ImmuneSense™ IBD Study

Stopped early

Conditions studied: Inflammatory Bowel Diseases

In brief

This study will enroll adult and pediatric participants across 3 phases: Research phase, Clinical Validation (CV) and Analytical Validation (AV) phase. Sites selected to participate in the study will enroll participants in the either the Research phase or CV and AV phase. Research Phase will enroll participants in Cohort 1 Pre-diagnosis/+GI symptoms only. CV and AV phase will be open to enrollment in parallel. CV phase will enroll participants in Cohort 2 Diagnosed IBD, Pre-treatment, Cohort 3 Potential Cross-Reactive Diseases and Cohort 4 Healthy controls. AV phase will enroll participants in Cohort 2 Diagnosed IBD, Pre-treatment and Cohort 4 Healthy controls. Enrollment will be ongoing until sponsor notification for closure.

Key facts

Study ID

NCT05769829

Run by

Adaptive Biotechnologies

People needed

484

Starts

2022-10-31

Expected to finish

2023-08-14

Last updated by the study team

2023-10-05

Who can join

Age: 18 and older, up to 89. Sex: any. Healthy volunteers: accepted.

You may not qualify if…

• Age <7 years or >89 years
• Known IBD (Ulcerative colitis, Crohn's disease, indeterminate colitis) and Celiac
• Known active malignancy
• Active Hepatitis B, C or HIV infection(s)
• Use of systemic high dose corticosteroids (above 20mg/day prednisone by mouth) within 30 days prior to the blood draw
• Protected populations including pregnant women, prisoners, mentally disabled persons, and wards-of-the state
• Any significant condition, laboratory abnormality, or psychiatric illness that would prevent the participant from safely participating in the study
• Donated more than 500cc or 1 pint of blood in the past 60 days prior to the blood draw (at the discretion of the investigator)
• Cohort 2: Diagnosed IBD, Pre-treatment Inclusion criteria
• Diagnosis of Crohn's disease or Ulcerative colitis made with endoscopy (within 6 months), clinical, imaging, and histological findings.
• Male and female participants of any race and ethnicity between 7 to 89 years of age (inclusive) at the time of enrolling in the study
• Must be able to communicate with the investigator, understand and comply with the requirements of the study
• Exclusion Criteria
• Age <7 years or >89 years
• Known active malignancy
• Known Celiac disease
• Active Hepatitis B, C or HIV infection(s)
• Active gastrointestinal infection within 30 days prior to enrollment
• Protected populations including pregnant women, prisoners, mentally disabled persons, and wards-of-the state
• Any significant condition, laboratory abnormality, or psychiatric illness that would prevent the participant from safely participating in the study
• Donated more than 500cc or 1 pint of blood in the past 60 days prior to the blood draw (at the discretion of the investigator)
• On any treatment for IBD- systemic corticosteroids within 30 days, immunomodulator, 5-ASA, biologic therapy
• Plan to initiate therapy as part of a clinical trial of a non-FDA-approved IBD therapy
• Cohort 3: Potential Cross-Reactive Disease States Inclusion criteria
• Confirmed, documented diagnoses for one of the following diseases:

Where it is running

• Hope Clinic & Research Center LLC — Hialeah, Florida, United States
• Gold Coast Health Research Center, LLC — Miami, Florida, United States
• Sanitas Research — Miami, Florida, United States
• Frontier Clinical Research, LLC — Uniontown, Pennsylvania, United States
• University Gastroenterology — Providence, Rhode Island, United States
• Gastroenterology Consultants of South Texas, PA — Brownsville, Texas, United States

Full record on ClinicalTrials.gov

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