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NCT05831176ACTIVE_NOT_RECRUITINGanonymous

A Phase 2, 2-Part, Open-Label, Single-Arm Study to Investigate the Efficacy and Safety of Dupilumab in Adult and Adolescent Patients With Eosinophilic Gastritis With or Without Eosinophilic Duodenitis

Sponsor

Source record

Regeneron Pharmaceuticals

Phase

Source record

Phase 2

Modality

AI-normalized

small molecule

Target

AI-normalized

IL-4 and IL-13 signaling pathways (dupilumab is a monoclonal antibody that inhibits IL-4 and IL-13 signaling).

Indication / condition

AI-normalized

Eosinophilic Gastritis (EoG)

Intervention

Source record

Dupilumab

Source & freshness

Source record

NCT ID

NCT05831176

Original source

ClinicalTrials.gov

Source last updated

Oct 08, 2025

Ingested at

Jun 18, 2026

Internal sync

Jun 18, 2026

Model version

trialsignal-ai-v1

Normalized confidence

96%

Validation status

validated

Open original registry record
View original source fields

NCT ID

NCT05831176

Title

A Phase 2, 2-Part, Open-Label, Single-Arm Study to Investigate the Efficacy and Safety of Dupilumab in Adult and Adolescent Patients With Eosinophilic Gastritis With or Without Eosinophilic Duodenitis

Sponsor

Regeneron Pharmaceuticals

Status

ACTIVE_NOT_RECRUITING

Phase

Phase 2

Condition raw

Eosinophilic Gastritis (EoG), Eosinophilic Duodenitis (EoD), Eosinophilic Gastrointestinal Disease (EGID), Eosinophilic Gastroenteritis

Condition normalized

Eosinophilic Gastritis (EoG), Eosinophilic Duodenitis (EoD), Eosinophilic Gastrointestinal Disease (EGID), Eosinophilic Gastroenteritis

Modality raw

small molecule

Modality normalized

small molecule

Target raw

IL-4 and IL-13 signaling pathways (dupilumab is a monoclonal antibody that inhibits IL-4 and IL-13 signaling).

Target normalized

IL-4 and IL-13 signaling pathways (dupilumab is a monoclonal antibody that inhibits IL-4 and IL-13 signaling).

Interventions

Dupilumab

Public preview

Source record

Dupilumab, marketed as Dupixent, is already established in the treatment of various allergic and inflammatory conditions, including asthma and atopic dermatitis. The current Phase 2 trial aims to expand its indications to eosinophilic gastritis (EoG) and eosinophilic duodenitis (EoD), which are niche but underserved markets. Given the increasing prevalence of eosinophilic gastrointestinal diseases, successful outcomes could position Regeneron and its collaborator Sanofi favorably against competitors in the immunotherapy space. The trial's focus on both efficacy and safety, along with the potential for a broader therapeutic application, enhances its commercial viability. However, the exclusion of patients with EoD only may limit the addressable patient population.

AI-generated analysis supports research triage only. Verify source records, publications, sponsor disclosures and IP databases before making diligence decisions. Model: trialsignal-ai-v1.

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TrialSignal

Clinical trial intelligence report

A Phase 2, 2-Part, Open-Label, Single-Arm Study to Investigate the Efficacy and Safety of Dupilumab in Adult and Adolescent Patients With Eosinophilic Gastritis With or Without Eosinophilic Duodenitis

Source-linked diligence brief with registry provenance, taxonomy normalization and premium analytical context.

Generated

Jun 18, 2026

NCT ID

NCT05831176

Status

ACTIVE_NOT_RECRUITING

Phase

Phase 2

Sponsor

Regeneron Pharmaceuticals

Executive brief

Investment-Ready Snapshot

Dupilumab, marketed as Dupixent, is already established in the treatment of various allergic and inflammatory conditions, including asthma and atopic dermatitis. The current Phase 2 trial aims to expand its indications to eosinophilic gastritis (EoG) and eosinophilic duodenitis (EoD), which are niche but underserved markets. Given the increasing prevalence of eosinophilic gastrointestinal diseases, successful outcomes could position Regeneron and its collaborator Sanofi favorably against competitors in the immunotherapy space. The trial's focus on both efficacy and safety, along with the potential for a broader therapeutic application, enhances its commercial viability. However, the exclusion of patients with EoD only may limit the addressable patient population.

Source & freshness

Provenance

SourceClinicalTrials.gov
Source updatedOct 08, 2025
Internal syncJun 18, 2026
Model versiontrialsignal-ai-v1

https://clinicaltrials.gov/study/NCT05831176

Indication

Eosinophilic Gastritis (EoG)

Modality

small molecule

Target

IL-4 and IL-13 signaling pathways (dupilumab is a monoclonal antibody that inhibits IL-4 and IL-13 signaling).

Intervention

Dupilumab

Source record

Protocol Description

Detailed source ingestion pending.

Source record

Outcome Measures

Detailed source ingestion pending.

Source record

Eligibility

Detailed source ingestion pending.

AI analysis

Known Results And Readout Context

Detailed source ingestion pending.

IP intelligence

Patent And IP Landscape

Detailed source ingestion pending.

Source record

Contacts

Detailed source ingestion pending.