MyelofibrosisPhase 2NCT04640025
A Rollover Study to Provide Continued Treatment for Participants Previously Enrolled in Studies of Itacitinib
A Phase 2 study testing itacitinib in people with Myelofibrosis and Postlung Transplant (Bronchiolitis Obliterans), run by Incyte Corporation at 21 sites in 9 countries.
Trial summary
This is a mutli-center open-label study to provide continued supply of itacitinib to participants from the following Incyte-sponsored studies of itacitinib: INCB39110-209, INCB39110-213, INCB39110-214, INCB39110-230, and 39110-309. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myelofibrosis, Postlung Transplant (Bronchiolitis Obliterans), Chronic Graft Versus Host Disease
- What is being tested?
- itacitinib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 21 sitesin 9 countries
- Study dates
- 10 Mar 2021to 11 May 2026
- Phase
- Phase 2
- 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
- Currently enrolled and receiving treatment in an Incyte-sponsored itacitinib (INCB39110)-based clinical study (parent Protocol).
- Currently tolerating treatment as defined by the parent Protocol.
- Currently receiving clinical benefit from itacitinib-based treatment, as determined by the investigator.
- Has demonstrated compliance, as assessed by the investigator, with the parent protocol requirements.
- Willingness and ability to comply with scheduled visits, treatment plans, and any other study procedures indicated in this Protocol.
- Willingness to avoid pregnancy or fathering children..
- Ability to comprehend and willingness to sign an ICF.
Who cannot join
- Able to access itacitinib therapy commercially.
- Participants with an uncontrolled intercurrent illness or any concurrent condition that, in the investigator's opinion, would jeopardize the safety of the participant or compliance with the Protocol.
- Pregnant or breastfeeding women.
Trial locations and contacts
21 sites in 9 countries.
21 sites in 9 countries
United States8 sites
Anschutz Cancer Pavilion-University of Colorado
Aurora, Colorado, 80045
Cleveland Clinic
Cleveland, Ohio, 44195
City of Hope National Medical Center
Duarte, California, 31010
Parkview Cancer Institute
Fort Wayne, Indiana, 46845
Sarah Cannon Research Institute
Nashville, Tennessee, 37203
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Temple University Department of Thoracic Medicine and Surgery
Philadelphia, Pennsylvania, 19140
Texas Oncology San Antonio
San Antonio, Texas, 78240
Germany3 sites
Universitatsklinikum Halle (Saale)
Halle, D06120
University Medical Centre Hamburg-Eppendorf Centre of Oncology
Hamburg, 20251
University Hospital Mannheim
Mannheim, 68167
Italy3 sites
Azienda Policlinico Vittorio Emanuele
Catania, 95123
Azienda Ospedaliera Bianchi-Melacrino-Morelli Ospedali Riuniti
Reggio Calabria, 89100
Aou San Giovanni Di Dio E Ruggi
Salerno, 84131
Spain2 sites
Hospital Universitario Virgen de Las Nieves
Granada, 18012
Hospital Universitario Ramon Y Cajal
Madrid, 28034
Israel1 site
Hadassah Hebrew University Medical Center Ein Karem Hadassah
Jerusalem, 91120
About this study
Official title: A Phase 2, Open-Label, Multicenter, Rollover Study to Provide Continued Treatment for Participants Previously Enrolled in Studies of Itacitinib (INCB039110)
This is a mutli-center open-label study to provide continued supply of itacitinib to participants from the following Incyte-sponsored studies of itacitinib: INCB39110-209, INCB39110-213, INCB39110-214, INCB39110-230, and 39110-309. Eligible participants will receive treatment with itacitinib as per the treatment dose and schedule they received in the study in which they were originally enrolled. The original study is referred to as the "parent protocol".
Participants who receive itacitinib in this study may continue treatment as long as the regimen is tolerated, the participant is deriving clinical benefit (in the opinion of the investigator), and the participant does not meet discontinuation criteria.
- Conditions
- Myelofibrosis, Postlung Transplant (Bronchiolitis Obliterans), Chronic Graft Versus Host Disease
- Being tested
- itacitinib
- Keywords
- itacitinib, INCB39110
- Medical subject headings
- Primary Myelofibrosis, Bronchiolitis Obliterans, Bronchiolitis Obliterans Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
itacitinibDrug
Also called INCB039110
Participants will self-administer itacitinib orally using intact tablets with water and without regard to food.
| Study group | Role | What they receive |
|---|---|---|
| itacitinib | Experimental | Participants will receive treatment with itacitinib as per the treatment dose and schedule they received in the study in which they were originally enrolled. Participants who are receiving ruxolitinib under parent protocol INCB39110-209 may continue to receive it as described in that protocol. Receives: Drug: itacitinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment Emergent Adverse Events (TEAE's)
Adverse events reported for the first time or worsening of a pre-existing event after first dose of study drug/treatment.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2020
- Study start10 Mar 2021
- Primary completion11 May 2026
- Study completion11 May 2026
Why it stopped: The decision to close the study was made due to the expiration of remaining drug supply.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MyelofibrosisStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Individual patients will continue to be treated with itacitinib in accordance with the parent study under which they were enrolled.
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Incyte Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Lance Leopold, MD, Study director, Incyte Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04640025
- Sponsor's protocol ID
- INCB 39110-801
- Other IDs
- 2022-501661-47-00, 2020-002134-32
- Status last verified
- Jun 2026
- First submitted
- 18 Nov 2020
- Last updated
- 26 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Incyte shares data with qualified external researchers after a research proposal is submitted. These requests are reviewed and approved by a review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. The trial data availability is according to the criteria and process described on https://www.incyte.com/our-company/compliance-and-transparency
- Expanded access
- Available
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Open-Label, Multicenter, Rollover Study to Provide Continued Treatment for Participants Previously Enrolled in Studies of Itacitinib (INCB039110)
- ClinicalTrials.gov ID
- NCT04640025
- Acronym / sponsor ID
- INCB 39110-801
- Conditions
- Myelofibrosis, Postlung Transplant (Bronchiolitis Obliterans), Chronic Graft Versus Host Disease
- Keywords
- itacitinib, INCB39110
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The decision to close the study was made due to the expiration of remaining drug supply.
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Incyte CorporationIndustry (pharma, biotech, devices)
- Study start
- 10 Mar 2021 (actual)
- Primary completion
- 11 May 2026 (actual)
- Study completion
- 11 May 2026 (actual)
- First posted
- 23 Nov 2020 (actual)
- 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.
This is a mutli-center open-label study to provide continued supply of itacitinib to participants from the following Incyte-sponsored studies of itacitinib: INCB39110-209, INCB39110-213, INCB39110-214, INCB39110-230, and 39110-309. Eligible participants will receive treatment with itacitinib as per the treatment dose and schedule they received in the study in which they were originally enrolled. The original study is referred to as the "parent protocol".
Participants who receive itacitinib in this study may continue treatment as long as the regimen is tolerated, the participant is deriving clinical benefit (in the opinion of the investigator), and the participant does not meet discontinuation criteria.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Individual patients will continue to be treated with itacitinib in accordance with the parent study under which they were enrolled.
| Arm | Type | Receives |
|---|---|---|
| itacitinib | Experimental | Drug: itacitinibParticipants will receive treatment with itacitinib as per the treatment dose and schedule they received in the study in which they were originally enrolled. Participants who are receiving ruxolitinib under parent protocol INCB39110-209 may continue to receive it as described in that protocol. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Currently enrolled and receiving treatment in an Incyte-sponsored itacitinib (INCB39110)-based clinical study (parent Protocol).
- Currently tolerating treatment as defined by the parent Protocol.
- Currently receiving clinical benefit from itacitinib-based treatment, as determined by the investigator.
- Has demonstrated compliance, as assessed by the investigator, with the parent protocol requirements.
- Willingness and ability to comply with scheduled visits, treatment plans, and any other study procedures indicated in this Protocol.
Key exclusion criteria (3 listed)
- Able to access itacitinib therapy commercially.
- Participants with an uncontrolled intercurrent illness or any concurrent condition that, in the investigator's opinion, would jeopardize the safety of the participant or compliance with the Protocol.
- Pregnant or breastfeeding women.
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 |
|---|---|---|
| itacitinibAlso: INCB039110Participants will self-administer itacitinib orally using intact tablets with water and without regard to food. | Drug | itacitinib |
Primary outcome
Treatment Emergent Adverse Events (TEAE's)
Time frame: 3 years
Adverse events reported for the first time or worsening of a pre-existing event after first dose of study drug/treatment.
Results and safety
The study was stopped early (reason given: The decision to close the study was made due to the expiration of remaining drug supply.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2026.
- A Rollover Study to Provide Continued Treatment for Participants Previously Enrolled in Studies of ItacitinibLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Incyte shares data with qualified external researchers after a research proposal is submitted. These requests are reviewed and approved by a review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. The trial data availability is according to the criteria and process described on https://www.incyte.com/our-company/compliance-and-transparency
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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.
Lance Leopold, MD study director
Incyte Corporation
21 sites in 9 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing itacitinib in people with Myelofibrosis and Postlung Transplant (Bronchiolitis Obliterans), run by Incyte Corporation at 21 sites in 9 countries.
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 7 inclusion and 3 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: stopped early, as of the sponsor's last update on 26 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 21 sites in United States, Germany, Italy, Spain, Austria and 4 more countries. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 was stopped early (reason given: The decision to close the study was made due to the expiration of remaining drug supply.). Results are not available in the source record.
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?
Treatment Emergent Adverse Events (TEAE's) (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 Jun 2026.