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WITHDRAWN
NCT05660421
PHASE2

Itacitinib for the Treatment Steroid Refractory Immune Related Adverse Events Arising From Immune Checkpoint Inhibitors

Sponsor: Douglas Johnson

View on ClinicalTrials.gov

Summary

This phase II trial tests how well itacitinib works in in patients with immune related adverse events (irAEs) arising from immune checkpoint inhibitors (ICI) that do not respond to steroids (steroid refractory). Steroids are the usual treatment for these side effects. However, sometimes steroids do not improve or fix the side effects. Giving itacitinib may be effective in treating patients with known or suspected problems coming from ICIs, that do not resolve or improve with steroids, by reducing the patients immune system response that can cause the irAEs.

Official title: A Phase II Study of Itacitinib in Patients With Steroid Refractory Immune Related Adverse Events Arising From Immune Checkpoint Inhibitors

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

0

Start Date

2023-03-03

Completion Date

2025-04-03

Last Updated

2026-04-27

Healthy Volunteers

No

Interventions

DRUG

Itacitinib

Given by mouth

DRUG

Corticosteroid

Given by mouth or by vein

PROCEDURE

Endoscopic Procedure

Undergo endoscopic procedure

PROCEDURE

Skin biopsy

Undergo skin biopsy

PROCEDURE

Biospecimen Collection

Undergo collection of blood and stool