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

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ClinicalTrials.gov Identifier: NCT04243551
Recruitment Status : Recruiting
First Posted : January 28, 2020
Last Update Posted : May 12, 2021
Sponsor:
Collaborator:
National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by (Responsible Party):
Immunogenics, LLC

Tracking Information
First Submitted Date  ICMJE January 23, 2020
First Posted Date  ICMJE January 28, 2020
Last Update Posted Date May 12, 2021
Actual Study Start Date  ICMJE November 1, 2020
Estimated Primary Completion Date December 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 24, 2020)
Symptom Severity Reduction [ Time Frame: 6 months ]
The primary efficacy endpoint of this study is mean percent reduction in symptom severity relative to placebo.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 30, 2020)
  • 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.
  • 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.
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: January 24, 2020)
  • Health Related Quality of Life [ Time Frame: 6 months ]
    A second 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.
  • Health Related Quality of Life [ Time Frame: 6 months ]
    A second 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.
  • Health Related Quality of Life [ Time Frame: 6 months ]
    A second 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.
  • Health Related Quality of Life [ Time Frame: 6 months ]
    A second 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.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Prospective, Randomized, Double-Blind, Placebo-Controlled, Crossover Study in Symptomatic CD Patients
Official Title  ICMJE 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
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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE 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
Condition  ICMJE Celiac Disease
Intervention  ICMJE
  • Drug: Latiglutenase
    Administered orally (daily)
    Other Name: IMGX003
  • Other: 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: January 24, 2020)
120
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE February 2022
Estimated Primary Completion Date December 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
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 NCT04243551
Other Study ID Numbers  ICMJE IMGX003-NIAID-1821
U44AI134590 ( 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 Institute of Allergy and Infectious Diseases (NIAID)
Investigators  ICMJE
Principal Investigator: Joseph Murray, MD Mayo Clinic
PRS Account Immunogenics, LLC
Verification Date December 2020

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