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

NCT07475715 | Not Yet Recruiting Phase 2

• 1 other identifier: WOLWO-T4-2II12-1
• Study Type: interventional
• Target: 250
• Locations: 1 country
• Sites: 9

Brief 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

Outcome Measures

Primary Outcomes (1)

• daily combined scores of rhinitis symptoms and medication

  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 Outcomes (5)

• daily combined scores of rhinitis symptoms and medication

  Week 13-16; Week 25-28; Week 37-40

• daily total nasal symptom score

  Week 13-16; Week 25-28; Week 37-40; Week 49-52

• daily Rescue Medication Scores

  Week 13-16; Week 25-28; Week 37-40; Week 49-52

• daily combined scores of medication and rhinoconjunctivitis symptoms

  Week 13-16; Week 25-28; Week 37-40; Week 49-52

• adverse event

  Week 1-52

Other Outcomes (1)

• levels of immunoglobulins and inflammation-related indicators in serum and nasal secretions

  Day 169; Day 365

Study Arms (2)

Sublingual Film for Dermatophagoides pteronyssinus

EXPERIMENTAL

Subjects receive a Sublingual Film for Dermatophagoides pteronyssinus every day for 52 weeks.

Biological: Sublingual Film for Dermatophagoides pteronyssinus

Placebo

EXPERIMENTAL

Subjects receive a placebo every day for 52 weeks

Biological: Sublingual Film for Dermatophagoides pteronyssinus placebo

Interventions

Sublingual Film for Dermatophagoides pteronyssinus BIOLOGICAL

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.

Sublingual Film for Dermatophagoides pteronyssinus

Sublingual Film for Dermatophagoides pteronyssinus placebo BIOLOGICAL

Subjects receive a placebo（a look-alike substance that contains no drug） every day for 52 weeks

Placebo

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Zhejiang Wolwo Bio-Pharmaceutical Co., Ltd.: lead

Study Sites (9)

The Second Affiliated Hospital of Anhui Medical University

Hefei, Anhui, China

Location

The People's Hospital of Guangxi Zhuang Autonomous Region

Nanning, Guangxi, China

Location

Hainan General Hospital

Haikou, Hainan, China

Location

Jingzhou Central Hospital

Jingzhou, Hubei, China

Location

Tongji Hospital, Tongji Medical College of Hust

Wuhan, Hubei, 430030, China

Location

Hunan Provincial People's Hospital

Changsha, Hunan, China

Location

The First Affiliated Hospital of University of South China

Hengyang, Hunan, China

Location

The First Affiliated Hospital of Nanchang University

Nanchang, Jiangxi, China

Location

Beijing Tongren Hospital, Capital Medical University

Beijing, 100730, China

Location

MeSH Terms

Interventions

Antigens, Dermatophagoides

Intervention Hierarchy (Ancestors)

Antigens; Biological Factors

Central Study Contacts

Wang Jiazheng

CONTACT

+8615800536923; wangjiazheng@wolwobiotech.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 5, 2026
• First Posted: March 16, 2026
• Study Start: March 23, 2026
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): December 7, 2027
• Last Updated: March 16, 2026

Record last verified: 2026-03

Locations

CN (9)