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NCT Number: NCT06695897

A Non-interventional Observational Study to Assess Long-term Efficacy and Safety of Dupilumab for the Treatment of Patients (>= 12 Years) With Eosinophilic Esophagitis Under Real-world-conditions in Germany

This is a longitudinal, observational non-interventional study (NIS) designed to characterize the patient population who receives dupilumab for eosinophilic esophagitis (EoE) treatment in a real-world setting in Germany with respect to their medical history, socio-demographic and disease characteristics, comorbidities (including type 2 inflammatory and atopic conditions), concomitant therapies and prior EoE treatments. Furthermore, this NIS aims to describe the long-term effectiveness of dupilumab for the treatment of EoE as assessed by the treating physician and reported by the patient, and its effect on health-related quality of life (HRQoL) during an individual observational period of two years. In addition, data on real-world use patterns and long-term safety data of dupilumab treatment for EoE will be collected.

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Key information

Age range

12 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Investigational Site Number: 0000001

Dachau, Bavaria, 85221, Germany

Location status: Recruiting

About this study

The study duration for each participant is planned to be 2 years. Total study duration is approximately 4 years.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients diagnosed with EoE who are inadequately controlled by, are intolerant to, or who are not candidates for conventional medicinal therapy
  • Patients for whom the treating physician has decided to initiate new treatment with dupilumab for EoE according to EU-SmPC independently from entry in study or for whom treatment with dupilumab for EoE according to EU-SmPC has been started within the last 7 days. The decision to initiate dupilumab treatment is made by the treating physician and the patient according to the patients' medical need and to the standard of best medical practice. This decision is made independently and before inclusion in this NIS.
  • ≥ 12 years of age at baseline visit
  • ≥ 40 kg bodyweight
  • Voluntary study participation and signed written informed consent by patient and parent(s)/guardian(s), if applicable

Exclusion criteria

  • Patients who have a contraindication to dupilumab according to the current EU-SmPC.
  • Patients who have been treated with dupilumab for more than 7 days
  • Any acute or chronic condition that, in the treating physician's opinion, would limit the patients' ability to complete questionnaires or to participate in this study or impact the interpretation of the results.
  • Participation in an ongoing interventional or observational study that might, in the treating physician's opinion, influence the assessments for the current study (parallel inclusion in another Sanofi-independent registry might be possible if the patient gives consent)

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Treatment and study plan

Dupilumab

Drug

This study will not administer any treatment, only observe the treatment as prescribed in real-world clinical practice.

Primary outcomes

  1. Descriptive statistical analysis of medical history characteristics

    Time frame: At baseline

  2. Descriptive statistical analysis of socio-demographic characteristics

    Time frame: At baseline

  3. Descriptive statistical analysis of disease characteristics

    Time frame: At baseline

Secondary outcomes

  1. Absolut change from baseline in endoscopic reference score (EREFS)

    Time frame: After 3, 6 (optional), 12 and 24 months of dupilumab treatment

    Absolut change from baseline in EREFS (including inflammatory and fibrostenotic subscore)

  2. Proportion of patients with eosinophils per high power field (EOS/hpf) < 15 in esophageal biopsies

    Time frame: After 3, 6 (optional), 12 and 24 months of dupilumab treatment

  3. Change in clinical symptoms from baseline

    Time frame: From baseline until 1, 3, 6, 9, 12, 18 and 24 months of dupilumab treatment

    Change in clinical symptoms (as assessed in clinical practice) from baseline

  4. Behavioral changes regarding food intake from baseline

    Time frame: From baseline until 1, 3, 6, 9, 12, 18 and 24 months of dupilumab treatment

    Behavioral changes regarding food intake (as reported by the patient)

  5. Absolute change from baseline in Dysphagia Numerical Rating Scale (NRS)

    Time frame: After 1, 3, 6, 9, 12, 18 and 24 months of dupilumab treatment

    Scale from 0 (no trouble to swallow) - 10 (maximum trouble to swallow)

  6. Absolute change from baseline in Hospital Anxiety and Depression Scale (HADS)

    Time frame: After 1, 3, 6, 9, 12, 18 and 24 months of dupilumab treatment

  7. Absolute change from baseline Pediatric Eosinophilic Esophagitis Symptom Scores (PEESS v2.0)

    Time frame: After 1, 3, 6, 9, 12, 18 and 24 months of dupilumab treatment

  8. Absolute change from baseline Pediatric Quality of Life Inventory (PEDS-QL)

    Time frame: After 1, 3, 6, 9, 12, 18 and 24 months of dupilumab treatment

  9. Number of hospitalizations due to EoE

    Time frame: During the last 12 months before baseline and after 12 and 24 months of dupilumab treatment

  10. Number of sick leave days at work due to EoE

    Time frame: During the last 12 months before baseline and after 12 and 24 months of dupilumab treatment

  11. Reason(s) for initiation of dupilumab treatment

    Time frame: At baseline

  12. Descriptive statistical analysis of details on dupilumab treatment

    Time frame: Throughout the study, for approximately 24 months after dupilumab treatment

    Descriptive analysis: form of administration, location of administration

  13. Analysis of treatment emergent adverse events (TEAEs)

    Time frame: Throughout the study, for approximately 24 months after initiation of dupilumab treatment

    Quantity of treatment emergent adverse events, quantity of TEAE that lead to ending of therapy, collection of type of TEAE

Study contacts

Contact information is provided by the study sponsor or research team.

Trial Transparency email recommended (Toll free for US & Canada)

CONTACT

[email protected]

800-633-1610 ext. option 6

Sponsors and collaborators

Lead sponsor

Sanofi

Industry

Collaborators

  • Regeneron Pharmaceuticals

Registry information

Official study title

Prospective, Non-interventional Observational Study to Characterize Dupilumab in the Long-term Management of Eosinophilic Esophagitis, Safety and Patient Reported Outcomes (Quality of Life) in Clinical Routine

Acronym: ProMEAL

Important dates

Study start
2024
Primary completion
2027
Study completion
2029
First posted
Nov 19, 2024
Registry last updated
Mar 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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