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House Dust Mite AllergyPhase 3NCT06920771

A Randomized, Double-Blind, Placebo-Controlled, Multi-Centre Study to Assess the Efficacy of PURETHAL Mites Mixture 50,000 AUeq/mL Subcutaneous Immunotherapy in Adult Subjects With Moderate to Severe Allergic Rhinitis/Rhinoconjunctivitis With or Without Asthma Induced by House Dust Mite (HDM)

A Phase 3 study testing PURETHAL Mites 50,000 AUeq/ml in people with House Dust Mite Allergy and House Dust Mite Rhinitis, run by HAL Allergy at 68 sites in 5 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

Rationale: Allergic rhinitis/rhinoconjunctivitis (ARC) is a global health problem, affecting 10-25% of the population. Allergen-specific immunotherapy is the only disease-modifying therapeutic option for subjects with house dust mites (HDM)-induced allergic rhinitis/rhinoconjunctivitis. Read more about this study

Who is it for?
Ages 18 to 65 years
What is being tested?
PURETHAL Mites 50,000 AUeq/ml
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
691 participants
Where
68 sitesin 5 countries
Study dates
9 Sep 2024to 30 Mar 2026
Phase
Phase 3
Are there results?
None posted in the registry

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 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Prior to screening, subjects need to have signed the current approved Informed Consent Form (ICF).
  • Male or female subjects age 18-65 years at the time of informed consent.
  • 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.
  • 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.
  • Forced Expiratory Volume 1 (FEV1) \> 70% at Screening.
  • 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;
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  • ≤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.
  • 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.
  • 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).
  • Allergen specific serum IgE level for D. pter and/or D. far of \> 0.7 U/mL, assessed at Screening.
  • 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.
  • Negative serum pregnancy test at screening for women of childbearing potential.
  • 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:
  • combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation (oral, intravaginal, transdermal)
  • progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable, implantable)
  • intrauterine device (IUD)
  • intrauterine hormone-releasing system (IUS)
  • bilateral tubal occlusion
  • vasectomised partner
  • sexual abstinence Waivers to the inclusion criteria will NOT be allowed.

Who cannot join

  • 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.
  • Nasal surgery and/or severe nasal or severe oral disease within 6 months prior to Screening.
  • Patients not adhering to the e-Diary procedure and/or procedure for Rescue Medication use during e-Diary phase.
  • Severe asthma (GINA 2022 treatment steps 4 - 5).
  • Uncontrolled asthma, as defined by any of the following:
  • Asthma Control Test (ACT) ≤19,
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  • FEV1 ≤70% of predicted value,
  • Emergency room visit for asthma attack/exacerbation within 6 months prior to screening,
  • At least 1 hospitalization due to asthma within the last year,
  • History of intubation/mechanical ventilation due to asthma,
  • More than 2 courses of oral steroids used for treatment of asthma within the last 6 months prior to Screening,
  • Daily use of inhaled corticosteroids \>400mcg budesonide or equivalent.
  • History of anaphylaxis with cardio-respiratory symptoms (food allergy, drugs or an idiopathic reaction).
  • 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.
  • AIT (subcutaneous, sublingual or oral) with other allergens than HDM within the last 3 months prior to screening or planned during the trial period.
  • 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)

Trial locations and contacts

68 sites in 5 countries.

68 sites in 5 countries

Poland34 sites

  • NZOZ Homeo Medicus Poradnia Alergologiczna

    Bialystok

  • Prywatna Praktyka Lekarska Gabinet Pediatryczno-Alergologiczny Anna Płoszczuk

    Bialystok

  • Specjalistyczna Praktyka Lekarska AlerMedica

    Bialystok

  • Centrum Medyczne KERmed

    Bydgoszcz

  • Pratia - Ośrodek Badań Klinicznych

    Częstochowa

  • Clinica Vitae Spółka z o. o.

    Gdansk

  • Indywidualna Specjalistyczna Praktyka Lekarska Elżbieta Matusz

    Gryfice

  • Centrum Medyczne Angelius Provita

    Katowice

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

    Katowice

  • PZU Zdrowie Centra Medyczne Kielce

    Kielce

  • Indywidualna Specjalistyczna Praktyka Lekarska Jan Zdanowski Specjalista Alergolog

    Koszalin

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

    Krakow

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

    Krakow

  • Małopolskie Centrum Alergologii sp z o.o.

    Krakow

  • Clinmedica Research sp. z o.o.

    Lodz

  • CM Szpital Św. Rodziny

    Lodz

  • IP Clinic Sp. z o. o.

    Lodz

  • Medical University of Lodz

    Lodz

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

    Lubin

  • ALERGOTEST s.c. Specjalistyczne Centrum Medyczne

    Lublin

  • Centrum Alergoologii Specjalistyczna Przychodnia Alergologiczna

    Lublin

  • Pro Life Medica Sp. z o.o.

    Lublin

  • Uniwersytecki Szpital Kliniczny Nr 4 w Lublinie

    Lublin

  • Centrum Alergologii

    Poznan

  • NZOZ Alergo-Med

    Poznan

  • Poradnie Specjalistyczne Alergologia Plus - Justyna Rakowicz

    Poznan

  • NSZOZ Puls Med

    Skarżysko-Kamienna

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

    Tarnów

  • Gabinet Lekarski Bożena Kubicka-Kozik

    Tomaszów Mazowiecki

  • Centrum Alergologii Irmed Irena Wojciechowska

    Warsaw

  • ETG Warszawa

    Warsaw

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

    Warsaw

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

    Wroclaw

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

    Wroclaw

Other trials in Poland

Germany19 sites

  • Emovis GmbH

    Berlin

  • Praxis Dr. Ginko

    Bonn

  • Praxis Dr. Elke Decot

    Dreieich

  • HNO-Praxis Dr. Udo Schäfer

    Dresden

  • HNO Praxis Dr. Uta Thieme

    Duisburg

  • Medizentrum Essen-Borbeck

    Essen

  • Pneumologisches Forschungsinstitut Hohegeest GbR

    Geesthacht

  • HNO-Facharztpraxis Alte Post

    Göttingen

  • HNO Research GmbH

    Itzehoe

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

    Kiel, 24105

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

    Leipzig

  • Praxis Dr. Bohn

    Mittweida

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

    Neu-Isenburg

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

    Neuenhagen

  • KliFOs - Klinische Forschung Osnabrück

    Osnabrück

  • Studienzentrum Dr.Schlenska

    Peine

  • Studienzentrum Dr.Laßmann

    Saalfeld

  • Allergo GmbH - Prüfzentrum Schorndorf

    Schorndorf

  • Klinikum Stuttgart - Krankenhaus Bad Cannstatt

    Stuttgart

Other trials in Germany

Lithuania7 sites

  • CD8 clinic

    Kaunas

  • Lithuanian University of Health Sciences Kauno klinikos

    Kaunas

  • Inovatyvios alergologijos centras

    Vilnius

  • JSC Center for Diagnosis and Treatment of Allergic Diseases

    Vilnius

  • JSC Family Doctor

    Vilnius

  • JSC Inlita

    Vilnius

  • JSC Verkiu clinic

    Vilnius

Other trials in Lithuania

Bulgaria6 sites

  • UMBAL Kaspela

    Plovdiv

  • Medical Center Prolet EOOD

    Rousse

  • Medical Center Smolyan

    Smolyan

  • DCC Convex

    Sofia

  • Diagnostic-Consulativ Senter Ascendent

    Sofia

  • University Hospital Alexandrovska

    Sofia

Other trials in Bulgaria

Latvia2 sites

  • LOR Clinic

    Riga

  • The Center of Investigation in Treatment of Allergyc Diseases

    Riga

Other trials in Latvia

About this study

Official title: A Randomized, Double-Blind, Placebo-Controlled, Multi-Centre Study to Assess the Efficacy of PURETHAL Mites Mixture 50,000 AUeq/mL Subcutaneous Immunotherapy in Adult Subjects With Moderate to Severe Allergic Rhinitis/Rhinoconjunctivitis With or Without Asthma Induced by House Dust Mite

Rationale: Allergic rhinitis/rhinoconjunctivitis (ARC) is a global health problem, affecting 10-25% of the population. Allergen-specific immunotherapy is the only disease-modifying therapeutic option for subjects with house dust mites (HDM)-induced allergic rhinitis/rhinoconjunctivitis. This Phase 3 clinical study aims to demonstrate the effecacy of PURETHAL Mites (PM) Mixture subcutaneous immunotherapy (SCIT) compared to a placebo over one year of treatment in patients with moderate to severe HDM- induced allergic rhinitis/rhinoconjunctivitis (ARC), while also prioritizing the safety of the treatment. PM Mixture is a suspension of chemically modified extract from the house dust mites Dermatophagoides pteronyssinus (D. pter) and Dermatophagoides farinae (D. far), adsorbed to aluminium hydroxide. Modified extracts (allergoids) are associated with reduced allergenicity but with preserved immunogenicity. Based on the previous studies the dose of 0.5 mL of PM Mixture solution with concentration 50,000 AUeq/mL (allergen units in millilitre) was selected for this Phase 3 clinical study.

Objectives: The primary objective is to assess the efficacy of PM Mixture 50,000 AUeq/mL (0.5 mL) SCIT based on an average Total Combined Rhinitis Score (TCRS), which will be compared between PM Mixture and placebo groups. The TCRS consists of rhinitis symptom score and medication score measured daily over the last 8 weeks of the 1 year treatment.

Read more

Other secondary efficacy parameters will be compared between treatment groups to show efficacy: rhinitis symptom and medication scores separately as well as a combined symptom and medication score for nasal symptoms only (CSMS(n)); Total Combined Conductivities Score; nasal provocation test; immunological blood markers such as immunoglobulins E, G and G4; and Rhinitis Quality of Life Questionnaire (standardised) (RQLQ(S)).

Trial design: This is a randomized, double-blind, placebo controlled multi-centre clinical trial where subjects are participating for about 14 months.

Trial population: Patients (18-65 years of age) suffering from moderate to severe ARC induced by HDM with or without controlled asthma can be included in the study. The main criteria to evaluate the HDM allergy will be done by the following parameters: allergic medical history to HDM minimum 1 year; positive skin prick test and nasal provocation test HDM D. pter and/or D. far; certain level of allergen-specific immunoglobulin E to D. pter or D. far, and most importantly they should have sufficient rhinitis symptom score measured during 2 weeks at screening. Additionally patients should have sufficient lung functions confirmed by the spirometry, they may have asthma which should be controlled. Patients with a chronic or acute disease that might place the subject at an additional risk will not be included. Certain medications which can interfere with the study treatment or increase the health risks should be washed-out and can not be taken during the study.

Approximately 920 HDM-allergic subjects will be screened in order after the screening period to enroll 552 subjects.

Being tested
PURETHAL Mites 50,000 AUeq/ml, Biological/Vaccine: Placebo
Keywords
PM0059, House dust mite, House dust mite allergy, House dust mite rhinitis, allergy, rhinitis, total nasal symptom score, TNSS, subcutaneous, Purethal
Medical subject headings
Dust Mite Allergy, Hypersensitivity, Rhinitis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PURETHAL Mites 50,000 AUeq/mlBiological

    Biological/Vaccine: Placebo

    Increasing volumes of placebo, will be administered by subcutaneous injection (starting with 0.05 ml) at weekly intervals till the maintenance dose (0.5 ml) is reached. Subsequently, maintenance dosages, corresponding to 0.5 ml of placebo, are given at 4-weekly intervals

  • Biological/Vaccine: PlaceboBiological

    Increasing dosages, corresponding to increasing volumes of drug solution (starting with 0.05 ml), will be administered by subcutaneous injection at weekly intervals till the maintenance dose (0.5 ml) is reached. Subsequently, maintenance dosages, corresponding to 0.5 ml of drug solution, are given at 4-weekly intervals.

Study groups in NCT06920771
Study groupRoleWhat they receive
Placebo Comparator: placeboPlacebo comparatorIncreasing volumes of placebo, will be administered by subcutaneous injection (starting with 0.05 ml) at weekly intervals till the maintenance dose (0.5 ml) is reached. Subsequently, maintenance dosages, corresponding to 0.5 ml of placebo, are given at 4-weekly intervals.
Receives: Biological: PURETHAL Mites 50,000 AUeq/ml; Biological: Biological/Vaccine: Placebo
Experimental: PURETHAL Mites, 50,000 AU/mlActive comparatorIncreasing dosages, corresponding to increasing volumes of drug solution (starting with 0.05 ml), will be administered by subcutaneous injection at weekly intervals till the maintenance dose (0.5 ml) is reached. Subsequently, maintenance dosages, corresponding to 0.5 ml of drug solution, are given at 4-weekly intervals.
Receives: Biological: PURETHAL Mites 50,000 AUeq/ml; Biological: Biological/Vaccine: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Primary objective

    To assess clinical efficacy of PM Mixture 50,000 AUeq/mL (0.5 mL) SCIT in subjects suffering from moderate to severe HDM-induced ARC, measured by difference in the average Total Combined Rhinitis Score (TCRS) during the last 8 weeks of one (± 1 month) year treatment, between PM treatment and placebo.

    Each symptom will be individually graded and then summed to a maximum of 24 points.

    Measured: Last 8 weeks (before end of study) of the intervention.

Secondary outcomes (1)

  1. To assess the effect of PM treatment by comparing the average daily Total Nasal Symptom Score (TNSS) between PM and placebo during the last 8 weeks of one (± 1 month) year treatment of subjects with HDM-allergic ARC.

    To assess the effect of PM treatment by comparing the average daily Total Nasal Symptom Score (TNSS) between PM and placebo during the last 8 weeks of one (± 1 month) year treatment of subjects with HDM-allergic ARC.

    Measured: The last 8 weeks of one (± 1 month) year treatment.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Apr 2025
  2. Study start9 Sep 2024
  3. Primary completion30 Mar 2026
  4. Study completion30 Mar 2026

Resources

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
691 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06920771
Sponsor's protocol ID
PM/0059
Other IDs
2023-504942-75-01, 2023
Status last verified
Apr 2026
First submitted
18 Oct 2024
Last updated
10 Aug 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing PURETHAL Mites 50,000 AUeq/ml in people with House Dust Mite Allergy and House Dust Mite Rhinitis, run by HAL Allergy at 68 sites in 5 countries.

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 20 inclusion and 19 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: finished, as of the sponsor's last update on 10 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 68 sites in Poland, Germany, Lithuania, Bulgaria, Latvia. 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. Some participants in this study may receive a placebo. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Primary objective (time frame: Last 8 weeks (before end of study) of the intervention.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06920771.

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 10 Aug 2026.

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