Clinical Trials

Inclusion Criteria:

• Provision of signed and dated informed consent form

• Stated willingness to comply with all study procedures and availability for the duration of the study

• Male or female, aged ≥ 18 years and ≤ 70 years

• Participant has a confirmed diagnosis of UC or CD

• Individuals for whom a provider is considering initiating an anti-IL-23 (risankizumab, mirikizumab, guselkumab), anti-a4b7 (vedolizumab), or a within-class anti-TNF biologic (adalimumab, infliximab, certolizumab) due to loss of response, or incomplete response of current medication

  • Loss of response – objective flare after initial response.

  • Incomplete response or partial response (or primary non responder, PNR ) – pharmacokinetic failure, pharmacodynamic failure.

  • Therapy complications – e.g. drug-induced lupus, infusion reactions, skin cancer, demyelinating disorders, etc.

Exclusion Criteria:

• Inability to consent

• Ileostomy, history of IPAA

• Inability to return for a 4-6 month standard of care endoscopy

• Prior exposure to anti-IL-23 (risankizumab, mirikizumab, guselkumab) or anti-a4b7 (vedolizumab)

• Current use of small molecules such as JAK-inhibitors or S1P1 receptor modulators

• Current use of anti-IL 23 p40 drugs (ustekinumab)

• Reason for therapy change not due to incomplete response, PNR or secondary LOR, such as but not limited to:

  • Insurance

  • Patient choice

• Current known infection with Clostridioides difficile

• Female who is pregnant, breast-feeding or intends to become pregnant

• Any disorder, which in the investigator’s opinion might jeopardize participant’s safety or compliance with the protocol

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

Eligibility last updated 10/08/2025. Questions regarding updates should be directed to the study team contact.