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JAK Inhibitor

Itacitinib for Immune-Related Side Effects

Phase 2

Waitlist Available

Led By Douglas Johnson, MD

Research Sponsored by Douglas Johnson

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up days 14 and 28

Awards & highlights

No Placebo-Only Group

Summary

This trial tests if itacitinib can help treat immune-related side effects from ICIs that don't respond to steroids. It reduces immune system response that can cause these side effects.

Who is the study for?

This trial is for patients with blood cancers or tumors who have side effects from immune checkpoint inhibitors that steroids can't fix. They must be experiencing specific moderate to severe symptoms, have tried steroids and possibly other immunomodulators, and not have certain infections or heart conditions. Women of childbearing potential and sexually active men must agree to use contraception.

What is being tested?

The study tests Itacitinib's effectiveness in treating steroid-refractory immune-related adverse events caused by cancer treatments known as immune checkpoint inhibitors. Participants will undergo various assessments including biopsies and endoscopic procedures to evaluate the response.

What are the potential side effects?

Potential side effects of Itacitinib may include infection risks due to immune system suppression, liver enzyme changes, blood disorders like anemia or low platelet counts, gastrointestinal issues, skin reactions, and possible allergic responses.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ days 14 and 28

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~days 14 and 28

This trial's timeline: 3 weeks for screening, Varies for treatment, and days 14 and 28 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Secondary study objectives

Hospitalization presence

Need for therapy escalation and absence of steroids

Need for therapy escalation and presence of steroids

+5 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment (itacitinib)Experimental Treatment5 Interventions

Patients receive itacitinib PO and corticosteroids PO or IV. Patients may undergo endoscopy and skin biopsy throughout the study. Patients also undergo blood collection throughout the study.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Itacitinib

2020

Completed Phase 3

~980

Corticosteroid

2005

Completed Phase 4

~2210