A Study of IBI112 in Chinese Patients With Psoriasis Who Were Previously Treated With Biologics

Innovent Biologics

Status and phase: Completed; Phase 2

Conditions: Psoriasis

Treatments: Drug: regular treatment; Drug: Intensive treatment

Study type: Interventional

Funder types: Industry

Identifiers

NCT05970978

CIBI112A202CN

Details and patient eligibility

About

This is a multicenter, open-label study aim to evaluate the efficacy and safety of IBI112 in Chinese participants with plaque psoriasis who were treated with biologics and switched to IBI112. The study will enroll 160 participants who were diagnosed with plaque psoriasis. The whole study consists of 4 weeks of screening, 32 or 36 weeks of treatment and a safety follow-up visit at Week 44.

Enrollment: 152 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. 18 to 75 years old;
2. Evaluated suitable for continuing biologic therapy for plaque psoriasis by the investigator;
3. Received previous biologic therapy with at least 4 months.

Exclusion criteria

1. Diagnosed with guttate psoriasis, pustular psoriasis, erythrodermic psoriasis, or drug-induced psoriasis (e.g., psoriasis caused by beta blockers, calcium channel inhibitors, etc.) at screening;
2. Previously treated with IBI112 or other IL-23 inhibitors;
3. Treated with two biologics for psoriasis within 4 months prior to screening;
4. Treated with topical therapy for psoriasis within 2 weeks prior to the first dose administration, or treated with systemic non-biological agents or phototherapy within 4 weeks prior to the first dose administration;
5. Treated with Natalizumab, or B/T cell regulators (e.g., Rituximab, Abatacept, or Visilizumab) within 12 months prior to the first dose administration;
6. Not willing to avoid constant sunshine and other ultraviolet light sources exposure during the study;
7. Treated with an investigational biologic within 6 months prior to the first dose administration, or any investigational therapy within 30 days, or an investigational drug within 5 half-lives, or currently participating in a clinical study.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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152 participants in 2 patient groups

Response to previous biologic therapy

Experimental group

Description:

Participants with sPGA0 or 1 score and the body surface area affected with psoriasis lesions \<3% at baseline; or PASI-75 was achieved after treated with the previous biologics. 200mg of IBI112 will be administered subcutaneously at week 0, 12, 24 and 36.

Treatment:

Drug: regular treatment

Poor response to previous biologic therapy

Experimental group

Description:

Participants with sPGA score ≥2 at baseline, or body surface area affected with psoriasis lesions ≥3% at baseline, o PASI-75 was not reached after treated with previous biologics. 200mg of IBI112 will be administered subcutaneously at week 0, 4, 8, 20 and 32.

Treatment:

Drug: Intensive treatment