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JAK1/2 Inhibitor

Baricitinib for Graft-versus-Host Disease

Phase 1
Waitlist Available
Led By Mark A Schroeder, M.D.
Research Sponsored by Washington University School of Medicine
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 day 180
Awards & highlights

Study Summary

This trial is exploring the possibility that a JAK1/2 inhibitor called baricitinib may help to decrease the toxicities of allogeneic hematopoietic stem cell transplantation (HSCT) while still allowing the transplant to engraft and providing graft-versus-leukemia (GVL) effects.

Eligible Conditions
  • Graft-versus-Host Disease

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 180
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 180 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Cumulative incidence of grade III-IV acute GVHD
Cumulative incidence of graft failure
Secondary outcome measures
Treatment related mortality

Side effects data

From 2015 Phase 3 trial • 1307 Patients • NCT01710358
10%
Upper respiratory tract infection
6%
Ovarian cyst
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo Treatment B
Placebo Follow-up
Adalimumab Follow-up
BaricitinibTreatment B
Adalimumab Treatment A
Baricitinib Treatment A
Adalimumab Treatment B
Baricitinib Follow-up
Placebo Treatment A
Rescue

Trial Design

2Treatment groups
Experimental Treatment
Group I: Baricitinib 4 mg Dose LevelExperimental Treatment1 Intervention
On Day 0 the allograft will be infused per standard institutional practice Baricitinib will be administered PO at a starting dose of 4 mg daily from Day -3 to Day 100 After Day 100, for patients at a dose of 4 mg daily, reduce baricitinib to 2 mg daily for one month, then every other day for one month or 1 mg daily for one month (depending on drug supply) then discontinue.
Group II: Baricitinib 2 mg Dose LevelExperimental Treatment1 Intervention
On Day 0 the allograft will be infused per standard institutional practice Baricitinib will be administered PO at a starting dose of 2 mg daily from Day -3 to Day 100 After Day 100, for patients already dose reduced to 2 mg daily, reduce baricitinib to 2 mg every other day for one month or 1 mg daily for one month (depending on drug supply) then discontinue.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Baricitinib
2017
Completed Phase 3
~9510

Find a Location

Who is running the clinical trial?

Washington University School of MedicineLead Sponsor
1,928 Previous Clinical Trials
2,297,062 Total Patients Enrolled
Mark A Schroeder, M.D.Principal InvestigatorWashington University School of Medicine
4 Previous Clinical Trials
128 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has Baricitinib been trialed elsewhere prior to this undertaking?

"Currently, 32 research studies are taking place surrounding Baricitinib. Of these, 15 have progressed to a Phase 3 level. With the majority of investigations located in Pune, Maharashtra there are also an additional 1417 trial sites across the globe."

Answered by AI

Has the FDA sanctioned Baricitinib for use by healthcare providers?

"Baricitinib's safety has been assessed at a score of 1 because it is currently in Phase one trial, where data on efficacy and security are still limited."

Answered by AI

What is the sample size of this research endeavor?

"Currently, this clinical trial is not open to new participants. The study was posted on April 7th 2020 and last edited August 30th 2022. If you're searching for other medical trials, there are 171 studies involving disease currently recruiting patients and 32 Baricitinib research programmes seeking volunteers."

Answered by AI

Is enrolment in this research endeavor available to participants at the moment?

"Clinicaltrials.gov denotes that this research endeavour, which was initially posted on April 7th 2020 and edited lastly on August 30th 2022, is not currently recruiting patients. However, 203 other studies are presently enrolling participants at the moment."

Answered by AI

What ailments have been effectively treated with Baricitinib?

"Hospitalized patients are typically given baricitinib, which is also effective in treating coronavirus disease 2019 (covid‑19), extracorporeal membrane oxygenation treatment, and rheumatoid arthritis."

Answered by AI
~5 spots leftby Mar 2025