NCT07475715

Efficacy and Safety of Sublingual Immunotherapy for Allergic Rhinitis Due to House Dust Mites

A Clinical Study on the Efficacy and Safety of Sublingual Film for Dermatophagoides Pteronyssinus in Chinese Adult Patients With Dust Mite Allergic Rhinitis - A Randomized, Double-Blind, Placebo-Controlled Phase II Clinical Trial

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 250 (estimated)
• Sponsor: Zhejiang Wolwo Bio-Pharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

To evaluate the efficacy and safety of different doses of Sublingual Film for Dermatophagoides Pteronyssinus in adult patients with Dust Mite Allergic Rhinitis via a randomized, double-blind, placebo-controlled Phase II clinical trial, and to explore the optimal dose for the Phase III clinical trial. This study consisted of 5 groups, including 4 treatment groups with different doses and 1 placebo group. Subjects used Sublingual Film for Dermatophagoides pteronyssinus or a placebo (a look-alike substance that contains no drug) for approximately 52 weeks, and recorded in E-diary the usage of the investigational product, adverse events, concomitant medications, and the use of rescue medication. Four efficacy data collection periods (each lasting 4 weeks) were scheduled during the trial: Week 13-16, Week 25-28, Week 37-40, and Week 49-52. During these efficacy data collection periods, subjects were required to complete E-diary to record rhinitis symptoms (conjunctivitis symptoms were recorded simultaneously for subjects with concurrent conjunctivitis).

Conditions

• Allergic Rhinitis Due to Dust Mite

Interventions

Type	Name	Description
BIOLOGICAL	Sublingual Film for Dermatophagoides pteronyssinus	In the first week, subjects received Sublingual Film for Dermatophagoides pteronyssinus at 15 BU. From the second week onward, subjects received the Sublingual Film for Dermatophagoides pteronyssinus at 150 BU until Week 52.
BIOLOGICAL	Sublingual Film for Dermatophagoides pteronyssinus	In the first week, subjects received Sublingual Film for Dermatophagoides pteronyssinus at 150 BU. From the second week onward, subjects received the Sublingual Film for Dermatophagoides pteronyssinus at 450 BU until Week 52.
BIOLOGICAL	Sublingual Film for Dermatophagoides pteronyssinus	In the first week, subjects received Sublingual Film for Dermatophagoides pteronyssinus at 450 BU. From the second week onward, subjects received the Sublingual Film for Dermatophagoides pteronyssinus at 1350 BU until Week 52
BIOLOGICAL	Sublingual Film for Dermatophagoides pteronyssinus	In the first week, subjects received Sublingual Film for Dermatophagoides pteronyssinus at 450 BU. In the second week, subjects received Sublingual Film for Dermatophagoides pteronyssinus at 1350 BU. From the third week onward, subjects received the Sublingual Film for Dermatophagoides pteronyssinus at 2700 BU until Week 52.
BIOLOGICAL	Sublingual Film for Dermatophagoides pteronyssinus placebo	Subjects receive a placebo（a look-alike substance that contains no drug） every day for 52 weeks

Timeline

• Start date: 2026-03-23
• Primary completion: 2027-06-01
• Completion: 2027-12-07
• First posted: 2026-03-16
• Last updated: 2026-03-16

Locations

9 sites across 1 country: China