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Latiglutenase as a Treatment for Celiac Disease

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. Read our disclaimer for details. Identifier: NCT03585478
Recruitment Status : Completed
First Posted : July 13, 2018
Last Update Posted : December 15, 2021
National Institutes of Health (NIH)
National Center for Complementary and Integrative Health (NCCIH)
Information provided by (Responsible Party):
Immunogenics, LLC

Brief Summary:
Single Center, Randomized, Double-Blind, Placebo Controlled, Gluten Challenge Trial in Patients with Well-Controlled Celiac Disease

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

Detailed Description:
This is a phase 2, single-center, prospective, randomized, double-blind, placebo-controlled, study in patients with well-controlled celiac disease. Patients with confirmed CD diagnosis (biopsy) will be recruited to participate in the study. Informed consent must be obtained prior to performing any screening procedures. Patients who meet Visit 1 protocol enrollment criteria will be enrolled and begin the screening period. Patients that fail to meet screening period eligibility will be discontinued from study participation at Visit 2. At Visit 2, eligibility will be confirmed, adverse events will be documented at Visit 2. Patients who continue to meet eligibility requirements at Visit 3 will begin the next treatment phase. During the treatment phase patients will self-administer treatment and gluten daily with their evening meal. At the end of the treatment period, Visit 4, patient eligibility will be confirmed and adverse events will be documented. The final visit, Visit 5, will be a safety follow-up visit.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 79 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Double-Blind, Placebo Controlled, Gluten Challenge Trial of the Efficacy, Safety and Tolerability of 6-weeks Treatment of Latiglutenase (IMGX003) Administration in Patients With Well-Controlled Celiac Disease
Actual Study Start Date : March 1, 2019
Actual Primary Completion Date : January 22, 2021
Actual Study Completion Date : January 22, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Celiac Disease

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

Placebo Comparator: Placebo
Other: Placebo
Placebo administered orally (daily)

Primary Outcome Measures :
  1. Histologic Protection [ Time Frame: 6 weeks ]
    The primary efficacy endpoint of this study is histologic protection as measured by EGD (Vh:Cd), such that PBO>Latiglutenase

Secondary Outcome Measures :
  1. Symptom Severity [ Time Frame: 6 weeks ]
    Mean percent worsening in severity for patient selected GI symptoms

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

Inclusion Criteria:

  • Biopsy confirmed CD diagnosis
  • Self-reported adherence to a gluten-free diet for ≥ 12 months
  • Agree to maintain dosing of approved prescribed and OTC medications
  • Willing to take study treatment with evening meal during any single day
  • Willing to take gluten foodstuff with evening meal during any single day
  • Willing to maintain GFD for entire study duration
  • Willing to agree to minimal ingestion outside of three main daily meals
  • Willing and able to comply with all study procedures
  • Access to the internet via smartphone, tablet, computer or equivalent to facilitate daily symptom reporting
  • Must sign informed consent

Exclusion Criteria:

  • Active dermatitis herpetiformis at the time of screening
  • IBS (Irritable Bowel Syndrome)
  • History of any form of colitis
  • Received any systemic biologics (such as monoclonal antibodies or other protein therapeutics where the half-life overlaps with the study start) within 6 months prior to study start
  • Taking any oral probiotic supplements (not including probiotics contained in commercially available food preparations) 6 months prior to entry
  • Use of any immunosuppressive medications (i.e., for chronic treatment of autoimmune disease or transplant-rejection prophylaxis) 6 months prior to entry
  • History of alcohol abuse, illegal drug use
  • Unwilling to practice highly effective birth control (unless surgically sterilized or post-menopausal)
  • Received any experimental drug within 30 days of randomization, in the case of experimental biologics at least 6 months prior to randomization
  • Uncontrolled complications of celiac disease, which, in the opinion of the investigator, could affect immune response or pose an increased risk to the patient
  • Inability to give informed consent
  • Any medical condition, other than celiac disease, which, in the opinion of the investigator, could adversely affect the patient's participation in the trial.

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 identifier (NCT number): NCT03585478

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United States, Minnesota
Mayo Clinic - 200 First Street SW
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Immunogenics, LLC
National Institutes of Health (NIH)
National Center for Complementary and Integrative Health (NCCIH)
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Principal Investigator: Joseph Murray, MD Mayo Clinic
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Immunogenics, LLC Identifier: NCT03585478    
Other Study ID Numbers: IMGX003-NCCIH-1721
1R33AT009637-01 ( U.S. NIH Grant/Contract )
First Posted: July 13, 2018    Key Record Dates
Last Update Posted: December 15, 2021
Last Verified: September 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:
Additional relevant MeSH terms:
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Celiac Disease
Malabsorption Syndromes
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Metabolic Diseases