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Study of Latiglutenase in T1D/CD Patients

Prospective, Double-Blind, Placebo-Controlled, Crossover Study of the Efficacy and Safety of Latiglutenase Treatment in Type 1 Diabetes Patients With Celiac Disease While Undergoing Periodic Gluten Exposure

Status
Terminated
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04839575
Enrollment
13
Registered
2021-04-09
Start date
2021-04-06
Completion date
2022-12-19
Last updated
2024-08-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Celiac Disease

Keywords

Celiac

Brief summary

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.

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.

Interventions

DRUGLatiglutenase

Administered orally (daily)

DRUGPlacebo

Administered orally (daily)

Sponsors

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
CollaboratorNIH
Immunogenics, LLC
CollaboratorINDUSTRY
Entero Therapeutics
Lead SponsorINDUSTRY

Study design

Allocation
NON_RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)

Masking description

The PI, CRA and study biostatistician will be masked until database lock.

Intervention model description

A two-period crossover design will be used where the treatment sequences will be assigned at random.

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Symptom Severity Reduction6 monthsThe primary efficacy endpoint of this study is absolute mean reduction in symptom severity relative to placebo.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026