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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
Be older than 18 years old
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
Timeline
Screening ~ 3 weeks3 visits
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)
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)
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 moreSide effects data
From 2020 Phase 3 trial • 439 Patients • NCT0313960434%
Thrombocytopenia
29%
Anaemia
25%
Oedema peripheral
22%
Hyperglycaemia
21%
Hypertension
20%
Diarrhoea
19%
Hypokalaemia
18%
Platelet count decreased
18%
Nausea
17%
Neutropenia
16%
Cytomegalovirus viraemia
16%
Pyrexia
15%
Cough
14%
Alanine aminotransferase increased
14%
Hypertriglyceridaemia
13%
Dyspnoea
13%
Fatigue
13%
Hypomagnesaemia
13%
Tremor
12%
Cytomegalovirus infection reactivation
12%
Abdominal pain
12%
Blood creatinine increased
12%
Constipation
11%
Decreased appetite
11%
Arthralgia
11%
Aspartate aminotransferase increased
11%
Dizziness
11%
Muscular weakness
11%
Vomiting
10%
Insomnia
9%
Fall
9%
Headache
8%
Upper respiratory tract infection
8%
Dry eye
8%
Dysuria
8%
Anxiety
8%
Back pain
7%
Blood cholesterol increased
7%
Hypotension
7%
Hyponatraemia
7%
Hypophosphataemia
7%
Pain in extremity
7%
Urinary tract infection
7%
Hypocalcaemia
7%
Neutrophil count decreased
7%
Dry mouth
7%
Cytomegalovirus infection
6%
Hypoalbuminaemia
6%
Pruritus
6%
White blood cell count decreased
6%
Asthenia
6%
Blood alkaline phosphatase increased
5%
Acute kidney injury
5%
Pneumonia
5%
Gamma-glutamyltransferase increased
5%
Oral candidiasis
5%
Rash
5%
Weight decreased
5%
Pancytopenia
5%
Dysgeusia
5%
Dyspepsia
5%
Epstein-Barr virus infection reactivation
4%
Hyperkalaemia
4%
Epistaxis
3%
Febrile neutropenia
3%
Oedema
3%
Rhinorrhoea
3%
Dry skin
3%
Leukopenia
3%
Nasopharyngitis
3%
Neuropathy peripheral
3%
Vision blurred
2%
Cystitis haemorrhagic
2%
Syncope
2%
Sepsis
1%
Thrombotic microangiopathy
1%
Graft versus host disease in gastrointestinal tract
1%
Viral haemorrhagic cystitis
1%
Bronchopulmonary aspergillosis
1%
Adenovirus infection
1%
Escherichia sepsis
1%
Failure to thrive
1%
Malignant neoplasm progression
1%
Ophthalmic herpes zoster
1%
Oral herpes
1%
Pulmonary embolism
1%
Septic shock
1%
Pneumonia influenzal
1%
Myopathy
1%
Steroid diabetes
1%
Pseudomonal sepsis
1%
Respiratory failure
100%
80%
60%
40%
20%
0%
Study treatment Arm
Itacitinib Plus Corticosteroids
Placebo Plus Corticosteroids
Total
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
368 Previous Clinical Trials
55,446 Total Patients Enrolled
SCRI Development Innovations, LLCLead Sponsor
191 Previous Clinical Trials
13,548 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- 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.You have chronic graft-versus-host disease (cGVHD) that does not respond to steroid treatment.You have had a previous cancer that has come back or required treatment after a stem cell transplant.You have severe problems with your organs that are not caused by the disease being studied.You have liver problems that are not improving or a specific liver disease called veno-occlusive disease that has not been resolved.You have personal, family, social, or geographical circumstances that make it difficult for you to follow the study's rules.
Research Study Groups:
This trial has the following groups:- Group 1: Itacitinib
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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