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Prospective Double-Blind PBO-Controlled Combined Crossover Randomized Withdrawal Study of Latiglutenase in T1D/CD Pts

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ClinicalTrials.gov Identifier: NCT04839575
Recruitment Status : Recruiting
First Posted : April 9, 2021
Last Update Posted : April 9, 2021
Sponsor:
Collaborator:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
Immunogenics, LLC

Brief Summary:
This is a phase 2, single-center prospective, double-blind, placebo-controlled, crossover with randomized withdrawal study in Type 1 diabetes and celiac disease subjects attempting a GFD for at least one year prior to screening.

Condition or disease Intervention/treatment Phase
Celiac Disease Drug: Latiglutenase Drug: Placebo Phase 2

Detailed Description:
This is a phase 2, single-center prospective, double-blind, placebo-controlled, crossover with randomized withdrawal 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: A 2-period, 2-treatment (2x2) crossover and randomized withdrawal design will be used where the treatment sequences will be assigned at random.
Masking: Double (Participant, Investigator)
Masking Description: The PI, CRA and study biostatistician will be masked until database lock.
Primary Purpose: Treatment
Official Title: A Prospective, Double-Blind, Placebo-Controlled, Combined Crossover and Randomized Withdrawal Study of the Efficacy and Safety of Latiglutenase Treatment in Type 1 Diabetes Patients With Celiac Disease While Undergoing Periodic Gluten Exposure
Estimated Study Start Date : April 2021
Estimated Primary Completion Date : April 2023
Estimated Study Completion Date : June 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Celiac Disease

Arm Intervention/treatment
Active Comparator: Latiglutenase IMGX003 Drug: Latiglutenase
Administered orally (daily)
Other Name: IMGX003

Placebo Comparator: Placebo Drug: Placebo
Administered orally (daily)




Primary Outcome Measures :
  1. Symptom Severity Reduction [ Time Frame: 6 months ]
    The primary efficacy endpoint of this study is mean percentage reduction in symptom severity relative to placebo.



Information from the National Library of Medicine

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Ages Eligible for Study:   14 Years to 80 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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:

  • Wheat allergy
  • History of peptic ulcer disease, esophagitis, IBS, IBD
  • Active colitis
  • Subjects with known rapid gastric emptying (post-bariatrc 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04839575


Contacts
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Contact: Jack Syage, PhD 9496790900 jsyage@immunogenx.com
Contact: Anna Norum 9496790900 anorum@immunogenx.com

Locations
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United States, California
Stanford University Recruiting
Palo Alto, California, United States, 94306
Sponsors and Collaborators
Immunogenics, LLC
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Investigators
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Principal Investigator: David Maahs, MD Stanford University
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Responsible Party: Immunogenics, LLC
ClinicalTrials.gov Identifier: NCT04839575    
Other Study ID Numbers: IMGX003-NIDDK-1921
1R44DK121606-01 ( U.S. NIH Grant/Contract )
First Posted: April 9, 2021    Key Record Dates
Last Update Posted: April 9, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Immunogenics, LLC:
Celiac
Additional relevant MeSH terms:
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Celiac Disease
Malabsorption Syndromes
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Metabolic Diseases