Latiglutenase for Celiac Disease

Overseen By Ana Ramos

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Entero Therapeutics

Disqualifiers: Wheat allergy, Type 1 diabetes, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 1

83 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial is testing a new treatment for people with celiac disease who still have symptoms despite following a gluten-free diet. The goal is to see if this new treatment can help reduce their symptoms.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is Latiglutenase safe for humans?

The available research does not provide specific safety data for Latiglutenase, but it has been tested in humans for celiac disease without reported safety concerns in the provided studies. ^{1 2 3 4 5}

How does the drug Latiglutenase differ from other treatments for celiac disease?

Latiglutenase is unique because it is an oral enzyme therapy that uses two specific enzymes to break down gluten in the stomach, potentially reducing symptoms for celiac patients who accidentally consume gluten, unlike the standard gluten-free diet which requires complete avoidance of gluten. ^{1 5 6 7 8}

What data supports the effectiveness of the drug Latiglutenase for Celiac Disease?

Latiglutenase has shown some promise in improving symptoms for certain celiac disease patients who are seropositive (having specific antibodies in their blood) while on a gluten-free diet, although it did not show significant improvement in intestinal healing compared to a placebo. ^{1 2 5 6 9}

Who Is on the Research Team?

Joseph Murray, MD

Principal Investigator

Mayo Clinic

Are You a Good Fit for This Trial?

Inclusion Criteria

You have had at least one symptom that you would describe as moderate or worse in the past 28 days.

Willing to take study treatment daily

Must sign informed consent

Exclusion Criteria

You have been told by a doctor that you have Type 1 Diabetes.

You are allergic to wheat.

You have a history of stomach ulcers, esophagus inflammation, irritable bowel syndrome, or inflammatory bowel disease.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Treatment Period 1

Participants receive either Latiglutenase or placebo for the first 6-week period

6 weeks

Crossover

Participants switch to the alternate treatment (Latiglutenase or placebo) for another 6-week period

6 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Latiglutenase
• Placebo

How Is the Trial Designed?

Group I: Latiglutenase Active Control 1 Intervention

IMGX003

Group II: Placebo Placebo Group 1 Intervention

Placebo

Who Is Running the Clinical Trial?

Entero Therapeutics

Lead Sponsor

Trials

10

Recruited

410+

Immunogenics, LLC

Lead Sponsor

Trials

4

Recruited

220+

National Institute of Allergy and Infectious Diseases (NIAID)

Collaborator

Trials

3,361

Recruited

5,516,000+

Published Research Related to This Trial

In a phase 2 trial involving 41 adults with celiac disease, the glutenase ALV003 significantly protected against gluten-induced mucosal injury, as evidenced by stable villus height to crypt depth ratios and intraepithelial lymphocyte counts compared to the placebo group.

While ALV003 showed efficacy in preventing mucosal damage during a gluten challenge, there were no significant differences in patient symptoms between the ALV003 and placebo groups, indicating that while the treatment may protect the intestine, it does not necessarily alleviate symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Glutenase ALV003 attenuates gluten-induced mucosal injury in patients with celiac disease. Lähdeaho, ML., Kaukinen, K., Laurila, K., et al.[2015]

Citations

1. United States pubmed.ncbi.nlm.nih.gov

No Difference Between Latiglutenase and Placebo in Reducing Villous Atrophy or Improving Symptoms in Patients With Symptomatic Celiac Disease. [2021]

2. United States pubmed.ncbi.nlm.nih.gov

Latiglutenase Improves Symptoms in Seropositive Celiac Disease Patients While on a Gluten-Free Diet. [2018]

3. Switzerland pubmed.ncbi.nlm.nih.gov

Gluten Degrading Enzymes for Treatment of Celiac Disease. [2021]

4. Netherlands pubmed.ncbi.nlm.nih.gov

The effects of modified versus unmodified wheat gluten administration in patients with celiac disease. [2018]

5. Netherlands pubmed.ncbi.nlm.nih.gov

Current pharmacological approaches and potential future therapies for Celiac disease. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Glutenase ALV003 attenuates gluten-induced mucosal injury in patients with celiac disease. [2015]

7. England pubmed.ncbi.nlm.nih.gov

Coeliac Disease: background and biochemical aspects. [2015]

8. United States pubmed.ncbi.nlm.nih.gov

Celiac disease: from pathogenesis to novel therapies. [2022]

9. United States pubmed.ncbi.nlm.nih.gov

Immunological effects of transglutaminase-treated gluten in coeliac disease. [2021]