Ignite Creation Date:
2025-12-24 @ 9:25 PM
Ignite Modification Date:
2025-12-25 @ 7:11 PM
Study NCT ID:
NCT05908032
Status:
COMPLETED
Last Update Posted:
2024-11-08
First Post:
2023-06-02
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Study of CM310 in Subjects With Allergic Rhinitis
Sponsor:
Keymed Biosciences Co.Ltd
Organization:
Study Overview
Official Title:
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
Status Verified Date:
2023-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PHECDA
Brief 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.
All participants will receive standard of care treatment as concomitant medications. CM310 or placebo will be administered as add-on therapy.
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: