BridgeMD
Tests treatment safety and results for Allergic Rhinoconjunctivitis
Official title Evaluation of the Efficacy of Allergen-specific Immunotherapy Using Assessment in an Allergen Exposure chamber-a Randomized Placebo-controlled Double-blind Study
ClinicalTrials.gov ID: NCT06778213
What this study is testing
What is NovoHelisen Depot?
NovoHelisen Depot is an investigational medicine, given as an once-daily infusion into a vein, being studied as a potential treatment for allergic rhinoconjunctivitis.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 4: studies an already-approved treatment
- Time commitment: about 10 months
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65
You may be able to join if
- To be eligible for trial participation, patients must meet all the following
- Written informed consent given from patient according to local requirements before any trial-related activities started (a trial-related activity is...
- 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...
- 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.
You likely can't join 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
See the full eligibility criteria
Who can join
- To be eligible for trial participation, patients must meet all the following
- 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...
- 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...
- 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. 2017, Bousquet et al. 2001) Symptoms for 4 or more consecutive weeks in the previous years and for at least 4 days per week...
What rules you out
- 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...
- Wish to breastfeed or breastfeeding Immunotherapy criteria:
- History of a confirmed anaphylaxis after an AIT injection
- Current treatment with any kind of AIT
- AIT with HDM allergoids or allergens within the last 5 years
- AIT with unknown allergen within the last 5 years Sensitization criteria
- Clinically relevant symptoms to perennial and seasonal allergens which interfere with the assessment period of October to January. Exceptions are symptoms to allergens of cat and dog, if the patient has no direct...
- Clinically relevant chronic rhinoconjunctival or respiratory symptoms related to other reasons than allergy
- Chronic persistent rhinitis symptoms for 20 years or longer
- Forced expiratory volume in 1 second (FEV1) \< 70 % of predicted normal values according to Quanjer (Quanjer et al. 2012) under adequate asthma treatment according to GINA recommendation (GINA 2022)
- Uncontrolled or partly controlled asthma according to GINA recommendation (GINA 2022)
- Asthma exacerbation within the last 6 months prior to randomization defined as unscheduled doctors visit, hospitalization, or emergency unit visit requiring the use of systemic corticosteroids or change of controller...
- Severe acute or chronic diseases (e.g., COVID-19, chronic urticaria, mastocytosis, active tuberculosis, diabetes mellitus type I, malignant neoplasia, chronic renal failure), severe inflammatory diseases (liver, kidneys)
- Autoimmune diseases, immune defects including immunosuppression, immune-complexinduced immunopathies (e.g., HIV, post-transplant patients, lupus erythematodes [SLE], vitiligo, Grave's disease, multiple sclerosis)
- Severe psychiatric and psychological disorders including impairment of cooperation (e.g., alcohol or drug abuse)
- Recurrent seizures (e.g., febrile convulsion, untreated epilepsy)
- Irreversible secondary alterations of the reactive organ (e.g., emphysema, bronchiectasis)
- For assessment the normal reference ranges of the central laboratory should be applied. If out of range, laboratory values greater than grade 1 according to the FDA Guidance for Industry (Toxicity Grading Scale for...
- Use of β-blockers (locally or systemically) and/or angiotensin-converting enzyme (ACE) inhibitors
- Contraindication for use of adrenalin (e.g., acute, or chronic symptomatic coronary heart disease, severe hypertension)
- Completion or ongoing treatment with anti-IgE-antibodies (e.g., omalizumab) or anti IL4/IL13 antibodies (e.g., dupilumab) or other biological medication interfering with the TH2 pathway
- Completed or ongoing long-term treatment with tranquilizer or other psychoactive drugs
The study team makes the final eligibility decision.
Where it's taking place
- Wroclaw, DL, Poland
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 10 months per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Wroclaw, DL, Poland. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.