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Acute Graft-versus-host DiseasePhase 1NCT03497273

Safety of Itacitinib in Combination With Corticosteroids for Treatment of Steroid-Naive Acute Graft-Versus-Host Disease in Japanese Subjects

A Phase 1 study testing Itacitinib and Corticosteroid in people with Acute Graft-versus-host Disease, run by Incyte Corporation at 17 sites in Japan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study is to assess the safety and tolerability of itacitinib in combination with corticosteroids in Japanese subjects with Grades II to IV acute graft-versus-host disease (aGVHD). Read more about this study

Who is it for?
Ages 20 years and older
Conditions the study is for
Acute Graft-versus-host Disease
What is being tested?
Itacitinib and Corticosteroid
Could I receive a placebo?
No, everyone receives an active treatment
How many people
14 participants
Where
17 sitesJapan
Study dates
20 Mar 2018to 17 Feb 2020
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 20 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Japanese; subject was born in Japan and has not lived outside of Japan for a total of > 10 years, and subject can trace maternal and paternal Japanese ancestry.
  • Has undergone 1 allo-hematopoietic stem cell transplant (HSCT) from any donor and source (unrelated, sibling, haploidentical donors with any matching) using bone marrow, peripheral blood or cord blood for hematologic malignancies. Recipients of myeloablative and reduced-intensity conditioning regimens are eligible.
  • Clinically suspected Grades II to IV aGVHD as per Mount Sinai Acute GVHD International Consortium (MAGIC) criteria, occurring after allo-HSCT and any anti-GVHD prophylactic medication.
  • Evidence of myeloid engraftment (eg, absolute neutrophil count [ANC] ≥ 0.5 × 10^9/L for 3 consecutive assessments if ablative therapy was previously used). Use of growth factor supplementation is allowed.
  • Female subjects should agree to use medically acceptable contraceptive measures, should not be breastfeeding, and must have a negative pregnancy test before the start of study drug administration if of childbearing potential or must have evidence of non-childbearing potential by fulfilling protocol-defined criteria at screening.

Who cannot join

  • Has received more than 1 allo-HSCT.
  • Has received more than 2 days of systemic corticosteroids for aGVHD.
  • Presence of GVHD overlap syndrome.
  • Presence of an active uncontrolled infection (defined as hemodynamic instability attributable to sepsis or new symptoms, worsening physical signs, or radiographic findings attributable to infection; persisting fever without signs or symptoms will not be interpreted as an active uncontrolled infection).
  • Known human immunodeficiency virus infection.
  • Active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection that requires treatment or at risk for HBV reactivation. For subjects with negative HBsAg and positive total hepatitis B core antibody and for subjects who are positive for HCV antibody, HBV DNA and HCV RNA must be undetectable upon testing.
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  • Evidence of relapsed primary disease or having been treated for relapse after the allo-HSCT was performed.
  • Any corticosteroid therapy (for indication other than GVHD) at doses > 1 mg/kg per day methylprednisolone or equivalent within 7 days of enrollment.
  • Severe organ dysfunction unrelated to underlying GVHD, including the following:
  • Cholestatic disorders or unresolved veno-occlusive disease of the liver.
  • Clinically significant or uncontrolled cardiac disease.
  • Clinically significant respiratory disease that requires mechanical ventilation support or 50% oxygen.
  • Serum creatinine > 2.0 mg/dL or creatinine clearance < 40 mL/min measured or calculated by Cockroft-Gault equation
  • Received Janus kinase (JAK) inhibitor therapy after allo-HSCT for any indication. Treatment with a JAK inhibitor before allo-HSCT is permitted.
  • Known allergies, hypersensitivity, or intolerance to any of the study medications, excipients, or similar compounds.

Trial locations and contacts

17 sites in 1 country.

17 sites in 1 country

Japan17 sites

  • JA-Aichi Anjo Kosei Hospital

    Anjo-Shi, Aichi-ken, 446-8602

  • St. Luke's International Hospital

    Chūōku, Tokyo-To, 104-8560

  • Tokai University Hospital

    Isehara-Shi, Kanagawa, 259-1193

  • Jiaikai Imamura General Hospital

    Kagoshima, Kagoshima-ken, 890-0064

  • NHO Kumamoto Medical Center

    Kumamoto, Kumamoto, 860-0008

  • Jikei University Hospital

    Minatoku, Tokyo-To, 105-8471

  • Shizuoka Cancer Center

    Nagaizumi-cho, Shizuoka, 411-8777

  • Nagoya University Hospital

    Nagoya, Aichi-ken, 466-8560

  • Hyogo College of Medicine Hospital

    Nishinomiya-Shi, Hyōgo, 663-8501

  • Okayama University Hospital

    Okayama, Okayama-ken, 700-8558

  • Osaka City University Hospital

    Osaka, Osaka, 545-8586

  • Hokuyukai Sapporo Hokuyu Hospital

    Sapporo, Hokkaido, 003-0006

  • Hokkaido University Hospital

    Sapporo, Hokkaido, 060-8648

  • Tohoku University Hospital

    Sendai, Miyagi, 980-8574

  • Jichi Medical University Hospital

    Shimotsuke-shi, Tochigi, 329-0498

  • University of Tsukuba Hospital

    Tsukuba, Ibaraki, 305-8576

  • Kanagawa Cancer Center

    Yokohama, Kanagawa, 241-8515

Other trials in Japan

About this study

Official title: An Open-Label Single-Arm Phase 1 Study Evaluating Safety of Itacitinib in Combination With Corticosteroids for the Treatment of Steroid-Naive Acute Graft-Versus-Host Disease in Japanese Subjects

The purpose of this study is to assess the safety and tolerability of itacitinib in combination with corticosteroids in Japanese subjects with Grades II to IV acute graft-versus-host disease (aGVHD).

Being tested
Itacitinib, Corticosteroid
Keywords
JAK1 inhibitor, GVHD, acute GVHD, Japan, corticosteroids

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ItacitinibDrug

    Also called INCB039110

    Itacitinib administered orally once daily at the protocol-defined dose.

  • CorticosteroidDrug

    Either oral prednisolone or intravenous methylprednisolone at the investigator's discretion.

Study groups in NCT03497273
Study groupRoleWhat they receive
Itacitinib + corticosteroidsExperimentalItacitinib administered in combination with corticosteroids.
Receives: Drug: Itacitinib; Drug: Corticosteroid

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of treatment-emergent adverse events

    Defined as any adverse event reported for the first time or worsening of a pre-existing event after first dose of study drug.

    Measured: Up to approximately 12 months

Secondary outcomes (9)

  1. Cmax of INCB039110

    Maximum observed plasma concentration.

    Measured: Up to approximately 1 month

  2. Cl/F of INCB039110

    Apparent oral dose clearance.

    Measured: Up to approximately 1 month

  3. Objective response rate

    Defined as the proportion of participants demonstrating a complete response, very good partial response, or partial response.

    Measured: Up to 100 days

  4. Nonrelapse mortality

    Defined as the proportion of participants who died due to causes other than malignancy.

    Measured: Up to approximately 12 months

  5. Duration of response

    Defined as the interval from first response until GVHD progression or death.

    Measured: Up to approximately 12 months

  6. Time to response

    Defined as the interval from treatment initiation to first response.

    Measured: Up to approximately 12 months

  7. Malignancy relapse rate

    Defined as the proportion of participants whose underlying malignancy relapses.

    Measured: Up to approximately 12 months

  8. Failure-free survival

    Defined as the proportion of participants who are still alive, have not relapsed, have not required additional therapy for aGVHD, and have not demonstrated signs or symptoms of chronic GVHD (cGVHD).

    Measured: Up to 6 months

  9. Overall survival

    Defined as the interval from study enrollment to death due to any cause.

    Measured: Up to approximately 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Apr 2018
  2. Study start20 Mar 2018
  3. Primary completion30 Nov 2019
  4. Study completion17 Feb 2020

Resources

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
14 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03497273
Sponsor's protocol ID
INCB 39110-118
Status last verified
Mar 2020
First submitted
6 Apr 2018
Last updated
3 Mar 2020
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Itacitinib and Corticosteroid in people with Acute Graft-versus-host Disease, run by Incyte Corporation at 17 sites in Japan.

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 5 inclusion and 15 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 3 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 17 sites in Japan. 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?

Number of treatment-emergent adverse events (time frame: Up to approximately 12 months). 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 NCT03497273.

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 3 Mar 2020.

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