Clinical Trials

Inclusion Criteria:

• Completed the DBT period for 2624 weeks, including the upper gastrointestinal endoscopies with duodenal biopsies at Week 26
  • If the participant undergoes early discontinuation from the study treatment before completing the DBT period for 26 weeks for reasons other than safety, and the participant is willing to participate in the OLE period, they can be included if the other criteria for the OLE have been met. 17.
• For women of childbearing potential: negative pregnancy test result at Week 26 (Day 183) and willing to remain abstinent or continue the use of two effective methods of contraception.

Exclusion Criteria:

• Documented history (i.e., included in the participant’s medical records) of medically diagnosed refractory CeD (RCD) type I (RCD I) or II (RCD II). RCD is defined by CeD patients who have been following a GFD strictly for more than 12 months and who have persistent villous atrophy and severe symptoms, signs and/or parameters of substantial malabsorption (e.g., severe diarrhea, weight loss as defined below) where no other medical cause can be identified. The presence of aberrant or monoclonal T cells on immunohistochemistry, flow cytometry or TCR-gamma sequencing, which defines RCD II, will also be excluded.
  • Malabsorption is defined as the following four criteria to exclude gluten-independent RCD (must have all four). The following confirmation will be performed during the screening period, in the investigator’s opinion:
    • Significant weight loss (>8 kg unintended weight loss in the past 6 months).
    • Low hemoglobin (<10 g/dL).
    • Deficiencies of multiple nutrients (meet 3 or more):
      • Low albumin (<3.0 g/dL)
      • Vitamin A, D, E, or K
      • Vitamin B6
      • Vitamin B12
      • Folate
      • Iron
      • Magnesium
      • Zinc
• Any uncontrolled complications of CeD in the investigator's judgment (e.g., enteropathy-associated T cell lymphoma, ulcerative jejunitis, intestinal perforation).
• Any other uncontrolled autoimmune diseases in the investigator's judgment.
• Any treatment related to symptoms by the total score of CDSD GI scorein this study (e.g., analgesics, antiemetic drugs, antidiarrheal drugs, PPI, H2 blocker, gastric mucosal protective drug).
  • A participant who is on regularly or prophylactically use of these treatments is eligible if these treatments are stopped when obtaining the consent for study participation and his/her health status is judged stable in the investigator's judgment prior to entering in run-in period.
  • If medically required and there are no alternative treatments, these treatments can be used as needed (i.e., PRN use) only after the onset of any symptoms in the investigator's judgement as long as reported as protocol deviation.

Note: Other protocol defined Inclusion/Exclusion Criteria may apply.

Eligibility last updated 04/21/2025. Questions regarding updates should be directed to the study team contact.