NCT03585478

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
79

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Mar 2019

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 29, 2018

Completed
14 days until next milestone

First Posted

Study publicly available on registry

July 13, 2018

Completed
8 months until next milestone

Study Start

First participant enrolled

March 1, 2019

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 22, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 22, 2021

Completed
Last Updated

December 15, 2021

Status Verified

September 1, 2021

Enrollment Period

1.9 years

First QC Date

June 29, 2018

Last Update Submit

November 30, 2021

Conditions

Celiac Disease

Keywords

Celiac

Outcome Measures

Primary Outcomes (1)

  • Histologic Protection

    The primary efficacy endpoint of this study is histologic protection as measured by EGD (Vh:Cd), such that PBO\>Latiglutenase

    6 weeks

Secondary Outcomes (1)

  • Symptom Severity

    6 weeks

Study Arms (2)

Latiglutenase

ACTIVE COMPARATOR

IMGX003

Drug: Latiglutenase

Placebo

PLACEBO COMPARATOR

Placebo

Other: Placebo

Interventions

LatiglutenaseDRUG

Latiglutenase administered orally (daily)

Also known as: IMGX003
Latiglutenase
PlaceboOTHER

Placebo administered orally (daily)

Placebo

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic - 200 First Street SW

Rochester, Minnesota, 55905, United States

Location

Related Publications (1)

  • Murray JA, Syage JA, Wu TT, Dickason MA, Ramos AG, Van Dyke C, Horwath I, Lavin PT, Maki M, Hujoel I, Papadakis KA, Bledsoe AC, Khosla C, Sealey-Voyksner JA; CeliacShield Study Group. Latiglutenase Protects the Mucosa and Attenuates Symptom Severity in Patients With Celiac Disease Exposed to a Gluten Challenge. Gastroenterology. 2022 Dec;163(6):1510-1521.e6. doi: 10.1053/j.gastro.2022.07.071. Epub 2022 Aug 2.

    PMID: 35931103DERIVED

MeSH Terms

Conditions

Celiac Disease

Interventions

ALV003

Condition Hierarchy (Ancestors)

Malabsorption SyndromesIntestinal DiseasesGastrointestinal DiseasesDigestive System DiseasesMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Joseph Murray, MD

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 29, 2018

First Posted

July 13, 2018

Study Start

March 1, 2019

Primary Completion

January 22, 2021

Study Completion

January 22, 2021

Last Updated

December 15, 2021

Record last verified: 2021-09

Data Sharing

IPD Sharing
Will not share

Locations

US(1)