Phase 2 Clinical Research Study

Advancing Care for
Active Celiac Disease

We are evaluating DONQ52, a study medication designed to reduce small intestinal damage and manage symptoms for individuals who continue to experience challenges despite maintaining a gluten-free diet.

See If You Pre-Qualify
Medically Credible & HIPAA Compliant
Sponsored by Chugai Pharmaceutical

Understanding the DONQ52 Clinical Research Study

Advancing science for individuals living with active Celiac Disease (CeD) who continue to experience symptoms despite a gluten-free lifestyle.

The Purpose of the Study

The primary objective of this clinical trial is to evaluate the efficacy and safety of an investigational medication, DONQ52. Researchers are studying how this treatment may help improve small intestinal damage and reduce the symptoms often triggered by inadvertent gluten exposure.

This study specifically focuses on participants who have been diagnosed with Celiac Disease and have attempted to maintain a gluten-free diet (GFD) for at least one year, yet still face ongoing health challenges.

What to Expect

  • 01
    Initial Screening: A review of your medical history, HLA DQ2.5 genotype testing, and a baseline assessment of your current symptoms.
  • 02
    Study Participation: Participants will be randomly assigned to receive either DONQ52 or a placebo while continuing their gluten-free diet.
  • 03
    Clinical Monitoring: Regular check-ins, including two upper gastrointestinal endoscopies with duodenal biopsies to monitor intestinal healing.
Study Phase 2 • Clinical Research

Study of DONQ52 in Active Celiac Disease

Understanding the criteria for participation is the first step in joining this clinical research study. This study evaluates how DONQ52 may help improve intestinal health and manage symptoms for individuals living with Celiac Disease.

You May Qualify If...

  • You have a medically documented diagnosis of Celiac Disease (CeD).
  • You have been attempting a gluten-free diet for at least 12 months.
  • You have a Body Mass Index (BMI) between 18 and 40.
  • You test positive for the HLA DQ2.5 genotype (tested during screening).
  • You have experienced recent symptoms like bloating, pain, or nausea.
  • You are willing to undergo two endoscopies with biopsies during the study.

You May Not Qualify If...

  • You have a diagnosis of Refractory Celiac Disease (RCD).
  • You have known allergies to wheat, barley, rye, or study ingredients.
  • You carry the HLA-DQ8 genotype rather than the required DQ2.5.
  • You have a history of cancer within the last 5 years.
  • You have had a history of severe allergic reactions to biological products.

Not sure if you qualify?

Our quick screening tool can help determine if this study is a potential fit for you. It takes less than 2 minutes.

Participant Support

Study Benefits & Care Commitment

As a participant in the DONQ52 Celiac Disease study, your health, safety, and contribution to medical science are our highest priorities.

Study Medication

Eligible participants will receive the investigational study medication, DONQ52, or a placebo at no cost throughout the study duration.

Health Monitoring

Receive regular medical check-ups, including upper gastrointestinal endoscopies and blood tests, to monitor your Celiac health.

Financial Support

Compensation

Participants may be compensated for their time and effort related to study visits, including the required medical procedures and diary entries.

Specialist Access

Gain access to a dedicated team of gastroenterologists and research professionals specializing in Celiac disease management.

Travel Reimbursement

Reimbursement for reasonable travel expenses to and from the clinical site may be provided to facilitate your participation.

Scientific Impact

Your participation helps advance medical understanding of how to reduce small intestinal damage in individuals living with Celiac disease.

Participant Transparency Program

Common Questions About the DONQ52 Study

We believe in providing clear, medically-grounded information to help you make an informed decision about participating in Celiac Disease research.

What is a clinical trial and is it safe?

A clinical trial is a highly regulated scientific study conducted to evaluate the safety and effectiveness of a new medical approach. For the DONQ52 study, the safety of our participants is our primary concern. This Phase 2 trial follows rigorous protocols approved by Institutional Review Boards (IRB) and regulatory authorities. You will be closely monitored by a team of specialized physicians and medical staff throughout the entire process.

How long will I be in the study?

The duration of participation varies depending on the specific phase of the study, but typically involves a screening period, a treatment phase, and a follow-up period. Since this study involves monitoring small intestinal damage and gluten-related symptoms, participants should expect to maintain their gluten-free diet (GFD) for the duration of the study while attending scheduled clinic visits for monitoring.

What are the possible risks and side effects?

All medical research carries some level of risk. Potential side effects of DONQ52 are being carefully studied. Some participants may experience discomfort during required procedures, such as the upper gastrointestinal endoscopies or during the Simulated Inadvertent Gluten Exposure (SIGE). Our medical team will provide a detailed Informed Consent Form (ICF) that lists all known risks before you decide to join.

Will my information be kept confidential?

Yes. Your privacy is protected by law. All data collected during the DONQ52 study is de-identified, meaning your name and personal details are replaced with a unique code. Only authorized study personnel will have access to the link between that code and your identity, and your information will never be shared for marketing purposes.

Can I leave the study if I change my mind?

Participation is entirely voluntary. You have the right to withdraw from the study at any time, for any reason, without any penalty or loss of benefits to which you are otherwise entitled. If you choose to leave, we simply ask that you notify the study team so they can ensure a safe transition and conduct a final health check.

Will I receive the actual medication or a placebo?

This is a placebo-controlled Phase 2 study. This means participants will be randomly assigned (like the flip of a coin) to receive either the active study drug, DONQ52, or a placebo. A placebo looks exactly like the study drug but contains no active medication. This comparison is the gold standard in medical research to determine if the study drug is truly effective in reducing intestinal damage.

What happens after the study ends?

Once the study concludes, you will have a final follow-up visit to ensure your health is stable. While you may not have continued access to the study medication immediately, the data you provided will be instrumental in helping Chugai Pharmaceutical advance treatments for the Celiac community. We will also provide information on how you can receive a summary of the study results once they are finalized.

Still have questions about the DONQ52 study?