A Randomized, Double-Blind, Placebo Controlled, Crossover Trial to Evaluate Safety and Efficacy of AGY in Celiac Disease

(AGY-010 Trial)

Recruiting at 1 trial location

Overseen By Dory Sample, MSN, MPH

Age: Any Age

Sex: Any

Trial Phase: Phase 2

Sponsor: Igy Inc.

Must not be taking: ASA/NSAIDs

Disqualifiers: Severe CD complications, Type 1 diabetes, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 14 weeks

161 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial is testing AGY, a treatment that neutralizes a harmful protein in gluten, in people with celiac disease who still have symptoms despite a gluten-free diet. The study aims to see if AGY can reduce symptoms and improve quality of life. Participants will be of various ages and have confirmed celiac disease. AGY is a novel egg yolk-derived antibody designed to neutralize gluten and improve the efficacy of a gluten-free diet in celiac disease patients.

Do I need to stop my current medications to join the trial?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you use ASA (aspirin) or NSAIDs (non-steroidal anti-inflammatory drugs) daily.

What safety data exists for placebo treatments in clinical trials?

Placebo treatments, often used as a control in clinical trials, have been studied for their safety and effectiveness across different diseases. While they are generally considered safe, the specific reactions can vary depending on the condition being treated. ^{1 2 3 4 5}

How does the treatment AGY differ from other treatments for this condition?

The treatment AGY is unique because it is being compared to a placebo (an inactive treatment) in a clinical trial, which helps determine its true effectiveness. This approach is important to ensure that any observed benefits are due to AGY itself and not other factors. ^{1 3 6 7 8}

Research Team

Justine Turner, MD, PhD

Principal Investigator

University of Alberta

Eligibility Criteria

Inclusion Criteria

I experience periodic symptoms that are related to celiac disease.

After following a gluten-free diet for at least 12 months, some people with celiac disease may be able to eat a limited amount of gluten without experiencing any symptoms.

history of CD

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive AGY or placebo in a double-blind, crossover design to evaluate efficacy and safety

14 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• AGY
• placebo

Participant Groups

Group I: AGY Experimental Treatment 1 Intervention

capsule containing egg yolk with AGY

Group II: placebo Placebo Group 1 Intervention

capsule containing plain egg yolk

Who Is Running the Clinical Trial?

Igy Inc.

Lead Sponsor

Trials

2

Recruited

170+

Vetanda Group Ltd

Collaborator

Trials

1

Recruited

160+

Vetanda

Collaborator

Trials

1

Recruited

160+

Findings from Research

A new checklist called TIDieR-Placebo has been developed to improve the reporting of placebo or sham interventions in clinical trials, ensuring that researchers clearly describe these components alongside active treatments.

The checklist was created through expert consultation and aims to enhance the transparency of trial results, which is crucial for accurately assessing the benefits and harms of active interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

TIDieR-Placebo: A guide and checklist for reporting placebo and sham controls. Howick, J., Webster, RK., Rees, JL., et al.[2020]

In a review of 200 randomized drug trials published in 2013, only 1 trial (0.5%) used an active placebo, indicating that these control groups are rarely employed in clinical research.

Active placebos are more commonly found in trials involving drugs with noticeable side effects, as they help reduce the risk of unblinding, although they also carry the risk of causing unintended therapeutic effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Active placebo control groups of pharmacological interventions were rarely used but merited serious consideration: a methodological overview. Jensen, JS., Bielefeldt, AØ., Hróbjartsson, A.[2018]

The proposed equivalence procedure evaluates whether a new treatment maintains a specified percentage of the effect of a known active agent compared to placebo, addressing errors from both historical and current studies.

This method is particularly useful in clinical settings, such as thrombolytic therapy for acute myocardial infarction, and includes considerations for sample size requirements to ensure robust results.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Establishing equivalence by showing that a specified percentage of the effect of the active control over placebo is maintained. Holmgren, EB.[2019]

The study systematically analyzed placebo effects from randomized, placebo-controlled trials, revealing that while placebos can influence clinical symptoms, they do not affect laboratory values like blood glucose in diabetics.

Placebo side effects were found to be similar to those of active treatments, highlighting the importance of careful placebo use in clinical research to ensure patient safety and informed consent.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Placebo treatment is effective differently in different diseases--but is it also harmless? A brief synopsis. Weihrauch, TR.[2019]

In a randomized trial with 20 individuals with spinal cord injury, high-frequency repetitive transcranial magnetic stimulation (rTMS) showed significant improvements in lower limb muscle strength, particularly in total leg and knee flexor/extensor strength, compared to sham stimulation.

While rTMS improved the lower extremity motor score (LEMS) at discharge, it did not significantly enhance gait function, suggesting that rTMS may aid muscle strength recovery but has a limited effect on gait performance in the short term.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of repetitive transcranial magnetic stimulation on recovery in lower limb muscle strength and gait function following spinal cord injury: a randomized controlled trial. Krogh, S., Aagaard, P., Jønsson, AB., et al.[2022]

References

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

TIDieR-Placebo: A guide and checklist for reporting placebo and sham controls. [2020]

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

Utility and pitfalls of some statistical methods in active controlled clinical trials. [2019]

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

Active placebo control groups of pharmacological interventions were rarely used but merited serious consideration: a methodological overview. [2018]

4. England pubmed.ncbi.nlm.nih.gov

Establishing equivalence by showing that a specified percentage of the effect of the active control over placebo is maintained. [2019]

5. England pubmed.ncbi.nlm.nih.gov

Placebo treatment is effective differently in different diseases--but is it also harmless? A brief synopsis. [2019]

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

Spinal Manipulative Therapy Effects in Autonomic Regulation and Exercise Performance in Recreational Healthy Athletes: A Randomized Controlled Trial. [2021]

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

Effects of repetitive transcranial magnetic stimulation on recovery in lower limb muscle strength and gait function following spinal cord injury: a randomized controlled trial. [2022]

8. England pubmed.ncbi.nlm.nih.gov

Transcranial direct current stimulation combined with robotic training in incomplete spinal cord injury: a randomized, sham-controlled clinical trial. [2022]