Treatment for uncontrolled seasonal allergic rhinitis using a monoclonal antibody

The Efficacy and Safety of IL4Rα Monoclonal Antibody in Patients With Uncontrolled Seasonal Allergic Rhinitis Under Conventional Treatment: A Randomized, Double-Blind, Placebo-controlled Investigator Initiated Trial.

This study is testing a new monoclonal antibody treatment for people with severe seasonal allergies who haven't found relief from regular medications.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 90 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Tongji Hospital (Academic / other)
• Locations: 1 site (Wuhan, Hubei)
• Trial ID: NCT06028490 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the efficacy of an IL4Rα monoclonal antibody in patients suffering from uncontrolled seasonal allergic rhinitis (SAR). Participants must have experienced SAR for at least two years and have not found relief from standard treatments. The study will involve administering either the monoclonal antibody or a placebo to evaluate symptom improvement over the course of the trial. The primary focus is on patients with significant symptoms, as indicated by a high total nasal symptom score (TNSS).

Who should consider this trial

Good fit: Ideal candidates are individuals diagnosed with uncontrolled seasonal allergic rhinitis who have not responded adequately to standard treatments.

Not a fit: Patients with other nasal comorbidities or those whose allergen exposure is expected to change significantly during the study may not benefit from this trial.

Why it matters

Potential benefit: If successful, this treatment could provide significant relief for patients suffering from severe seasonal allergic rhinitis.

How similar studies have performed: Other studies have explored monoclonal antibodies for allergic conditions, showing promising results, but this specific approach is relatively novel.

Eligibility criteria

Key Inclusion Criteria:

1. Subjects meet the diagnosis of SAR which has been prevalent for at least 2 years, and: standard treatment regimen for SAR was ineffective or subjective symptom control was unsatisfactory in the subject; positive test for at least one allergen associated with the development of SAR; pre-baseline symptom episodes of ≥ 4 days/week and a baseline TNSS of ≥ 6 points.
2. Consent to highly effective contraception

Key Exclusion Criteria:

1. Other nasal comorbidities or co-morbidities/states that may be present at the time of screening；
2. It is expected that subjects' exposure to allergens in their home or work environments may change significantly during the study period.
3. Patients with asthma requiring stable use of inhaled controlled medications;
4. Previous or current malignant tumor within 5 years prior to screening;
5. Presence of other acute or chronic diseases or abnormal laboratory tests at the time of screening that, in the investigator's assessment, may have a more serious impact on the efficacy or safety assessment of the subject;
6. Live/live attenuated vaccine within 3 months prior to baseline;
7. Subjects with very limited outdoor activity during the daytime, as inferred from their regular daily routine;
8. Unwillingness or inability to comply with the permitted and prohibited medication/treatment specifications of the study, inability to meet the pre-randomization drug elution cycle specified in the protocol;
9. Women who are pregnant or breastfeeding;
10. History of alcohol or drug abuse within 3 months prior to screening.

Where this trial is running

Wuhan, Hubei

• Tongji Hosptial affiliated to Tongji Medical college of Huazhong University of Science and Technology — Wuhan, Hubei, China (Recruiting)

Study contacts

• Study coordinator: Zheng Liu, PHD

Conditions Allergic Rhinitis