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

Innovent Biologics

Status and phase: Completed; Phase 3

Conditions: Psoriasis

Treatments: Drug: placebo /IBI112; Drug: IBI112

Study type: Interventional

Funder types: Industry

Identifiers

NCT05645627

CIBI112A301

Details and patient eligibility

About

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.

Enrollment: 500 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

500 participants in 3 patient groups, including a placebo group

Group 1

Placebo Comparator group

Description:

Participants receive placebo through week 16,placebo participants will cross over to receive IBI112 through week 48

Treatment:

Drug: placebo /IBI112

Group 2

Experimental group

Description:

Participants receive Dose 1 IBI112 through week 16 ,and then will receive Dose 2 IBI112 through week 48

Treatment:

Drug: IBI112

Drug: IBI112

Group 3

Experimental group

Description:

Participants receive Dose 1 IBI112 through week 16 ,and then will receive Dose 3 IBI112 through week 48

Treatment:

Drug: IBI112

Drug: IBI112