Study Medication

What is the study medication?

The study medication, DONQ52, is an antibody (a protein found in the immune system). It is being developed as a potential celiac disease treatment. DONQ52 is designed to target a molecule known to cause celiac disease symptoms when gluten is ingested. This may protect the small intestine of a person with celiac disease.

• The study medication is considered investigational, meaning that it can only be used for research and has not yet been approved by the FDA. Study staff will inject the study medication under your skin, either on your stomach or thigh. You will have either 1 or 7 doses, depending on which part of the study you join. A single dose may involve multiple injections based on weight.

Will I receive the study medication?

You will be randomly assigned to receive either the study medication or placebo (no active ingredients). You have a 3 in 4 chance of receiving the study medication.

What is an “investigational medicine?”

Investigational means the study medication is not approved by regulatory authorities like the US Food and Drug Administration (FDA), and it can only be used in clinical research studies like LILY.