Graft-versus-host Disease (GVHD)Phase 1NCT02614612
Study of Itacitinib in Combination With Corticosteroids for the Treatment of Acute GVHD
A Phase 1 study testing Itacitinib (200 mg), Itacitinib (300 mg) and prednisone or methylprednisolone (corticosteroids) in people with Graft-versus-host Disease (GVHD), run by Incyte Corporation at 23 sites in United States.
Trial summary
To determine if Itacitinib in combination with corticosteroids is safe and tolerable in patients with Grade IIB-IVD acute graft-versus-host disease (GVHD). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Graft-versus-host Disease (GVHD)
- What is being tested?
- Itacitinib (200 mg), Itacitinib (300 mg) and prednisone or methylprednisolone (corticosteroids)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 23 sitesUnited States
- Study dates
- Dec 2015to Aug 2018
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Have undergone first allo-HSCT from any donor source (matched unrelated donor, sibling, haploidentical) using bone marrow, peripheral blood stem cells, or cord blood for hematologic malignancies. Recipients of nonmyeloablative and myeloablative transplants are eligible.
- Clinically suspected Grades IIB to IVD acute GVHD as per modified MN-CIBMTR criteria, occurring after allo-HSCT with any conditioning regimen and any anti-GVHD prophylactic program.
- Subjects may, but are not required to, have previously received corticosteroids for acute GVHD:
- Evidence of myeloid engraftment. Use of growth factor supplementation is allowed.
Who cannot join
- Has received more than 1 hematopoietic stem cell transplantation.
- Has progressed on more than 2 prior treatment regimens for acute GVHD.
- Presence of an active uncontrolled infection.
- Subjects with relapsed primary disease, or subjects who have been treated for relapse after the allogeneic hematopoietic stem-cell transplantation (allo-HSCT) was performed.
- Inadequate recovery from toxicity and/or complications from the prior allo-HSCT.
- Any corticosteroid therapy (for indications other than GVHD) at doses > 1 mg/kg per day methylprednisolone or equivalent within 7 days of randomization.
- Previously received JAK inhibitor therapy for any indication.
Trial locations and contacts
23 sites in 1 country.
23 sites in 1 country
United States23 sites
Study site
Atlanta, Georgia
Study site
Boston, Massachusetts
Study site
Chicago, Illinois
Study site
Cincinnati, Ohio
Study site
Cleveland, Ohio
Study site
Coral Gables, Florida
Study site
Denver, Colorado
Study site
Detroit, Michigan
Study site
Duarte, California
Study site
Hershey, Pennsylvania
Study site
Kansas City, Kansas
Study site
La Jolla, California
Study site
Los Angeles, California
Study site
Nashville, Tennessee
Study site
New Orleans, Louisiana
Study site
New York, New York
Study site
Omaha, Nebraska
Study site
Pittsburgh, Pennsylvania
Study site
Portland, Oregon
Study site
Rochester, New York
Study site
San Antonio, Texas
Study site
St Louis, Missouri
Study site
Westwood, Kansas
About this study
Official title: A Randomized, Parallel-Cohort Phase 1 Study of Itacitinib in Combination With Corticosteroids for the Treatment of Acute Graft Versus Host Disease
To determine if Itacitinib in combination with corticosteroids is safe and tolerable in patients with Grade IIB-IVD acute graft-versus-host disease (GVHD).
- Conditions
- Graft-versus-host Disease (GVHD)
- Being tested
- Itacitinib (200 mg), Itacitinib (300 mg), prednisone or methylprednisolone (corticosteroids)
- Keywords
- Acute Graft Versus Host Disease
- Medical subject headings
- Graft vs Host Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Itacitinib (200 mg)Drug
Also called INCB039110
Itacitinib (300 mg)Drug
Also called INCB039110
prednisone or methylprednisolone (corticosteroids)Drug
All subjects will receive prednisone 2.5 mg/kg per day PO (or methylprednisolone 2 mg/kg IV daily) on Days 1 through 5. Subjects will be tapered as tolerated beginning on Day 6 to no less than 0.25 mg/kg per day PO (or methylprednisolone 0.2 mg/kg per day) by Day 28. After Day 28, corticosteroids should be tapered according to institutional guidelines to attain ≤ prednisone 0.2 mg/kg per day (or ≤ methylprednisolone 0.16 mg/kg per day) by Day 56.
| Study group | Role | What they receive |
|---|---|---|
| Itacitinib (200 mg) | Experimental | Itacitinib (200 mg) + prednisone or methylprednisolone (corticosteroids) Receives: Drug: Itacitinib (200 mg); Drug: prednisone or methylprednisolone (corticosteroids) |
| Itacitinib (300 mg) | Experimental | Itacitinib (300 mg) + prednisone or methylprednisolone (corticosteroids) Receives: Drug: Itacitinib (300 mg); Drug: prednisone or methylprednisolone (corticosteroids) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assess safety and tolerability of study treatment as measured by the frequency and severity of adverse events and serious adverse events
Measured: First dose of study drug to 30 days after the last dose of study drug
Secondary outcomes (5)
Overall Response Rate (ORR)
Measured: Days 14, 28, 56 and 100
Maximum Observed Plasma Concentration (Cmax) of the two treatment groups Itacitinib
Measured: Day 1 and Day 7
Time to Reach the Maximum Plasma Concentration (Tmax) of the two treatment groups Itacitinib
Measured: Day 1 and Day 7
Area Under the Plasma Concentration-time Curve (AUC) of the two treatment groups Itacitinib
Measured: Day 1 and Day 7
Minimum observed plasma concentration (Cmin) of the two treatment groups Itacitinib
Measured: Day 1 and Day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2015 (estimated)
- Study startDec 2015
- Primary completionJun 2016
- Study completionAug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Graft-versus-host Disease (GVHD)Studies of the same condition, open and under way.
- More trials run by Incyte CorporationThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Incyte Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Rodica Morariu-Zamfir, MD, Study director, Incyte Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02614612
- Sponsor's protocol ID
- INCB 39110-108
- Status last verified
- Mar 2019
- First submitted
- 20 Nov 2015
- Last updated
- 8 Mar 2019
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Pratta M, Paczesny S, Socie G, Barkey N, Liu H, Owens S, Arbushites MC, Schroeder MA, Howell MD. A biomarker signature to predict complete response to itacitinib and corticosteroids in acute graft-versus-host disease. Br J Haematol. 2022 Aug;198(4):729-739. doi: 10.1111/bjh.18300. Epub 2022 Jun 11.
PubMed 35689489Schroeder MA, Khoury HJ, Jagasia M, Ali H, Schiller GJ, Staser K, Choi J, Gehrs L, Arbushites MC, Yan Y, Langmuir P, Srinivas N, Pratta M, Perales MA, Chen YB, Meyers G, DiPersio JF. A phase 1 trial of itacitinib, a selective JAK1 inhibitor, in patients with acute graft-versus-host disease. Blood Adv. 2020 Apr 28;4(8):1656-1669. doi: 10.1182/bloodadvances.2019001043.
PubMed 32324888
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Parallel-Cohort Phase 1 Study of Itacitinib in Combination With Corticosteroids for the Treatment of Acute Graft Versus Host Disease
- ClinicalTrials.gov ID
- NCT02614612
- Acronym / sponsor ID
- INCB 39110-108
- Conditions
- Graft-versus-host Disease (GVHD)
- Keywords
- Acute Graft Versus Host Disease
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Incyte CorporationIndustry (pharma, biotech, devices)
- Study start
- Dec 2015
- Primary completion
- Jun 2016 (actual)
- Study completion
- Aug 2018 (actual)
- First posted
- 25 Nov 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To determine if Itacitinib in combination with corticosteroids is safe and tolerable in patients with Grade IIB-IVD acute graft-versus-host disease (GVHD).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Itacitinib (200 mg) | Experimental | Drug: Itacitinib (200 mg), Drug: prednisone or methylprednisolone (corticosteroids)Itacitinib (200 mg) + prednisone or methylprednisolone (corticosteroids) |
| Itacitinib (300 mg) | Experimental | Drug: Itacitinib (300 mg), Drug: prednisone or methylprednisolone (corticosteroids)Itacitinib (300 mg) + prednisone or methylprednisolone (corticosteroids) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Have undergone first allo-HSCT from any donor source (matched unrelated donor, sibling, haploidentical) using bone marrow, peripheral blood stem cells, or cord blood for hematologic malignancies. Recipients of nonmyeloablative and myeloablative transplants are eligible.
- Clinically suspected Grades IIB to IVD acute GVHD as per modified MN-CIBMTR criteria, occurring after allo-HSCT with any conditioning regimen and any anti-GVHD prophylactic program.
- Subjects may, but are not required to, have previously received corticosteroids for acute GVHD:
- Evidence of myeloid engraftment. Use of growth factor supplementation is allowed.
Key exclusion criteria (7 listed)
- Has received more than 1 hematopoietic stem cell transplantation.
- Has progressed on more than 2 prior treatment regimens for acute GVHD.
- Presence of an active uncontrolled infection.
- Subjects with relapsed primary disease, or subjects who have been treated for relapse after the allogeneic hematopoietic stem-cell transplantation (allo-HSCT) was performed.
- Inadequate recovery from toxicity and/or complications from the prior allo-HSCT.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Itacitinib (200 mg)Also: INCB039110 | Drug | Itacitinib (200 mg) |
| Itacitinib (300 mg)Also: INCB039110 | Drug | Itacitinib (300 mg) |
| prednisone or methylprednisolone (corticosteroids)All subjects will receive prednisone 2.5 mg/kg per day PO (or methylprednisolone 2 mg/kg IV daily) on Days 1 through 5. Subjects will be tapered as tolerated beginning on Day 6 to no less than 0.25 mg/kg per day PO (or methylprednisolone 0.2 mg/kg per day) by Day 28. After Day 28, corticosteroids should be tapered according to institutional guidelines to attain ≤ prednisone 0.2 mg/kg per day (or ≤ methylprednisolone 0.16 mg/kg per day) by Day 56. | Drug | Itacitinib (200 mg), Itacitinib (300 mg) |
Primary outcome
Assess safety and tolerability of study treatment as measured by the frequency and severity of adverse events and serious adverse events
Time frame: First dose of study drug to 30 days after the last dose of study drug
5 secondary outcomes
Overall Response Rate (ORR)
Time frame: Days 14, 28, 56 and 100
Maximum Observed Plasma Concentration (Cmax) of the two treatment groups Itacitinib
Time frame: Day 1 and Day 7
Time to Reach the Maximum Plasma Concentration (Tmax) of the two treatment groups Itacitinib
Time frame: Day 1 and Day 7
Area Under the Plasma Concentration-time Curve (AUC) of the two treatment groups Itacitinib
Time frame: Day 1 and Day 7
Minimum observed plasma concentration (Cmin) of the two treatment groups Itacitinib
Time frame: Day 1 and Day 7
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2019.
- Derived from this study: PubMed 35689489Pratta M, Paczesny S, Socie G, Barkey N, Liu H, Owens S, Arbushites MC, Schroeder MA, Howell MD. A biomarker signature to predict complete response to itacitinib and corticosteroids in acute graft-versus-host disease. Br J Haematol. 2022 Aug;198(4):729-739. doi: 10.1111/bjh.18300. Epub 2022 Jun 11.
- Derived from this study: PubMed 32324888Schroeder MA, Khoury HJ, Jagasia M, Ali H, Schiller GJ, Staser K, Choi J, Gehrs L, Arbushites MC, Yan Y, Langmuir P, Srinivas N, Pratta M, Perales MA, Chen YB, Meyers G, DiPersio JF. A phase 1 trial of itacitinib, a selective JAK1 inhibitor, in patients with acute graft-versus-host disease. Blood Adv. 2020 Apr 28;4(8):1656-1669. doi: 10.1182/bloodadvances.2019001043.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rodica Morariu-Zamfir, MD study director
Incyte Corporation
23 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Itacitinib (200 mg), Itacitinib (300 mg) and prednisone or methylprednisolone (corticosteroids) in people with Graft-versus-host Disease (GVHD), run by Incyte Corporation at 23 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 23 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assess safety and tolerability of study treatment as measured by the frequency and severity of adverse events and serious adverse events (time frame: First dose of study drug to 30 days after the last dose of study drug). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02614612, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Mar 2019.