Back to resultsA Study to Evaluate the Efficacy and Safety Study of Povorcitinib in Participants With Inadequately Controlled Moderate to Severe Asthma
Primary Purpose
Moderate to Severe Asthma
Status
Recruiting
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
povorcitinib
placebo
ICS-LABA
Sponsored by
About this trial
This is an interventional treatment trial for Moderate to Severe Asthma focused on measuring Asthma, Moderate to Severe, INCB54707, Povorcitinib, ICS-LABA
Eligibility Criteria
Inclusion Criteria: Physician-diagnosed asthma requiring treatment with medium- to high-dose ICS-LABA for at least 12 months prior to screening. Pre-BD FEV1 < 80% predicted according to central over read value at Visit 2. Documented historical post-BD reversibility of FEV1 ≥ 12% and ≥ 200 mL in FEV1 within 12 months prior to screening OR Post-BD reversibility of FEV1 ≥ 12% and ≥ 200 mL in FEV1 according to central over read value at Visit 2. At least 2 documented asthma exacerbations (requiring treatment with systemic CS, hospitalization, or emergency department visit) within 12 months prior to screening but not within the past 4 weeks prior to screening ACQ-6 ≥ 1.5 at screening. Exclusion Criteria: Maintenance use of asthma controllers other than ICS-LABA. Have undergone bronchial thermoplasty. Current smokers or participants with a smoking history of ≥ 10 pack-years and participants using vaping products, including electronic cigarettes. Women who are pregnant (or who are considering pregnancy) or breastfeeding. Current conditions or history of other diseases, as follows: Clinically important pulmonary disease other than asthma ,Thrombocytopenia, coagulopathy, or platelet dysfunction. Venous and arterial thrombosis, deep vein thrombosis, pulmonary embolism, moderate to severe heart failure (NYHA Class III or IV), cerebrovascular accident, myocardial infarction, coronary stenting, or CABG surgery. Diagnosis of other significant cardiovascular diseases, including but not limited to angina, peripheral arterial disease, or uncontrolled arrhythmias such as atrial fibrillation, supraventricular tachycardia, ventricular tachycardia, and forms of carditis. Recipient of an organ transplant that requires continued immunosuppression. Immunocompromised (eg, lymphoma, acquired immunodeficiency syndrome, Wiskott-Aldrich syndrome). Any malignancies or history of malignancies. Note: Participants with cured nonmetastatic basal cell or squamous cell carcinoma of the skin, superficial bladder cancer, prostate intraepithelial neoplasm, carcinoma in situ of the cervix, or other noninvasive malignancy or cancers from which the participant has been disease-free for > 1 year after treatment with curative intent are eligible. Chronic or recurrent infectious disease. Receipt of any biologic drugs used for asthma < 12 weeks or 5 half-lives (if known), whichever is longer, prior to screening
Sites / Locations
- Allervie Clinical ResearchRecruiting
- Kern Allergy Medical Clinic, IncRecruiting
- Jonathan Corren Md, Inc
- Qway ResearchRecruiting
- Direct Helpers Research Center
- Verus Clinical Research CorpRecruiting
- Care Research Center, IncRecruiting
- Anderson Allergy and Asthma
- Heuer Md Research Inc
- Advanced Clinical Research AtlantaRecruiting
- Northshore Medical Group
- University of Michigan Health Center-Allergy Specialty Clinic At Domino'S Farms
- Aa Medical Research CenterRecruiting
- Montefiore Medical Center (Mmc)
- Northwell Health Physician Partners
- Onsite Clinical Solutions, Llc Charlotte Central Office
- Temple University Hospital
- Clinical Research of Rock HillRecruiting
- Howland Allergy and Asthma Pllc Dba Orion Clinical ResearchRecruiting
- Linq Research, LlcRecruiting
- Quality Assurance Research Center
- Uclouvain - Institut de Recherche Irec
- Chu St Pierre
- Centre Hospitalier Universitaire (Chu) de Liege
- Synergy Respiratory Care
- Centre For Lung Health
- Dynamic Drug AdvancementRecruiting
- Hamilton Allergy
- Ottawa Allergy Research CorporationRecruiting
- Inspiration Research Limited
- S. Fikry Medicine Professional Corporation
- Dr. Syed Anees Medicine Professional Corporation
- Universitatsklinikum Bonn Aoer
- Ikf Pneumologie Frankfurt, Clinical Research Center Respiratory Diseases
- Hannover Medical School
- Pneumologische Gemeinschaftspraxis Kroker-Schaeben-Schmidt
- Ikf Pneumologie Mainz
- Petrus-Krankenhaus - Klinik Fuer Innere Medizin I Pneumologie Allergologie Schlaf Und Intensivmediz
- Nihonbashi Medical and Allergy ClinicRecruiting
- Fukuwa ClinicRecruiting
- National Hospital Organization Fukuoka National Hospital
- Tohno Chuo ClinicRecruiting
- Kyosokai Amc Nishi-Umeda Clinic
- Lee Clinic
- Idaimae Minami Yojo Int ClinicRecruiting
- Tokyo Shinagawa HospitalRecruiting
- Takahashi Medical Clinic
- Kouwa ClinicRecruiting
- Kaiseikai Kita Shin Yokohama Internal Medicine ClinicRecruiting
- Allergy Clinic Homeo Medicus
- Uniwersyteckie Centrum Kliniczne
- Nzoz Atopia
- Uniwersytecki Szpital Kliniczny Nr.1 Im. N. Barlickiego
- Szpital Specjalistyczny Cdt Medicus
- Ostrowieckie Centrum Medyczne Spka Cywilna Anna Olech-Cudzik Krzysztof Cudzik
- Pim Mswia
- Giromed Institute/ Clinica Tres Torrres
- Hospital Clinic Barcelona Main
- Hospital de Basurto
- Hospital General Universitario Gregorio Maranon
- Hospital Universitario Fundacion Jimenez Diaz
- Hospital Universitario Virgen de La Arrixaca
- Complejo Hospitalario Universitario de Santiago de Compostela
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Placebo Comparator
Experimental
Experimental
Experimental
Arm Label
Inhaled Corticoseroid Long Acting Beta-Agonist(ICS-LABA) + placebo
ICS-LABA + povorcitinib Dose 1
ICS-LABA + povorcitinib Dose 2
ICS-LABA + povorcitinib Dose 3
Arm Description
Participants will receive stable background therapy with ICS-LABA in combination with placebo once daily (QD) for 24 weeks during the placebo-controlled period. Participants will be allocated to 1 of 3 doses of povorcitinib during the extension period of 28 weeks
Participants will receive stable background therapy with ICS-LABA in combination with povorcitinib dose 1 once daily (QD) for 24 weeks during the placebo-controlled period, and Participants will continue to take the same dose of povorcitinib during the extension period of 28 weeks
Participants will receive stable background therapy with ICS-LABA in combination with povorcitinib dose 2 once daily (QD) for 24 weeks during the placebo-controlled period, and Participants will continue to take the same dose of povorcitinib during the extension period of 28 weeks
Participants will receive stable background therapy with ICS-LABA in combination with povorcitinib dose 3 once daily (QD) for 24 weeks during the placebo-controlled period, and Participants will continue to take the same dose of povorcitinib during the extension period of 28 weeks
Outcomes
Primary Outcome Measures
Absolute change in pre-bronchodilator forced expiratory volume in the first 1 second (pre-BD FEV1)
To assess the effect of povorcitinib on lung function (pre-BD FEV1) between baseline and week 24
Secondary Outcome Measures
Number of asthma exacerbations during the Placebo Controlled (PC) period
Defined as a worsening of asthma
Absolute change from baseline in pre-BD FEV1 at each visit
Percent change from baseline in pre-BD FEV1 at each visit
Absolute change from baseline in post-BD FEV1 at week 24
Percent change from baseline in post-BD FEV1 at week 24
Absolute change from baseline in pre-BD FVC at each visit
Percent change from baseline in pre-BD FVC at each visit
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05851443
Brief Title
A Study to Evaluate the Efficacy and Safety Study of Povorcitinib in Participants With Inadequately Controlled Moderate to Severe Asthma
Official Title
A Phase 2, Double-Blind, Randomized, Placebo-Controlled, Dose-Ranging, Efficacy and Safety Study of Povorcitinib in Participants With Inadequately Controlled Moderate to Severe Asthma
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 11, 2023 (Actual)
Primary Completion Date
December 20, 2024 (Anticipated)
Study Completion Date
August 8, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Incyte Corporation
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The study is being conducted to evaluate the effect of 3 dosing regimens of povorcitinib on pulmonary function
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Moderate to Severe Asthma
Keywords
Asthma, Moderate to Severe, INCB54707, Povorcitinib, ICS-LABA
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
240 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Inhaled Corticoseroid Long Acting Beta-Agonist(ICS-LABA) + placebo
Arm Type
Placebo Comparator
Arm Description
Participants will receive stable background therapy with ICS-LABA in combination with placebo once daily (QD) for 24 weeks during the placebo-controlled period. Participants will be allocated to 1 of 3 doses of povorcitinib during the extension period of 28 weeks
Arm Title
ICS-LABA + povorcitinib Dose 1
Arm Type
Experimental
Arm Description
Participants will receive stable background therapy with ICS-LABA in combination with povorcitinib dose 1 once daily (QD) for 24 weeks during the placebo-controlled period, and Participants will continue to take the same dose of povorcitinib during the extension period of 28 weeks
Arm Title
ICS-LABA + povorcitinib Dose 2
Arm Type
Experimental
Arm Description
Participants will receive stable background therapy with ICS-LABA in combination with povorcitinib dose 2 once daily (QD) for 24 weeks during the placebo-controlled period, and Participants will continue to take the same dose of povorcitinib during the extension period of 28 weeks
Arm Title
ICS-LABA + povorcitinib Dose 3
Arm Type
Experimental
Arm Description
Participants will receive stable background therapy with ICS-LABA in combination with povorcitinib dose 3 once daily (QD) for 24 weeks during the placebo-controlled period, and Participants will continue to take the same dose of povorcitinib during the extension period of 28 weeks
Intervention Type
Drug
Intervention Name(s)
povorcitinib
Other Intervention Name(s)
INCB54707
Intervention Description
povorcitinib
Intervention Type
Other
Intervention Name(s)
placebo
Intervention Description
placebo
Intervention Type
Drug
Intervention Name(s)
ICS-LABA
Intervention Description
Background Therapy
Primary Outcome Measure Information:
Title
Absolute change in pre-bronchodilator forced expiratory volume in the first 1 second (pre-BD FEV1)
Description
To assess the effect of povorcitinib on lung function (pre-BD FEV1) between baseline and week 24
Time Frame
Baseline ; Week 24
Secondary Outcome Measure Information:
Title
Number of asthma exacerbations during the Placebo Controlled (PC) period
Description
Defined as a worsening of asthma
Time Frame
Up to 28 weeks
Title
Absolute change from baseline in pre-BD FEV1 at each visit
Time Frame
Up to 14 months
Title
Percent change from baseline in pre-BD FEV1 at each visit
Time Frame
Up to 14 months
Title
Absolute change from baseline in post-BD FEV1 at week 24
Time Frame
Baseline; Week 24
Title
Percent change from baseline in post-BD FEV1 at week 24
Time Frame
Baseline; Week 24
Title
Absolute change from baseline in pre-BD FVC at each visit
Time Frame
Up to 14 months
Title
Percent change from baseline in pre-BD FVC at each visit
Time Frame
Up to 14 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Physician-diagnosed asthma requiring treatment with medium- to high-dose ICS-LABA for at least 12 months prior to screening.
Pre-BD FEV1 < 80% predicted according to central over read value at Visit 2.
Documented historical post-BD reversibility of FEV1 ≥ 12% and ≥ 200 mL in FEV1 within 12 months prior to screening OR Post-BD reversibility of FEV1 ≥ 12% and ≥ 200 mL in FEV1 according to central over read value at Visit 2.
At least 2 documented asthma exacerbations (requiring treatment with systemic CS, hospitalization, or emergency department visit) within 12 months prior to screening but not within the past 4 weeks prior to screening
ACQ-6 ≥ 1.5 at screening.
Exclusion Criteria:
Maintenance use of asthma controllers other than ICS-LABA.
Have undergone bronchial thermoplasty.
Current smokers or participants with a smoking history of ≥ 10 pack-years and participants using vaping products, including electronic cigarettes.
Women who are pregnant (or who are considering pregnancy) or breastfeeding.
Current conditions or history of other diseases, as follows:
Clinically important pulmonary disease other than asthma ,Thrombocytopenia, coagulopathy, or platelet dysfunction.
Venous and arterial thrombosis, deep vein thrombosis, pulmonary embolism, moderate to severe heart failure (NYHA Class III or IV), cerebrovascular accident, myocardial infarction, coronary stenting, or CABG surgery.
Diagnosis of other significant cardiovascular diseases, including but not limited to angina, peripheral arterial disease, or uncontrolled arrhythmias such as atrial fibrillation, supraventricular tachycardia, ventricular tachycardia, and forms of carditis.
Recipient of an organ transplant that requires continued immunosuppression.
Immunocompromised (eg, lymphoma, acquired immunodeficiency syndrome, Wiskott-Aldrich syndrome).
Any malignancies or history of malignancies. Note: Participants with cured nonmetastatic basal cell or squamous cell carcinoma of the skin, superficial bladder cancer, prostate intraepithelial neoplasm, carcinoma in situ of the cervix, or other noninvasive malignancy or cancers from which the participant has been disease-free for > 1 year after treatment with curative intent are eligible.
Chronic or recurrent infectious disease.
Receipt of any biologic drugs used for asthma < 12 weeks or 5 half-lives (if known), whichever is longer, prior to screening
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Incyte Corporation Call Center (US)
Phone
1.855.463.3463
Email
medinfo@incyte.com
First Name & Middle Initial & Last Name or Official Title & Degree
Incyte Corporation Call Center (ex-US)
Phone
+800 00027423
Email
eumedinfo@incyte.com
Facility Information:
Facility Name
Allervie Clinical Research
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35209
Country
United States
Individual Site Status
Recruiting
Facility Name
Kern Allergy Medical Clinic, Inc
City
Bakersfield
State/Province
California
ZIP/Postal Code
93301
Country
United States
Individual Site Status
Recruiting
Facility Name
Jonathan Corren Md, Inc
City
Los Angeles
State/Province
California
ZIP/Postal Code
90025
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Qway Research
City
Hialeah
State/Province
Florida
ZIP/Postal Code
33010
Country
United States
Individual Site Status
Recruiting
Facility Name
Direct Helpers Research Center
City
Hialeah
State/Province
Florida
ZIP/Postal Code
33012
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Verus Clinical Research Corp
City
Miami
State/Province
Florida
ZIP/Postal Code
33125
Country
United States
Individual Site Status
Recruiting
Facility Name
Care Research Center, Inc
City
Miami
State/Province
Florida
ZIP/Postal Code
33175
Country
United States
Individual Site Status
Recruiting
Facility Name
Anderson Allergy and Asthma
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Heuer Md Research Inc
City
Orlando
State/Province
Florida
ZIP/Postal Code
32819
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Advanced Clinical Research Atlanta
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30309
Country
United States
Individual Site Status
Recruiting
Facility Name
Northshore Medical Group
City
Glenview
State/Province
Illinois
ZIP/Postal Code
60026
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
University of Michigan Health Center-Allergy Specialty Clinic At Domino'S Farms
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48106
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Aa Medical Research Center
City
Flint
State/Province
Michigan
ZIP/Postal Code
48504
Country
United States
Individual Site Status
Recruiting
Facility Name
Montefiore Medical Center (Mmc)
City
Bronx
State/Province
New York
ZIP/Postal Code
10461
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Northwell Health Physician Partners
City
New Hyde Park
State/Province
New York
ZIP/Postal Code
11040
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Onsite Clinical Solutions, Llc Charlotte Central Office
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28226
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Temple University Hospital
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19140
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Clinical Research of Rock Hill
City
Rock Hill
State/Province
South Carolina
ZIP/Postal Code
29732
Country
United States
Individual Site Status
Recruiting
Facility Name
Howland Allergy and Asthma Pllc Dba Orion Clinical Research
City
Austin
State/Province
Texas
ZIP/Postal Code
78759
Country
United States
Individual Site Status
Recruiting
Facility Name
Linq Research, Llc
City
Pearland
State/Province
Texas
ZIP/Postal Code
77584
Country
United States
Individual Site Status
Recruiting
Facility Name
Quality Assurance Research Center
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78207
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Uclouvain - Institut de Recherche Irec
City
Brussels
ZIP/Postal Code
01200
Country
Belgium
Individual Site Status
Not yet recruiting
Facility Name
Chu St Pierre
City
Bruxelles
ZIP/Postal Code
01000
Country
Belgium
Individual Site Status
Not yet recruiting
Facility Name
Centre Hospitalier Universitaire (Chu) de Liege
City
Liege
ZIP/Postal Code
04000
Country
Belgium
Individual Site Status
Not yet recruiting
Facility Name
Synergy Respiratory Care
City
Sherwood Park
State/Province
Alberta
ZIP/Postal Code
T8H 0N2
Country
Canada
Individual Site Status
Not yet recruiting
Facility Name
Centre For Lung Health
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5Z 1M9
Country
Canada
Individual Site Status
Not yet recruiting
Facility Name
Dynamic Drug Advancement
City
Ajax
State/Province
Ontario
ZIP/Postal Code
L1S2J5
Country
Canada
Individual Site Status
Recruiting
Facility Name
Hamilton Allergy
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8S 1G5
Country
Canada
Individual Site Status
Not yet recruiting
Facility Name
Ottawa Allergy Research Corporation
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1H 1E4
Country
Canada
Individual Site Status
Recruiting
Facility Name
Inspiration Research Limited
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5T 3A9
Country
Canada
Individual Site Status
Not yet recruiting
Facility Name
S. Fikry Medicine Professional Corporation
City
Waterloo
State/Province
Ontario
ZIP/Postal Code
N2J 1C4
Country
Canada
Individual Site Status
Not yet recruiting
Facility Name
Dr. Syed Anees Medicine Professional Corporation
City
Windsor
State/Province
Ontario
ZIP/Postal Code
N8X 1T3
Country
Canada
Individual Site Status
Not yet recruiting
Facility Name
Universitatsklinikum Bonn Aoer
City
Bonn
ZIP/Postal Code
53105
Country
Germany
Individual Site Status
Not yet recruiting
Facility Name
Ikf Pneumologie Frankfurt, Clinical Research Center Respiratory Diseases
City
Frankfurt Am Main
ZIP/Postal Code
60596
Country
Germany
Individual Site Status
Not yet recruiting
Facility Name
Hannover Medical School
City
Hannover
ZIP/Postal Code
30625
Country
Germany
Individual Site Status
Not yet recruiting
Facility Name
Pneumologische Gemeinschaftspraxis Kroker-Schaeben-Schmidt
City
Koblenz
ZIP/Postal Code
56068
Country
Germany
Individual Site Status
Not yet recruiting
Facility Name
Ikf Pneumologie Mainz
City
Mainz
ZIP/Postal Code
55128
Country
Germany
Individual Site Status
Not yet recruiting
Facility Name
Petrus-Krankenhaus - Klinik Fuer Innere Medizin I Pneumologie Allergologie Schlaf Und Intensivmediz
City
Wuppertal
ZIP/Postal Code
42283
Country
Germany
Individual Site Status
Not yet recruiting
Facility Name
Nihonbashi Medical and Allergy Clinic
City
Chuo-ku
ZIP/Postal Code
103-0022
Country
Japan
Individual Site Status
Recruiting
Facility Name
Fukuwa Clinic
City
Chuo-ku
ZIP/Postal Code
104-0031
Country
Japan
Individual Site Status
Recruiting
Facility Name
National Hospital Organization Fukuoka National Hospital
City
Fukuoka City
ZIP/Postal Code
811-1394
Country
Japan
Individual Site Status
Not yet recruiting
Facility Name
Tohno Chuo Clinic
City
Mizunami-shi
ZIP/Postal Code
509-6134
Country
Japan
Individual Site Status
Recruiting
Facility Name
Kyosokai Amc Nishi-Umeda Clinic
City
Osaka-shi
ZIP/Postal Code
530-0001
Country
Japan
Individual Site Status
Not yet recruiting
Facility Name
Lee Clinic
City
Osaka-shi
ZIP/Postal Code
531-0073
Country
Japan
Individual Site Status
Not yet recruiting
Facility Name
Idaimae Minami Yojo Int Clinic
City
Sapporo
ZIP/Postal Code
064-0804
Country
Japan
Individual Site Status
Recruiting
Facility Name
Tokyo Shinagawa Hospital
City
Shinagawa-ku
ZIP/Postal Code
140-8522
Country
Japan
Individual Site Status
Recruiting
Facility Name
Takahashi Medical Clinic
City
Tokyo
ZIP/Postal Code
185-0014
Country
Japan
Individual Site Status
Not yet recruiting
Facility Name
Kouwa Clinic
City
Toshima-ku
ZIP/Postal Code
170-0003
Country
Japan
Individual Site Status
Recruiting
Facility Name
Kaiseikai Kita Shin Yokohama Internal Medicine Clinic
City
Yokohama
ZIP/Postal Code
223-0059
Country
Japan
Individual Site Status
Recruiting
Facility Name
Allergy Clinic Homeo Medicus
City
Bialystok
ZIP/Postal Code
15-687
Country
Poland
Individual Site Status
Not yet recruiting
Facility Name
Uniwersyteckie Centrum Kliniczne
City
Gdansk
ZIP/Postal Code
80-214
Country
Poland
Individual Site Status
Not yet recruiting
Facility Name
Nzoz Atopia
City
Kraków
ZIP/Postal Code
31-159
Country
Poland
Individual Site Status
Not yet recruiting
Facility Name
Uniwersytecki Szpital Kliniczny Nr.1 Im. N. Barlickiego
City
Lodz
ZIP/Postal Code
90-153
Country
Poland
Individual Site Status
Not yet recruiting
Facility Name
Szpital Specjalistyczny Cdt Medicus
City
Lubin
ZIP/Postal Code
59-300
Country
Poland
Individual Site Status
Not yet recruiting
Facility Name
Ostrowieckie Centrum Medyczne Spka Cywilna Anna Olech-Cudzik Krzysztof Cudzik
City
Ostrowiec Swietokrzyski
ZIP/Postal Code
27-400
Country
Poland
Individual Site Status
Not yet recruiting
Facility Name
Pim Mswia
City
Warszawa
ZIP/Postal Code
02-507
Country
Poland
Individual Site Status
Not yet recruiting
Facility Name
Giromed Institute/ Clinica Tres Torrres
City
Barcelona
ZIP/Postal Code
08017
Country
Spain
Individual Site Status
Not yet recruiting
Facility Name
Hospital Clinic Barcelona Main
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Individual Site Status
Not yet recruiting
Facility Name
Hospital de Basurto
City
Bilbao
ZIP/Postal Code
48013
Country
Spain
Individual Site Status
Not yet recruiting
Facility Name
Hospital General Universitario Gregorio Maranon
City
Madrid
ZIP/Postal Code
28007
Country
Spain
Individual Site Status
Not yet recruiting
Facility Name
Hospital Universitario Fundacion Jimenez Diaz
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Individual Site Status
Not yet recruiting
Facility Name
Hospital Universitario Virgen de La Arrixaca
City
Murcia
ZIP/Postal Code
30120
Country
Spain
Individual Site Status
Not yet recruiting
Facility Name
Complejo Hospitalario Universitario de Santiago de Compostela
City
Santiago de Compostela
ZIP/Postal Code
15706
Country
Spain
Individual Site Status
Not yet recruiting
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Incyte shares data with qualified external researchers after a research proposal is submitted. These requests are reviewed and approved by a review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. The trial data availability is according to the criteria and process described on https://www.incyte.com/our-company/compliance-and-transparency
IPD Sharing Time Frame
Data will be shared after the primary publication or 2 years after the study has ended for market authorized products and indications.
IPD Sharing Access Criteria
Data from eligible studies will be shared with qualified researchers according to the criteria and process described in the Data Sharing section of the www.incyteclinicaltrials.com website. For approved requests, the researchers will be granted access to anonymized data under the terms of a data sharing agreement.
IPD Sharing URL
https://www.incyte.com/our-company/compliance-and-transparency
Learn more about this trial
A Study to Evaluate the Efficacy and Safety Study of Povorcitinib in Participants With Inadequately Controlled Moderate to Severe Asthma
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