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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04243551
Recruitment Status : Recruiting
First Posted : January 28, 2020
Last Update Posted : August 2, 2022
Sponsor:
Collaborator:
National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by (Responsible Party):
Immunogenics, LLC

Study Description
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Brief Summary:
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.

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

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: A two-period crossover design will be used where the two possible 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: 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
Actual Study Start Date : November 1, 2019
Estimated Primary Completion Date : May 2023
Estimated Study Completion Date : May 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Celiac Disease

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


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


Secondary Outcome Measures :
  1. Health Related Quality of Life [ Time Frame: 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.

  2. Health Related Quality of Life [ Time Frame: 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-S health survey relative to placebo.

  3. Health Related Quality of Life [ Time Frame: 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 ICDSQ health survey relative to placebo.

  4. Health Related Quality of Life [ Time Frame: 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 SF-12 health survey relative to placebo.


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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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): NCT04243551


Contacts
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Contact: Jack Syage, PhD 9496790900 jsyage@immunogenx.com
Contact: Ana Ramos 9496790900 aramos@immunogenx.com

Locations
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United States, Minnesota
Mayo Clinic Recruiting
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Immunogenics, LLC
National Institute of Allergy and Infectious Diseases (NIAID)
Investigators
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Principal Investigator: Joseph Murray, MD Mayo Clinic
More Information
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Responsible Party: Immunogenics, LLC
ClinicalTrials.gov Identifier: NCT04243551    
Other Study ID Numbers: IMGX003-NIAID-1821
U44AI134590 ( U.S. NIH Grant/Contract )
First Posted: January 28, 2020    Key Record Dates
Last Update Posted: August 2, 2022
Last Verified: August 2022
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