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

Phase 2

Completed

• Conditions: Psoriasis
• Interventions: Drug: regular treatment; Drug: Intensive treatment

• Registration Number: NCT05970978
• Lead Sponsor: Innovent Biologics (Suzhou) Co. Ltd.

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-07-24
• Study First Submitted QC: 2023-07-24
• Study First Posted: 2023-08-02
• Study Start: 2023-08-28
• Primary Completion: 2024-07-19
• Study Completion: 2025-01-26
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-24
• Last Update Posted: 2025-04-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 152

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Response to previous biologic therapy	regular treatment	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.
Poor response to previous biologic therapy	Intensive treatment	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.

Primary Outcome Measures

Name	Time	Method
Percentage of participants who achieve sPGA clean (0) or nearly clean (1) ，and BSA < 3%	Week 16

Secondary Outcome Measures

Name	Time	Method
Percentage of participants who achieve sPGA clean (0) at Week 16.	Week 16
Percentage of participants with a DLQI score of 0/1 at Week 16.	Week 16
Percentage of participants with sPGA 0/1 or sPGA 0 or DLQI 0/1 at Week 44.	Week 44
Percentage of participants who achieve sPGA 0 or 1 at week 16 and maintain that up to Week 44	Week 16 up to Week 44

Trial Locations

Locations (1)

Dermatology Hospital of Shandong First Medical University (Shandong Provincial Hospitial of Dermatology); 🇨🇳 Jinan, Shandong, China