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

IMGX003-NIAID-1821

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.

2019-11-01

2023-12-01

2023-12-01

Active (not recruiting)

Early phase I

120

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

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'A two-period crossover design will be used where the two possible treatment sequences will be assigned at random.', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'DOUBLE', 'maskingDescription': 'The PI, CRA and study biostatistician will be masked until database lock.', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}}, 'enrollmentInfo': {'count': 120, 'type': 'ESTIMATED'}}

2023-07-20