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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Placebo DONQ52
DrugPlacebo DONQ52 subcutaneous injection
Simulated Inadvertent Gluten Exposure (SIGE) capsule
Dietary supplementSIGE gluten capsules orally
DONQ52
DrugDONQ52 subcutaneous injection
Simulated Inadvertent Gluten Exposure (SIGE) capsule
Dietary supplementSIGE gluten capsules orally
Treatment groups
92 Participants
are divided into 2 treatment groupsGroup A: Placebo + SIGE Gluten capsulePlacebo comparator 2 interventions
Group B: DONQ52 + SIGE Gluten capsuleExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
Change in Villous Height to Crypt Depth Ratio (Vh:Cd)
The Vh:Cd ratio represents mucosal architectural changes and a lower Vh:Cd ratio indicates more severe intestinal injury characterized by a flattening of the mucosa. The difference in the adjusted mean change from baseline (Run-in) to Week 27 in Vh:Cd between DONQ52 and placebo groups will be estimated using the analysis of covariance (ANCOVA) method. A negative change from baseline indicates worsening disease.
Time frame
Baseline to Week 27Secondary outcomes
1
Change in Average of total score of Celiac Disease Symptom Diary (CDSD) Gastrointestinal (GI) domain (abdominal pain, diarrhea, nausea, and bloating) calculated as two-week average.
CDSD symptom severity score is an average of the daily symptom severity scores during the week. The daily symptom severity score is the average of the severity score for diarrhea, abdominal pain, bloating, nausea, and tiredness ranging from 0 to 4. Symptom severity is evaluated using 5-point Likert-type scales (none, mild, moderate, severe, and very severe). Higher scores indicate more severe symptoms. Results are reported as mean change from baseline at Week 13-14 and Week 25-26. A negative change from baseline indicates improvement.
Time frame
Baseline to Week 272
Change in Average of the total score of non-stool GI symptoms (abdominal pain, nausea, and bloating) calculated as two-week average.
CDSD GI symptom severity score is an average of the daily non-stool GI symptom severity scores during the week. The daily non-stool GI symptom severity score is the average of the severity score for abdominal pain, nausea, and bloating, ranging from 0 to 4. Symptom severity is evaluated using 5-point Likert-type scales (none, mild, moderate, severe, and very severe). Higher scores indicate more severe symptoms. Results are reported as mean change from baseline at Week 13-14 and Week 25-26. A negative change from baseline indicates improvement.
Time frame
Baseline to Week 273
Change in Average of diarrhea frequency score as assessed by CDSD frequency supplement calculated as two-week average.
Diarrhea frequency score assessed by CDSD frequency supplement is an average of the daily diarrhea frequency score during the week. Results are reported as mean change from baseline at Week 13-14 and Week 25-26. A negative change from baseline indicates improvement.
Time frame
Baseline to Week 274
Relationship between the total score of CDSD GI domain and Patient Global Impression of Severity (PGI-S) or Patient Global Impression of Change (PGI-C).
The PGI-S is a Patient-Reported Outcome (PRO) measure assessing participant's impression of overall severity of disease symptoms. The PGI-S consists of single-item which asks participant's disease severity over the past 7 days and 14 days. It is rated on a 5-point scale from None to Very Severe. This PGI-S has been specifically modified to focus on celiac disease symptoms (i.e., abdominal pain, bloating, diarrhea, and nausea), adapting the standard PGI-S framework to be celiac disease-specific. The PGI-C is a PRO measure assessing participant's impression of the overall change in disease symptoms. The PGI-C consists of single-item which asks the change of participant's clinical status since the start of the study. It is rated on a 7-point scale from Very Much Improved to Very Much Worse. This PGI-C has been specifically modified to focus on celiac disease symptoms (i.e., CDSD GI items), adapting the standard PGI-C framework to be celiac disease-specific.
Time frame
Baseline to 47 weeksSponsors and contacts
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Source ClinicalTrials.gov