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NCT04805398
Subcutaneously CM310/Placebo in Patients With Chronic Rhinosinusitis With Nasal Polyposis (CROWNS-1)
Phase 2 trial testing CM310 in Chronic Rhinosinusitis (Diagnosis) in 56 participants. Completed in 18 March 2022.
18 March 2022
Quick facts
| Lead sponsor | Keymed Biosciences Co.Ltd |
|---|---|
| Phase | Phase 2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | quadruple |
| Primary purpose | treatment |
| Enrollment | 56 |
| Start date | 6 April 2021 |
| Primary completion | 18 March 2022 |
| Estimated completion | 18 March 2022 |
| Sites | 19 locations across China |
Drugs / interventions tested
- CM310 — full drug profile →
- Placebo
Conditions studied
- Chronic Rhinosinusitis (Diagnosis) — all drugs for Chronic Rhinosinusitis (Diagnosis) →
- Nasal Polyps — all drugs for Nasal Polyps →
Sponsor
Keymed Biosciences Co.Ltd — full company profile →
Who can join
Adults 18 to 70, any sex, with Chronic Rhinosinusitis (Diagnosis) or Nasal Polyps. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This is a multi-center, randomized, double blind, placebo-controlled study to evaluate the efficacy, safety, PK, PD and immumogenicity of CM310 in comparison to placebo in addition to a background treatment of mometasone furcate nasal spray (MFNS) in patients with chronic rhinosinusitis with nasal polyposis (CRSwNP).
Publications & conference data
6 peer-reviewed publications reference this trial (live from Europe PMC):
-
Biologics for chronic rhinosinusitis.
Chong LY, Piromchai P, Sharp S, Snidvongs K, et al · · 2021 · cited 44× · PMID 33710614 · DOI 10.1002/14651858.cd013513.pub3 -
Efficacy and safety of CM310 in severe eosinophilic chronic rhinosinusitis with nasal polyps (CROWNS-1): a multicentre, randomised, double-blind, placebo-controlled phase 2 clinical trial.
Zhang Y, Yan B, Shen S, Song X, et al · · 2023 · cited 43× · PMID 37483544 · DOI 10.1016/j.eclinm.2023.102076 -
Chinese Position Paper on Biologic Therapy for Chronic Rhinosinusitis With Nasal Polyps.
Xian M, Yan B, Song X, Chen J, et al · · 2025 · cited 6× · PMID 40042059 · DOI 10.1111/all.16519 -
Targeted Biologic Therapies in Severe Asthma: Mechanisms, Biomarkers, and Clinical Applications.
Văruț RM, Dalia D, Radivojevic K, Trasca DM, et al · · 2025 · cited 4× · PMID 40732309 · DOI 10.3390/ph18071021 -
Optimizing Biologic Treatment Selection in Chronic Rhinosinusitis with Nasal Polyps: A Network Meta-Analysis of Efficacy and Safety Across 22 RCTs.
Safia A, Khater A, Abd Elhadi U, Merchavy S, et al · · 2025 · cited 1× · PMID 41155574 · DOI 10.3390/ph18101455 -
Evaluating stapokibart in the treatment of seasonal allergic rhinitis.
Wang M, Li J, Zhang L, Zhang Y. · · 2025 · PMID 40900141 · DOI 10.1080/1750743x.2025.2554562
Verify or expand the search:
- PubMed search for NCT04805398
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of CM310
Trials testing the same drug.
- NCT06547333 — A Study of CM310 in Subjects With Moderate to Severe Chronic Obstructive Pulmonary Disease · Phase 2, PHASE3 · not yet recruiting
- NCT06495229 — Study of CM310 in Adolescent Subjects With Atopic Dermatis · Phase 3 · active not recruiting
- NCT06171048 — Study Evaluating the Pharmacokinetics of CM310 in Healthy Subjects · Phase 1 · unknown
- NCT06171074 — Study of CM310 in Subjects With Seasonal Allergic Rhinitis · Phase 2 · unknown
- NCT06116565 — A Study of CM310 in Subjects With Moderate-to-Severe Atopic Dermatitis · Phase 2 · unknown
Other recruiting trials for Chronic Rhinosinusitis (Diagnosis)
Currently open trials in the same condition.
- NCT05427695 — Topical Probiotic Sinus Irrigations for Treating Chronic Sinusitis · Phase 2 · recruiting
- NCT06986629 — Effect of Photobiostimulation Versus Pulsed Electromagnetic Field on Quality of Life in Adults With Chronic Rhinosinusit · NA · recruiting
- NCT05882903 — The Effect of Intra-sinus Application of Betamethasone Dipropionate Nasal Cream on Patients with Chronic Rhinosinusitis · Phase 2 · recruiting
- NCT05857228 — Viral and Epigenetic Influences in CRSwNP · active not recruiting
- NCT04670172 — Real-Life Chronic Rhinosinusitis Outcome Registry · recruiting
Other Keymed Biosciences Co.Ltd trials
Trials by the same sponsor.
- NCT07519577 — A Study of CM512 in Patients With Chronic Rhinosinusitis With Nasal Polyposis （NEZHA-2） · Phase 2 · not yet recruiting
- NCT07166211 — Study of CM512 Injection in Subjects With Chronic Spontaneous Urticaria(CSU) · Phase 2 · recruiting
- NCT07175493 — A Study of CM336 in Patients With Relapsed or Refractory Autoimmune Cytopenia · Phase 1, PHASE2 · recruiting
- NCT07011524 — Study of CM512 Injection in Subjects With Moderate-to-severe Asthma · Phase 2 · recruiting
- NCT07039578 — Study Evaluating the Efficacy and Safety of CM336 Injection in the Treatment of Light-Chain Amyloidosis · Phase 2 · recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04805398 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Keymed Biosciences Co.Ltd
- Last refreshed: 29 June 2022
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04805398.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing