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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
92
Placebo DONQ52 subcutaneous injection
SIGE gluten capsules orally
DONQ52 subcutaneous injection
Stamford Therapeutics Consortium
Stamford, Connecticut, United States
RECRUITINGNovum Clinical Research
Clermont, Florida, United States
RECRUITINGGuardian Angel Research Center
Tampa, Florida, United States
RECRUITINGChange 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 27
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 27
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 27
Change in Average of diarrhea frequency score as assessed by CDSD frequency supplement calculated as two-week average.
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SIGE gluten capsules orally
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 27
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 weeks
Incidence and severity of adverse events (AEs) and their causal relationship to the investigational medicinal products (IMPs).
An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (e.g., a markedly abnormal physical examination finding, vital sign value, laboratory test value), symptom, or disease temporally associated with the use of a drug whether or not it is considered related to the drug.The investigator clinically judges whether an AE was caused by the IMP. This assessment of causality, often categorized as "related" or "not related," is a distinct step performed after an event has been identified and recorded as an AE.
Time frame: Baseline to 47 weeks
Serum DONQ52 concentration.
Time frame: Day1 to 47 weeks
Prevalence of anti-drug antibodies (ADAs) to DONQ52.
Time frame: Day1 to 47 weeks
Incidence of anti-drug antibodies (ADAs) to DONQ52.
Time frame: Day1 to 47 weeks