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Trial record 13 of 40 for:    Recruiting, Not yet recruiting, Available Studies | "Malabsorption Syndromes" | United States

Latiglutenase as a Treatment for Celiac Disease

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ClinicalTrials.gov Identifier: NCT03585478
Recruitment Status : Not yet recruiting
First Posted : July 13, 2018
Last Update Posted : July 17, 2018
Sponsor:
Collaborators:
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 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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 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
Estimated Study Start Date : July 2018
Estimated Primary Completion Date : February 2020
Estimated Study Completion Date : May 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Celiac Disease

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

Placebo Comparator: Placebo
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

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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
  • 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 ClinicalTrials.gov identifier (NCT number): NCT03585478


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

Locations
United States, Minnesota
Mayo Clinic - 200 First Street SW Not yet recruiting
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Immunogenics, LLC
National Institutes of Health (NIH)
National Center for Complementary and Integrative Health (NCCIH)
Investigators
Principal Investigator: Joseph Murray, MD Mayo Clinic

Responsible Party: Immunogenics, LLC
ClinicalTrials.gov Identifier: NCT03585478     History of Changes
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: July 17, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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:
Celiac Disease
Malabsorption Syndromes
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Metabolic Diseases