriasis.

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-17within 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 Hsa received IBI112

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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104 participants in 2 patient groups, including a placebo group

placebo

Placebo Comparator group

Description:

Participants receive placebo through week 16,placebo participants will cross over to receive IBI112 through week 44

Treatment:

Drug: placebo

IBI112

Experimental group

Description:

Participants receive IBI112 through week 44

Treatment:

Drug: IBI112