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

March 11, 2026 updated by: Zhejiang Wolwo Bio-Pharmaceutical Co., Ltd.

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

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).

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

250

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
      • Beijing, China, 100730
        • Beijing Tongren Hospital, Capital Medical University
        • Contact:
    • Anhui
      • Hefei, Anhui, China
        • The Second Affiliated Hospital of Anhui Medical University
        • Contact:
    • Guangxi
      • Nanning, Guangxi, China
        • The People's Hospital of Guangxi Zhuang Autonomous Region
        • Contact:
    • Hainan
      • Haikou, Hainan, China
        • Hainan General Hospital
        • Contact:
    • Hubei
      • Jingzhou, Hubei, China
        • Jingzhou Central Hospital
        • Contact:
      • Wuhan, Hubei, China, 430030
        • Tongji Hospital, Tongji Medical College of Hust
        • Contact:
    • Hunan
      • Changsha, Hunan, China
        • Hunan Provincial People's Hospital
        • Contact:
      • Hengyang, Hunan, China
        • The First Affiliated Hospital of University of South China
        • Contact:
    • Jiangxi
      • Nanchang, Jiangxi, China
        • The First Affiliated Hospital of Nanchang University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Aged between 18 and 60 (including 18 and 60), male or female;
  • Diagnosed with allergic rhinitis (documented by medical records/prescriptions/specific IgE test reports for allergens, etc.) for ≥ 6 months prior to screening;
  • Skin Prick Test (SPT) during screening shows a maximum wheal diameter of ≥ 5 mm for Dermatophagoides pteronyssinus;
  • Dermatophagoides pteronyssinus (or mite mix containing Dermatophagoides pteronyssinus) specific immunoglobulin E (IgE) levels of class 3 or higher during screening;
  • Pulmonary function test (routine spirometry) during screening shows FEV₁ % predicted ≥ 70%;
  • Total daily nasal symptom score ≥ 6 for at least 5 days out of the last consecutive 10 days within the 14 days prior to randomization;
  • Use of symptomatic medication for allergic rhinitis on at least 5 days out of the last consecutive 10 days within the 14 days prior to randomization;
  • Subjects have fully understood the purpose, nature, methods and potential adverse reactions of the trial, voluntarily participate in this clinical trial, and are able to provide written informed consent prior to initiation of any study procedures;
  • Subjects are able to communicate well with the investigators and understand and comply with all requirements of this clinical trial.

Exclusion Criteria:

  • Subjects have a history of seasonal allergic rhinitis, and the onset season may overlap with the baseline or primary efficacy data collection period;
  • Subjects have a serum specific IgE test result of Grade ≥ 2 for common allergens such as pollen, animal dander, and mold; and in the investigator's judgment, the subject has a history of allergen exposure/contact and will be exposed to/come into contact with the relevant allergens during the trial;
  • Currently suffering from nasal diseases such as chronic sinusitis or nasal polyps that, in the investigator's judgment, may affect the evaluation of efficacy;
  • Received beta-blockers or angiotensin-converting enzyme (ACE) inhibitors prior to dosing, with a washout period of less than 5 elimination half-lives of the respective drug;
  • Received mite-allergen and specific immunotherapy (including Subcutaneous Immunotherapy and Sublingual Immunotherapy) within 3 years prior to dosing, or is currently receiving any allergen-specific immunotherapy;
  • Received Anti-IgE antibody therapy (e.g., omalizumab) or other biological agents affecting IgE production (e.g., dupilumab, spicabiosen) prior to dosing, with a washout period of less than 5 elimination half-lives of the respective drug;
  • Received systemic immunosuppressive therapy within 14 days prior to dosing;
  • Currently suffering from oral diseases such as oral ulcers, or upper gastrointestinal diseases including esophagitis and dysphagia that, in the investigator's judgment, may affect medication compliance;
  • Has a history of severe allergic reaction/anaphylaxis;
  • Experienced an asthma exacerbation requiring emergency treatment or hospitalization within 1 year prior to screening; or had > 2 episodes of nocturnal awakening due to asthma within 1 month prior to screening; or used inhaled short-acting beta2 agonists > 2 times per week;
  • Has a history of irreversible obstructive respiratory disease, severe cardiovascular disease, severe autoimmune disease, immunodeficiency disorder, or malignant tumor;
  • Lactating female, positive pregnancy test, or female of childbearing potential unwilling to use effective contraception during the trial;
  • Participated in another clinical trial and received investigational medicinal product within 1 month prior to screening;
  • Any other condition that, in the investigator's opinion, renders the subject unsuitable for participation in this study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Sublingual Film for Dermatophagoides pteronyssinus
Subjects receive a Sublingual Film for Dermatophagoides pteronyssinus every day for 52 weeks.
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.
Experimental: Placebo
Subjects receive a placebo every day for 52 weeks
Biological: Sublingual Film for Dermatophagoides pteronyssinus placebo
Subjects receive a placebo（a look-alike substance that contains no drug） every day for 52 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
daily combined scores of rhinitis symptoms and medication
Time Frame: Week 49-52
the daily combined scores of medication and rhinitis symptoms (ranging from 0 to 6); which was calculated as the combined score of daily average scores of 4 rhinitis symptoms (rhinorrhea, nasal congestion, nasal itching, sneezing) and the daily rescue medication score. Higher scores indicate more severe symptoms and a worse outcome.
Week 49-52

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
daily combined scores of rhinitis symptoms and medication
Time Frame: Week 13-16; Week 25-28; Week 37-40
the daily combined scores of medication and rhinitis symptoms (ranging from 0 to 6); which was calculated as the combined score of daily average scores of 4 rhinitis symptoms (rhinorrhea, nasal congestion, nasal itching, sneezing) and the daily rescue medication score. Higher scores indicate more severe symptoms and a worse outcome.
Week 13-16; Week 25-28; Week 37-40
daily total nasal symptom score
Time Frame: Week 13-16; Week 25-28; Week 37-40; Week 49-52
daily total nasal symptom score was the sum of four nasal symptom scores for nasal congestion, discharge, itching and sneezing (ranging from 0 to 12). Nasal symptoms were rated on a 4-point scale, while 0 = no symptoms, 1 = mild symptoms (sign/symptom clearly present, but minimal awareness; easily tolerated), 2 = moderate symptoms (definite awareness of sign/symptom that is bothersome but tolerable), and 3 = severe symptoms (sign/symptom that is hard to tolerate; causes interference with activities of daily living and/or sleeping)
Week 13-16; Week 25-28; Week 37-40; Week 49-52
daily Rescue Medication Scores
Time Frame: Week 13-16; Week 25-28; Week 37-40; Week 49-52
daily Rescue Medication Scores is the rescue medication score in each day (ranging from 0 to 3). 0 = no rescue medication uses, 1 = Oral and/or topical non-sedative H1 antihistamines, 2 = Intranasal corticosteroids (Rhinocort) with/without H1 antihistamines, and 3 = Oral corticosteroids with/without intranasal corticosteroids, with/without H1 antihistamines.
Week 13-16; Week 25-28; Week 37-40; Week 49-52
daily combined scores of medication and rhinoconjunctivitis symptoms
Time Frame: Week 13-16; Week 25-28; Week 37-40; Week 49-52
the daily combined scores of medication and rhinoconjunctivitis symptoms (ranging from 0 to 6); which was calculated as the combined score of daily average scores of 6 rhinoconjunctivitis symptoms (rhinorrhea, nasal congestion, nasal itching, sneezing, ocular pruritus, and watery eyes) and the daily rescue medication score. Higher scores indicate more severe symptoms and a worse outcome.
Week 13-16; Week 25-28; Week 37-40; Week 49-52
adverse event
Time Frame: Week 1-52
Week 1-52

Other Outcome Measures

Outcome Measure
Time Frame
levels of immunoglobulins and inflammation-related indicators in serum and nasal secretions
Time Frame: Day 169; Day 365
Day 169; Day 365

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Zhejiang Wolwo Bio-Pharmaceutical Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

March 23, 2026

Primary Completion (Estimated)

June 1, 2027

Study Completion (Estimated)

December 7, 2027

Study Registration Dates

First Submitted

March 5, 2026

First Submitted That Met QC Criteria

March 11, 2026

First Posted (Actual)

March 16, 2026

Study Record Updates

Last Update Posted (Actual)

March 16, 2026

Last Update Submitted That Met QC Criteria

March 11, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • WOLWO-T4-2II12-1

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Allergic Rhinitis Due to Dust Mite

Clinical Trials on Sublingual Film for Dermatophagoides pteronyssinus

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Uzbekistan

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe