Efficacy of Anti-Integrin avb6 Autoantibody for Immune Checkpoint Inhibitor-Induced Colitis

Efficacy of Anti-Integrin avb6 Autoantibody for Immune Checkpoint Inhibitor-Induced Colitis - avb6-ICI Colitis Trial

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000058198

Enrollment

Registered

2025-06-23

Start date

2025-07-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Immune Checkpoint Inhibitor-Induced Colitis

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. 20 years old or more 2. Patients who developed colitis after receiving anti-PD-1, anti-PD-L1, anti-CTLA-4 antibody therapy for malignancy 3. Patients diagnosed with immune checkpoint inhibitor-induced colitis, confirmed through colonoscopy, including histopathological examination 4. Consent for this trial

Exclusion criteria

Exclusion criteria: 1. Patients with a history of Crohn's disease or ulcerative colitis 2. Patients with infectious enteritis caused by pathogenic microorganisms such as Clostridioides difficile, Campylobacter jejuni, or Cytomegalovirus 3. Patients deemed inappropriate for inclusion by the investigator

Design outcomes

Primary

Measure	Time frame
Association Between Serum Anti-Integrin avb6 Antibody Titers and Steroid Responsiveness and Relapse in Patients with Immune Checkpoint Inhibitor-Induced Colitis	—

Secondary

Measure	Time frame
Association Between Serum Anti-Integrin avb6 Antibody Titers and Disease Activity Association Between Serum Anti-Integrin avb6 Antibody Titers and Intestinal Lesions	—

Countries

Japan

Contacts

Public ContactYoshiki Morihisa

Kobe City Medical Center General Hospital Department of Gastroenterology

yoshiki_morihisa@kcho.jp078-302-4321

Outcome results