CLINICAL TRIALS PROFILE FOR ITACITINIB

Clinical Trials for Itacitinib

Trial ID	Title	Status	Sponsor	Phase	Summary
NCT01626573 ↗	A Study Exploring the Safety, Tolerability, and Efficacy of a 28 Day Course Followed by an Additional 56 Day Course of Itacitinib in Subjects With Active Rheumatoid Arthritis	Completed	Incyte Corporation	Phase 2	This is a study evaluating a 28-day course followed by a 56-day course of itacitinib in patients with active rheumatoid arthritis (RA). The study will evaluate safety and efficacy parameters of itacitinib.
NCT01633372 ↗	An Open Label Study of Itacitinib Administered Orally in Patients With Myelofibrosis	Completed	Incyte Corporation	Phase 2	This is a study of itacitinib (INCB039110) in patients with myelofibrosis. This study will evaluate safety and efficacy parameters of itacitinib (INCB039110).
NCT01634087 ↗	A Study of Escalating Doses of Itacitinib Administered Orally in Patients With Plaque Psoriasis	Completed	Incyte Corporation	Phase 2	This is a study of itacitinib in patients with chronic plaque psoriasis. This study will evaluate safety and efficacy parameters of itacitinib.
NCT01858883 ↗	Safety Study of Itacitinib (INCB039110) in Combination With Gemcitabine and Nab-Paclitaxel in Subjects With Advanced Solid Tumors	Completed	Incyte Corporation	Phase 1/Phase 2	Test the hypothesis that itacitinib (INCB039110) can be administered safely in combination with gemcitabine and nab-paclitaxel in subjects with advanced or metastatic cancer.
NCT01905813 ↗	Study of INCB040093 in Subjects With Previously Treated B-Cell Malignancies	Active, not recruiting	Incyte Corporation	Phase 1	The study will be conducted in three parts. Part 1 is a dose escalation phase to determine the maximum tolerated dose (MTD) of INCB040093, a PI3Kδ inhibitor, or a tolerated, pharmacologically active dose; Part 2 will evaluate the combination of INCB040093 and itacitinib (INCB039110), a JAK1 inhibitor, to determine the MTD of the combination or a tolerated dose that produces substantial pharmacologic inhibition of both targets; Part 3 will further evaluate the chosen doses of INCB040093 alone and in combination with itacitinib (INCB039110) in subjects with relapsed/refractory B-cell malignancies.
NCT02018861 ↗	A Phase 1/2, Open-Label, Dose Escalation, Safety and Tolerability Study of INCB050465 and Itacitinib in Subjects With Previously Treated B-Cell Malignancies (CITADEL-101)	Completed	Incyte Corporation	Phase 1/Phase 2	Open-label, dose-escalation study in subjects with previously treated B-cell malignancies to find maximum tolerated dose (MTD) or pharmacologic active dose of a PI3Kδ inhibitor, parsaclisib, as monotherapy and in combination with: itacitinib (INCB039110), a JAK1 inhibitor; rituximab; and rituximab, ifosfamide, carboplatin, and etoposide. Parsaclisib inhibits PI3Kδ, a protein involved in growth and survival of B-cell cancer cells.

Clinical Trial Conditions for Itacitinib

Condition Name

Condition Name for
Intervention	Trials
Solid Tumors	4
Myelofibrosis	4
B-Cell Malignancies	3
Non Small Cell Lung Cancer	3

Condition MeSH

Condition MeSH for
Intervention	Trials
Graft vs Host Disease	15
Primary Myelofibrosis	7
Neoplasms	7
Carcinoma, Non-Small-Cell Lung	5

Clinical Trial Locations for Itacitinib

Trials by Country

Trials by Country for
Location	Trials
United States	316
Japan	15
Canada	13
Spain	8
France	8

Trials by US State

Trials by US State for
Location	Trials
California	22
Texas	21
New York	19
Pennsylvania	17
Ohio	16

Clinical Trial Progress for Itacitinib

Clinical Trial Phase

Clinical Trial Phase for
Clinical Trial Phase	Trials
Phase 3	1
Phase 2/Phase 3	1
Phase 2	26

Clinical Trial Status

Clinical Trial Status for
Clinical Trial Phase	Trials
Recruiting	19
Completed	9
Active, not recruiting	8

Clinical Trial Sponsors for Itacitinib

Sponsor Name

Sponsor Name for
Sponsor	Trials
Incyte Corporation	40
National Cancer Institute (NCI)	6
M.D. Anderson Cancer Center	4

Sponsor Type

Sponsor Type for
Sponsor	Trials
Industry	45
Other	27
NIH	7