Evaluation of the Efficacy of Allergen-specific Immunotherapy Using Assessment in an Allergen Exposure chamber-a Randomized Placebo-controlled Double-blind Study

NCT06778213 | Recruiting Phase 4

• 1 other identifier: ALL-MED
• Study Type: interventional
• Target: 67
• Locations: 1 country
• Sites: 1

Brief Summary

The main objective of the study is to measure and correlate clinical parameters suitable for the assessment of allergen immunotherapy (AIT) with an aluminum hydroxide-adsorbed preparation of house dust mite (Dermatophagoides pteronyssinus/ Dermatophagoides farinae) allergens in adults with moderate to severe allergic rhinitis/rhinoconjunctivitis with or without controlled allergic bronchial asthma caused by house dust mite (HDM) allergens. The assessment of clinical responses will be evaluated following an allergen challenge in allergen exposure chamber (AEC) before and during the course of AIT. Patients' response to therapy will be evaluated as well as in the AEC and by patient's personal environment (Diary).

Conditions

Allergic Rhinoconjunctivitis

Keywords

allergen-specific immunotherapy; biomarker assessment; allergen exposure chamber; house dust mite; allergic rhinoconjunctivitis

Outcome Measures

Primary Outcomes (1)

• Total nasal symptom score

  The primary efficacy analysis is the analysis of correlation between TNSS recorded in the AEC and the average CSMS over 2 weeks as recorded in the eDiary.

  12 months

Secondary Outcomes (2)

• Change of the TNSS

  12 months

• Change in average CSMS

  12 months

Study Arms (2)

verum

ACTIVE COMPARATOR

Immunotherapy - NovoHelisen Depot according to desensitisation protocol 5 times weekly increasing injections 250-5000 TU, 10 times monthly maintenance injections 5000 TU

Biological: NovoHelisen Depot

placebo

PLACEBO COMPARATOR

5 times weekly increasing placebo injections, 10 times monthly placebo injections

Biological: NovoHelisen Depot

Interventions

NovoHelisen Depot BIOLOGICAL

allergen immunotherapy treatment for 12 months with house dust mite allergen preparation

placebo; verum

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Written informed consent given from patient according to local requirements before any trial-related activities started (a trial-related activity is any procedure that would not have been performed during the routine management of the patient)
• Legally competent male or female outpatient between 18 and ≤ 65 years
• IgE-mediated moderate to severe allergic rhinitis or rhinoconjunctivitis with or without allergic asthma caused by HDM allergens documented by
• Positive Skin prick test (SPT) result to D. pteronyssinus allergens:
• D. pteronyssinus test solution (wheal diameter) ≥ 3 mm and Positive histamine-control reaction (wheal diameter) ≥ 3 mm and Negative NaCl-control reaction (wheal diameter) \< 2 mm Immunoassay result for specific IgE ≥ 0.70 kU/L to D. pteronyssinus
• Symptoms of rhinitis or rhinoconjunctivitis e.g., during the months October to February or over the entire year for at least 2 years before enrolment.
• Assessment of persistent, moderate-severe rhinitis acc. to ARIA guidelines (Brozek et al.
• , Bousquet et al. 2001) Symptoms for 4 or more consecutive weeks in the previous years and for at least 4 days per week during those weeks More than one of the symptoms evaluated as "troublesome" by the patients and/or impairing their daily activities, leisure or sport, school, or work and/or involving sleep disturbance 6. Symptoms requiring regular intake of anti-symptomatic medication 7. Previous symptomatic anti-allergic medication for at least 2 seasons prior to enrolment 8. At entry to this trial: No diagnosis of bronchial asthma in medical history or confirmed diagnosis of asthma as being "well controlled" according to GINA recommendation (GINA 2022)

You may not qualify if:

• General criteria:
• Patients are unable to understand and comply with the requirements of the trial, as judged by the investigator
• Currently participating in another clinical trial or participating in any other clinical trial within 30 days prior informed consent for this trial
• Low adherence to trial procedures expected or inability to understand instructions/trial documents
• Involvement in the planning and conduct of the trial
• Any relationship of dependence with the investigator
• Previous randomization to treatment in the present trial
• Mentally disabled
• Institutionalized due to an official or judicial order For female patients with childbearing potential (i.e., females who are not chemically or surgically sterilized or females who are not post-menopausal)
• Positive urine pregnancy test or pregnant
• Wish to become pregnant during the course of the trial
• Not using highly effective and reliable contraception, as judged by the investigator (reliable and highly effective methods of birth control defined as a failure rate of less than 1% per year \[CTFG recommendations 2020\]) during the trial. Sexual abstinence is an allowed method of birth control (sexual abstinence is considered a highly effective method only if defined as refraining from heterosexual intercourse during the entire period of risk associated with the study treatments. The reliability of sexual abstinence needs to be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the subject.) Males are not required to use any contraception during the study.
• Wish to breastfeed or breastfeeding
• Immunotherapy criteria:
• History of a confirmed anaphylaxis after an AIT injection

Sponsors & Collaborators

• Wroclaw Medical University: lead
• ALL-MED Medical Research Institute, Wroclaw, Poland: collaborator
• Allergopharma GmbH & Co. KG: collaborator

Study Sites (1)

ALL-MED Medical Research Institute

Wroclaw, DL, 53-201, Poland

RECRUITING

Related Publications (4)

• Zemelka-Wiacek M, Kosowska A, Winiarska E, Sobanska E, Jutel M. Validated allergen exposure chamber is plausible tool for the assessment of house dust mite-triggered allergic rhinitis. Allergy. 2023 Jan;78(1):168-177. doi: 10.1111/all.15485. Epub 2022 Sep 1.

  PMID: 35980665 BACKGROUND

• Kosowska A, Zemelka-Wiacek M, Smolinska S, Wyrodek E, Adamczak B, Jutel M. Clinical validation of grass pollen exposure chamber in patients with allergic rhinitis triggered by timothy grass. Clin Exp Allergy. 2024 Jul;54(7):489-499. doi: 10.1111/cea.14482. Epub 2024 Apr 14.

  PMID: 38616622 BACKGROUND

• Jutel M, Zemelka-Wiacek M, Okamoto Y, Pfaar O. Algorithms in Allergy: Assessment of Rhinitis Using Allergen Exposure Chambers. Allergy. 2025 Mar;80(3):904-907. doi: 10.1111/all.16444. Epub 2024 Dec 17. No abstract available.

  PMID: 39688144 BACKGROUND

• Zemelka-Wiacek M, Kosowska A, Jutel M. Symptom Assessment of Patients with Allergic Rhinitis Using an Allergen Exposure Chamber. J Vis Exp. 2023 Mar 3;(193). doi: 10.3791/64801.

  PMID: 36939263 BACKGROUND

Related Links

• ALLEC Allergen Exposure Chamber

Study Officials

• Agnieszka M Chuda, MSc

  ALL-MED Specjalistyczna Opieka Medyczna. Medyczny Instytut Badawczy

  STUDY DIRECTOR

Central Study Contacts

Marek M Jutel, prof.

CONTACT

+48731021221; marek.jutel@all-med.wroclaw.pl

Magdalena E Zemelka-Wiacek, Dr

CONTACT

+48507019921; magdalena.zemelka-wiacek@umw.edu.pl

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: double-blind
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Model Details: A randomized placebo-controlled double-blind study

Study Record Dates

• First Submitted: January 10, 2025
• First Posted: January 16, 2025
• Study Start: November 2, 2024
• Primary Completion: April 2, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: January 28, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

PL (1)