A study testing dust mite allergy extracts from Dermatophagoides pteronyssinus and Dermatophagoides farinae for patients with allergic rhinoconjunctivitis with or without controlled asthma

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What is this study about?

This clinical trial studies allergic rhinoconjunctivitis caused by house dust mites, specifically two types called Dermatophagoides pteronyssinus and Dermatophagoides farinae. Allergic rhinoconjunctivitis is a condition where the nose and eyes become inflamed and irritated due to an allergic reaction, causing symptoms like sneezing, runny nose, itchy eyes, and watery eyes. Some patients in the study may also have controlled asthma, which is a breathing condition that can cause wheezing, coughing, and shortness of breath. The treatments being tested are Depigoid Mite-Mix and Depigoid FORTE Mite-Mix, which are injections containing modified extracts from these house dust mites, as well as placebo. These injections are given under the skin to help the body become less sensitive to these allergens over time. Additional medications may be used during the study including various inhaled medicines for asthma such as budesonide, salbutamol, formoterol fumarate dihydrate, beclometasone dipropionate, and terbutaline sulfate, as well as allergy medications like desloratadine, montelukast sodium, levocabastine, and fluticasone furoate. Diagnostic products containing extracts of Dermatophagoides pteronyssinus and Dermatophagoides farinae will also be used to test allergic reactions.

The purpose of this study is to determine whether these house dust mite extract injections are effective in reducing allergy symptoms and are safe to use in patients with moderate to severe persistent allergic rhinoconjunctivitis. The study will compare how well two different concentrations of the treatment work compared to placebo after patients receive twelve injections. The study will also examine whether the treatment improves quality of life, reduces the need for other allergy medications, and helps the immune system respond differently to these allergens.

Patients will receive injections under the skin over a period of three years. During the study, patients will record their daily symptoms and medication use through an electronic diary on their mobile phone. Various tests will be performed throughout the study including skin prick tests, eye provocation tests to measure allergic reactions, blood tests to measure immune system responses, and breathing tests for patients with asthma. Patients will also complete questionnaires about their symptoms, quality of life, and satisfaction with the treatment at different time points during and after the treatment period. The study will monitor patients for any side effects or unwanted reactions to the treatment throughout the entire study duration and for up to two years after completing the initial treatment period.

1 Initial assessment and baseline measurements

At the beginning of the study, several tests will be performed to establish your baseline condition.

Your allergy will be confirmed through a skin prick test (a small needle prick on your skin to test for allergic reactions) to dust mites called Dermatophagoides pteronyssinus and Dermatophagoides farinae. The skin reaction must be at least 3 millimeters in size.

A blood test will be performed to measure specific IgE (proteins in your blood that indicate allergies) to the dust mites and their specific components. The level must be above 0.7 kU/L.

A conjunctival provocation test will be performed, which involves applying dust mite extract to your eye to confirm your allergic reaction.

If you have asthma, a spirometry test will be performed to measure your lung function. Your FEV₁ (the amount of air you can forcefully exhale in one second) must be at least 70% of the expected value.

If you have asthma, a FeNO test will be performed to measure inflammation in your lungs by analyzing your exhaled breath.

You will complete questionnaires to assess your symptoms, quality of life, and asthma control if applicable. These include the RQLQ or AdolRQLQ questionnaire for rhinoconjunctivitis quality of life, and if you have asthma, the AQLQ or pAQLQ for asthma quality of life and the ACT for asthma control.

You will rate your symptoms using a Visual Analogue Scale, which is a line where you mark how severe your symptoms are.

Your cSMS score (a combined score of your symptoms and medication use) must be at least 1.5 points to participate.

An electronic diary application will be installed on your mobile device to record your daily symptoms and medication use throughout the study.

Blood samples will be collected to measure baseline levels of total and specific IgE, total and specific IgG4 (another type of antibody), and total IgA2 against the dust mites.

If you are a woman of childbearing potential, a urine pregnancy test will be performed, which must be negative.

2 Treatment phase – First 12 administrations

You will receive treatment through subcutaneous immunotherapy, which means injections under your skin.

You will be randomly assigned to receive one of three treatments: Depigoid Mite-Mix at a concentration of 50 DPP/ml, Depigoid FORTE Mite-Mix at a concentration of 150 DPP/ml, or placebo (an inactive substance with no medication).

The treatment contains modified extracts of the dust mites Dermatophagoides pteronyssinus and Dermatophagoides farinae.

You will receive a total of 12 injections during this phase.

Throughout this period, you will record your daily symptoms and medication use in the electronic diary on your mobile device. This includes tracking your dSS score (daily symptom score) and dMS score (daily medication score) for rhinoconjunctivitis, and if you have asthma, your dSSa score (daily symptom score for asthma) and dMSa score (daily medication score for asthma).

After the 6th injection, you will complete the same questionnaires as at baseline to assess changes in your symptoms, quality of life, and asthma control if applicable.

After the 12th injection, all baseline assessments will be repeated, including the conjunctival provocation test, blood tests for immunological parameters, spirometry and FeNO if you have asthma, and all questionnaires.

After the 12th injection, you will also complete the ESPIA questionnaire to evaluate your satisfaction with the treatment.

3 Continuation of treatment – First year

After completing the first 12 injections, you will continue receiving the same treatment through subcutaneous injections.

The injections will continue at regular intervals throughout the first year of treatment.

You will continue recording your daily symptoms and medication use in the electronic diary.

You will continue to monitor any side effects or reactions to the treatment.

At the end of the first year (after completing the first study period), all assessments will be repeated, including the conjunctival provocation test, blood tests, spirometry and FeNO if you have asthma, and all questionnaires including the ESPIA satisfaction questionnaire.

4 Second year of treatment

You will continue receiving subcutaneous injections of the same treatment throughout the second year.

You will continue recording your daily symptoms and medication use in the electronic diary.

You will continue to monitor any side effects or reactions to the treatment.

At the end of the second year, all assessments will be repeated, including the conjunctival provocation test, blood tests for immunological parameters, spirometry and FeNO if you have asthma, and all questionnaires including the ESPIA satisfaction questionnaire.

5 Third year of treatment

You will continue receiving subcutaneous injections of the same treatment throughout the third year.

You will continue recording your daily symptoms and medication use in the electronic diary.

You will continue to monitor any side effects or reactions to the treatment throughout the entire three-year treatment period.

The total duration of the treatment phase is three years.

6 Rescue medications during the study

Throughout the study, you may use rescue medications to manage your symptoms as needed.

For rhinoconjunctivitis symptoms, you may use desloratadine 5 mg tablets taken by mouth, fluticasone furoate 27.5 micrograms nasal spray, or levocabastine 0.5 mg/ml eye drops.

If you have asthma, you may use salbutamol 100 micrograms per dose inhaler, terbutaline 500 micrograms per inhalation powder inhaler, montelukast 10 mg tablets taken by mouth, budesonide 200 micrograms per dose inhaler, or formoterol combined with beclometasone inhalers in various concentrations (100/6 micrograms or 200/6 micrograms per inhalation).

Your use of these medications will be recorded in your electronic diary as part of the study assessments.

Who Can Join the Study?

You or your legal representative must understand and sign the informed consent form, which is a document explaining the study details and confirming your agreement to participate.
You must be 12 years of age or older.
You must have moderate to severe persistent allergic rhinoconjunctivitis, which means ongoing allergy symptoms affecting your nose and eyes that are more than mild, for at least one year. This condition is caused by dust mites, specifically types called D. pteronyssinus and D. farinae.
You may also have controlled asthma, which means your asthma symptoms are well-managed with treatment, but this is not required.
Your allergy must be confirmed by a skin prick test, which is a test where small amounts of allergens are placed on your skin to see if you react. The reaction must be at least 3 millimeters in size for both types of dust mites. A test done within the past 12 months can be used.
You must have a blood test showing specific IgE levels, which are antibodies your body makes in response to allergens, greater than 0.7 kU/L for both types of dust mites. A test done within the past 12 months can be used.
You must have a blood test showing specific IgE levels greater than 0.7 kU/L for at least one major allergen from each dust mite type, such as Der p 1, Der p 2, Der p 23, Der f 1, or Der f 2. A test done within the past 12 months can be used.
You must have a positive conjunctival provocation test, which is a test where allergen extract is applied to your eye to see if it causes an allergic reaction. A test done within the past 12 months can be used.
You must have a cSMS score of at least 1.5 points at the time you join the study. This is a scoring system that measures your allergy symptoms and medication use.
You or your legal representative must have a mobile phone compatible with the cSMS application and access to the internet, as this will be used to track your symptoms during the study.
If you have asthma, it must be controlled according to standard guidelines, and your FEV₁ must be at least 70 percent. FEV₁ is a breathing test that measures how much air you can forcefully exhale in one second.
If you are a woman who can become pregnant, you must have a negative urine pregnancy test before starting the study and agree to use an effective contraceptive method, which is birth control, from 14 days before the first treatment until 4 weeks after the last treatment.
You must be willing to follow all study procedures and be available for follow-up visits throughout the entire duration of the study.

Who Cannot Join the Study?

The exclusion criteria for this clinical trial have not been provided in the available information. Please consult with the research team or your healthcare provider to learn about specific conditions or situations that would prevent participation in this study.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Bellvitge University Hospital	L'hospitalet De Llobregat	Spain
Hospital Universitario Y Politecnico La Fe	Valencia	Spain
Hospital Jerez de la Frontera	Jerez De La Frontera	Spain

Other Sites

Site Name	City	Country
Hospital Sant Joan De Deu Barcelona	Esplugues De Llobregat	Spain
Hospital Universitario Basurto	Bilbao	Spain
Hospital Universitari Joan XXIII De Tarragona	Tarragona	Spain
El Hospital Universitario De Gran Canaria Dr. Negrin	Las Palmas De Gran Canaria	Spain
Complejo Hospitalario Universitario Insular Materno Infantil	Las Palmas De Gran Canaria	Spain
Hospital General De Granollers	Granollers	Spain
Althaia Xarxa Assistencial Universitaria De Manresa Fundacio Privada	Manresa	Spain
Hospital General Universitario De Albacete	Albacete	Spain
Consorci Sanitari De Terrassa	Terrassa	Spain
Hospital Quironsalud Malaga	Malaga	Spain
Hospital Provincial De Conxo	Santiago De Compostela	Spain
Hospital Clinic De Barcelona	Barcelona	Spain
University Clinical Hospital Virgen De La Arrixaca	Murcia	Spain
Hospital General Universitario De Valencia	Valencia	Spain
Hospital General Universitario De Castellon	Castello De La Plana	Spain
Parc Sanitari Sant Joan De Deu	Sant Boi De Llobregat	Spain
Hospital Universitario De Canarias	La Laguna	Spain
Servei De Salut De Les Illes Balears	Palma	Spain
Area De Salud De Burgos Y Soria	Burgos	Spain
Hospital Teresa Herrera C.H.U.A.C.	A Coruna Galicia	Spain
Hospital Municipal de Badalona	Badalona	Spain
Hiequxid Fykqdvag Ssvd Poqa Ctffiy	Barcelona	Spain
Hlriqikq Df Lv Sydvg Csrp I Swpn Ptq	Barcelona	Spain
Hroiquar Ulqdcuaheublg Hjqffczg Tlzqu y Pgaorf Ibzdkqag Cxteiv dfbdeykxtghbvazvl (rnxj	Badalona	Spain
Heirjdty Vdrt dvwxqnzh	Barcelona	Spain

Trial status

Country	Status	Recruitment Start
Spain	Not yet recruiting	31.03.2026

Trial locations

Investigated drugs:

Depigmented polymerized allergenic extracts of D. pteronyssinus and D. farinae is an allergy immunotherapy treatment given as injections under the skin. This medication contains specially processed extracts from two types of house dust mites that commonly cause allergies. The treatment works by gradually exposing your immune system to small amounts of these allergens to help reduce your allergic reactions over time. In this study, the medication is being tested to see if it can help improve symptoms of allergic rhinoconjunctivitis, which includes sneezing, runny nose, and itchy eyes, and may also help people who have controlled asthma along with their allergies.

Placebo is an inactive substance that looks like the real medication but contains no active ingredients. It is used in this study to compare against the actual allergy treatment to help determine if the real medication is truly effective.

Allergic Rhinoconjunctivitis – Allergic rhinoconjunctivitis is a condition where the body’s immune system overreacts to allergens, causing inflammation in both the nose and eyes. When a person with this condition is exposed to allergens like dust mites, pollen, or pet dander, their immune system releases chemicals that trigger symptoms. Common symptoms include sneezing, a runny or stuffy nose, itchy nose and throat, red and watery eyes, and itchy eyes. The condition can be seasonal, occurring during specific times of the year, or perennial, happening year-round depending on the allergen. The severity can range from mild to severe, and symptoms may significantly affect daily activities and sleep quality. In some cases, people with allergic rhinoconjunctivitis may also develop asthma or have existing asthma that worsens due to allergen exposure.

Asthma – Asthma is a chronic respiratory condition that affects the airways in the lungs, causing them to become inflamed and narrowed. When a person with asthma is exposed to triggers such as allergens, exercise, cold air, or respiratory infections, the muscles around the airways tighten and the lining produces excess mucus. This leads to symptoms including wheezing, shortness of breath, chest tightness, and coughing, particularly at night or early morning. The condition can vary in severity from mild intermittent symptoms to severe persistent symptoms that require ongoing management. Asthma symptoms can worsen suddenly in what is called an exacerbation or asthma attack. Between episodes, people with well-controlled asthma may have few or no symptoms and normal lung function.

Trial ID:

2025-521230-29-00

Trial Phase:

Therapeutic confirmatory (Phase III)

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A study testing dust mite allergy extracts from Dermatophagoides pteronyssinus and Dermatophagoides farinae for patients with allergic rhinoconjunctivitis with or without controlled asthma

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?