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

NCT05970978 | Completed Phase 2

• 1 other identifier: CIBI112A202CN
• Study Type: interventional
• Target: 152
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Percentage of participants who achieve sPGA clean (0) or nearly clean (1) ，and BSA < 3%

  Week 16

Secondary Outcomes (4)

• 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

Study Arms (2)

Response to previous biologic therapy

EXPERIMENTAL

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.

Drug: regular treatment

Poor response to previous biologic therapy

EXPERIMENTAL

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.

Drug: Intensive treatment

Interventions

regular treatment DRUG

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

Also known as: Response to previous biologic therapy

Response to previous biologic therapy

Intensive treatment DRUG

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

Also known as: Poor response to previous biologic therapy

Poor response to previous biologic therapy

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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;
• Previously treated with IBI112 or other IL-23 inhibitors;
• Treated with two biologics for psoriasis within 4 months prior to screening;
• 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;
• Treated with Natalizumab, or B/T cell regulators (e.g., Rituximab, Abatacept, or Visilizumab) within 12 months prior to the first dose administration;
• Not willing to avoid constant sunshine and other ultraviolet light sources exposure during the study;
• 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.

Sponsors & Collaborators

• Innovent Biologics (Suzhou) Co. Ltd.: lead

Study Sites (1)

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

Jinan, Shandong, 250000, China

Location

Related Publications (1)

• Yang Q, Yang B, Gu H, Wu L, Qin L, Wang L, Li Y, Gu L, Shen Z, Zhang S, Lu J, Shi Y, Tao X, Cui Y, Zhang S, Ren H, Li L, Man X, Chen H, Xiao R, Yang Z, Ren Y, Ye R, Du H, Zhang F. Efficacy and Safety of Switching to Picankibart from Non-interleukin-23 Subunit p19 Inhibitors in Patients with Plaque Psoriasis: A Multicenter, Open-Label, Phase 2 Trial. Adv Ther. 2026 Jan 27. doi: 10.1007/s12325-025-03419-w. Online ahead of print.

  PMID: 41591649 DERIVED

MeSH Terms

Conditions

Psoriasis

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 24, 2023
• First Posted: August 2, 2023
• Study Start: August 28, 2023
• Primary Completion: July 19, 2024
• Study Completion: January 26, 2025
• Last Updated: April 27, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)