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NOT YET RECRUITING
NCT07475715
PHASE2

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

Sponsor: Zhejiang Wolwo Bio-Pharmaceutical Co., Ltd.

View on ClinicalTrials.gov

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).

Official title: 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

Key Details

Gender

All

Age Range

18 Years - 60 Years

Study Type

INTERVENTIONAL

Enrollment

250

Start Date

2026-03-23

Completion Date

2027-12-07

Last Updated

2026-03-16

Healthy Volunteers

No

Interventions

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

Locations (9)

The Second Affiliated Hospital of Anhui Medical University

Hefei, Anhui, China

The People's Hospital of Guangxi Zhuang Autonomous Region

Nanning, Guangxi, China

Hainan General Hospital

Haikou, Hainan, China

Jingzhou Central Hospital

Jingzhou, Hubei, China

Tongji Hospital, Tongji Medical College of Hust

Wuhan, Hubei, China

Hunan Provincial People's Hospital

Changsha, Hunan, China

The First Affiliated Hospital of University of South China

Hengyang, Hunan, China

The First Affiliated Hospital of Nanchang University

Nanchang, Jiangxi, China

Beijing Tongren Hospital, Capital Medical University

Beijing, China