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

NCT ID: NCT05970978

Last Updated: 2025-04-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 152 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-08-28
• Study Completion Date: 2025-01-26

Brief Summary

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.

Conditions

Psoriasis

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Response to previous biologic therapy

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.

Group Type: EXPERIMENTAL

regular treatment

Intervention Type: DRUG

IBI112 200mg s.c. at week 0, 12, 24 and 36.

Poor response to previous biologic therapy

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.

Group Type: EXPERIMENTAL

Intensive treatment

Intervention Type: DRUG

IBI112 200mg s.c. at week 0, 4, 8, 20 and 32.

Interventions

regular treatment

IBI112 200mg s.c. at week 0, 12, 24 and 36.

Intervention Type: DRUG

Intensive treatment

IBI112 200mg s.c. at week 0, 4, 8, 20 and 32.

Intervention Type: DRUG

Other Intervention Names

Response to previous biologic therapy; Poor response to previous biologic therapy

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Innovent Biologics (Suzhou) Co. Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Dermatology Hospital of Shandong First Medical University (Shandong Provincial Hospitial of Dermatology)

Jinan, Shandong, China

Countries

China

Other Identifiers

CIBI112A202CN

Identifier Type: -

Identifier Source: org_study_id