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Janus Kinase (JAK) Inhibitor

Itacitinib for Bronchiolitis Obliterans Syndrome

Phase 1 & 2
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
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to approximately 24 months
Awards & highlights

Study Summary

This trialstudies the effects of a drug on lung transplant patients with bronchiolitis obliterans syndrome.

Eligible Conditions
  • Bronchiolitis Obliterans Syndrome

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to approximately 24 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to approximately 24 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Phase 1: Change from baseline in forced expiratory volume in 1 second (FEV1)
Phase 1: Number of treatment-emergent adverse events
Phase 2: Change from baseline in FEV1 response rate
Secondary outcome measures
Phase 1 and 2: AUC0-t of itacitinib
Phase 1 and 2: Categorical summary or change from baseline in EQ-5D-3L questionnaire
Phase 1 and 2: Change from baseline in QOL-SF-12 questionnaire
+8 more

Side effects data

From 2020 Phase 3 trial • 439 Patients • NCT03139604
34%
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%
Graft versus host disease in gastrointestinal tract
1%
Thrombotic microangiopathy
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

4Treatment groups
Experimental Treatment
Group I: Itacitinib 600 mgExperimental Treatment1 Intervention
Phase 1: Itacitinib 600 mg once daily. There can be required dose adjustments in the protocol for concurrent CYP3A administration
Group II: Itacitinib 400 mgExperimental Treatment1 Intervention
Phase 1: Itacitinib 400 mg once daily. There can be required dose adjustments in the protocol for concurrent CYP3A administration.
Group III: Itacitinib 300 mgExperimental Treatment1 Intervention
Phase 1: Itacitinib 300 mg twice daily. There can be required dose adjustments in the protocol for concurrent CYP3A administration.
Group IV: ItacitinibExperimental Treatment1 Intervention
Phase 2: Itacitinib administered orally at the recommended dose from Phase 1.
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 CorporationLead Sponsor
364 Previous Clinical Trials
55,124 Total Patients Enrolled
9 Trials studying Bronchiolitis Obliterans Syndrome
1,795 Patients Enrolled for Bronchiolitis Obliterans Syndrome
Kevin O'Hayer, MDStudy DirectorIncyte Corporation
2 Previous Clinical Trials
410 Total Patients Enrolled

Media Library

Itacitinib (Janus Kinase (JAK) Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT03978637 — Phase 1 & 2
Bronchiolitis Obliterans Syndrome Research Study Groups: Itacitinib 600 mg, Itacitinib 400 mg, Itacitinib 300 mg, Itacitinib
Bronchiolitis Obliterans Syndrome Clinical Trial 2023: Itacitinib Highlights & Side Effects. Trial Name: NCT03978637 — Phase 1 & 2
Itacitinib (Janus Kinase (JAK) Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03978637 — Phase 1 & 2

Frequently Asked Questions

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

How many medical organizations are administering this research study?

"This medical research is recruiting patients from numerous sites, such as the University Health Network Toronto General Hospital in Canada, Hospital of the University of Pennsylvania in Philadelphia and Temple University Department of Thoracic Medicine and Surgery located in Los Angeles. There are 8 other locations partaking too."

Answered by AI

What goals are being sought through this experiment?

"Incyte Corporation, the sponsor of this trial has declared that over 24 months time period, Phase 2 Change from baseline in FEV1 response rate is the primary outcome measure. The secondary outcomes evaluated by this medical experiment include Cmin of itacitinib (minimum serum concentration across a dose interval), categorical summary or change from baseline EQ-5D-3L questionnaire (assessment for mobility, self-care and other health metrics) and Time to progression (interval between treatment start date and disease progression)."

Answered by AI

What is the current capacity for participants in this medical experiment?

"At this moment, recruitment for the trial is closed. It was initially listed on February 4th 2020 and last updated on October 14th 2022. Individuals in search of other medical studies may find solace knowing that there are currently 1,417 trials actively recruiting participants with bronchiolitis obliterans and 23 research projects looking to admit patients taking Itacitinib."

Answered by AI

Could you elaborate on the past research endeavors related to Itacitinib?

"First studied in 2013 (NCT01905813), Itacitinib has since been the subject of 12 clinical studies with completion. Currently, 23 trials are active and many of them have set up shop in Toronto, Ontario."

Answered by AI

Are there still opportunities to participate in this trial?

"This trial is no longer accepting participants, with the last update on October 14th 2022. However, if you are still looking for medical studies to join there are currently 1,417 trials recruiting patients affected by bronchiolitis obliterans and an additional 23 involving Itacitinib."

Answered by AI

Does this investigation have any precedent?

"Currently, 23 clinical trials for Itacitinib are being conducted in 76 cities and 20 nations. This drug was first tested by Incyte Corporation back in 2013, where 121 participants completed the Phase 1 stage of its approval process. Since then, 12 more research studies have reached completion."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Safety and Efficacy of Itacitinib in Participants With Bronchiolitis Obliterans Syndrome Following Lung Transplantation
2020. "Safety and Efficacy of Itacitinib in Participants With Bronchiolitis Obliterans Syndrome Following Lung Transplantation". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03978637.
~4 spots leftby Apr 2025
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