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Janus Kinase (JAK) Inhibitor

Itacitinib for Graft-versus-Host Disease

Phase 2
Waitlist Available
Research Sponsored by SCRI Development Innovations, LLC
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients who have undergone allo-hematopoietic stem cell transplant(s) (HSCT) from any donor HLA type (related or unrelated donor with any degree of HLA matching) using any graft source (bone marrow, peripheral blood stem cells, or cord blood). Recipients of non-myeloablative, myeloablative, and reduced intensity conditions are eligible.
cGVHD must be refractory to steroids defined by at least one criteria:
Timeline
Screening 3 weeks
Treatment Varies
Follow Up cgvhd status will be assessed prior to the start of study treatment, throughout study treatment, and when study treatment ends (approximately 2 years)
Awards & highlights

Study Summary

This trial is testing if a combination of itacitinib with existing immunosuppressive therapies is safe and effective for treating cGVHD.

Eligible Conditions
  • Chronic Graft-versus-Host Disease

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
You have received a stem cell transplant from a donor, regardless of how much the donor's genes match yours. It doesn't matter if the transplant used bone marrow, peripheral blood stem cells, or cord blood, or if it was a strong or gentle treatment.
Select...
You have chronic graft-versus-host disease (cGVHD) that does not respond to steroid treatment.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~cgvhd status will be assessed prior to the start of study treatment, throughout study treatment, and when study treatment ends (approximately 2 years)
This trial's timeline: 3 weeks for screening, Varies for treatment, and cgvhd status will be assessed prior to the start of study treatment, throughout study treatment, and when study treatment ends (approximately 2 years) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Overall response rate (ORR)
Secondary outcome measures
Assessment of safety based on frequency of adverse events
Number of patients that can withdraw or decrease steroids
Number of patients with recurrence or progression of cGVHD
+3 more

Side effects data

From 2020 Phase 3 trial • 439 Patients • NCT03139604
33%
Thrombocytopenia
27%
Anaemia
25%
Oedema peripheral
23%
Hyperglycaemia
20%
Diarrhoea
18%
Hypertension
18%
Neutropenia
17%
Cough
17%
Hypokalaemia
16%
Nausea
15%
Pyrexia
15%
Fatigue
14%
Cytomegalovirus viraemia
14%
Platelet count decreased
13%
Hypertriglyceridaemia
12%
Abdominal pain
12%
Alanine aminotransferase increased
12%
Cytomegalovirus infection reactivation
12%
Headache
11%
Vomiting
11%
Constipation
11%
Decreased appetite
11%
Insomnia
11%
Hypomagnesaemia
11%
Tremor
10%
Arthralgia
10%
Blood creatinine increased
10%
Dyspnoea
10%
Fall
10%
Muscular weakness
9%
Dizziness
9%
Back pain
9%
Hyponatraemia
8%
Dry eye
8%
Hypoalbuminaemia
8%
Hypocalcaemia
8%
Upper respiratory tract infection
8%
Aspartate aminotransferase increased
7%
Asthenia
7%
Anxiety
7%
Urinary tract infection
7%
Pruritus
7%
Dry mouth
7%
Acute kidney injury
6%
Hypophosphataemia
6%
Pneumonia
6%
Blood alkaline phosphatase increased
6%
Blood cholesterol increased
6%
Dysuria
6%
Hyperkalaemia
6%
Pain in extremity
6%
Hypotension
6%
Neutrophil count decreased
6%
Cytomegalovirus infection
5%
Dyspepsia
5%
Oedema
5%
Epistaxis
5%
White blood cell count decreased
5%
Oral candidiasis
5%
Rhinorrhoea
4%
Neuropathy peripheral
4%
Nasopharyngitis
4%
Gamma-glutamyltransferase increased
4%
Epstein-Barr virus infection reactivation
4%
Leukopenia
4%
Pancytopenia
4%
Vision blurred
4%
Weight decreased
4%
Dry skin
3%
Dysgeusia
3%
Febrile neutropenia
3%
Sepsis
3%
Rash
2%
Graft versus host disease in gastrointestinal tract
2%
Respiratory failure
2%
Septic shock
1%
Bacteraemia
1%
Enterococcal bacteraemia
1%
Influenza
1%
Graft versus host disease
1%
Pulmonary embolism
1%
Staphylococcal bacteraemia
1%
Viral haemorrhagic cystitis
1%
Bronchitis
1%
Bronchopulmonary aspergillosis
1%
Confusional state
1%
Dehydration
1%
Adenovirus infection
1%
Escherichia sepsis
1%
Malignant neoplasm progression
1%
Multiple organ dysfunction syndrome
1%
Myopathy
1%
Presyncope
1%
Syncope
1%
Thrombotic microangiopathy
1%
Failure to thrive
1%
Acute graft versus host disease
1%
Cystitis haemorrhagic
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo Plus Corticosteroids
Total
Itacitinib Plus Corticosteroids

Trial Design

1Treatment groups
Experimental Treatment
Group I: ItacitinibExperimental Treatment1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Itacitinib
2020
Completed Phase 3
~910

Find a Location

Who is running the clinical trial?

Incyte CorporationIndustry Sponsor
361 Previous Clinical Trials
55,035 Total Patients Enrolled
SCRI Development Innovations, LLCLead Sponsor
191 Previous Clinical Trials
13,548 Total Patients Enrolled

Media Library

Itacitinib (Janus Kinase (JAK) Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04200365 — Phase 2
Graft-versus-Host Disease Research Study Groups: Itacitinib
Graft-versus-Host Disease Clinical Trial 2023: Itacitinib Highlights & Side Effects. Trial Name: NCT04200365 — Phase 2
Itacitinib (Janus Kinase (JAK) Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04200365 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is Itacitinib the subject of any other research?

"First researched in 2013, itacitinib has been subjected to 12 trials and is now being studied across 23 active studies. Of these locations, many can be found in the city of Austin, Texas."

Answered by AI

Is this experiment a pioneering endeavor in its field?

"Since 2013, Itacitinib has been the subject of numerous clinical trials. The first such study was sponsored by Incyte Corporation and included 121 patients; after a successful conclusion, it subsequently received its Phase 1 drug approval in 2013. Currently, this medication is being tested across 76 cities and 20 countries - with 23 active studies taking place worldwide."

Answered by AI

What is the total number of medical facilities currently running this experiment?

"This trial is presently recruiting at 5 different sites, including the cities of Austin, Denver and San Antonio. To reduce time spent travelling to these locations, it would be wise to select a site closest in proximity to you."

Answered by AI

Has Itacitinib garnered official governmental approval from the FDA?

"Our team assigned itacitinib a score of 2 since there is early evidence supporting its safety but no clinical data demonstrating effectiveness."

Answered by AI

Is the research team currently recruiting participants for this investigation?

"Clinicaltrials.gov reports that this medical trial commenced recruitment on the 5th of June 2020 and was last updated on 24 January 2022, alluding to an open call for patients."

Answered by AI

How many participants have thus far enrolled in this research endeavor?

"Incyte Corporation, the sponsor of this investigation, requires forty eligible subjects to commence their study. The sites chosen for recruitment include South Austin Medical Center in Texas and Colorado Blood Cancer Institute located in Denver."

Answered by AI
~3 spots leftby Mar 2025