Prospective, Randomized, Double-Blind, Placebo-Controlled, Crossover Study in Symptomatic CD Patients

Multicenter, Prospective, Randomized, Double-Blind, Placebo-Controlled, Crossover Study of the Efficacy and Safety of Latiglutenase Treatment in Symptomatic Celiac Disease Patients Maintained on a Gluten-Free Diet While Undergoing Periodic Gluten Exposure

Status

Terminated

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04243551

Enrollment

Registered

2020-01-28

Start date

2019-11-01

Completion date

2023-10-31

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

Detailed description

This is a phase 2b, multicenter, prospective, randomized, double-blind, placebo-controlled, crossover study in symptomatic celiac disease patients attempting a GFD for at least one year prior to screening. Seropositive patients (blood test confirmed at Visit 0) will be scheduled for a Screening Visit (Visit 1) whereas seronegative patients will be discontinued from study participation (screen failures). Patients who meet Visit 1 protocol enrollment criteria will be enrolled and begin the first of two 6 week periods.

Interventions

DRUGLatiglutenase

Administered orally (daily)

OTHERPlacebo

Administered orally (daily)

Study design

Allocation

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 two possible treatment sequences will be assigned at random.

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

Inclusion criteria

* Biopsy confirmed CD 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

* Wheat allergy * History of peptic ulcer disease, esophagitis, IBS, IBD * Active colitis, dermatitis herpetiformis * Diagnosed with Type 1 Diabetes * Patients 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

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

Secondary

Measure	Time frame	Description
Health Related Quality of Life	6 months	A secondary efficacy endpoint includes a change from baseline to end of study treatment period in health-related quality of life as measured by PGI-I health survey relative to placebo.

Countries

United States

Outcome results

None listed

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