Study of DONQ52 in Active Celiac Disease
ConditionCeliac Disease
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorChugai Pharmaceutical
About this trial
The main aim is to see how DONQ52 works to improve small intestinal damage and reduce celiac-related symptoms due to gluten exposure, in participants with celiac disease (CeD) attempting to maintain a gluten-free diet (GFD) in treated participants versus placebo controls.
Eligibility criteria
Qualifiers
Body mass index (BMI) of 18 to 40 (kg/m2) at screening.
Willingness to ingest a gluten-free product and Simulated Inadvertent Gluten Exposure (SIGE) products as per the study protocol.
History of medically diagnosed, and adequately documented (i.e., included in the participant's medical records), CeD
Attempting a GFD for at least 12 months prior to the screening visit.
Disqualifiers
Participants with documented history (i.e., included in the participant's medical records) of medically diagnosed Refractory Celiac Disease (RCD) or suspected RCD by the investigator.
History of IgE-mediated reactions to wheat, barley, rye, or other ingredients in gluten-free and SIGE products used in this study (i.e., methylcellulose, and gelatin).
History of cancer, including hematological malignancy and solid tumors, within 5 years prior to the screening visit, or history of T cell lymphoma or B cell lymphoma ever.
History of hypersensitivity reactions including anaphylaxis to a biological medical product or any of the excipients.
Trial design
Treatments tested in this trial
- Placebo DONQ52
- Simulated Inadvertent Gluten Exposure (SIGE) capsule
- DONQ52
- Simulated Inadvertent Gluten Exposure (SIGE) capsule
Treatment groups
92 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov