A Trial to Determine Efficacy, Safety, and Tolerability of 6-weeks Treatment of Latiglutenase (IMGX003) Administration in Patients with Well-Controlled Celiac Disease

Overview

About this study

The purpose of this study is to demonstrate a positive correlation of histologic protection (biological signature) and symptom protection (clinical outcome) for latiglutenase treatment versus placebo in Celiac Disease (CD) patients undergoing a deliberate gluten challenge.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Please contact the study team to discuss whether or not you are eligible to participate in a study.

Inclusion Criteria:

  • Male and female.
  • Aged 18 - 80 years old.
  • Biopsy confirmed CD diagnosis (Pathology report confirmation by principal investigator).
  • Self-reported adherence to a gluten-free diet for ≥ 12 months (documented by medical history).
  • TG2 IgA antibody negative.
  • Agree to maintain dosing of approved prescribed and OTC medications throughout the course of the study.
  • Willing to take study treatment with each daily evening meal (e.g., dinner).
  • Willing to take gluten foodstuff with each daily evening meal (e.g., dinner).
  • If using a statin, willing to withhold statin therapy for 48 hours prior to in-clinic simvastatin ingestion and testing.
  • Willing to maintain GFD for entire study duration.
  • Willing to undergo multiple esophagogastroduodenoscopy procedures during the course of the trial.
  • Access to a reliable telephone that would allow MSM dosing compliance telephone calls.
  • Access to the internet via smartphone, tablet or computer device or equivalent to facilitate daily (end-of-day) symptom reporting.
  • Willing to agree to minimal ingestion outside of three main daily meals.
  • Willing to limit snacks outside the daily evening meal (e.g., dinner) to gluten-free snacks.
  • Willing to not ingest grapefruit in any form (i.e., whole fruit, pulp, juice, etc.) during the 48 hour period prior to and during study visits 3 & 4.
  • Willing and able to comply with all study procedures.
  • Must read and understand English.
  • Must sign informed consent.

Exclusion Criteria:

  • Active dermatitis herpetiformis lesions at the time of screening.
  • History of any form of colitis.
  • History of IgE-mediated reactions to wheat (i.e., “wheat allergy”).
  • Any clinical contraindications to performing an endoscopy with intestinal biopsy.
  • Received any systemic biologics (such as monoclonal antibodies or other protein therapeutics where the half-life overlaps with 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.
  • Use of systemic cortisone-like medications within 28-days prior to and during study treatment.
  • History of alcohol abuse, illegal drug use (e.g. amphetamines, barbiturates, benzodiazepines, cannabinoids, cocaine, and opiates) or medical and recreational cannabinoid use within the past 12 months.
  • Laboratory values:
    • Elevated liver function tests (Alanine Aminotransferase [ALT], Aspartate Transaminase[AST],Alkaline Phosphatase [Alk Phos], or Gamma-Glutamyl Transferase [GGT]) > 2.5 times the upper limit of normal (ULN);
    • Total bilirubin > 1.5x ULN;
    • Serum creatinine > 1.5x ULN;
    • Hemoglobin < 10 g/dL or 100 g/L;
    • Calcium  < 8.0 mg/mL;
    • Platelet count< 75.0 x 109/L or 75,000/mm3;
    • Partial thromboplastin time (PTT) or prothrombin time (PT/INR) > 1.5 ULN;
    • Serum potassium < 3.0 mmol/L, > 5 mmol/L;
    • Total white blood cell count (WBC)  < 3.0 x 109/L or 3000/mm3;
    • Total lymphocyte < 1.0 x 109/L or 1000/mm3.
  • Current untreated or active peptic ulcer disease, Grade B or greater esophagitis, motility disorders such as irritable bowel syndrome, functional dyspepsia, inflammatory bowel disease, and symptomatic GERD (gastroesophageal reflux disease) other than celiac disease.
  • Women of Child Bearing Potential (WOCBP): positive urine pregnancy test.
  • Unwilling to practice highly effective birth control (unless surgically sterilized or post-menopausal).
  • Other than oral contraceptives, use of prescribed medications or over-the-counter medications that, in the opinion of the investigator might interfere with study results.
  • Current use of anticoagulants (warfarin sodium, heparin, full-dose aspirin [325 – 650 mg/dose] or clopidogrel) during the 7-day period prior to randomization.
  • Currently taking any medication(s) contraindicated for use with simvastatin that cannot be stopped 48 hours prior to visits 3 & 4 and restarted after visits 3 & 4, respectively.
  • Received any experimental drug within 30 days of randomization, in the case of experimental biologics at least 6 months prior to randomization.
  • The existence of any uncontrolled chronic disease or condition [for example HIV-AIDS, hepatitis, Type 1 or 2 diabetes, or cancer (other than skin cancer)], other than celiac disease.
  • Uncontrolled complications of celiac disease, which, in the opinion of the investigator, could affect immune response or pose an increased risk to the patient (e.g. Type 1 diabetes or other autoimmune disease).
  • Known allergy or hypersensitivity to any of the components of the placebo, IMGX003 (including sulfites), E. coli, or E. coli-derived proteins and simvastatin.
  • Known adverse respiratory effects caused by sulfites.
  • 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.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Joseph Murray, M.D.

Open for enrollment

Contact information:

Carol Van Dyke CCRP

(507) 266-7842

VanDyke.Carol@mayo.edu

More information

Publications

Publications are currently not available

Study Results Summary

Not yet available

Supplemental Study Information

Not yet available

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CLS-20438530

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