Observational study on severe asthma patients receiving biological therapy

3TR Asthma Biologics Cohort (ABC) Study - A Part of the 3TR (Taxonomy, Treatment, Targets and Remission) Consortium for the Identification of the Molecular Mechanisms of Non-response to Treatment, Relapses, and Remission in Autoimmune, Inflammatory, and Allergic Conditions

This study is tracking patients with severe asthma who are starting a new biological therapy for three years to see how well it works and understand their individual responses.

Quick facts

• Study type: Observational
• Enrollment: 600 (estimated)
• Sex: All
• Sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) (Academic / other)
• Drugs / interventions: Benralizumab
• Locations: 2 sites (Copenhagen and 1 other locations)
• Trial ID: NCT06126692 on ClinicalTrials.gov

What this trial studies

The 3TR-ABC study is a multicenter observational cohort study that follows patients with severe asthma starting biological therapy for three years. It aims to assess treatment responses and examine clinical characteristics, biomarkers, and immunological mechanisms related to remission and non-response. Patients will be characterized at baseline and monitored with formal assessments at various intervals, allowing for stratification into remission, clinical responders, and non-responders based on their treatment response. The study is part of a larger consortium focused on advancing precision medicine in autoimmune and inflammatory diseases.

Who should consider this trial

Good fit: Ideal candidates include patients with severe asthma requiring high-dose inhaled corticosteroids or systemic corticosteroids and experiencing frequent exacerbations.

Not a fit: Patients with mild or moderate asthma who do not require monoclonal antibody treatments may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved understanding and management of severe asthma, potentially allowing for better-targeted therapies.

How similar studies have performed: Other studies have shown promise in using biologics for severe asthma, but this specific approach within a large consortium is relatively novel.

Eligibility criteria

Inclusion Criteria:

* Patients with severe asthma that requires High dose ICS (corresponding to minimum 1600 micrograms Budesonide per day) + either LABA, LTRA, or LAMA OR Fixed Prednisolone treatment (OCS) minimum 50% of the time. Minimum 2 exacerbations in the last year or fixed Prednisolone treatment (OCS) minimum 50% of the time OR ACQ\>1.5 AND Fulfils national criteria for specific biologic treatment.
* Patients with mild/moderate asthma that requires Low/Medium dose of ICS/LABA +/- LTRA. ACQ \< 1.5. No exacerbations in the last year or need of Prednisolone treatment (OCS). Markers of T2 inflammation (B-eos ≥ 0.15 actual or ≥ 0.30 the last year or Sputum eos ≥ 3%, FeNO ≥ 25, allergens positivity). Not direct candidate for treatments with monoclonal antibodies.
* Healthy volunteers that reports no respiratory diseases, No history of asthma or respiratory symptoms, normal lung function. No history of allergies. No lower or upper respiratory infections in the past 4 weeks.

Exclusion Criteria:

* Patients with severe asthma:

  1. Known hypersensitivity to the active substance or any of the excipients
  2. Participation in an interventional clinical trial within 3 months of visit 1 or receipt of any investigational medicinal product within 3 months or 5 half-lives. Participation in other observational studies is acceptable if in the view of the investigator it will not impact on the study outcomes.
  3. Other clinically significant medical disease or uncontrolled concomitant disease that is likely, in the opinion of the investigator, to require a change in therapy or impact the ability to participate in the study.
* Patients with mild/moderate asthma:

  1. Unable to understand written information due to language barriers.
  2. Unable to give informed consent, i.e., patients who are incapable.
  3. Show sign of symptoms of uncontrolled asthma (ACQ score higher than 1.5, OCS use, history of exacerbations within the past year).
* Healthy volunteers:

  1. Unable to understand written information due to language barriers.
  2. Unable to give informed consent, i.e., patients who are incapable.

Where this trial is running

Copenhagen and 1 other locations

• Bispebjerg Hospital — Copenhagen, Denmark (Recruiting)
• Amsterdam University Medical Center — Amsterdam, North Holland, Netherlands (Recruiting)

Study contacts

• Principal investigator: Anke-Hilse Maitland-van der Zee, Prof.Dr. — Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
• Study coordinator: Susanne Vijverberg, Dr.

Conditions Severe Asthma; Remission; Monoclonal antibodies; Biologics