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Janus Kinase (JAK) Inhibitor

Ruxolitinib for Graft-versus-Host Disease

Phase 3
Waitlist Available
Research Sponsored by Incyte Corporation
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from baseline to lplv (approximately 5 years)
Awards & highlights

Study Summary

This trial will test if a drug called ruxolitinib is better than the best available treatment for people with a certain type of GvHD that doesn't respond well to steroids.

Eligible Conditions
  • Graft-versus-Host Disease

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from baseline to lplv (approximately 5 years)
This trial's timeline: 3 weeks for screening, Varies for treatment, and from baseline to lplv (approximately 5 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
Efficacy of Ruxolitinib Versus Investigator's Choice Best Available Therapy (BAT) in Participants With Moderate or Severe Steroid Refractory Chronic Graft Versus Host Disease (SR-cGvHD) Assessed by Overall Response Rate (ORR) at the Cycle 7 Day 1 Visit
Secondary outcome measures
AUCinf of Ruxolitinib After Single (Cycle 1 Day 1) and Multiple (Cycle 1 Day 15) Doses
AUClast of Ruxolitinib After Single (Cycle 1 Day 1) and Multiple (Cycle 1 Day 15) Doses
BOR During Cross-over Treatment With Ruxolitinib
+20 more

Side effects data

From 2020 Phase 3 trial • 149 Patients • NCT02038036
33%
Anaemia
19%
Hypertension
17%
Nasopharyngitis
16%
Weight increased
14%
Herpes zoster
14%
Constipation
14%
Abdominal pain
14%
Headache
12%
Pruritus
12%
Back pain
12%
Epistaxis
12%
Pyrexia
12%
Dizziness
10%
Asthenia
10%
Fatigue
10%
Cough
10%
Oedema peripheral
10%
Arthralgia
9%
Thrombocytosis
9%
Upper respiratory tract infection
9%
Hypercholesterolaemia
7%
Dyslipidaemia
7%
Pain in extremity
7%
Haematoma
7%
Abdominal discomfort
7%
Diarrhoea
7%
Dyspepsia
7%
Vomiting
7%
Blood lactate dehydrogenase increased
7%
Memory impairment
7%
Dyspnoea
5%
Tinnitus
5%
Osteoarthritis
5%
Leukocytosis
5%
Thrombocytopenia
5%
Flatulence
5%
Nausea
5%
Sinusitis
5%
Basal cell carcinoma
5%
Neuropathy peripheral
5%
Hyperuricaemia
3%
Blood creatine phosphokinase increased
3%
Cystitis
3%
Bronchitis
3%
Paraesthesia
3%
Skin ulcer
3%
Abdominal pain upper
3%
Pulmonary embolism
3%
Pneumonia
3%
Influenza
3%
Myalgia
3%
Urinary tract infection
3%
Depression
2%
Localised infection
2%
Urethral stenosis
2%
Night sweats
2%
Acute pulmonary oedema
2%
Intervertebral disc protrusion
2%
Vertigo
2%
Peripheral artery thrombosis
2%
Ureterolithiasis
2%
Pericardial effusion
2%
Acute myocardial infarction
2%
Syncope
2%
Gastrooesophageal reflux disease
2%
General physical health deterioration
2%
Atrial fibrillation
2%
Cardiac disorder
2%
Mitral valve incompetence
2%
Vertigo positional
2%
Retinal artery occlusion
2%
Visual acuity reduced
2%
Gastrointestinal haemorrhage
2%
Oesophageal varices haemorrhage
2%
Lower respiratory tract infection
2%
Pyelonephritis
2%
Respiratory tract infection
2%
Sepsis
2%
Tendon rupture
2%
Ulna fracture
2%
Weight decreased
2%
Decreased appetite
2%
Hyponatraemia
2%
Blast cell crisis
2%
Bone marrow tumour cell infiltration
2%
Lung adenocarcinoma
2%
Metastases to spine
2%
Myelofibrosis
2%
Prostatic adenoma
2%
Squamous cell carcinoma of skin
2%
Nephrolithiasis
2%
Gamma-glutamyltransferase increased
2%
Haematocrit increased
2%
Musculoskeletal pain
2%
Ischaemic stroke
2%
Diabetes mellitus
100%
80%
60%
40%
20%
0%
Study treatment Arm
All Crossover Patients
Best Available Therapy
Ruxolitinib

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: RuxolitinibExperimental Treatment1 Intervention
Ruxolitinib for the treatment period and extension period.
Group II: Best Available TherapyActive Control9 Interventions
Best available therapy for the treatment period and extension period, with optional crossover to ruxolitinib after Cycle 6.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ruxolitinib
2018
Completed Phase 3
~1140

Find a Location

Who is running the clinical trial?

Incyte CorporationLead Sponsor
364 Previous Clinical Trials
54,835 Total Patients Enrolled
Fitzroy Dawkins, MDStudy DirectorIncyte Corporation
6 Previous Clinical Trials
238 Total Patients Enrolled
Rodica Morariu-ZamfirStudy DirectorIncyte Corporation

Frequently Asked Questions

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

Are there a lot of hospitals participating in this clinical trial within the state?

"To make things as convenient as possible for potential enrollees, the 35 sites for this trial are situated in cities across the country. These include Tucson, Los Angeles, Duarte, and many others."

Answered by AI

Is this the first time Ruxolitinib has been trialed?

"As of now, 1098 clinical trials involving Ruxolitinib are ongoing with 216 of them being Phase 3 trials. The majority of these are situated in Philadelphia, but there are a total of 33800 locations running these tests."

Answered by AI

What are the most popular ailments that Ruxolitinib has been known to cure?

"Ruxolitinib is most commonly used as treatment for psoriasis. It can also be used to treat a variety of other conditions like polyangiitis, newly diagnosed acute lymphoblastic leukaemia, and lung cancer."

Answered by AI

How many people are in this clinical trial in total?

"This trial is no longer looking for new participants. The clinical trial was first posted on 3/7/2018 and was last updated on 6/9/2022. For patients searching for other studies, there are 167 clinical trials actively recruiting participants with disease and 1098 studies for Ruxolitinib actively searching for patients."

Answered by AI

What are researchers expecting to find out from this clinical trial?

"The primary outcome of this 168 day trial is to measure the efficacy of ruxolitinib compared to the best available therapy (BAT) in participants with moderate or severe SR-cGvHD. This will be done by assessing the overall response rate (ORR) at the Cycle 7 Day 1 Visit. Secondary outcomes include percentage of participants successfully tapered off all corticosteroids at Cycle 7 Day 1 and the pharmacokinetics parameters of CL/F and Vz/F of ruxolitinib."

Answered by AI

Has Ruxolitinib undergone FDA approval processes?

"There is some evidence of efficacy from Phase 3 trials and multiple rounds of data supporting safety, so Power gave Ruxolitinib a safety score of 3."

Answered by AI

Are we able to enroll patients in this trial at this time?

"This study is not admitting new patients at this time. The listing for this clinical trial was first created on March 7th, 2018 and was last updated on June 9th, 2022. However, there are 167 other trials for patients with diseases and 1098 trials for Ruxolitinib that are still recruiting patients."

Answered by AI
Recent research and studies
~43 spots leftby Apr 2025