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JAK Inhibitor
Itacitinib for Immune-Related Side Effects
Phase 2
Recruiting
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
Study 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.Check my eligibility
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.See study design
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
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Incidence of immune related adverse events (irAE)
Secondary outcome measures
Hospitalization presence
Need for therapy escalation and absence of steroids
Need for therapy escalation and presence of steroids
+5 moreTrial 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
Skin biopsy
2018
Completed Phase 4
~950
Biospecimen Collection
2004
Completed Phase 2
~1700
Corticosteroid
2005
Completed Phase 4
~2210
Itacitinib
2020
Completed Phase 3
~910
Endoscopic Procedure
2015
N/A
~250
Find a Location
Who is running the clinical trial?
Incyte CorporationIndustry Sponsor
365 Previous Clinical Trials
55,270 Total Patients Enrolled
Douglas JohnsonLead Sponsor
Douglas Johnson, MDPrincipal InvestigatorVanderbilt University/Ingram Cancer Center
1 Previous Clinical Trials
29 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have been treated with an immune checkpoint inhibitor.I am currently on IV antibiotics for a serious infection.I have had an organ or stem cell transplant and am experiencing complications.I have been treated with drugs that affect my immune system before joining this study.I am experiencing moderate to severe side effects from immune therapy.My organs and bone marrow are working well.I have not taken JAK inhibitors in the last 8 weeks.I have a heart condition that may make it unsafe for me to join the study.I've taken high-dose steroids for over 2 days without my condition improving.I have HIV with a CD4 count below 200.I have had a moderate to severe side effect from immunotherapy.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (itacitinib)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Has itacitinib been recognized by the FDA as an acceptable therapeutic option?
"Our team has given Treatment (itacitinib) a score of 2, as this Phase 2 trial provides evidence that the drug is safe but none to support its efficacy."
Answered by AI
Does this medical experiment have room for any new participants?
"In accordance to clinicaltrials.gov, this particular research trial is not actively enrolling patients at the moment. Although, it was first listed on January 31st 2023 and recently edited in December 2022. Alongside that, there are currently 2460 other trials actively seeking participants."
Answered by AI
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