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Can allergy shots quiet the sneezing and stuffy nose caused by dust mites?

NCT ID NCT06920771

Disease control Sponsor: HAL Allergy Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 10, 2026 · Last updated Aug 11, 2026 · Updated 1 time

Summary

This trial tests whether a series of allergy shots, called PURETHAL Mites, can reduce symptoms like sneezing, runny nose, and congestion in adults with moderate to severe house dust mite allergies, with or without asthma. Participants receive either the active treatment or a placebo over about a year, and their symptom and medication scores are compared. The goal is to see if this immunotherapy can provide meaningful relief and improve quality of life for people whose allergies are triggered by dust mites.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
PURETHAL Mites mixture, a modified house dust mite extract given as allergy shots
What this could lead to
If successful, this could offer a disease-modifying treatment that reduces allergy symptoms and medication use for people with house dust mite allergies.
What could go wrong
This is a Phase 3 trial, but results are not guaranteed. The treatment may not outperform placebo, and allergy shots can cause local reactions or, rarely, more serious allergic responses.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

691 people

The number who actually took part.

Started

Sep 2024

Finished

Mar 2026

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 65 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Prior to screening, subjects need to have signed the current approved Informed Consent Form (ICF). 2. Male or female subjects age 18-65 years at the time of informed consent. 3. Clinical history consistent with moderate-severe HDM allergic rhinitis (with or without asthma) according to the ARIA classification (Allergic Rhinitis and its Impact on Asthma) (Bousquet et al., 2008), for at least one year prior to the first dosing. 4. Subjects should be able and willing to complete daily e-Diaries for a period of 4 weeks during the screening period, 1 week after maintenance visit 7, and for a period of 8 weeks at the end of treatment under the same living conditions. 5. Forced Expiratory Volume 1 (FEV1) \> 70% at Screening. 6. If a subject is asthmatic, asthma must be clinically controlled for at least three months before the screening using inhaled steroids and / or Long Acting Beta Agonists (corresponding to GINA treatment steps 1 -3) and inhaled steroid use should be on a stable, not higher dose than of ≤400 µg budesonide per day or dose-equivalent (≤500 µg beclometasone dipropionate; ≤160 µg ciclesonide; ≤250 µg fluticasone propionate; ≤200 µg mometasone furoate). Patients with asthma should use their standard asthma medication throughout the whole study period to ensure their asthma remains controlled. 7. Positive SPT to D. pter and/or D. far (mean wheal diameter ≥ 3 mm, negative control should be \< 2 mm, histamine positive control should be ≥ 3 mm), assessed at Screening. 8. Subjects with a positive NPT for D. pter extract at Screening (Lebel score ≥6 at 10,000 AU/mL, test should be postponed, if baseline score is ≥ 3 or if negative control score is \> 3). 9. Allergen specific serum IgE level for D. pter and/or D. far of \> 0.7 U/mL, assessed at Screening. 10. Subjects need to have an average daily TNSS of at least 8 out of 12 points at baseline, determined according to the daily e-Diary entries during 2 weeks of baseline assessment. Subjects should have a minimum e-Diary entry compliance of 70% for which the average is calculated. 11. Negative serum pregnancy test at screening for women of childbearing potential. 12. Females of childbearing potential must be using highly effective and acceptable methods of birth control (as per the CTFG recommendations) to prevent pregnancy and agree to continue to practice an acceptable method of contraception for the duration of participation in the trial. Contraceptive measures considered adequate are: 1. combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation (oral, intravaginal, transdermal) 2. progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable, implantable) 3. intrauterine device (IUD) 4. intrauterine hormone-releasing system (IUS) 5. bilateral tubal occlusion 6. vasectomised partner 7. sexual abstinence Waivers to the inclusion criteria will NOT be allowed. Exclusion Criteria: 1. A clinically relevant history of symptomatic seasonal ARC and/or a positive SPT (mean wheal diameter ≥ 3 mm) caused by an allergen (including animal hair and dander), to which the subject is regularly exposed and/or exposure is overlapping with the e-Diary completion periods at Screening and at the end of treatment. 2. Nasal surgery and/or severe nasal or severe oral disease within 6 months prior to Screening. 3. Patients not adhering to the e-Diary procedure and/or procedure for Rescue Medication use during e-Diary phase. 4. Severe asthma (GINA 2022 treatment steps 4 - 5). 5. Uncontrolled asthma, as defined by any of the following: 1. Asthma Control Test (ACT) ≤19, 2. FEV1 ≤70% of predicted value, 3. Emergency room visit for asthma attack/exacerbation within 6 months prior to screening, 4. At least 1 hospitalization due to asthma within the last year, 5. History of intubation/mechanical ventilation due to asthma, 6. More than 2 courses of oral steroids used for treatment of asthma within the last 6 months prior to Screening, 7. Daily use of inhaled corticosteroids \>400mcg budesonide or equivalent. 6. History of anaphylaxis with cardio-respiratory symptoms (food allergy, drugs or an idiopathic reaction). 7. Previous treatment with AIT with HDM allergen or a cross-reacting allergen for more than 1 month at the maintenance level within the last 5 years. Initiation of HDM SCIT is acceptable, if treatment has been discontinued before reaching maintenance dose. 8. AIT (subcutaneous, sublingual or oral) with other allergens than HDM within the last 3 months prior to screening or planned during the trial period. 9. Participation in a clinical trial within the last 3 months prior to screening (e.g. new investigational drug or biological) or during the trial. 10. Any vaccination (including COVID-19) less than 1 week prior to screening, during screening and the up-dosing phase and the TCRS scoring periods. 11. Any immunosuppressive treatment or anti-IgE therapy within the last 6 months prior to the first dosing of the trial drug and during the trial 12. Any treatment with β-adrenergic blockers unless prescribed as per treatment standards to the subject if the medical benefit will prevail the risks upon investigators discretion. 13. Hypersensitivity to any of the other components of the investigational product. 14. Severe immune disorders (including autoimmune diseases) and/or diseases requiring immunosuppressive medication. 15. Active COVID-19 infection at the time of screening or 2 weeks before. 16. Active malignancies or any malignant disease in the last 5 years. 17. A chronic or acute disease that in the opinion of the investigator might place the subject at an additional risk, including but not limited to the following: cardiovascular insufficiency, any severe or unstable lung diseases, endocrine disorders, clinically significant renal or hepatic diseases, haematological disorders, severe atopic dermatitis, other relevant skin diseases (affecting SPT testing areas). 18. Diseases with a contraindication for the use of adrenaline/epinephrine (e.g. hyperthyroidism, glaucoma). 19. Use of prohibited medication and/or not able to discontinue medications that are prohibited during the specified trial periods. 20. Moderate to severe nasal obstructive disease such as polyps, septum deviation. 21. Clinically significant chronic sinusitis or ocular infection. 22. Female subjects of childbearing potential who are pregnant or lactating. 23. Alcohol, drug, or medication abuse within the past year and during the trial. 24\. Any (expected) lack of cooperation or compliance upon the discretion of the investigator. 25. Severe psychiatric, psychological, or neurological disorders. 26. Employees of the Sponsor, CRO, clinical study site and/or who are 1st grade relatives, or partners of the investigator. 27. Known commitment to an institution by virtue of an order issued either by the judicial or the administrative authorities 28. Expected changes in average HDM exposure during the trial (e.g. new avoidance measures, relocation and holidays or trips lasting more than 10 days during the efficacy assessment period)

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Conditions

The condition(s) this trial relates to.

allergic disease allergic rhinitis Dust Mite Allergy perennial allergic rhinitis rhinitis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

House dust mite allergy House dust mite rhinitis

Contacts and locations

Locations

  • ALERGOTEST s.c. Specjalistyczne Centrum Medyczne

    Lublin, Poland

  • Alergo-Med Specjalistyczna Przychodnia Lekarska Sp. z o. o.

    Tarnów, Poland

  • All-Med - Specjalistyczna Opieka Medyczna - Medyczny Instytut Badawczy

    Wroclaw, Poland

  • Allergo GmbH - Prüfzentrum Schorndorf

    Schorndorf, Germany

  • BAG Prof. G. Hoheisel/Dr. A. Bonitz Praxis für Pneumologie und Allergologie - Studienzentrum

    Leipzig, Germany

  • Ballenberger, Freytag, Wenisch -Institut für klinische Forschung GmbH

    Neu-Isenburg, Germany

  • CD8 clinic

    Kaunas, Lithuania

  • CM Szpital Św. Rodziny

    Lodz, Poland

  • Centrum Alergologii

    Poznan, Poland

  • Centrum Alergologii Irmed Irena Wojciechowska

    Warsaw, Poland

  • Centrum Alergoologii Specjalistyczna Przychodnia Alergologiczna

    Lublin, Poland

  • Centrum Diagnostyczno-Terapeutyczne Medicus Sp. z o.o.

    Lubin, Poland

  • Centrum Medyczne Angelius Provita

    Katowice, Poland

  • Centrum Medyczne KERmed

    Bydgoszcz, Poland

  • Centrum Nowoczesnych Terapii "Dobry Lekarz" Sp. z o.o.

    Krakow, Poland

  • Clinica Vitae Spółka z o. o.

    Gdansk, Poland

  • Clinmedica Research sp. z o.o.

    Lodz, Poland

  • DCC Convex

    Sofia, Bulgaria

  • Diagnostic-Consulativ Senter Ascendent

    Sofia, Bulgaria

  • ETG Warszawa

    Warsaw, Poland

  • Emovis GmbH

    Berlin, Germany

  • Gabinet Lekarski Bożena Kubicka-Kozik

    Tomaszów Mazowiecki, Poland

  • HNO Praxis Dr. Uta Thieme

    Duisburg, Germany

  • HNO Research GmbH

    Itzehoe, Germany

  • HNO-Facharztpraxis Alte Post

    Göttingen, Germany

  • HNO-Praxis Dr. Udo Schäfer

    Dresden, Germany

  • Hospital Schleswig-Holstein. Klinik für Dermatologie, Venerologie und Allergologie.

    Kiel, 24105, Germany

  • IP Clinic Sp. z o. o.

    Lodz, Poland

  • Indywidualna Specjalistyczna Praktyka Lekarska Elżbieta Matusz

    Gryfice, Poland

  • Indywidualna Specjalistyczna Praktyka Lekarska Jan Zdanowski Specjalista Alergolog

    Koszalin, Poland

  • Inovatyvios alergologijos centras

    Vilnius, Lithuania

  • JSC Center for Diagnosis and Treatment of Allergic Diseases

    Vilnius, Lithuania

  • JSC Family Doctor

    Vilnius, Lithuania

  • JSC Inlita

    Vilnius, Lithuania

  • JSC Verkiu clinic

    Vilnius, Lithuania

  • KliFOs - Klinische Forschung Osnabrück

    Osnabrück, Germany

  • Klinikum Stuttgart - Krankenhaus Bad Cannstatt

    Stuttgart, Germany

  • Krakowskie Centrum Medyczne Sp. z o.o - FutureMeds Kraków

    Krakow, Poland

  • LOR Clinic

    Riga, Latvia

  • Lithuanian University of Health Sciences Kauno klinikos

    Kaunas, Lithuania

  • Małopolskie Centrum Alergologii sp z o.o.

    Krakow, Poland

  • Medical Center Prolet EOOD

    Rousse, Bulgaria

  • Medical Center Smolyan

    Smolyan, Bulgaria

  • Medical University of Lodz

    Lodz, Poland

  • Medizentrum Essen-Borbeck

    Essen, Germany

  • NSZOZ Puls Med

    Skarżysko-Kamienna, Poland

  • NZOZ Alergo-Med

    Poznan, Poland

  • NZOZ Centrum Usług Medycznych "PROXIMUM" Sp. z o. o.

    Wroclaw, Poland

  • NZOZ Homeo Medicus Poradnia Alergologiczna

    Bialystok, Poland

  • POLIMEDICA CENTRUM BADAŃ, PROFILAKTYKI I LECZENIA Sp. z o.o. - POLIMEDICA PTG

    Warsaw, Poland

  • PZU Zdrowie Centra Medyczne Kielce

    Kielce, Poland

  • Pneumologisches Forschungsinstitut Hohegeest GbR

    Geesthacht, Germany

  • Poradnie Specjalistyczne Alergologia Plus - Justyna Rakowicz

    Poznan, Poland

  • Pratia - Ośrodek Badań Klinicznych

    Częstochowa, Poland

  • Praxis Dr. Bohn

    Mittweida, Germany

  • Praxis Dr. Elke Decot

    Dreieich, Germany

  • Praxis Dr. Ginko

    Bonn, Germany

  • Pro Life Medica Sp. z o.o.

    Lublin, Poland

  • Prywatna Praktyka Lekarska Gabinet Pediatryczno-Alergologiczny Anna Płoszczuk

    Bialystok, Poland

  • Specjalistyczna Praktyka Lekarska AlerMedica

    Bialystok, Poland

  • Specjalistyczna Praktyka Lekarska dr n.med. Joanna Orlicz-Widawska

    Katowice, Poland

  • Studienzentrum Dr.Laßmann

    Saalfeld, Germany

  • Studienzentrum Dr.Schlenska

    Peine, Germany

  • Studienzentrum MOL BAG Dres. E.Hippke & S. Runge

    Neuenhagen, Germany

  • The Center of Investigation in Treatment of Allergyc Diseases

    Riga, Latvia

  • UMBAL Kaspela

    Plovdiv, Bulgaria

  • University Hospital Alexandrovska

    Sofia, Bulgaria

  • Uniwersytecki Szpital Kliniczny Nr 4 w Lublinie

    Lublin, Poland

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