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Clinical research on the treatment of allergic rhinitis with Sipukibart

Clinical research on the treatment of allergic rhinitis with Sipukibart

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500111842
Enrollment
Unknown
Registered
2025-11-06
Start date
2025-12-01
Completion date
Unknown
Last updated
2025-11-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Allergic rhinitis

Interventions

Control group:Specific immunotherapy was performed by subcutaneous injection of allergens, once a week for 16 consecutive weeks, and then changed to once every 4 weeks.
Experimental Group:Subcutaneous injection of Sipukibart injection. The initial dose is 600mg, and then every 2 weeks, 300mg each time.

Sponsors

Tongji Hospital of Tongji University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Age over 18 years old, gender not limited; 2. Those who meet the standards of the "Guidelines for the Diagnosis and Treatment of Allergic Rhinitis (2022)", have positive serum specific IgE or positive skin prick test, and whose condition is not well controlled by commonly used drugs at present; 3. The patient or his/her legal representative can understand and sign the informed consent form; 4. Be willing and able to cooperate in completing all the examinations and follow-ups required for the research. 5. The control group consisted of those who were positive for dust mite allergens and were willing to undergo subcutaneous desensitization treatment.

Exclusion criteria

Exclusion criteria: 1. Severe systemic diseases such as severe cardiopulmonary dysfunction, liver and kidney insufficiency, severe immune deficiency or a history of malignant tumors; 2. Those who are allergic to the research drug or its excipients; 3. Those who have participated in other clinical trials within the past three months; 4. Pregnant or lactating women; 5. Other circumstances where the researcher deems it unsuitable to participate in this study.

Design outcomes

Primary

MeasureTime frame
Total Nasal Symptom Score,TNSS;Total Ocular Symptom Score,TOSS;

Secondary

MeasureTime frame
Rhinoconjunctivitis Quality of Life Questionnaire Score,RQLQ;Drug score;Nasal nitric oxide test;Olfactory function score;

Countries

China

Contacts

Public ContactShaoqing Yu

Tongji Hospital of Tongji University

yu_shaoqing@163.com+86 21 66111042

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026