Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2022-502570-16-00 | Registry Identifier | EU CT Number |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The study is being conducted to evaluate the effect of 3 dosing regimens of povorcitinib on pulmonary function
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Inhaled Corticoseroid Long Acting Beta-Agonist(ICS-LABA) + placebo | Placebo Comparator | 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 |
|
| ICS-LABA + povorcitinib Dose 1 | Experimental | 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 |
|
| ICS-LABA + povorcitinib Dose 2 | Experimental | 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 |
|
| ICS-LABA + povorcitinib Dose 3 | Experimental | 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 |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| povorcitinib | Drug | povorcitinib |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Baseline ; Week 24 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of asthma exacerbations during the Placebo Controlled (PC) period | Defined as a worsening of asthma | Up to 28 weeks |
| Absolute change from baseline in pre-BD FEV1 at each visit | Up to 14 months |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Allervie Clinical Research | Birmingham | Alabama | 35209 | United States | ||
| Kern Allergy Medical Clinic, Inc |
Not provided
| Label | URL |
|---|---|
| A Study to Evaluate the Efficacy and Safety Study of Povorcitinib in Participants With Inadequately Controlled Moderate to Severe Asthma | View source |
Not provided
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
Data will be shared after the primary publication or 2 years after the study has ended for market authorized products and indications.
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.
Not provided
Not provided
Not provided
Not provided
|
| placebo | Other | placebo |
|
| ICS-LABA | Drug | Background Therapy |
|
| Percent change from baseline in pre-BD FEV1 at each visit | Up to 14 months |
| Absolute change from baseline in post-BD FEV1 at week 24 | Baseline; Week 24 |
| Percent change from baseline in post-BD FEV1 at week 24 | Baseline; Week 24 |
| Absolute change from baseline in pre-BD FVC at each visit | Up to 14 months |
| Percent change from baseline in pre-BD FVC at each visit | Up to 14 months |
| Bakersfield |
| California |
| 93301 |
| United States |
| Integrated Research of Inland, Inc | Upland | California | 91786 | United States |
| Qway Research | Hialeah | Florida | 33010 | United States |
| Direct Helpers Research Center | Hialeah | Florida | 33012 | United States |
| Care Research Inc | Miami | Florida | 33130 | United States |
| Verus Clinical Research Corp | Miami | Florida | 33135 | United States |
| Dr. de Armas Research Center, Llc | Miami | Florida | 33174 | United States |
| Care Research Center, Inc | Miami | Florida | 33175 | United States |
| Anderson Allergy and Asthma | Orlando | Florida | 32806 | United States |
| Heuer Md Research Inc | Orlando | Florida | 32819 | United States |
| Advanced Clinical Research Atlanta | Atlanta | Georgia | 30309 | United States |
| Covenant Pulmonary Critical Care | East Point | Georgia | 30344 | United States |
| Northshore Medical Group | Glenview | Illinois | 60026 | United States |
| Henry Ford Hospital | Detroit | Michigan | 48202 | United States |
| Aa Medical Research Center | Flint | Michigan | 48504 | United States |
| Revive Research Institute | Southfield | Michigan | 48075 | United States |
| Northwell Health Physician Partners | New Hyde Park | New York | 11040 | United States |
| Pioneer Clinical Research Ny | New York | New York | 10016 | United States |
| Montefiore Medical Center (Mmc) | The Bronx | New York | 10461 | United States |
| Onsite Clinical Solutions, Llc Charlotte Central Office | Charlotte | North Carolina | 28277 | United States |
| Temple University Hospital | Philadelphia | Pennsylvania | 19140 | United States |
| Clinical Research of Rock Hill | Rock Hill | South Carolina | 29732 | United States |
| Howland Allergy and Asthma Pllc Dba Orion Clinical Research | Austin | Texas | 78759 | United States |
| Linq Research, Llc | Pearland | Texas | 77584 | United States |
| Quality Assurance Research Center | San Antonio | Texas | 78212 | United States |
| Fundacion Respirar | Buenos Aires | 01426 | Argentina |
| Fundacion Cidea | Buenos Aires | 1125 ABE | Argentina |
| Mautalen Salud E Investigacion | Buenos Aires | C1128AAF | Argentina |
| Care: Centro de Alergia Y Enfermedades Respiratorias | CABA | C1414AIF | Argentina |
| INAER | Capitalfederal | C1425BEN | Argentina |
| Centro de Medicina Respiratoria | Concepción del Uruguay | 03260 | Argentina |
| Instituto de Medicina Respiratoria - Imer | Córdoba | X5003DCE | Argentina |
| Fundacion Enfisema | Mar del Plata | B7612ENA | Argentina |
| Centro Medico Dharma | Mendoza | 05500 | Argentina |
| Polo de Salud Vistalba | Mendoza | 05509 | Argentina |
| Fundacion Scherbovsky | Mendoza | M5500AXR | Argentina |
| INSARES | Mendoza | MENDOZA (5500) | Argentina |
| Centro Respiratorio Quilmes | Quilmes | 01878 | Argentina |
| Centro Respiratorio Infantil | Rosario | 02000 | Argentina |
| Instituto de Diagnostico Abc | Rosario | 02000 | Argentina |
| Instituto Especialidades de La Salud Rosario | Rosario | 02000 | Argentina |
| Instituto Medico de La Fundacion Estudios Clinicos | Rosario | S2000 DEJ | Argentina |
| Centro Medico Respire | San Fernando | 01644 | Argentina |
| Ierim Instituto de Enfermedades Respiratorias E Investigacion Medica | San Juan Bautista | 01888 | Argentina |
| Ipr Instituto de Patologias Respiratorias | San Miguel de Tucumán | 04000 | Argentina |
| Cimer - Centro Integral de Medicina Respiratoria Srl | San Miguel de Tucumán | T4000 CBC | Argentina |
| Iba Medica | Santa Fe | S3000ASF | Argentina |
| Synergy Respiratory Care | Sherwood Park | Alberta | T8H 0N2 | Canada |
| Centre For Lung Health | Vancouver | British Columbia | V5Z 1M9 | Canada |
| Dynamic Drug Advancement | Ajax | Ontario | L1S2J5 | Canada |
| Ottawa Allergy Research Corporation | Ottawa | Ontario | K1H 1E4 | Canada |
| S. Fikry Medicine Professional Corporation | Waterloo | Ontario | N2J 1C4 | Canada |
| Dr. Syed Anees Medicine Professional Corporation | Windsor | Ontario | N8X 1T3 | Canada |
| Pneumologische Gemeinschaftspraxis Kroker-Schaeben-Schmidt | Bendorf | 56170 | Germany |
| Universitatsklinikum Bonn Aoer | Bonn | 53127 | Germany |
| Ikf Pneumologie Frankfurt, Clinical Research Center Respiratory Diseases | Frankfurt am Main | 60596 | Germany |
| Hannover Medical School | Hanover | 30625 | Germany |
| Ikf Pneumologie Mainz | Mainz | 55128 | Germany |
| Nihonbashi Medical and Allergy Clinic | Chūōku | 103-0022 | Japan |
| Fukuwa Clinic | Chūōku | 104-0031 | Japan |
| National Hospital Organization Fukuoka National Hospital | Fukuoka | 811-1394 | Japan |
| Kishiwada City Hospital | Kishiwada | 596-8501 | Japan |
| Kirigaoka Tsuda Hospital | Kitakyushu-shi | 802-0052 | Japan |
| Tohno Chuo Clinic | Mizunami-shi | 509-6134 | Japan |
| Kyosokai Amc Nishi-Umeda Clinic | Osaka | 530-0001 | Japan |
| Lee Clinic | Osaka | 531-0073 | Japan |
| Sakaide City Hospital | Sakaide-shi | 762-8550 | Japan |
| Idaimae Minami Yojo Int Clinic | Sapporo | 064-0804 | Japan |
| Tokyo Shinagawa Hospital | Shinagawa-ku | 140-8522 | Japan |
| Takahashi Medical Clinic | Tokyo | 185-0014 | Japan |
| Kouwa Clinic | Toshima-ku | 170-0003 | Japan |
| Local Independent Administrative Institution Mie Prefectural General Medical Center | Yokkaichi-shi | 510-8561 | Japan |
| Kaiseikai Kita Shin Yokohama Internal Medicine Clinic | Yokohama | 223-0059 | Japan |
| Allergy Clinic Homeo Medicus | Bialystok | 15-687 | Poland |
| Uniwersyteckie Centrum Kliniczne | Gdansk | 80-214 | Poland |
| Nzoz Atopia | Krakow | 31-142 | Poland |
| Szpital Specjalistyczny Cdt Medicus | Lubin | 59-300 | Poland |
| Ostrowieckie Centrum Medyczne Spka Cywilna Anna Olech-Cudzik Krzysztof Cudzik | Ostrowiec Świętokrzyski | 27-400 | Poland |
| Pim Mswia | Warsaw | 02-507 | Poland |
| Giromed Institute/ Clinica Tres Torrres | Barcelona | 08017 | Spain |
| Hospital Clinic Barcelona Main | Barcelona | 08036 | Spain |
| ID | Term |
|---|---|
| D001249 | Asthma |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012130 | Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
Not provided
Not provided