T Cell Receptor (TCR) Sequencing and Transcriptional Profiling in Adult Celiac Disease Patients Undergoing Gluten Challenge

NCT ID: NCT04614571

Last Updated: 2024-06-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-11-02
• Study Completion Date: 2024-05-30

Brief Summary

The primary objectives are:

• Characterize the T cell receptor (TCR) repertoire in duodenal biopsy samples of participants pre- and post-challenge.
• Compare for each patient the TCR repertoire of duodenal biopsy samples with the peripheral blood TCR repertoire of each study participant
• Characterize the transcriptome of duodenal biopsy samples and blood from study participants pre- and post-challenge

The secondary objectives are:

• Ex vivo identification and validation of DQ-restricted gliadin specific TCRs.
• Characterize the gluten-challenge induced changes in small intestine histology using standard for Celiac Disease (CeD) histological assessments

Conditions

Celiac Disease

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Gluten Challenge

Group Type: OTHER

Gluten Powder

Intervention Type: DIETARY_SUPPLEMENT

Administered orally daily for 14 days

Interventions

Gluten Powder

Administered orally daily for 14 days

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

Inclusion Criteria

1. Have a body mass index (BMI) ≥17 and ≤40 kg/m2 and a body weight >45 kg at the Screening Visit

2. Be judged to be in good health as defined in the protocol

3. Have well-controlled biopsy-proven CeD, compliant with a GFD for ≥6 months preceding Screening as defined in the protocol

4. Be HLA-DQ2 and/or HLA-DQ8 positive as defined in the protocol

Exclusion Criteria

1. Have a history of gluten triggered acute symptoms (≤24 hours after gluten exposure), and/or severe symptoms (abdominal pain interfering with daily activities, diarrhea with >5 stools/day), and/or prolonged symptoms (duration >7 days)

2. Have a history of clinically significant endocrine, cardiovascular, hematological, hepatic, immunological (other than CeD or autoimmune thyroid disease), renal, respiratory, genitourinary, or major neurological (including stroke and chronic seizures) abnormalities or disease

3. Have participated in another investigational trial within 4 weeks before Screening

4. Have a history of cancer (malignancy) other than nonmelanoma skin cancer

5. Have a history of significant multiple and/or severe allergies (e.g., latex allergy)

6. Presence of HIV (HIV Ab), hepatitis B (HBsAg, HBAb) or Hepatitis C (HCV Ab) seropositivity at screening

7. Ongoing immunosuppression or receive any treatment that might alter T cell repertoire or phenotype

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Regeneron Pharmaceuticals

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Trial Administrator

Role: STUDY_DIRECTOR

Regeneron Pharmaceuticals

Locations

Celiac Research Centre Mass General Hospital

Boston, Massachusetts, United States

Countries

United States

Other Identifiers

0000-CD-CES-1880

Identifier Type: -

Identifier Source: org_study_id