Drugs / CM310

Trials 36 · a red edge is where a trial was stopped

PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 14 trials
Phase 1 NCT07040072 Oct 2025 → Jun 2027 expected head and neck squamous cell carcinoma Beijing Tongren Hospital Recruiting No outcome recorded
Phase 1 NCT06171048 Apr 2024 → Apr 2025 Keymed Biosciences Co.Ltd Unknown No outcome recorded
Phase 1 NCT05702450 Mar → Jul 2023 Keymed Biosciences Co.Ltd Completed No outcome recorded
Phase 1 NCT06161090 Sep 2019 → Jan 2020 Keymed Biosciences Co.Ltd Completed No outcome recorded
Phase 1/22 trials
Phase 1/2 NCT06162507 Dec 2023 → Jul 2024 atopic eczema Keymed Biosciences Co.Ltd Completed No outcome recorded
Phase 1/2 NCT04893941 Jul 2020 → Jan 2021 atopic eczema Keymed Biosciences Co.Ltd Completed No outcome recorded
Phase 216 trials
Phase 2 NCT07617324 Jun → Oct 2026 expected seasonal allergic rhinitis Chengdu Kangnuoxing Biopharma,Inc. Not yet recruiting No outcome recorded
Phase 2 NCT06883552 Oct 2025 → Oct 2026 expected non-small cell lung carcinoma Sichuan University Not yet recruiting No outcome recorded
Phase 2 NCT06525597 Sep 2024 → Oct 2025 overdue allergic rhinitis Keymed Biosciences Co.Ltd Recruiting No outcome recorded
Phase 2 NCT06171074 Mar 2024 → Mar 2025 seasonal allergic rhinitis Keymed Biosciences Co.Ltd Unknown No outcome recorded
Phase 2 NCT06116565 Mar 2024 → Mar 2026 atopic eczema Keymed Biosciences Co.Ltd Unknown No outcome recorded
Phase 2 NCT06300203 Mar 2024 → Jun 2026 overdue seasonal allergic rhinitis Beijing Tongren Hospital Recruiting No outcome recorded
Phase 2 NCT05908721 Aug → Dec 2023 allergic rhinitis Keymed Biosciences Co.Ltd Completed No outcome recorded
Phase 2 NCT05715320 Mar 2023 → Jul 2024 atopic eczema Keymed Biosciences Co.Ltd Completed No outcome recorded
Phase 2 NCT05579925 Oct 2022 → Jul 2023 atopic eczema Keymed Biosciences Co.Ltd Completed No outcome recorded
Phase 2 NCT05452343 Aug 2022 → Mar 2024 Keymed Biosciences Co.Ltd Unknown No outcome recorded
Phase 2/32 trials
Phase 2/3 NCT06547333 Sep 2024 → Apr 2032 expected chronic obstructive pulmonary disease CSPC ZhongQi Pharmaceutical Technology Co., Ltd. Not yet recruiting No outcome recorded
Phase 2/3 NCT05761028 Apr 2023 → May 2032 expected asthma CSPC ZhongQi Pharmaceutical Technology Co., Ltd. Recruiting No outcome recorded
Phase 37 trials
Phase 3 NCT07678931 Aug → Dec 2026 expected seasonal allergic rhinitis Chengdu Kangnuoxing Biopharma,Inc. Not yet recruiting No outcome recorded
Phase 3 NCT07210554 Nov 2025 → Mar 2028 expected bullous pemphigoid Chengdu Kangnuoxing Biopharma,Inc. Not yet recruiting No outcome recorded
Phase 3 NCT06495229 Aug 2024 → Aug 2026 overdue atopic eczema Keymed Biosciences Co.Ltd Active not recruiting No outcome recorded
Phase 3 NCT06424470 Jun 2024 → Feb 2026 prurigo nodularis Keymed Biosciences Co.Ltd Completed No outcome recorded
Phase 3 NCT06277765 Mar 2024 → Jan 2025 atopic eczema Keymed Biosciences Co.Ltd Completed No outcome recorded
Phase 3 NCT05908032 Aug → Dec 2023 seasonal allergic rhinitis Keymed Biosciences Co.Ltd Completed No outcome recorded
Phase 3 NCT05265923 Apr 2022 → Oct 2023 atopic eczema Keymed Biosciences Co.Ltd Completed No outcome recorded
Phase 41 trial
Phase 4 NCT06801353 Feb → Dec 2025 overdue chronic rhinosinusitis Beijing Tongren Hospital Not yet recruiting No outcome recorded
Phase not applicable4 trials
NCT07616609 Jun 2026 → Dec 2028 expected chronic rhinosinusitis Beijing Tongren Hospital Not yet recruiting No outcome recorded
NCT07240376 Nov 2025 → Dec 2026 expected rhinitis Huazhong University of Science and Technology Not yet recruiting No outcome recorded
NCT07143864 Sep 2025 → Dec 2026 expected primary cutaneous amyloidosis First Affiliated Hospital of Chongqing Medical University Not yet recruiting No outcome recorded
NCT05728684 Feb 2023 → Feb 2024 immunoglobulin G4-related sclerosing disease Beijing Friendship Hospital Unknown No outcome recorded
Also used as a comparator or background therapy in 1 trial
PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 3 NCT05436275 Comparator Aug 2022 → Jun 2024 chronic rhinosinusitis Keymed Biosciences Co.Ltd Completed No outcome recorded

Evidence & citations 7 cited values

Every value below carries the sentence it was read from. 41 sources stand behind the page.

FieldValueCited text
Known as CM310 “efficacy and safety of stapokibart (CM310) in uncontrolled seasonal allergic rhinitis (MERAK): an investigator-initiated, placebo-controlled, randomised, double-blind, phase 2 trial.” PMID 38356731 Feb 2024
25

“The goal of this clinical trial is to learn if Stapokibart (CM310) works to treat Non-Allergic Rhinitis with Eosinophilia Syndrome (NARES) in adults.” NCT07240376

“Study of CM310 in Patients With Uncontrolled Seasonal Allergic Rhinitis” NCT06300203

NCT06547333

NCT04893707

NCT05186909

NCT05728684

NCT05131464

NCT05908032

NCT05908721

NCT06171048

NCT05761028

NCT04805411

NCT04805398

NCT05715320

NCT06171074

NCT05452343

NCT05579925

NCT05265923

NCT04893941

NCT05702450

NCT06277765

NCT05436275

NCT06116565

NCT06161090

NCT06495229

Known as Stapokibart “BACKGROUND: Stapokibart/CM310, a humanized monoclonal antibody targeting the interleukin-4 receptor α chain, has shown promising treatment benefits in patients with...” PMID 39080181 Jul 2024
15

“efficacy and safety of stapokibart (CM310) in uncontrolled seasonal allergic rhinitis (MERAK): an investigator-initiated, placebo-controlled, randomised, double-blind, phase 2 trial.” PMID 38356731 Feb 2024

Stapokibart is a novel anti-interleukin-4 receptor α (IL-4Rα) monoclonal antibody approved for the treatment of adults with moderate-to-severe atopic dermatitis (AD).” PMID 41284735 Mar 2026

Stapokibart, a novel humanized monoclonal antibody that targets interleukin-4Rα, has been approved in China for the treatment of adults with moderate-to-severe AD.” PMID 41697953 May 2026

“An Open-label, Single-arm Clinical Study of Stapokibart Injection in Combination with Tislelizumab Injection in Patients with Non-Small Cell Lung Cancer” NCT06883552

“Pharmacokinetics, Pharmacodynamics, Safety, and Tolerability of Stapokibart in Healthy Volunteers and Adult Subjects with Atopic Dermatitis.” PMID 38833140 Jun 2024

NCT07143864

NCT07240376

NCT07617324

NCT07678931

NCT06424470

NCT06525597

NCT07040072

NCT07616609

NCT06801353

NCT07210554

Known as Stapokibart Injection Stapokibart Injection in Combination with Tislelizumab Injection in Patients with NSCLC” NCT06883552
Action Inhibit inhibits IL-4 and IL-13 signaling” PMID 37483544 Jul 2023
Modality Monoclonal antibody “CM310, a humanised anti-interleukin (IL)-4 receptor alpha monoclonal antibodyPMID 37483544 Jul 2023
Route Subcutaneous “receive subcutaneously either CM310 (300 mg) or placebo” PMID 37483544 Jul 2023
Target IL4R “CM310, a humanised anti-interleukin (IL)-4 receptor alpha monoclonal antibody” PMID 37483544 Jul 2023