Celiac DiseasePhase 2NCT04243551
Prospective, Randomized, Double-Blind, Placebo-Controlled, Crossover Study in Symptomatic CD Patients
A Phase 2 study testing Latiglutenase in people with Celiac Disease, run by Entero Therapeutics at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Celiac Disease
- What is being tested?
- Latiglutenase
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 83 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2019to 31 Oct 2023
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
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.
Read the 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.
- Conditions
- Celiac Disease
- Being tested
- Latiglutenase, Placebo
- Keywords
- Celiac
- Medical subject headings
- Celiac Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LatiglutenaseDrug
Also called IMGX003
Administered orally (daily)
PlaceboOther
Administered orally (daily)
| Study group | Role | What they receive |
|---|---|---|
| Latiglutenase | Active comparator | IMGX003 Receives: Drug: Latiglutenase |
| Placebo | Placebo comparator | Placebo Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Symptom Severity Reduction
The primary efficacy endpoint of this study is mean percent reduction in symptom severity relative to placebo.
Measured: 6 months
Secondary outcomes (4)
Health Related Quality of Life
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.
Measured: 6 months
Health Related Quality of Life
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.
Measured: 6 months
Health Related Quality of Life
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.
Measured: 6 months
Health Related Quality of Life
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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2020
- Study start1 Nov 2019
- Primary completion16 Oct 2023
- Study completion31 Oct 2023
Why it stopped: Due to low enrollment related to Covid.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Celiac DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- A two-period crossover design will be used where the two possible treatment sequences will be assigned at random.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 83 participants (actual)
Sponsor and investigators
- Lead sponsor
- Entero Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Joseph Murray, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04243551
- Sponsor's protocol ID
- IMGX003-NIAID-1821
- Other IDs
- U44AI134590
- Status last verified
- Jul 2023
- First submitted
- 23 Jan 2020
- Last updated
- 5 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT04243551
- Acronym / sponsor ID
- IMGX003-NIAID-1821
- Conditions
- Celiac Disease
- Keywords
- Celiac
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Due to low enrollment related to Covid.
- Enrolment
- 83 participants (actual)
- Lead sponsor
- Entero TherapeuticsIndustry (pharma, biotech, devices)
- Collaborators
- National Institute of Allergy and Infectious Diseases (NIAID)
- Study start
- 1 Nov 2019 (actual)
- Primary completion
- 16 Oct 2023 (actual)
- Study completion
- 31 Oct 2023 (actual)
- First posted
- 28 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- A two-period crossover design will be used where the two possible treatment sequences will be assigned at random.
| Arm | Type | Receives |
|---|---|---|
| Latiglutenase | Active comparator | Drug: LatiglutenaseIMGX003 |
| Placebo | Placebo comparator | Other: PlaceboPlacebo |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (8 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LatiglutenaseAlso: IMGX003Administered orally (daily) | Drug | Latiglutenase |
| PlaceboAdministered orally (daily) | Other | Placebo |
Primary outcome
Symptom Severity Reduction
Time frame: 6 months
The primary efficacy endpoint of this study is mean percent reduction in symptom severity relative to placebo.
4 secondary outcomes
Health Related Quality of Life
Time frame: 6 months
Health Related Quality of Life
Time frame: 6 months
Health Related Quality of Life
Time frame: 6 months
Health Related Quality of Life
Time frame: 6 months
Results and safety
The study was stopped early (reason given: Due to low enrollment related to Covid.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2024.
- Individual participant dataSharing planned: No
Related trials for Celiac Disease
RecruitingObservational study
Pathogenic Study of Adult Immune Enteropathies
Celiac Disease, Autoimmune Enteropathy
Not yet recruitingObservational study
MENA/Levant Epidemiological, Registry of Immunological & Clinical Traits (MERIT)
Antiphospholipid (aPL)-Positive, Rheumatic Arthritis
Not yet recruitingObservational study
European Appleby Registry for Pancreatic Cancer
Pancreatic Ductal Adenocarcinoma (PDAC)
Enrolling by invitation
Assessment of Nutritional Status in Celiac Disease Using Muscle Ultrasound in Pediatric Patients.
Celiac Disease in Children, Nutritional Assessment
Active, not recruiting
Celiac Disease in Childhood-Adulthood Transition
Celiac Disease, Celiac Disease in Children
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joseph Murray, MD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Latiglutenase in people with Celiac Disease, run by Entero Therapeutics at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 5 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Due to low enrollment related to Covid.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Symptom Severity Reduction (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2024.