Dupilumab
DrugAdministered as described in the protocol
Other names: DUPIXENT®, REGN668, SAR231893
NCT Number: NCT05831176
This study is researching an experimental drug called dupilumab. The study is focused on participants with active eosinophilic gastritis (EoG) with or without eosinophilic duodenitis (EoD). Participants with EoD only are not eligible for enrollment. EoG and EoD are uncommon, persistent, allergic/immune diseases in which eosinophils (a type of white blood cell) gather in large numbers in the stomach and small intestine and cause inflammation and damage.
The aim of the study is to evaluate the effect of dupilumab on relieving EoG (with or without EoD) symptoms and reducing inflammation in the stomach and, if applicable, small intestine in adults and adolescents aged 12 years and older after at least 24 weeks (about 6 months) and up to 52 weeks (1 year) of treatment.
The study is looking at several other research questions, including:
* What side effects may happen from taking the study drug * How much study drug is in the blood at different times * Whether the body makes antibodies against the study drug (which could make the drug less effective or could lead to side effects)
This study is active but is not currently recruiting participants.
Notify Me12 year and older
All sexes
Interventional
Phase 2
Stollery Children's Hospital - University of Alberta, Edmonton, Alberta, Canada
This study has 2 parts and a 12-week (about 3 months) Follow-up Period for all participants
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Key Inclusion Criteria:
Key Exclusion Criteria:
NOTE: Other Protocol Defined Inclusion / Exclusion Criteria Apply
Administered as described in the protocol
Other names: DUPIXENT®, REGN668, SAR231893
Time frame: Baseline up to 24 Weeks
Time frame: Baseline up to 52 Weeks
Time frame: Up to 52 Weeks
Time frame: Up to 52 Weeks
Time frame: Up to 52 Weeks
Time frame: Up to 52 Weeks
Assessed for only those with duodenal involvement
Time frame: Baseline up to 52 Weeks
EoG/EoD-SQ is a PRO collected daily via an eDiary. Symptoms are assessed using an 11-point numerical rating scale (0 through 10). Higher scores indicate a higher symptom burden. Symptom scores are summed on each day with a maximum daily score of 60. The TSS is calculated by averaging daily sum scores over 7 days, with a maximum TSS of 60.
Time frame: Baseline up to 52 Weeks
Time frame: Baseline up to 52 Weeks
Assessed for only those with duodenal involvement
Time frame: Baseline up to 52 Weeks
EoGHSS scores evaluate 11 features of gastric tissue. Total score is the sum of features scores divided by the maximum possible score for the biopsy. Total scores range from 0 - 1.
Time frame: Baseline up to 52 Weeks
Assessed for only those with diarrhea at baseline
Time frame: Baseline up to 52 Weeks
Assessed for only those with vomiting at baseline
Time frame: Baseline up to 52 Weeks
Assessed on gastric tissue
Normalized Enrichment Score (NES) reflects the degree to which the activity level of a set of 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.
Time frame: Baseline up to 52 Weeks
Assessed on duodenal tissue from participants with EoD
NES reflects the degree to which the activity level of a set of 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.
Time frame: Baseline up to 52 Weeks
Assessed on gastric tissue
NES reflects the degree to which the activity level of a set of 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.
Time frame: Up to 52 Weeks
Time frame: Up to 52 Weeks
A TEAE is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment.
Time frame: Up to 52 Weeks
An SAE is any untoward medical occurrence that at any dose:
Time frame: Up to 52 Weeks
An AESI (serious or non-serious) is one of scientific and medical concern specific to the sponsor's product or program, for which ongoing monitoring and rapid communication by the Investigator to the sponsor can be appropriate. Such an event might warrant further investigation in order to characterize and understand it
Time frame: Up to 52 Weeks
A TEAE is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment.
Time frame: Up to 52 Weeks
Immunogenicity will be characterized per drug molecule by ADA status
Time frame: Up to 52 Weeks
Immunogenicity will be characterized per drug molecule by ADA status
Time frame: Up to 52 Weeks
Immunogenicity will be characterized per drug molecule by NAb status
Time frame: Baseline up to 64 Weeks
The concentrations of functional dupilumab over time will be summarized by descriptive statistics by study arm for the overall population and for adolescent patients.
Regeneron Pharmaceuticals
Industry
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
Acronym: ENGAGE
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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