Study of Latiglutenase in T1D/CD Patients | NCT04839575

Studies
Study of Latiglutenase in T1D/CD Patients

NCT04839575

Sponsor

Entero Therapeutics

Status

Terminated

Last Update Posted

Aug 5, 2024Actual

Enrollment

13Actual

Phase

Phase 2

Conditions

Celiac Disease

Interventions

Latiglutenase
Placebo

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
1R44DK121606-01	U.S. NIH Grant/Contract		View source

Status Module

Record Verification Date

Jul 2023

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Covid-19 interruptions and enrollment challenges

Expanded Access Info

Not provided

Start Date

Apr 6, 2021Actual

Primary Completion Date

Dec 19, 2022Actual

Completion Date

Dec 19, 2022Actual

First Submitted Date

Apr 7, 2021

First Submission Date that Met QC Criteria

Apr 7, 2021

First Posted Date

Apr 9, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 1, 2024

Last Update Posted Date

Aug 5, 2024Actual

Name	Class
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)	NIH
Immunogenics, LLC	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Detailed Description

This is a phase 2, single-center prospective, double-blind, placebo-controlled, crossover study in Type 1 diabetes and celiac disease subjects attempting a GFD for at least one year prior to screening. Seropositive subjects (blood test confirmed at Visit 0) will be scheduled for a Screening Visit (Visit 1) whereas seronegative subjects will be discontinued from study participation (screen failures). Subjects who meet Visit 1 protocol enrollment criteria will be enrolled.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

13Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Latiglutenase	Active Comparator	IMGX003	Drug: Latiglutenase
Placebo	Placebo Comparator	Placebo	Drug: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Latiglutenase	Drug	Administered orally (daily)	Latiglutenase	IMGX003

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Symptom Severity Reduction	The primary efficacy endpoint of this study is absolute mean reduction in symptom severity relative to placebo.	6 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria (select):

Confirmed CD diagnosis
Confirmed T1D diagnosis
Seropositive
Gluten free diet (12 months minimum)
Experienced at least one self-reported moderate or greater severity symptom during the last 28 day period
Willing to take study treatment daily
Must sign informed consent

Exclusion Criteria (select):

Wheat allergy
History of peptic ulcer disease, esophagitis, IBS, IBD
Active colitis
Subjects with known rapid gastric emptying (post-bariatric surgery, Billroth I or II surgery)
Chronic infectious gastrointestinal illness or acute infectious gastrointestinal illness within the 4 week period prior to screening
Known refractory celiac disease (RCD1 or RCD2)
Inability to give informed consent

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
David Maahs, MD	Stanford University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Stanford University		Palo Alto	California	94306	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D002446	Celiac Disease

Ancestor Terms

ID	Term
D008286	Malabsorption Syndromes
D007410	Intestinal Diseases
D005767	Gastrointestinal Diseases
D004066	Digestive System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided