Trials / Completed
CompletedNCT05908032
Study of CM310 in Subjects With Allergic Rhinitis
A Randomized, Double-blind, Placebo-controlled Phase III Study to Evaluate the Efficacy and Safety of CM310 Under Background Treatment in Patients With Seasonal Allergic Rhinitis Inadequately Controlled With Current Recommended Therapies
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 108 (actual)
- Sponsor
- Keymed Biosciences Co.Ltd · Industry
- Sex
- All
- Age
- 18 Years – 65 Years
- Healthy volunteers
- Not accepted
Summary
This is a multicenter, randomized, double-blind, placebo-controlled phase III clinical study aimed at evaluating the efficacy and safety of CM310 in patients with seasonal allergic rhinitis, and observing the quality of life, PK, PD characteristics, and immunogenicity of subjects.
Detailed description
Allergic rhinitis (AR) is a non infectious chronic inflammatory disease of the nasal mucosa that is mainly mediated by immunoglobulin E (IgE) in atopic individuals exposed to allergens. All participants will receive standard of care treatment as concomitant medications. CM310 or placebo will be administered as add-on therapy.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | CM310 | IL-4Rα monoclonal antibody |
| BIOLOGICAL | Placebo | Placebo |
Timeline
- Start date
- 2023-08-10
- Primary completion
- 2023-12-04
- Completion
- 2023-12-04
- First posted
- 2023-06-18
- Last updated
- 2024-11-08
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT05908032. Inclusion in this directory is not an endorsement.