Clinical trial
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
Name
IMGX003-NIDDK-1921
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.
Trial arms
Trial start
2021-04-06
Estimated PCD
2022-12-19
Trial end
2022-12-19
Status
Terminated
Phase
Early phase I
Treatment
Latiglutenase
Administered orally (daily)
Arms:
Latiglutenase
Other names:
IMGX003
Placebo
Administered orally (daily)
Arms:
Placebo
Size
13
Primary endpoint
Symptom Severity Reduction
6 months
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
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'NON_RANDOMIZED', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'A two-period crossover design will be used where the 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': 13, 'type': 'ACTUAL'}}
Updated at
2023-07-20
1 organization
2 products
1 indication
Organization
ImmunogenicsProduct
PlaceboIndication
Celiac DiseaseProduct
Latiglutenase