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GVHD,AcutePhase 1/2NCT04220632

A Study of IBI377 in Combination With Corticosteroids for the Treatment of First-Line Acute Graft-Versus-Host Disease

A Phase 1/2 study testing Itacitinib, Prednisone and Methylprednisolone in people with GVHD,Acute, run by Innovent Biologics (Suzhou) Co. Ltd. at 1 site in China.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

The purpose of this study is to evaluate itacitinib in combination with corticosteroids as first-line treatment of participants with Grade II to IV acute graft-versus-host disease (aGVHD). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
GVHD,Acute
What is being tested?
Itacitinib, Prednisone and Methylprednisolone
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1 participants
Where
1 siteChina
Study dates
18 Jun 2020to 10 Oct 2020
Phase
Phase 1/2
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

  • Has undergone 1 allo-HSCT(hematopoietic stem cell transplantation) from any donor (related or unrelated with any degree of HLA(human leukocyte antigen) matching) and any donor source (bone marrow, peripheral blood stem cells, or cord blood) for a hematologic malignancy or disorder. Recipients of myeloablative and reduced-intensity conditioning regimens are eligible.
  • Clinically suspected Grade II to IV aGVHD as per MAGIC criteria, occurring after allo-HSCT and any GVHD prophylaxis regimen.
  • Evidence of myeloid engraftment. Use of growth factor supplementation is allowed.
  • Serum creatinine ≤ 2.0 mg/dL or creatinine clearance ≥ 40 mL/min measured or calculated by Cockroft Gault equation.
  • Willing to avoid pregnancy or fathering children.
  • Able to give written informed consent and comply with all study visits and procedures.
  • Able to swallow and retain oral medication.

Who cannot join

  • Has received more than 1 allo-HSCT.
  • Has received more than 2 days of systemic corticosteroids for acute-GVHD.
  • Presence of GVHD overlap syndrome.
  • Presence of 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.
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  • Participants with evidence of relapsed primary disease, or participants who have been treated for relapse after the allo-HSCT was performed.
  • Any corticosteroid therapy for indications other than GVHD at doses > 1 mg/kg per day methylprednisolone (or prednisone equivalent) within 7 days of randomization.
  • Severe organ dysfunction unrelated to underlying GVHD, including.
  • 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.
  • Currently breast feeding.
  • Received JAK(Janus kinase) inhibitor therapy after allo-HSCT for any indication. Treatment with a JAK inhibitor before allo-HSCT is permitted.
  • Treatment with any other investigational agent, device, or procedure within 21 days (or 5 half-lives, whichever is greater) of enrollment.
  • Any medical complications or conditions that would, in the investigator's judgment, interfere with full participation in the study, including administration of study drug and attending required study visits; pose a significant risk to the participant; or interfere with interpretation of study data.
  • Known allergies, hypersensitivity, or intolerance to any of the study medications, excipients, or similar compounds.

Trial locations and contacts

1 site in 1 country.

China1 site

  • The First Affiliated Hospital of Suzhou University

    Suzhou, Jiangsu

Other trials in China

About this study

Official title: An Open Label, Multicenter, Phase I/II Study of IBI377 in Combination With Corticosteroids for the Treatment of First-Line Acute Graft-Versus-Host Disease

The purpose of this study is to evaluate itacitinib in combination with corticosteroids as first-line treatment of participants with Grade II to IV acute graft-versus-host disease (aGVHD).

Read the detailed description

This is an open label, single-arm, multicenter Phase I/II study of IBI377 in combination with corticosteroids as first-line treatment of subjects with Grade II to IV aGVHD. In Phase I, the PK, safety, tolerability and efficacy of IBI377 will be assessed in 12 subjects. In Phase II, the efficacy and safety will be assessed in 48 subjects.

Conditions
GVHD,Acute
Being tested
Itacitinib, Prednisone, Methylprednisolone

What participants receive

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

  • ItacitinibDrug

    Also called IBI377

    at the protocol-defined dose administered orally once daily (QD) plus corticosteroids.

  • PrednisoneDrug

    Oral prednisone may be used to begin standard corticosteroid background treatment at the investigator's discretion, at a dose equivalent to methylprednisolone 2 mg/kg per day.

  • MethylprednisoloneDrug

    Oral prednisone may be used to begin standard corticosteroid background treatment at the investigator's discretion, at a dose equivalent to methylprednisolone 2 mg/kg per day.

Study groups in NCT04220632
Study groupRoleWhat they receive
Itacitinib+corticosteroidsExperimentalItacitinib administered in combination with corticosteroids
Receives: Drug: Itacitinib; Drug: Prednisone; Drug: Methylprednisolone

What is being measured

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

  1. Overall response rate based on Center for International Bloe index

    Defined as the percentage of participants demonstrating a complete response (CR), very good partial responseod and Marrow Transplant Research (CIBMTR) respons (VGPR), or partial response (PR).

    Measured: 28 days

Secondary outcomes (7)

  1. Nonrelapse mortality

    Defined as the percentage of participants who died due to causes other than malignancy relapse

    Measured: Month 6

  2. Duration of response

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

    Measured: Baseline through 30-35 days after end of treatment, expected to average approximately 6 months

  3. Cmax of itacitinib when administered in combination with corticosteroids

    Defined as maximum observed plasma concentration.

    Measured: Protocol-defined timepoints up to Day 28

  4. Cmin of itacitinib when administered in combination with corticosteroids

    Defined as minimum observed plasma concentration

    Measured: Protocol-defined timepoints up to Day 28

  5. Tmax of itacitinib when administered in combination with corticosteroids

    Defined as time to maximum plasma concentration

    Measured: Protocol-defined timepoints up to Day 28

  6. AUC(area under curve) of itacitinib when administered in combination with corticosteroids

    Protocol-defined timepoints up to Day 28

    Measured: Protocol-defined timepoints up to Day 28

  7. CL/F(clearance) of itacitinib when administered in combination with corticosteroids

    Defined as oral dose clearance

    Measured: Protocol-defined timepoints up to Day 28

Timeline

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

  1. First posted7 Jan 2020
  2. Study start18 Jun 2020
  3. Primary completion10 Oct 2020
  4. Study completion10 Oct 2020

Why it stopped: Adverse events of the first patient

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 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Sequential
Masking
None (open label)
Enrolment
1 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04220632
Sponsor's protocol ID
CIBI377A201
Status last verified
Oct 2020
First submitted
4 Jan 2020
Last updated
29 Oct 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Itacitinib, Prednisone and Methylprednisolone in people with GVHD,Acute, run by Innovent Biologics (Suzhou) Co. Ltd. at 1 site in China.

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 17 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 29 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. 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 combined 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.

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: Adverse events of the first patient). 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?

Overall response rate based on Center for International Bloe index (time frame: 28 days). 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 NCT04220632.

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 29 Oct 2020.

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