Allergic Rhinitis Due to Dust MitePhase 2NCT07475715
Efficacy and Safety of Sublingual Immunotherapy for Allergic Rhinitis Due to House Dust Mites
A Phase 2 study testing Sublingual Film for Dermatophagoides pteronyssinus in people with Allergic Rhinitis Due to Dust Mite, run by Zhejiang Wolwo Bio-Pharmaceutical Co., Ltd. at 9 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Allergic Rhinitis Due to Dust Mite
- What is being tested?
- Sublingual Film for Dermatophagoides pteronyssinus
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 250 participants
- Where
- 9 sitesChina
- Study dates
- 23 Mar 2026to 7 Dec 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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;
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- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
9 sites in 1 country. Contact the study team or a site near you to ask about taking part.
9 sites in 1 country
China9 sites
Beijing Tongren Hospital, Capital Medical University
Beijing, 100730
Zhang Luo, +861065141136, dr.luozhang@139.com
Hunan Provincial People's Hospital
Changsha, Hunan
Xiao Xuping, +86 0731-83929900, 469784129@qq.com
Hainan General Hospital
Haikou, Hainan
Wei Xin, +86 0898963399, 13016296267@163.com
The Second Affiliated Hospital of Anhui Medical University
Hefei, Anhui
Yang Jianming, +86 0551-3869420, 693671174@qq.com
The First Affiliated Hospital of University of South China
Hengyang, Hunan
Jiang Qingshan, +86 0734-8279009, 2365486131@qq.com
Jingzhou Central Hospital
Jingzhou, Hubei
Wan Lijia, +86 0716-8881888, 949222808@qq.com
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi
Ye Jing, +86 0791-88603000, yjholly@ncu.edu.cn
The People's Hospital of Guangxi Zhuang Autonomous Region
Nanning, Guangxi
Qu Shenhong, +86 0771-2186561, qshdoctor@163.com
Tongji Hospital, Tongji Medical College of Hust
Wuhan, Hubei, 430030
Zhu Rongfei, +862783662912, Zrf13092@163.com
About this study
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
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.
Read more
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
- Being tested
- Sublingual Film for Dermatophagoides pteronyssinus, Sublingual Film for Dermatophagoides pteronyssinus placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sublingual Film for Dermatophagoides pteronyssinusBiological
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 pteronyssinusBiological
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.
Sublingual Film for Dermatophagoides pteronyssinusBiological
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
Sublingual Film for Dermatophagoides pteronyssinusBiological
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.
Sublingual Film for Dermatophagoides pteronyssinus placeboBiological
Subjects receive a placebo（a look-alike substance that contains no drug） every day for 52 weeks
| Study group | Role | What they receive |
|---|---|---|
| Sublingual Film for Dermatophagoides pteronyssinus | Experimental | Subjects receive a Sublingual Film for Dermatophagoides pteronyssinus every day for 52 weeks. Receives: Biological: Sublingual Film for Dermatophagoides pteronyssinus |
| Placebo | Experimental | Subjects receive a placebo every day for 52 weeks Receives: Biological: Sublingual Film for Dermatophagoides pteronyssinus placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Week 49-52
Secondary outcomes (5)
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.
Measured: Week 13-16; Week 25-28; Week 37-40
daily total nasal symptom score
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)
Measured: Week 13-16; Week 25-28; Week 37-40; Week 49-52
daily Rescue Medication Scores
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.
Measured: Week 13-16; Week 25-28; Week 37-40; Week 49-52
daily combined scores of medication and rhinoconjunctivitis symptoms
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.
Measured: Week 13-16; Week 25-28; Week 37-40; Week 49-52
adverse event
Measured: Week 1-52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2026
- Study start23 Mar 2026 (estimated)
- Primary completion1 Jun 2027 (estimated)
- Study completion7 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Allergic Rhinitis Due to Dust MiteStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhejiang Wolwo Bio-Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07475715
- Sponsor's protocol ID
- WOLWO-T4-2II12-1
- Status last verified
- Mar 2026
- First submitted
- 5 Mar 2026
- Last updated
- 16 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07475715
- Acronym / sponsor ID
- WOLWO-T4-2II12-1
- Conditions
- Allergic Rhinitis Due to Dust Mite
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Zhejiang Wolwo Bio-Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 23 Mar 2026 (estimated)
- Primary completion
- 1 Jun 2027 (estimated)
- Study completion
- 7 Dec 2027 (estimated)
- First posted
- 16 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sublingual Film for Dermatophagoides pteronyssinus | Experimental | Biological: Sublingual Film for Dermatophagoides pteronyssinusSubjects receive a Sublingual Film for Dermatophagoides pteronyssinus every day for 52 weeks. |
| Placebo | Experimental | Biological: Sublingual Film for Dermatophagoides pteronyssinus placeboSubjects receive a placebo every day for 52 weeks |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- 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%;
Key exclusion criteria (14 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sublingual Film for Dermatophagoides pteronyssinusIn 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 |
| Sublingual Film for Dermatophagoides pteronyssinusIn 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 |
| Sublingual Film for Dermatophagoides pteronyssinusIn 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 |
| Sublingual Film for Dermatophagoides pteronyssinusIn 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 |
| Sublingual Film for Dermatophagoides pteronyssinus placeboSubjects receive a placebo（a look-alike substance that contains no drug） every day for 52 weeks | Biological | Placebo |
Primary outcome
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.
5 secondary outcomes
daily combined scores of rhinitis symptoms and medication
Time frame: 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 Rescue Medication Scores
Time frame: 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
adverse event
Time frame: Week 1-52
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Sublingual Film for Dermatophagoides pteronyssinus in people with Allergic Rhinitis Due to Dust Mite, run by Zhejiang Wolwo Bio-Pharmaceutical Co., Ltd. at 9 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 16 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Wang Jiazheng (+8615800536923, wangjiazheng@wolwobiotech.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
daily combined scores of rhinitis symptoms and medication (time frame: Week 49-52). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Mar 2026.