A Study of CM326 in Patients With Chronic Rhinosinusitis With Nasal Polyps (DUBHE)


Keymed Biosciences

Status and phase

Active, not recruiting
Phase 2
Phase 1


Chronic Rhinosinusitis With Nasal Polyps


Other: Placebo
Drug: CM326

Study type


Funder types




Details and patient eligibility


This is a multi-center, randomized, double blind, placebo-controlled, dose escalation study to evaluate the safety, tolerability, PK, PD, immunogenicity and preliminary efficacy of CM326 in patients with chronic rhinosinusitis with nasal polyps.

Full description

The study consists of 3 periods, a Screening Period, a Treatment Period and a Safety Follow-up Period. Subjects who meet eligibility criteria will be randomized to receive either CM326 or placebo subcutaneously.


113 estimated patients




18 to 70 years old


No Healthy Volunteers

Inclusion criteria

  • Subjects who are capable of understanding the nature of the study and voluntarily signing the ICF.
  • Male or female subjects, aged between 18 and 70 years old (inclusive), with a body mass index (BMI) ≥ 19 kg/m2.
  • Diagnosed with Chronic Rhinosinusitis With Nasal Polyps.
  • The total NPS score should be at least 3 points, with at least 1 point in each side of the nasal cavity.
  • Prior treatment with systemic corticosteroids (SCS) within two years before screening, and/or contraindicate to or intolerance to systemic corticosteroids, and/or with prior surgery to nasal polyps 6 months before the screening.
  • Ongoing symptoms for at least 4 weeks before screening:1) Nasal congestion/obstruction; 2) Other symptom, e.g., loss of smell or rhinorrhea.

Exclusion criteria

  • Allergic or intolerant to mometasone furoate spray or CM326/placebo.
  • Have used of systemic immunosuppressants for inflammatory or autoimmune diseases within 8 weeks or 5 half-lives prior to randomization.
  • Have initiated leukotriene receptor antagonist therapy within 4 weeks prior to randomization.
  • have received allergen-specific immunotherapy that initiated within 3 months prior to randomization or planned to be initiated during the study period.
  • Have undergone nasal surgery (including nasal polypectomy) within 6 months prior to screening.
  • Have received medium- and short-acting systemic corticosteroids (including oral, intravenous, intramuscular corticosteroids), nasal dripping corticosteroids, traditional Chinese medicine (including systemic and local herbal products preparations) for chronic rhinosinusitis (CRS) within 4 weeks prior to screening, or long-acting systemic corticosteroids.
  • With concomitant asthma (including suspected diagnosis of asthma) will be excluded if they meet the following conditions: predicted FEV1 of≤ 60%, or acute exacerbation of asthma within 3 months prior to screening requiring SCS or hospitalization (> 24 hours), or using inhaled corticosteroids (ICS) of > 1000 μg fluticasone propionate or others at equivalent doses
  • With antrochoanal polyps.
  • With severe deviation of the nasal septum occludes at least one nostril.
  • With persistent rhinitis medicamentosas.
  • With allergic granulomatous angiitis (Churg-Strauss syndrome), granulomatosis with polyangiitis (Wegener's granulomatosis), Young's syndrome, Kartagener's syndrome or other dyskinetic ciliary syndromes, cystic fibrosis.
  • With acute sinusitis, nasal infection, or upper respiratory tract infection at screening.
  • Have symptoms or whose CT scan suggests allergic fungal sinusitis.
  • With malignant or benign neoplasm of nasal cavities.
  • With other uncontrolled serious diseases or recurrent chronic diseases.
  • Have severe hepatic and renal impairment.
  • Have received live attenuated vaccines within 12 weeks prior to randomization, or during the planned study; or have received inactivated vaccines (e.g., novel coronavirus vaccines) within 30 days prior to randomization.
  • With known or suspected immunosuppression, including, but not limited to, the history of invasive opportunistic infections.
  • Subjects who are pregnant or planning to become pregnant, or breastfeeding during the study.
  • With a history of large alcohol consumption or a history of drug abuse within 3 months prior to screening.
  • With other medical or non-medical conditions that are not suitable for participation in the study in the opinion of the investigator.

Trial design

Primary purpose




Interventional model

Sequential Assignment


Quadruple Blind

113 participants in 5 patient groups

Group 1: 55mg Q2W
Experimental group
CM326 55 mg or matched placebo, every 2 weeks, subcutaneous (SC)
Drug: CM326
Other: Placebo
Group 2: 110mg Q2W
Experimental group
CM326 110 mg or matched placebo, every 2 weeks, subcutaneous (SC)
Drug: CM326
Other: Placebo
Group 3: 220mg Q2W
Experimental group
CM326 220 mg or matched placebo, every 2 weeks, subcutaneous (SC)
Drug: CM326
Other: Placebo
Group 4: 220mg Q4W
Experimental group
CM326 220mg or matched placebo, every 4 weeks, subcutaneous (SC)
Drug: CM326
Other: Placebo
Group 5: CM326 220 mg Q2W
Experimental group
CM326 220 mg, every 2 weeks, subcutaneous (SC)
Drug: CM326

Trial contacts and locations



Data sourced from clinicaltrials.gov

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