itacitinib for Graft-versus-Host Disease

Parkview Cancer Institute, Fort Wayne, IN
Graft-versus-Host Disease+2 More Conditionsitacitinib - Drug
All Sexes

Study Summary

This trial is designed to provide itacitinib to people who have already been taking it and who may benefit from continued treatment. Eligible participants will receive the same dose and schedule of itacitinib as they received in the previous study. Treatment may be continued as long as the participant does not experience negative side effects, still derives benefit from the drug, and does not meet any other criteria for discontinuation.

Eligible Conditions
  • Chronic Graft-versus-Host Disease
  • Bronchiolitis Obliterans
  • Myelofibrosis

Treatment Effectiveness

Phase-Based Effectiveness

1 of 3
Phase 2

Study Objectives

1 Primary · 0 Secondary · Reporting Duration: 3 years

3 years
Treatment Emergent Adverse Events (TEAE's)

Trial Safety

Phase-Based Safety

2 of 3
This is further along than 68% of similar trials

Awards & Highlights

No Placebo Group
All patients enrolled in this trial will receive the new treatment.

Trial Design

1 Treatment Group

1 of 1

Experimental Treatment

100 Total Participants · 1 Treatment Group

Primary Treatment: itacitinib · No Placebo Group · Phase 2

Experimental Group · 1 Intervention: itacitinib · Intervention Types: Drug
First Studied
Drug Approval Stage
How many patients have taken this drug
Not yet FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 3 years

Who is running the clinical trial?

Incyte CorporationLead Sponsor
331 Previous Clinical Trials
48,057 Total Patients Enrolled
Lance Leopold, MDStudy DirectorIncyte Corporation
14 Previous Clinical Trials
1,457 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 0 Total Inclusion Criteria

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Frequently Asked Questions

Does this research endeavor introduce a novel approach to the field?

"The pharmaceutical Incyte Corporation has been researching itacitinib since 2013, conducting 23 trials across 20 countries and 76 cities. To date, 12 of these studies have concluded, with the earliest trial containing 121 patients who were able to successfully complete Phase 1 drug approval." - Anonymous Online Contributor

Unverified Answer

How many healthcare institutions are participating in this research endeavor?

"City of Hope National Medical Center in Duarte, Temple University in Cleveland and the Cleveland Clinic Vancouver are amongst 8 sites running this trial. There is also a selection of other clinical centres hosting this study." - Anonymous Online Contributor

Unverified Answer

Has the FDA given its approval to itacitinib?

"There is some evidence for itacitinib's safety, yet no proof of efficacy. For this reason, our team at Power gave a rating of 2 to its safety profile." - Anonymous Online Contributor

Unverified Answer

Is the enrollment of participants open in this investigation?

"Affirmative. confirms that this trial is actively searching for participants, which began on March 10th 2021 and was amended most recently in November 15th 2022. This medical study requires the enrollment of 100 individuals across 8 research sites." - Anonymous Online Contributor

Unverified Answer

Has itacitinib been tested in prior experiments?

"Currently, 23 clinical trials are being conducted on itacitinib. One of these is in the final phase 3 stage. The majority of studies take place at research sites within Philadelphia, Pennsylvania, but there are a total of 397 locations evaluating this medication's efficacy and safety." - Anonymous Online Contributor

Unverified Answer

How many participants are participating in this research endeavor?

"Affirmative, the information on verifies that this experiment is in need of volunteers - it was initially posted on March 10th 2021 and updated most recently on November 15 2022. 100 participants are expected to join at 8 different medical centres." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.