Eosinophilic EsophagitisProMEALNCT06695897
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
An observational study of Eosinophilic Esophagitis, run by Sanofi at 15 sites in Germany.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 12 years and olderHealthy volunteers can take part
- Conditions the study is for
- Eosinophilic Esophagitis
- What is being tested?
- Dupilumab
- How many people
- 150 participants
- Where
- 15 sitesGermany
- Study dates
- 28 May 2025to 29 May 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Patients suffering from EoE, ≥ 12 years of age with at least 40 kg bodyweight who are planned to be initiated with dupilumab for the treatment of EoE according to the prescribing information, i.e., the current Summary of Product Characteristics approved in the European Union (EU-SmPC).
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
15 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Trial Transparency email recommended (Toll free for US & Canada) contact
15 sites in 1 country
Germany15 sites, 15 recruiting
- Recruiting
Investigational Site Number: 0000009
Aschaffenburg, Bavaria, 63739
- Recruiting
Investigational Site Number: 0000014
Augsburg, Bavaria, 86154
- Recruiting
Investigational Site Number: 0000004
Berlin, 10409
- Recruiting
Investigational Site Number: 0000007
Bochum, North Rhine-Westphalia, 44791
- Recruiting
Investigational Site Number: 0000003
Burbach, North Rhine-Westphalia, 57299
- Recruiting
Investigational Site Number: 0000001
Dachau, Bavaria, 85221
- Recruiting
Investigational Site Number: 0000012
Erlangen, Bavaria, 91054
- Recruiting
Investigational Site Number: 0000005
Giessen, Hesse, 35392
- Recruiting
Investigational Site Number: 0000006
Guelders, North Rhine-Westphalia, 47608
- Recruiting
Investigational Site Number: 0000008
Leipzig, Saxony, 4103
- Recruiting
Investigational Site Number: 0000015
Magdeburg, Saxony-Anhalt, 39130
- Recruiting
Investigational Site Number: 0000010
Münster, North Rhine-Westphalia, 48143
- Recruiting
Investigational Site Number: 0000013
Osnabrück, Lower Saxony, 49074
- Recruiting
Investigational Site Number: 0000011
Wetzlar, Hesse, 35578
- Recruiting
Investigational Site Number: 0000002
Weyhe-Kirchweyhe, Lower Saxony, 28844
About this study
Official 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
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.
Read the detailed description
The study duration for each participant is planned to be 2 years. Total study duration is approximately 4 years.
- Conditions
- Eosinophilic Esophagitis
- Being tested
- Dupilumab
- Medical subject headings
- Eosinophilic Esophagitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DupilumabDrug
This study will not administer any treatment, only observe the treatment as prescribed in real-world clinical practice.
| Study group | Role | What they receive |
|---|---|---|
| Dupilumab arm | Patients who receive dupilumab for eosinophilic esophagitis (EoE) treatment in a real-world setting in Germany Receives: Drug: Dupilumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Descriptive statistical analysis of medical history characteristics
Measured: At baseline
Descriptive statistical analysis of socio-demographic characteristics
Measured: At baseline
Descriptive statistical analysis of disease characteristics
Measured: At baseline
Secondary outcomes (13)
Absolut change from baseline in endoscopic reference score (EREFS)
Absolut change from baseline in EREFS (including inflammatory and fibrostenotic subscore)
Measured: After 3, 6 (optional), 12 and 24 months of dupilumab treatment
Proportion of patients with eosinophils per high power field (EOS/hpf) < 15 in esophageal biopsies
Measured: After 3, 6 (optional), 12 and 24 months of dupilumab treatment
Change in clinical symptoms from baseline
Change in clinical symptoms (as assessed in clinical practice) from baseline
Measured: From baseline until 1, 3, 6, 9, 12, 18 and 24 months of dupilumab treatment
Behavioral changes regarding food intake from baseline
Behavioral changes regarding food intake (as reported by the patient)
Measured: From baseline until 1, 3, 6, 9, 12, 18 and 24 months of dupilumab treatment
Absolute change from baseline in Dysphagia Numerical Rating Scale (NRS)
Scale from 0 (no trouble to swallow) - 10 (maximum trouble to swallow)
Measured: After 1, 3, 6, 9, 12, 18 and 24 months of dupilumab treatment
Absolute change from baseline in Hospital Anxiety and Depression Scale (HADS)
Measured: After 1, 3, 6, 9, 12, 18 and 24 months of dupilumab treatment
Absolute change from baseline Pediatric Eosinophilic Esophagitis Symptom Scores (PEESS v2.0)
Measured: After 1, 3, 6, 9, 12, 18 and 24 months of dupilumab treatment
Absolute change from baseline Pediatric Quality of Life Inventory (PEDS-QL)
Measured: After 1, 3, 6, 9, 12, 18 and 24 months of dupilumab treatment
Number of hospitalizations due to EoE
Measured: During the last 12 months before baseline and after 12 and 24 months of dupilumab treatment
Number of sick leave days at work due to EoE
Measured: During the last 12 months before baseline and after 12 and 24 months of dupilumab treatment
Reason(s) for initiation of dupilumab treatment
Measured: At baseline
Descriptive statistical analysis of details on dupilumab treatment
Descriptive analysis: form of administration, location of administration
Measured: Throughout the study, for approximately 24 months after dupilumab treatment
Analysis of treatment emergent adverse events (TEAEs)
Quantity of treatment emergent adverse events, quantity of TEAE that lead to ending of therapy, collection of type of TEAE
Measured: Throughout the study, for approximately 24 months after initiation of dupilumab treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2024
- Study start28 May 2025
- Primary completion1 Jun 2027 (estimated)
- Study completion29 May 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Eosinophilic EsophagitisStudies of the same condition, open and under way.
- More trials run by SanofiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Regeneron Pharmaceuticals
- Responsible party
- Sponsor
- Investigators
- Clinical Sciences & Operations, Study director, Sanofi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06695897
- Sponsor's protocol ID
- OBS18402
- Other IDs
- U1111-1306-7545
- Acronym
- ProMEAL
- Status last verified
- Sep 2026
- First submitted
- 15 Nov 2024
- Last updated
- 17 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT06695897
- Acronym / sponsor ID
- ProMEAL / OBS18402
- Conditions
- Eosinophilic Esophagitis
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Collaborators
- Regeneron Pharmaceuticals
- Study start
- 28 May 2025 (actual)
- Primary completion
- 1 Jun 2027 (estimated)
- Study completion
- 29 May 2029 (estimated)
- First posted
- 19 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The study duration for each participant is planned to be 2 years. Total study duration is approximately 4 years.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Dupilumab arm | – | Drug: DupilumabPatients who receive dupilumab for eosinophilic esophagitis (EoE) treatment in a real-world setting in Germany |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients suffering from EoE, ≥ 12 years of age with at least 40 kg bodyweight who are planned to be initiated with dupilumab for the treatment of EoE according to the prescribing information, i.e., the current Summary of Product Characteristics approved in the European Union (EU-SmPC).
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DupilumabThis study will not administer any treatment, only observe the treatment as prescribed in real-world clinical practice. | Drug | Dupilumab arm |
Primary outcome
Descriptive statistical analysis of medical history characteristics
Time frame: At baseline
Descriptive statistical analysis of socio-demographic characteristics
Time frame: At baseline
Descriptive statistical analysis of disease characteristics
Time frame: At baseline
13 secondary outcomes
Absolut change from baseline in endoscopic reference score (EREFS)
Time frame: After 3, 6 (optional), 12 and 24 months of dupilumab treatment
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
Change in clinical symptoms from baseline
Time frame: From baseline until 1, 3, 6, 9, 12, 18 and 24 months of dupilumab treatment
Behavioral changes regarding food intake from baseline
Time frame: From baseline until 1, 3, 6, 9, 12, 18 and 24 months of dupilumab treatment
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
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
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
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
Number of hospitalizations due to EoE
Time frame: During the last 12 months before baseline and after 12 and 24 months of dupilumab treatment
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
Reason(s) for initiation of dupilumab treatment
Time frame: At baseline
Descriptive statistical analysis of details on dupilumab treatment
Time frame: Throughout the study, for approximately 24 months after dupilumab treatment
Analysis of treatment emergent adverse events (TEAEs)
Time frame: Throughout the study, for approximately 24 months after initiation of dupilumab treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2026.
- Individual participant dataSharing planned: Yes. Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Trial Transparency email recommended (Toll free for US & Canada) contact
Clinical Sciences & Operations study director
Sanofi
15 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Eosinophilic Esophagitis, run by Sanofi at 15 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Trial Transparency email recommended (Toll free for US & Canada) (800-633-1610 ext. option 6, Contact-US@sanofi.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Descriptive statistical analysis of medical history characteristics (time frame: At baseline). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Sep 2026.