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Latiglutenase as a Treatment for Celiac Disease

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ClinicalTrials.gov Identifier: NCT03585478
Recruitment Status : Recruiting
First Posted : July 13, 2018
Last Update Posted : March 4, 2019
Sponsor:
Collaborators:
National Institutes of Health (NIH)
National Center for Complementary and Integrative Health (NCCIH)
Information provided by (Responsible Party):
Immunogenics, LLC

Tracking Information
First Submitted Date  ICMJE June 29, 2018
First Posted Date  ICMJE July 13, 2018
Last Update Posted Date March 4, 2019
Actual Study Start Date  ICMJE March 1, 2019
Estimated Primary Completion Date February 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 11, 2018)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03585478 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: July 11, 2018)
Symptom Severity [ Time Frame: 6 weeks ]
Mean percent worsening in severity for patient selected GI symptoms
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Latiglutenase as a Treatment for Celiac Disease
Official Title  ICMJE 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
Brief Summary Single Center, Randomized, Double-Blind, Placebo Controlled, Gluten Challenge Trial in Patients with Well-Controlled Celiac Disease
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  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Celiac Disease
Intervention  ICMJE
  • Drug: Latiglutenase
    Latiglutenase administered orally (daily)
    Other Name: IMGX003
  • Other: Placebo
    Placebo administered orally (daily)
Study Arms  ICMJE
  • Active Comparator: Latiglutenase
    IMGX003
    Intervention: Drug: Latiglutenase
  • Placebo Comparator: Placebo
    Placebo
    Intervention: Other: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: July 11, 2018)
80
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE May 2020
Estimated Primary Completion Date February 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Jack Syage, PhD 9496790900 jsyage@immunogenx.com
Contact: Ana Ramos 9496790900 aramos@immunogenx.com
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03585478
Other Study ID Numbers  ICMJE IMGX003-NCCIH-1721
1R33AT009637-01 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Immunogenics, LLC
Study Sponsor  ICMJE Immunogenics, LLC
Collaborators  ICMJE
  • National Institutes of Health (NIH)
  • National Center for Complementary and Integrative Health (NCCIH)
Investigators  ICMJE
Principal Investigator: Joseph Murray, MD Mayo Clinic
PRS Account Immunogenics, LLC
Verification Date February 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP