Population 1: Adult patients with celiac disease (CeD) who have been on a gluten-free diet for at least 6 months

Inclusion Criteria:

• 18 years of age or older

• Confirmed diagnosis by

  • upper endoscopy and pathology showing villous atrophy and increased intraepithelial lymphocytosis and 

  • positive celiac-specific serology test

• Have been following a gluten free diet for 6 months or more

Exclusion Criteria: 

• Younger than 18 years of age

• Patients with CeD who have been on a gluten-free diet for less than 6 months

• Patient with a history of other autoimmune conditions such as

  • Crohn’s disease

  • Ulcerative colitis

• Currently taking systemic steroids

• Currently on immunomodulatory therapies or who have received immunomodulatory drugs within 5 half-lives

• Active infection within 2 weeks of consent

• Participation in other research studies involving investigational drugs

• Currently pregnant

Population 2: Adult control subjects with no history of gluten sensitivity

Inclusion Criteria:

• 18 years of age or older

• No prior history of gluten sensitivity

Exclusion Criteria: 

• Younger than 18 years of age

• Diagnosis of celiac or other gluten sensitivity

• Patient with a history of other autoimmune conditions such as:

  • Crohn’s disease

  • Ulcerative colitis

• Currently taking systemic steroids

• Currently on immunomodulatory therapies or who have received immunomodulatory drugs within 5 half-lives

• Active infection within 2 weeks of consent

• Participation in other research studies involving investigational drugs

• Currently pregnant

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

Eligibility last updated 06/16/2026. Questions regarding updates should be directed to the study team contact.