GRAVITAS-309: Itacitinib and Corticosteroids as Initial Treatment for Chronic Graft-Versus-Host Disease

  • End date
    Apr 4, 2024
  • participants needed
  • sponsor
    Incyte Corporation
Updated on 11 August 2021
platelet count
cell transplantation
neutrophil count


The purpose of this study is to assess the efficacy and safety of itacitinib in combination with corticosteroids as first-line treatment for moderate or severe chronic graft-versus-host disease (cGVHD).

Condition Chronic Graft Versus Host Disease, chronic graft-versus-host disease
Treatment prednisone, Placebo, Methylprednisolone, itacitinib
Clinical Study IdentifierNCT03584516
SponsorIncyte Corporation
Last Modified on11 August 2021


Yes No Not Sure

Inclusion Criteria

Active, clinically diagnosed, moderate or severe cGVHD per NIH Consensus Criteria
Underwent allogeneic stem cell transplantation (allo-HCT)
Karnofsky Performance Status score 60%
Evidence of myeloid and platelet engraftment
Willingness to avoid pregnancy or fathering children based on protocol-defined criteria

Exclusion Criteria

Has received more than 3 days/72 hours of systemic corticosteroid treatment for cGVHD
Has received any other systemic treatment for cGVHD, including extracorporeal photopheresis (ECP)
Prior treatment with a Janus kinase (JAK) inhibitor for acute GVHD, unless the participant achieved complete or partial response and has been off JAK inhibitor treatment for at least 8 weeks before randomization
cGVHD occurring after a nonscheduled donor lymphocyte infusion (DLI) administered for pre-emptive treatment of malignancy recurrence
Evidence of relapsed primary malignancy
Clear my responses

How to participate?

Step 1 Connect with a site
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact


Preferred Language
Other Language
Please verify that you are not a bot.

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider


Browse trials for

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 



Reply by • Private

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note