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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

83 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-11-01

Study Completion Date

2023-10-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Celiac Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

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

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

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

Study Groups

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Latiglutenase

IMGX003

Group Type ACTIVE_COMPARATOR

Latiglutenase

Intervention Type DRUG

Administered orally (daily)

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Administered orally (daily)

Interventions

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Latiglutenase

Administered orally (daily)

Intervention Type DRUG

Placebo

Administered orally (daily)

Intervention Type OTHER

Other Intervention Names

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IMGX003

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No