parsaclisib (INCB50465) / Incyte, Innovent Biologics 
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20 Trials

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Trial + Data / EventsStatusPhNRegionInterventionsSponsorConditionsPrimary complStudy compl
parsaclisib (INCB50465) / Incyte
2020-003415-98: A phase 3 study of parsaclisib plus ruxolitinib in patients with myelofibrosis

Ongoing
3
212
Europe
parsaclisib, INCB050465, Tablet
Incyte Corporation, Incyte Corporation
myelofibrosis, myelofibrosis, Diseases [C] - Cancer [C04]
 
 
2020-003130-21: A phase 3 study of parsaclisib plus ruxolitinib in patients with myelofibrosis

Ongoing
3
440
Europe
parsaclisib, INCB050465, Tablet
Incyte Corporation, Incyte Corporation
myelofibrosis, myelofibrosis, Diseases [C] - Cancer [C04]
 
 
LIMBER-313, NCT04551066: To Evaluate the Efficacy and Safety of Parsaclisib and Ruxolitinib in Participants With Myelofibrosis

Active, not recruiting
3
252
Europe, Japan, US, RoW
parsaclisib, INCB050465, ruxolitinib, Jakafi, Jakavi, placebo
Incyte Corporation
Myelofibrosis, Primary Myelofibrosis, Post Essential Thrombocythemia Myelofibrosis, Post Polycythemia Vera Myelofibrosis
08/23
07/24
LIMBER-304, NCT04551053: To Evaluate Efficacy and Safety of Parsaclisib and Ruxolitinib in Participants With Myelofibrosis Who Have Suboptimal Response to Ruxolitinib

Oct 2023 - Dec 2023: Data from LIMBER-304 trial n combination with ruxolitinib for myelofibrosis
Active, not recruiting
3
177
Europe, Japan, US, RoW
parsaclisib, INCB050465, ruxolitinib, Jakafi, Jakavi, placebo
Incyte Corporation
Myelofibrosis, Primary Myelofibrosis, Post Essential Thrombocythemia Myelofibrosis, Post Polycythemia Vera Myelofibrosis
08/23
07/24
NCT04816578: To Evaluate the Efficacy and Safety of Parsaclisib and Ruxolitinib in Participants With Myelofibrosis (LIMBER-313)

Recruiting
3
440
US
parsaclisib, INCB050465, ruxolitinib, Jakafi, Jakavi, placebo
Incyte Corporation
Myelofibrosis, Primary Myelofibrosis, Post Essential Thrombocythemia Myelofibrosis, Post Polycythemia Vera Myelofibrosis
09/23
02/26
NCT05073458 / 2021-002844-66: Study of the Efficacy and Safety of Parsaclisib in Participants With Primary Warm Autoimmune Hemolytic Anemia

Terminated
3
13
Europe, Canada, Japan, US, RoW
parsaclisinib, INCB050465, placebo
Incyte Corporation, Incyte Corporation
Warm Autoimmune Hemolytic Anemia (wAIHA)
10/23
04/24
NCT04816565: To Evaluate Efficacy and Safety of Parsaclisib and Ruxolitinib in Participants With Myelofibrosis Who Have Suboptimal Response to Ruxolitinib (LIMBER-304)

Not yet recruiting
3
212
Europe, US
parsaclisib, INCB050465, ruxolitinib, Jakafi, Jakavi, placebo
Incyte Corporation
Myelofibrosis, Primary Myelofibrosis, Post Essential Thrombocythemia Myelofibrosis, Post Polycythemia Vera Myelofibrosis
11/23
12/23
2019-004948-30: A Phase 2, Open-Label, Multicenter, Rollover Study to Provide Continued Treatment for Participants With Advanced Malignancies Previously Enrolled in Studies of Parsaclisib (INCB050465)

Not yet recruiting
2
200
Europe
parsaclisib 20 mg Tablets, parsaclisib 5 mg Tablets, parsaclisib 2.5 mg Tablets, parsaclisib 1 mg Tablets, INCB050465 20 mg Tablets, INCB050465 5 mg Tablets, INCB050465 2.5 mg Tablets, INCB050465 1 mg Tablets, Tablet, IMBRUVICA 140 mg hard capsules
Incyte Corporation, INCYTE CORPORATION, Incyte Corporation
Advanced malignancies, Advanced malignancies, Diseases [C] - Cancer [C04]
 
 
CITADEL-204, NCT03144674 / 2017-000970-12: A Study of INCB050465 in Subjects With Relapsed or Refractory Marginal Zone Lymphoma

Checkmark Primary analysis data from CITADEL-204 trial for r/r MZL at ASH 2021
Dec 2021 - Dec 2021: Primary analysis data from CITADEL-204 trial for r/r MZL at ASH 2021
Checkmark Data from CITADEL-204 trial for r/r MZL at ASH 2020
Dec 2020 - Dec 2020: Data from CITADEL-204 trial for r/r MZL at ASH 2020
Active, not recruiting
2
110
Europe, US, RoW
Parsaclisib, INCB050465
Incyte Corporation
Lymphoma
01/21
05/24
CITADEL-203, NCT03126019 / 2017-001624-22: A Study of INCB050465 in Relapsed or Refractory Follicular Lymphoma

Checkmark Results from CITADEL-203 trial for r/r follicular lymphoma
Dec 2021 - Dec 2021: Results from CITADEL-203 trial for r/r follicular lymphoma
Checkmark Data from CITADEL-203 trial for relapsed/refractory follicular lymphoma at ASH 2020
Dec 2020 - Dec 2020: Data from CITADEL-203 trial for relapsed/refractory follicular lymphoma at ASH 2020
Active, not recruiting
2
126
Europe, Canada, US, RoW
Parsaclisib, INCB050465
Incyte Corporation
Lymphoma
02/21
07/24
CITADEL-205, NCT03235544 / 2017-003148-19: A Study of INCB050465 in Relapsed or Refractory Mantle Cell Lymphoma Previously Treated With or Without a Bruton's Tyrosine Kinase (BTK) Inhibitor

Checkmark Data from cohort 1 of CITADEL-205 trial for r/r mantle cell lymphoma at ASH 2020
Dec 2020 - Dec 2020: Data from cohort 1 of CITADEL-205 trial for r/r mantle cell lymphoma at ASH 2020
Checkmark Data from cohort 2 of CITADEL-205 trial for r/r mantle cell lymphoma at ASH 2020
Dec 2020 - Dec 2020: Data from cohort 2 of CITADEL-205 trial for r/r mantle cell lymphoma at ASH 2020
Completed
2
162
Europe, US, RoW
Parsaclisib, INCB050465
Incyte Corporation
Lymphoma
03/21
04/24
CIBI376A201, NCT04298879: IBI376 in Patients With Relapsed or Refractory Follicular Lymphoma/Marginal Zone Lymphoma

Completed
2
81
RoW
IBI376, Parsaclisib
Innovent Biologics (Suzhou) Co. Ltd.
Indolent Non-hodgkin Lymphoma
07/21
11/23
AIHA, NCT03538041 / 2017-003652-22: A Study of INCB050465 in Participants With Autoimmune Hemolytic Anemia

Completed
2
25
Europe, US
Parsaclisib, INCB050465
Incyte Corporation
Autoimmune Hemolytic Anemia
08/21
04/24
NCT04434937: Open-Label Study of Parsaclisib, in Japanese Participants With Relapsed or Refractory Follicular Lymphoma (CITADEL-213)

Completed
2
42
Japan
parsaclisib, INCB050465
Incyte Biosciences Japan GK
Lymphoma
02/23
10/23
NCT04509700: Rollover Study to Provide Continued Treatment for Participants With B-Cell Malignancies Previously Enrolled in Studies of Parsaclisib (INCB050465)

Recruiting
2
200
Europe, Japan, US, RoW
Parsaclisib, INCB050465, parsaclisib + itacitinib, INCB39110, parsaclisib + ruxolitinib, INCB018424, parsaclisib + ibrutinib
Incyte Corporation
B-Cell Malignancies
09/24
09/24
topMIND, NCT04809467 / 2020-005591-35: A Study Evaluating Safety, PK, and Efficacy of Tafasitamab and Parsaclisib in Participants With Relapsed/Refractory Non Hodgkin Lymphoma (R/R NHL) or Chronic Lymphocytic Leukemia (CLL)

Hourglass Jan 2023 - Dec 2023 : Proof-of-concept data from TopMIND trial in combination with parsaclisib for r/r NHL or CLL
Active, not recruiting
1/2
54
Europe, US
tafasitamab, INCMOR00208, parsaclisib, INCB050465
Incyte Corporation
Chronic Lymphocytic Leukemia, Non Hodgkin Lymphoma
12/24
12/24
J-MIND, NCT04661007: To Assess the Safety and Tolerability of Tafasitamab Alone or in Combination With Other Drugs in Japanese Participants With Non-Hodgkins Lymphoma (NHL)

Recruiting
1/2
65
Japan
tafasitamab, INCMOR00208, MOR00208, Xmab5574, lenalidomide, parsaclisib, R-CHOP
Incyte Biosciences Japan GK
Non Hodgkins Lymphoma, Diffuse Large B-cell Lymphoma
05/25
07/26
NCT03314922: A Study of INCB050465 in Japanese Subjects With Previously Treated B-Cell Lymphoma (CITADEL-111)

Completed
1b
17
Japan
Parsaclisib, INCB050465
Incyte Corporation
Lymphoma
05/20
03/23
NCT03589651: INCMGA00012 in Combination With Other Therapies in Patients With Advanced Solid Tumors

Completed
1b
83
US
Retifanlimab, Epacadostat, INCB024360, INCMGA00012, INCB050465
Incyte Corporation
Unresectable or Metastatic Solid Tumors
11/22
11/22
NCT05867030: Parsaclisib in Patients With Relapsed or Refractory Follicular Lymphoma

Withdrawn
1
560
NA
lenalidomide, Lainamei, rituximab, Halpryza, parsaclisib, IBI376
Innovent Biologics (Suzhou) Co. Ltd.
Follicular Lymphoma
08/29
04/33

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