Drugs / IBI112
Trials 7
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 11 trial | ||||||
| Phase 1 | NCT04511624 | Aug 2020 → Jul 2022 | — | Innovent Biologics (Suzhou) Co. Ltd. | Completed | No outcome recorded |
| Phase 23 trials · 2 met primary | ||||||
| Phase 2 | NCT05970978 | Aug 2023 → Jul 2024 | psoriasis | Innovent Biologics (Suzhou) Co. Ltd. | Completed | No outcome recorded |
| Phase 2 | NCT05377580 | Jul 2022 → Jun 2024 | ulcerative colitis | Innovent Biologics (Suzhou) Co. Ltd. | Completed | Met primary |
| Phase 2 | NCT05003531 | Sep 2021 → Mar 2022 | psoriasis | Innovent Biologics (Suzhou) Co. Ltd. | Completed | Met primary |
| Phase 33 trials · 2 met primary | ||||||
| Phase 3 | NCT07265284 | Dec 2025 → Sep 2026 overdue | psoriasis | Innovent Biopharmaceutical Technology (Hangzhou) Co., LTD. | Recruiting | No outcome recorded |
| Phase 3 | NCT06049810 | Oct 2023 → Apr 2025 | psoriasis | Innovent Biologics (Suzhou) Co. Ltd. | Completed | Met primary |
| Phase 3 | NCT05645627 | Feb → Aug 2023 | psoriasis | Innovent Biologics (Suzhou) Co. Ltd. | Completed | Met primary |
News releases announcing trial results or a regulatory action · 7
| Date | Issuer | Release |
|---|---|---|
| 2025-12-09 | Innovent Biologics (Suzhou) Co. Ltd. | Results Innovent Announces PECONDLE® (Picankibart Injection) Phase 3 Study (CLEAR-2) Meets Endpoints, Delivering Superior Long-Term Management Solution for Moderate-to-Severe Psoriasis innoventbio.com ↗ |
| 2025-11-28 | Innovent Biologics (Suzhou) Co. Ltd. | Regulatory China's First Domestic IL-23p19 Monoclonal Antibody: Innovent's PECONDLE® (Picankibart Injection) Received NMPA Approval innoventbio.com ↗
PECONDLE® (picankibart injection) has received approval from China's National Medical Products Administration (NMPA) for the treatment of moderate-to-severe plaque psoriasis in adult patients who are candidates for systematic therapy. |
| 2024-10-29 | Innovent Biologics (Suzhou) Co. Ltd. | Results Innovent Announces Results of a Phase 2 Study of Picankibart (Anti-IL-23p19 Antibody) in Plaque Psoriasis, Showing Robust Efficacy in Patients with Prior Inadequate Response to IL-17 Biologics innoventbio.com ↗
The study demonstrated that after 16-week of treatment with picankibart, the majority of patients (64.6%,42/65) who had inadequate response to previous biologic agents (mainly those targeting IL-17), achieved skin clearance or near clearance with a sPGA of 0 or 1. |
| 2024-10-17 | Innovent Biologics (Suzhou) Co. Ltd. | Results Innovent Announces Phase 2 Clinical Study of Picankibart (IBI112) in Chinese Patients with Ulcerative Colitis Met Primary Endpoint innoventbio.com ↗
The primary and secondary endpoints were met: |
| 2024-09-26 | Innovent Biologics (Suzhou) Co. Ltd. | Regulatory Innovent Announces NMPA Acceptance of NDA for Picankibart (Anti-IL-23p19 Antibody) for Treating Moderate to Severe Plaque Psoriasis innoventbio.com ↗
This NDA acceptance is based on positive results from the Phase 3 registrational clinical study CLEAR-1 (NCT05645627) in Chinese patients with moderate to severe plaque psoriasis. |
| 2024-05-28 | Innovent Biologics (Suzhou) Co. Ltd. | Results Innovent Announces Picankibart (IBI112) Achieved Primary Endpoints in a Phase 3 Clinical Trial in Treating Moderate to Severe Plaque Psoriasis, and Plans to Submit NDA to the NMPA innoventbio.com ↗
The co-primary endpoints were successfully met, showing a rapid and significant efficacy of picankibart |
| 2022-08-10 | Innovent Biologics (Suzhou) Co. Ltd. | Results Innovent Announces Phase 2 Clinical Study of Picankibart (IBI112) in Chinese Patients with Moderate-to-severe Plaque Psoriasis Met Primary Endpoint innoventbio.com ↗
the primary endpoint was met |
All press releases naming this drug 9 releases
Evidence & citations 4 cited values
Every value below carries the sentence it was read from. 8 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | IBI112 | “Safety and pharmacokinetics of IBI112, an IL-23 monoclonal antibody, in Chinese healthy volunteers: a first-in-human phase 1 study.” PMID 37358916 ↗ Jun 20236“IBI112 200mg s.c. at week 0, 12, 24 and 36.” NCT05970978 ↗ |
| Modality | Monoclonal antibody | “IBI112, an IL-23 monoclonal antibody” PMID 37358916 ↗ Jun 2023 |
| Route | Intravenous | “single subcutaneous or intravenous dose of IBI112” NCT04511624 ↗ |
| Route | Subcutaneous | “single subcutaneous or intravenous dose of IBI112” NCT04511624 ↗ |