Etrasimod for Immune Checkpoint Inhibitor Diarrhea and Colitis (NCT06521762) | Clinical Trial Compass
WithdrawnPhase 2
Etrasimod for Immune Checkpoint Inhibitor Diarrhea and Colitis
Stopped: The study was terminated early as no patients were enrolled.
United States0Started 2026-01
Plain-language summary
This is a randomized, double-blind, placebo-controlled, two-arm phase 2 study of etrasimod plus corticosteroids versus placebo plus corticosteroids for the treatment of IMDC CTCAE v5.0 grade ≥ 2 due to ICI therapy alone (α-PD-(L)1 monotherapy or combined with another ICI, such as α-CTLA-4 or α-LAG-3) or ICI plus an oral tyrosine kinase inhibitor that in the opinion of the treating physician requires treatment with corticosteroid-based immunosuppression and does not require immediate secondary immune suppression, such as vedolizumab or infliximab (or equivalent).
IMDC is one of the most common Immune Related Adverse Events (irAEs) from treatment with ICI. Current guidelines recommend steroid treatment for IMDC CTCAE grade ≥ 2, which requires temporary or permanent cessation of ICI therapy. Corticosteroids may interfere with the anti-tumor activity of ICIs and are therefore not co-administered. Strategies are needed to both reduce the dose and duration of corticosteroids needed for IMDC treatment and minimize the duration off ICI therapy before re-administering ICI (for those patients in whom it is deemed safe to rechallenge).
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. No known history of inflammatory bowel disease
✓. Vital signs at screening: pulse rate ≥ 50 beats per minute, systolic blood pressure ≥ 90 mm Hg, and diastolic blood pressure ≥ 55 mm Hg
✓. 12-lead electrocardiogram (ECG) that showed no clinically significant abnormalities as defined by the clinician's judgement at the time the ECG was performed
✓. Non-pregnant, as determined by qualitative urine hCG testing
✓. Non-lactating
✓. If premenopausal, be either surgically infertile OR using 2 acceptable methods of birth control for 30 days after the last dose of etrasimod is administered (inquire for a list of birth control methods considered acceptable)
Exclusion criteria
✕. difficile infection, or an intestinal bacterial or parasitic infection detected by a multiplexed stool infection assay
✕. Have received treatment for C. difficile infection within 30 days or another intestinal pathogen within 30 days prior to enrollment
What they're measuring
1
Average daily weight-adjusted dose of corticosteroids use
Timeframe: up to day 120 or when a censoring event occurs
. Have a known history of active or latent tuberculosis, or active hepatitis B or hepatitis C
✕. Have a known history of congenital or acquired immunodeficiency, including but not limited to common variable immune deficiency (CVID) and human immunodeficiency virus (HIV) infection
✕. Have evidence of abdominal abscess or toxic megacolon at the initial screening visit
✕. Type 1 diabetes mellitus
✕. Uncontrolled type 2 diabetes mellitus requiring insulin for routine management
✕. In the last 6 months, experienced myocardial infarction, unstable angina pectoris, stroke, transient ischemic attack, decompensated heart failure requiring hospitalization, or Class III or IV heart failure.