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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| regular treatment | Drug | IBI112 200mg s.c. at week 0, 12, 24 and 36. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of participants who achieve sPGA clean (0) or nearly clean (1) ,and BSA < 3% | Week 16 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dermatology Hospital of Shandong First Medical University (Shandong Provincial Hospitial of Dermatology) | Jinan | Shandong | 250000 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41591649 | Derived | 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 Mar;43(3):1274-1289. doi: 10.1007/s12325-025-03419-w. Epub 2026 Jan 27. |
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| ID | Term |
|---|---|
| D011565 | Psoriasis |
| ID | Term |
|---|---|
| D017444 | Skin Diseases, Papulosquamous |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| Intensive treatment | Drug | IBI112 200mg s.c. at week 0, 4, 8, 20 and 32. |
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| 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 |