Eosinophilic OesophagitisPhase 4NCT06101095
A Study Assessing Esophageal Function and Remodeling With Dupilumab Compared With Placebo for 24 Weeks Followed by 104 Weeks Open Label in Adult Participants With EoE (REMOdeling With Dupilumab in Eosinophilic Esophagitis Long-term Trial)
A Phase 4 study testing Dupilumab in people with Eosinophilic Oesophagitis, run by Sanofi at 30 sites in 5 countries.
Trial summary
This is parallel, Phase 4 study which consists of a 24 week (0.5 years) randomized, double blind, placebo controlled, 2-arm treatment period followed by an open label segment of 104 weeks (2 years) for a total of 128 weeks (2.5 years) to evaluate the effect of dupilumab treatment on esophageal function, and remodeling… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Eosinophilic Oesophagitis
- What is being tested?
- Dupilumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 69 participants
- Where
- 30 sitesin 5 countries
- Study dates
- 29 Nov 2023to 1 Feb 2028
- Phase
- Phase 4
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- A documented diagnosis of EoE by endoscopic biopsy.
- Baseline endoscopic biopsies with a demonstration on central reading of intraepithelial eosinophilic infiltration.
- History (by participant report) of an average of at least 2 episodes of dysphagia (with intake of solids) per week in the 4 weeks prior to screening.
- Body weight ≥40 kg.
Who cannot join
- Participants are excluded from the study if any of the following criteria apply:
- Other causes of esophageal eosinophilia or the following conditions: hypereosinophilic syndrome or eosinophilic granulomatosis with polyangiitis (Churg Strauss syndrome).
- Active Helicobacter pylori infection.
- History of achalasia, Crohn's disease, ulcerative colitis, celiac disease, and prior esophageal surgery.
- Any esophageal stricture unable to be passed with a standard, diagnostic, 9 to10 mm upper endoscope or any critical esophageal stricture that requires dilation at screening.
- History of bleeding disorders or esophageal varices.
Show all 10Show fewer
- Treatment with swallowed topical corticosteroids within 8 weeks prior to baseline.
- Initiation or change of a food elimination diet regimen or reintroduction of a previously eliminated food group in the 6 weeks prior to screening.
- Participation in prior dupilumab clinical study or participants currently treated or have been treated with commercially available dupilumab or contraindicated to dupilumab per local labelling.
- The above information is not intended to contain all considerations relevant to a potential participation in a clinical trial
Trial locations and contacts
30 sites in 5 countries.
30 sites in 5 countries
United States15 sites
Treasure Valley Medical Research- Site Number : 8400018
Boise, Idaho, 83706
University of North Carolina at Chapel Hill- Site Number : 8400007
Chapel Hill, North Carolina, 27514
Northwestern University- Site Number : 8400003
Chicago, Illinois, 60611
Cleveland Clinic - Cleveland- Site Number : 8400009
Cleveland, Ohio, 44195
GI Alliance - Glenview- Site Number : 8400012
Glenview, Illinois, 60026
Illinois Gastroenterology Group- Site Number : 8400004
Gurnee, Illinois, 60031
Private Practice - Dr. Martin Yudovich- Site Number : 8400015
Houston, Texas, 77087
University of Iowa- Site Number : 8400006
Iowa City, Iowa, 52242
Borland Groover Clinic- Site Number : 8400016
Jacksonville, Florida, 32256
GI Alliance - Mansfield- Site Number : 8400017
Mansfield, Texas, 76063
United Gastroenterologists - Murrieta- Site Number : 8400001
Murrieta, California, 92563
Penn Medicine: University of Pennsylvania Health System- Site Number : 8400010
Philadelphia, Pennsylvania, 19104
Mayo Clinic Hospital Rochester- Site Number : 8400008
Rochester, Minnesota, 55905
University of California San Francisco - Parnassus Heights- Site Number : 8400020
San Francisco, California, 94143
University of Massachusetts Chan Medical School- Site Number : 8400019
Worcester, Massachusetts, 01655
Brazil5 sites
Clínica Loema - Unidade I- Site Number : 0760007
Campinas, São Paulo, 13010-001
Hospital São Lucas da PUCRS - Porto Alegre - Avenida Ipiranga- Site Number : 0760006
Porto Alegre, Rio Grande do Sul, 90610-000
Itaigara Memorial - Hospital Dia- Site Number : 0760005
Salvador, Estado de Bahia, 41825-010
Hospital Alemao Oswaldo Cruz - São Paulo- Site Number : 0760003
São Paulo, 01323-020
Clinica de Alergia Martti Antila- Site Number : 0760001
Sorocaba, São Paulo, 18040-425
Israel5 sites
Investigational Site Number : 3760006
Haifa, 3104802
Investigational Site Number : 3760002
Haifa, 3109601
Investigational Site Number : 3760005
Jerusalem, 9103102
Investigational Site Number : 3760004
Jerusalem, 9112001
Investigational Site Number : 3760003
Tel Aviv, 6423906
Canada3 sites
Investigational Site Number : 1240002
Montreal, Quebec, H4A 3T2
Investigational Site Number : 1240006
Vancouver, British Columbia, V5Z 1M9
Investigational Site Number : 1240004
Vancouver, British Columbia, V6Z 2K5
Switzerland2 sites
Investigational Site Number : 7560001
Wetzikon, 8620
Investigational Site Number : 7560002
Zurich, 8091
About this study
Official title: A Phase 4, Randomized, Multicenter, Double-blind, Parallel-group, 24 Weeks, Placebo-controlled Study Followed by 104 Weeks Open-label to Assess Dupilumab Efficacy on Esophageal Function and Remodeling in Adult Participants With Eosinophilic Esophagitis (EoE)
This is parallel, Phase 4 study which consists of a 24 week (0.5 years) randomized, double blind, placebo controlled, 2-arm treatment period followed by an open label segment of 104 weeks (2 years) for a total of 128 weeks (2.5 years) to evaluate the effect of dupilumab treatment on esophageal function, and remodeling in adults with eosinophilic esophagitis.
Duration of study period (per participant)
Read more
- Screening period: Up to 12 weeks before Week 0
- Randomized double-blind period: 24 weeks
- Open label period: 104 weeks
- Post Investigational Medicinal Product (IMP) intervention follow-up period: up to 12 weeks or until the participants switch to commercialized dupilumab, whatever comes first.
There will be ten (10) site visits, and five (5) direct-to-participant IMP delivery visits (except if prohibited by local regulatory authorities or if participant is not willing. In this case, IMP will be dispensed at the study site).
Read the detailed description
The duration per participant will be up to 152 weeks.
- Conditions
- Eosinophilic Oesophagitis
- Being tested
- Dupilumab, Placebo
- 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
Subcutaneous injection (SC) as per protocol
PlaceboDrug
SC injection as per protocol
| Study group | Role | What they receive |
|---|---|---|
| Dupilumab | Experimental | Subcutaneous injection (SC) as per protocol Receives: Drug: Dupilumab |
| Placebo | Placebo comparator | SC injection as per protocol Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in esophageal distensibility plateau as measured by Functional Lumen Imaging Probe (EndoFLIP)
Distensibility plateau provides an assessment of esophageal function. An increase in distensibility plateau indicates an improvement in esophageal function and a decrease in distensibility plateau indicates a worsening of esophageal function.
Measured: From baseline to Week 24
Secondary outcomes (13)
Percent change from baseline in esophageal distensibility plateau as measured by Functional Lumen Imaging Probe
Distensibility plateau provides an assessment of esophageal function. An increase in distensibility plateau indicates an improvement in esophageal function and a decrease in distensibility plateau indicates a worsening of esophageal function.
Measured: From baseline up to Week 24
Absolute change from baseline in esophageal distensibility plateau as measured by Functional Lumen Imaging Probe
Distensibility plateau provides an assessment of esophageal function. An increase in distensibility plateau indicates an improvement in esophageal function and a decrease in distensibility plateau indicates a worsening of esophageal function.
Measured: From baseline up to Week128
Percent change from baseline in esophageal distensibility plateau as measured by Functional Lumen Imaging Probe
Distensibility plateau provides an assessment of esophageal function. An increase in distensibility plateau indicates an improvement in esophageal function and a decrease in distensibility plateau indicates a worsening of esophageal function.
Measured: From Baseline up to Week 128
Change from baseline in eosinophilic esophagitis-endoscopic reference score (EoE-EREFS)
EoE-EREFS, a scoring system for inflammatory and remodeling features of disease. The overall total score ranges from 0 to 18 with higher number indicating worse disease.
Measured: From baseline up to Week 128
Change from baseline in eosinophilic esophagitis (EoE-HSS) Grade
Severity (grade) and extent (stage) of esophageal abnormalities are scored using a 4-point scale (0 normal; 3 maximum change). Higher score indicates greater severity and extent of histological abnormalities.
Measured: From Baseline up to Week 128
Change from baseline in EoE-HSS Stage
Severity (grade) and extent (stage) of esophageal abnormalities are scored using a 4-point scale (0 normal; 3 maximum change). Higher score indicates greater severity and extent of histological abnormalities.
Measured: From Baseline up to Week 128
Proportion of participants who achieved peak Esophageal Intraepithelial Eosinophil Count of ≤6 eosinophils/high power field (Eos/HPF)
Esophageal intraepithelial eosinophil count obtained by esophageal endoscopy with biopsies (all 3 esophageal regions: proximal, mid, and distal).
Measured: At Weeks 24, 76 and 128
Proportion of participants who achieved peak Esophageal Intraepithelial Eosinophil Count of ≤15 Eos/HPF
Esophageal intraepithelial eosinophil count obtained by esophageal endoscopy with biopsies (all 3 esophageal regions: proximal, mid, and distal).
Measured: At Week 24
Proportion of participants who achieved peak Esophageal Intraepithelial Eosinophil Count of <15 Eos/HPF
Esophageal intraepithelial eosinophil count obtained by esophageal endoscopy with biopsies (all 3 esophageal regions: proximal, mid, and distal).
Measured: At Weeks 24, 76 and 128
Change from baseline in normalized enrichment score (NES) for EoE diagnostic panel (EDP) transcriptome signature
NES reflects the degree to which the activity level of a set of disease transcripts is overrepresented at the extremes (top or bottom) of the entire ranked list of transcripts within a sample and is normalized by accounting for the number of transcripts in the set. An NES of 0 indicates no change from baseline, a negative score reflects a reduction in the disease score (more like normal) and a positive score reflects worsening (more active disease).
Measured: From baseline up to Week 128 (EOT)
Change from baseline in normalized enrichment score (NES) for type 2 inflammation transcriptome signature
NES reflects the degree to which the activity level of a set of disease transcripts is overrepresented at the extremes (top or bottom) of the entire ranked list of transcripts within a sample and is normalized by accounting for the number of transcripts in the set. An NES of 0 indicates no change from baseline, a negative score reflects a reduction in the disease score (more like normal) and a positive score reflects worsening (more active disease).
Measured: From Baseline up to Week 128 (EOT)
Incidence of treatment-emergent adverse events (TEAEs), and serious adverse events (SAEs)
Measured: From the first IMP administration up to end of post treatment follow up period (week139)
Incidence of adverse events of special interest (AESIs)
Measured: From the first IMP administration up to end of post treatment follow up period (week139)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2023
- Study start29 Nov 2023
- Primary completion5 Nov 2025
- Study completion1 Feb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Eosinophilic OesophagitisStudies 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 69 participants (actual)
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
- NCT06101095
- Sponsor's protocol ID
- LPS17558
- Other IDs
- U1111-1280-5266, 2022-502491-23
- Status last verified
- Sep 2026
- First submitted
- 19 Oct 2023
- Last updated
- 30 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- 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
Publications
Dellon ES, Carlson DA, Greuter T, Collins MH, Lankarani A, Talreja N, Ravi K, Simoes Neto J, Afif W, Gonsalves NP, Lynch KL, Zaghloul S, Cunoosamy D, Durrani SR, Zhang M, Raphael BP, Angello JT, Radwan A, Almansa C, Biedermann L. Dupilumab Improves Esophageal Distensibility in EoE: 24-Week Results From the REMODEL Randomized Trial. Am J Gastroenterol. 2026 Oct 12. doi: 10.14309/ajg.0000000000004227. Online ahead of print.
PubMed 42861971Dellon ES, Savarino EV, Zaghloul S, Angello JT, Zhang M, Raphael BP, Radwan A, Bredenoord AJ. Study design of the phase IV, randomized, placebo-controlled REMOdeling with Dupilumab in Eosinophilic esophagitis Long-term (REMODEL) trial. Ther Adv Gastroenterol. 2025 Oct 9;18:17562848251383782. doi: 10.1177/17562848251383782. eCollection 2025.
PubMed 41084592
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 4, Randomized, Multicenter, Double-blind, Parallel-group, 24 Weeks, Placebo-controlled Study Followed by 104 Weeks Open-label to Assess Dupilumab Efficacy on Esophageal Function and Remodeling in Adult Participants With Eosinophilic Esophagitis (EoE)
- ClinicalTrials.gov ID
- NCT06101095
- Acronym / sponsor ID
- LPS17558
- Conditions
- Eosinophilic Oesophagitis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 69 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Collaborators
- Regeneron Pharmaceuticals
- Study start
- 29 Nov 2023 (actual)
- Primary completion
- 5 Nov 2025 (actual)
- Study completion
- 1 Feb 2028 (estimated)
- First posted
- 25 Oct 2023 (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 parallel, Phase 4 study which consists of a 24 week (0.5 years) randomized, double blind, placebo controlled, 2-arm treatment period followed by an open label segment of 104 weeks (2 years) for a total of 128 weeks (2.5 years) to evaluate the effect of dupilumab treatment on esophageal function, and remodeling in adults with eosinophilic esophagitis.
Duration of study period (per participant)
- Screening period: Up to 12 weeks before Week 0
- Randomized double-blind period: 24 weeks
- Open label period: 104 weeks
- Post Investigational Medicinal Product (IMP) intervention follow-up period: up to 12 weeks or until the participants switch to commercialized dupilumab, whatever comes first.
There will be ten (10) site visits, and five (5) direct-to-participant IMP delivery visits (except if prohibited by local regulatory authorities or if participant is not willing. In this case, IMP will be dispensed at the study site).
Detailed description
The duration per participant will be up to 152 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dupilumab | Experimental | Drug: DupilumabSubcutaneous injection (SC) as per protocol |
| Placebo | Placebo comparator | Drug: PlaceboSC injection as per protocol |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- A documented diagnosis of EoE by endoscopic biopsy.
- Baseline endoscopic biopsies with a demonstration on central reading of intraepithelial eosinophilic infiltration.
- History (by participant report) of an average of at least 2 episodes of dysphagia (with intake of solids) per week in the 4 weeks prior to screening.
- Body weight ≥40 kg.
Key exclusion criteria (10 listed)
- Other causes of esophageal eosinophilia or the following conditions: hypereosinophilic syndrome or eosinophilic granulomatosis with polyangiitis (Churg Strauss syndrome).
- Active Helicobacter pylori infection.
- History of achalasia, Crohn's disease, ulcerative colitis, celiac disease, and prior esophageal surgery.
- Any esophageal stricture unable to be passed with a standard, diagnostic, 9 to10 mm upper endoscope or any critical esophageal stricture that requires dilation at screening.
- History of bleeding disorders or esophageal varices.
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 |
|---|---|---|
| DupilumabSubcutaneous injection (SC) as per protocol | Drug | Dupilumab |
| PlaceboSC injection as per protocol | Drug | Placebo |
Primary outcome
Change from baseline in esophageal distensibility plateau as measured by Functional Lumen Imaging Probe (EndoFLIP)
Time frame: From baseline to Week 24
Distensibility plateau provides an assessment of esophageal function. An increase in distensibility plateau indicates an improvement in esophageal function and a decrease in distensibility plateau indicates a worsening of esophageal function.
13 secondary outcomes
Percent change from baseline in esophageal distensibility plateau as measured by Functional Lumen Imaging Probe
Time frame: From baseline up to Week 24
Absolute change from baseline in esophageal distensibility plateau as measured by Functional Lumen Imaging Probe
Time frame: From baseline up to Week128
Percent change from baseline in esophageal distensibility plateau as measured by Functional Lumen Imaging Probe
Time frame: From Baseline up to Week 128
Change from baseline in eosinophilic esophagitis-endoscopic reference score (EoE-EREFS)
Time frame: From baseline up to Week 128
Change from baseline in eosinophilic esophagitis (EoE-HSS) Grade
Time frame: From Baseline up to Week 128
Change from baseline in EoE-HSS Stage
Time frame: From Baseline up to Week 128
Proportion of participants who achieved peak Esophageal Intraepithelial Eosinophil Count of ≤6 eosinophils/high power field (Eos/HPF)
Time frame: At Weeks 24, 76 and 128
Proportion of participants who achieved peak Esophageal Intraepithelial Eosinophil Count of ≤15 Eos/HPF
Time frame: At Week 24
Proportion of participants who achieved peak Esophageal Intraepithelial Eosinophil Count of <15 Eos/HPF
Time frame: At Weeks 24, 76 and 128
Change from baseline in normalized enrichment score (NES) for EoE diagnostic panel (EDP) transcriptome signature
Time frame: From baseline up to Week 128 (EOT)
Change from baseline in normalized enrichment score (NES) for type 2 inflammation transcriptome signature
Time frame: From Baseline up to Week 128 (EOT)
Incidence of treatment-emergent adverse events (TEAEs), and serious adverse events (SAEs)
Time frame: From the first IMP administration up to end of post treatment follow up period (week139)
Incidence of adverse events of special interest (AESIs)
Time frame: From the first IMP administration up to end of post treatment follow up period (week139)
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 30 Sep 2026.
- Derived from this study: PubMed 42861971Dellon ES, Carlson DA, Greuter T, Collins MH, Lankarani A, Talreja N, Ravi K, Simoes Neto J, Afif W, Gonsalves NP, Lynch KL, Zaghloul S, Cunoosamy D, Durrani SR, Zhang M, Raphael BP, Angello JT, Radwan A, Almansa C, Biedermann L. Dupilumab Improves Esophageal Distensibility in EoE: 24-Week Results From the REMODEL Randomized Trial. Am J Gastroenterol. 2026 Oct 12. doi: 10.14309/ajg.0000000000004227. Online ahead of print.
- Derived from this study: PubMed 41084592Dellon ES, Savarino EV, Zaghloul S, Angello JT, Zhang M, Raphael BP, Radwan A, Bredenoord AJ. Study design of the phase IV, randomized, placebo-controlled REMOdeling with Dupilumab in Eosinophilic esophagitis Long-term (REMODEL) trial. Ther Adv Gastroenterol. 2025 Oct 9;18:17562848251383782. doi: 10.1177/17562848251383782. eCollection 2025.
- LPS17558 Plain Language Results SummaryLink provided by the sponsor.
- 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. This study is not recruiting at the moment.
Clinical Sciences & Operations study director
Sanofi
30 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Dupilumab in people with Eosinophilic Oesophagitis, run by Sanofi at 30 sites in 5 countries.
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 4 inclusion and 10 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: under way, not looking for participants, as of the sponsor's last update on 30 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 30 sites in United States, Brazil, Israel, Canada, Switzerland. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in esophageal distensibility plateau as measured by Functional Lumen Imaging Probe (EndoFLIP) (time frame: From baseline to Week 24). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06101095, which also lists 2 linked publications.
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 30 Sep 2026.