Study of Stapokibart Injection in Patients With Allergic Rhinitis (MIZAR)

Keymed Biosciences

Status and phase: Enrolling; Phase 2

Conditions: Allergic Rhinitis

Treatments: Drug: Placebo; Biological: Stapokibart Injection

Study type: Interventional

Funder types: Industry

Identifiers

NCT06525597

CM310-107101

Details and patient eligibility

About

This study is a Randomized, Double-blind, Placebo-controlled phase II clinical study evaluating the efficacy and safety of Stapokibart injection in patients with allergic rhinitis.

Full 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.

Enrollment: 120 estimated patients

Sex: All

Ages: 12 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Able to understand the study and voluntarily sign the Informed consent form.
• Diagnosed Allergic Rhinitis according to the Criteria stated in the Chinese Guidelines for the Diagnosis and Treatment of Allergic Rhinitis (2022, Revised Edition).
• Subjects with asthma must be evaluated by the researcher as having a stable condition.
• Has a positive skin prick test (SPT) or positive antigen-specific serum immunoglobulin E (IgE).

Exclusion criteria

• Use of anti-interleukin 4 receptor alpha subunit (IL-4Rα) monoclonal antibody, thymic stromal lymphopoietin (TSLP) monoclonal antibody, anti-IgE monoclonal antibody, other monoclonal antibodies, or other biologics within 10 weeks or 5 half-lives (whichever is longer) prior to the screening visit.
• Use of any investigational product within 4 weeks prior to the screening visit or planning to participate in other clinical studies during this study.
• Forced expiratory volume in 1 second (FEV1) ≤ 50% of the predicted value during the screening/run-in period.
• Have acute sinusitis, nasal infection, or upper respiratory tract infection at screening or within 2 weeks prior to screening.
• Have received a live-attenuated vaccine within 12 weeks prior to randomization or planning to receive one during the study.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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120 participants in 2 patient groups, including a placebo group

Stapokibart Group

Experimental group

Description:

Stapokibart, subcutaneous, once every two weeks

Treatment:

Biological: Stapokibart Injection

Placebo Group

Placebo Comparator group

Description:

Placebo, subcutaneous, once every two weeks

Treatment:

Drug: Placebo