Study of Stapokibart Injection in Patients With Allergic Rhinitis

NCT06525597 | Recruiting Phase 2

• 1 other identifier: CM310-107101
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Allergic Rhinitis

Outcome Measures

Primary Outcomes (1)

• Mean change from baseline in daily reflective total nasal symptom scores (rTNSS) over 4 weeks of treatment.

  The total nasal symptom score (TNSS) is the sum of the four symptom scores for rhinorrhea, nasal congestion, nasal itching, and sneezing, where each symptom is scored on a scale of 0 to 3.

  Up to week 4

Study Arms (2)

Stapokibart Group

EXPERIMENTAL

Stapokibart, subcutaneous, once every two weeks

Biological: Stapokibart Injection

Placebo Group

PLACEBO COMPARATOR

Placebo, subcutaneous, once every two weeks

Drug: Placebo

Interventions

Stapokibart Injection BIOLOGICAL

IL-4Rα monoclonal antibody

Stapokibart Group

Placebo DRUG

Placebo

Placebo Group

Eligibility Criteria

• Age: 12 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Keymed Biosciences Co.Ltd: lead

Study Sites (1)

Beijing Tongren Hospital, CMU

Beijing, Beijing Municipality, China

RECRUITING

MeSH Terms

Conditions

Rhinitis, Allergic

Condition Hierarchy (Ancestors)

Rhinitis; Nose Diseases; Respiratory Tract Diseases; Respiratory Hypersensitivity; Otorhinolaryngologic Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Luo Zhang

  Beijing Tong-Ren hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Qian Jia

CONTACT

028-88610620; qianjia@keymedbio.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 24, 2024
• First Posted: July 29, 2024
• Study Start: September 30, 2024
• Primary Completion: October 30, 2025
• Study Completion: October 30, 2025
• Last Updated: November 8, 2024

Record last verified: 2024-08

Locations

CN (1)