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3TR Asthma Biologics Cohort (ABC) Study

NCT06126692 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 600

Last updated 2023-11-13

No results posted yet for this study

Summary

The 3TR-ABC study is a multicentre observational prospective cohort study platform that follows patients with severe asthma from the start of biological therapy and three years onwards. In the 3TR-ABC platform, individual studies are conducted on specific biologics, using aligned study designs. The aim of the study is to assess response to treatment and examine clinical characteristics, biomarkers, and immunological mechanisms related to response, including remission and non-response, that might be new targets or explanations for insufficient treatment. Patients will be extensively characterized at baseline and then followed throughout the years with formal clinical and biological assessment at 4, 16, 52 weeks, and 2, 3 years. Based on the response to treatment, patients will be stratified into remission, clinical responders, and non-responders, and pre-treatment biomarker profiles obtained at the baseline visit will be compared, as well as the immunological response to treatment. Healthy individuals and patients with mild/moderate controlled asthma are included as reference groups and will undergo the same baseline visit as patients with severe asthma. Several bio-samples, to perform multi-omic analysis, will be taken to examine biological pathways associated with response and non-response to biologics.

Conditions

Sponsors & Collaborators

  • Bispebjerg Hospital

    collaborator OTHER

  • University Hospitals, Leicester

    collaborator OTHER

  • Karolinska Institutet

    collaborator OTHER

  • University Medical Center Groningen

    collaborator OTHER

  • Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

    lead OTHER

Principal Investigators

  • Anke-Hilse Maitland-van der Zee, Prof.Dr. · Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

  • Peter Bonta, MD · Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

  • Celeste Porsbjerg, Prof.Dr. · Bispebjerg Hospital

  • Christopher E. Brightling, Prof. Dr. · University of Leicester

  • Sven-Erik Dahlén, Prof. Dr. · Karolinska Intitutet

Eligibility

Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-01-10
Primary Completion
2027-11-30
Completion
2033-08-31

Countries

  • Denmark
  • Netherlands

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06126692 on ClinicalTrials.gov