A Phase 3 interventional study of CM512 and Placebo in Chronic Rhinosinusitis With Nasal Polyposis (CRSwNP), sponsored by Beijing Keymed Biosciences Co., Ltd.. Not yet recruiting at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-09-08.
Sponsored by Beijing Keymed Biosciences Co., Ltd. (part of Keymed Biosciences Co.Ltd) · Phase 3, Interventional, and Treatment
This is a multi-center, randomized, double blind, placebo-controlled Phase III study to evaluate the efficacy and safety of CM512, and to observe the life quality of subjects, the Pharmacokinetics, Pharmacodynamics and immunogenicity of CM512 in patients with chronic rhinosinusitis with nasal polyposis (CRSwNP)
This study consists of a screening/run-in period (up to 4 weeks), a treatment period (24-week double-blind treatment period + 24-week maintenance treatment period), and a 12-week safety follow-up period.
251 studies on the registry are indexed under Rhinosinusitis; 69 are open to participants now.
This study's planned enrollment of 240 is above the median of 74 across 177 interventional studies indexed under Rhinosinusitis.
Browse Rhinosinusitis studies →Beijing Keymed Biosciences Co., Ltd. is the lead sponsor of 3 studies on the registry; 2 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Biological: CM512
Drug: Placebo
subcutaneous injection
subcutaneous injection
Change from baseline in the Nasal Polyps Score (NPS) at week 24
NPS score ranges from 0-8 (sum of 0-4 for each nasal passage scores), higher score means a worse outcome.
Time frame: At week 24
Change from baseline in the Nasal Congestion Score (NCS) at week 24
Congestion Score is scored on a scale of 0 to 3.higher score means a worse outcome.
Time frame: At week 24
Start is estimated for Oct 2026; primary completion for Nov 2027, 13 months later.
Of 24 phase 3 interventional studies under Rhinosinusitis, half reached primary completion within 22 months of starting (the median), counting those still running; a quarter within 19 and three quarters within 37. This study's planned 13 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: CM512