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

K

Keymed Biosciences

Status and phase

Active, not recruiting
Phase 2
Phase 1

Conditions

Chronic Rhinosinusitis With Nasal Polyps

Treatments

Other: Placebo
Drug: CM326

Study type

Interventional

Funder types

Industry

Identifiers

NCT05324137
CM326NP001

Details and patient eligibility

About

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.

Enrollment

113 estimated patients

Sex

All

Ages

18 to 70 years old

Volunteers

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

Treatment

Allocation

Randomized

Interventional model

Sequential Assignment

Masking

Quadruple Blind

113 participants in 5 patient groups

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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