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NCT05851443 | RECRUITING | Moderate to Severe Asthma

A Study to Evaluate the Efficacy and Safety Study of Povorcitinib in Participants With Inadequately Controlled Moderate to Severe Asthma
Sponsor:

Incyte Corporation

Brief Summary:

The study is being conducted to evaluate the effect of 3 dosing regimens of povorcitinib on pulmonary function

Condition or disease

Moderate to Severe Asthma

Intervention/treatment

povorcitinib

placebo

ICS-LABA

Phase

PHASE2

Study Type : INTERVENTIONAL
Estimated Enrollment : 240 participants
Masking : DOUBLE
Primary Purpose : TREATMENT
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
Actual Study Start Date : 2023-07-11
Estimated Primary Completion Date : 2026-06-15
Estimated Study Completion Date : 2027-01-31

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years to 65 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
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.
  • * 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.
  • * 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
A Study to Evaluate the Efficacy and Safety Study of Povorcitinib in Participants With Inadequately Controlled Moderate to Severe Asthma

Location Details

NCT05851443

Please Choose a site

How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

COMPLETED

United States, alabama

Allervie Clinical Research

Birmingham, alabama, United States, 35209

RECRUITING

United States, California

Kern Allergy Medical Clinic, Inc

Bakersfield, California, United States, 93301

COMPLETED

United States, California

Integrated Research of Inland, Inc

Upland, California, United States, 91786

RECRUITING

United States, Florida

Qway Research

Hialeah, florida, United States, 33010

RECRUITING

United States, Florida

Direct Helpers Research Center

Hialeah, florida, United States, 33012

RECRUITING

United States, Florida

Care Research Inc

Miami, florida, United States, 33130

RECRUITING

United States, Florida

Verus Clinical Research Corp

Miami, florida, United States, 33135

COMPLETED

United States, Florida

Dr. of Arms Research Center, Llc

Miami, florida, United States, 33174

COMPLETED

United States, Florida

Care Research Center, Inc

Miami, florida, United States, 33175

COMPLETED

United States, Florida

Anderson Allergy and Asthma

Orlando, florida, United States, 32806

COMPLETED

United States, Florida

Heuer Md Research Inc

Orlando, florida, United States, 32819

COMPLETED

United States, Georgia

Advanced Clinical Research Atlanta

Atlanta, Georgia, United States, 30309

COMPLETED

United States, Georgia

Covenant Pulmonary Critical Care

East Point, Georgia, United States, 30344

COMPLETED

United States, Illinois

Northshore Medical Group

Glenview, Illinois, United States, 60026

COMPLETED

United States, road cancer

Henry Ford Hospital

Detroit, road cancer, United States, 48202

COMPLETED

United States, road cancer

Aa Medical Research Center

Flint, road cancer, United States, 48504

COMPLETED

United States, road cancer

Revive Research Institute

Southfield, road cancer, United States, 48075

COMPLETED

United States, New York

Northwell Health Physician Partners

New Hyde Park, New York, United States, 11040

COMPLETED

United States, New York

Pioneer Clinical Research Ny

New York, New York, United States, 10016

COMPLETED

United States, New York

Montefiore Medical Center (Mmc)

The Bronx, New York, United States, 10461

COMPLETED

United States, North Carolina

Onsite Clinical Solutions, Llc Charlotte Central Office

Charlotte, North Carolina, United States, 28277

COMPLETED

United States, Pennsylvania

Temple University Hospital

Philadelphia, Pennsylvania, United States, 19140

COMPLETED

United States, South Carolina

Clinical Research of Rock Hill

Rock Hill, South Carolina, United States, 29732

RECRUITING

United States, Texas

Howland Allergy and Asthma Pllc Dba Orion Clinical Research

Austin, Texas, United States, 78759

RECRUITING

United States, Texas

Linq Research, Llc

Pearland, Texas, United States, 77584

RECRUITING

United States, Texas

Quality Assurance Research Center

Saint Anthony, Texas, United States, 78207

RECRUITING

Argentina,

Breathe Foundation

Buenos Aires, Argentina, 01426

RECRUITING

Argentina,

Cidea Foundation

Buenos Aires, Argentina, 1125 ABE

RECRUITING

Argentina,

Mautalen Health And Research

Buenos Aires, Argentina, C1128AAF

RECRUITING

Argentina,

INAER

Buenos Aires, Argentina, C1425BEN

RECRUITING

Argentina,

Care: Allergy and Respiratory Diseases Center

CABA, Argentina, C1414AIF

RECRUITING

Argentina,

Respiratory Medicine Center

Conception of Uruguay, Argentina, 03260

RECRUITING

Argentina,

Institute of Respiratory Medicine - Imer

Córdoba, Argentina, X5003DCE

NOT YET RECRUITING

Argentina,

CIMER

Lanus, Argentina, 01824

RECRUITING

Argentina,

Emphysema Foundation

Mar del Plata, Argentina, I will put 12 yen

RECRUITING

Argentina,

Vistalba Health Center

Mendoza, Argentina, 05509

RECRUITING

Argentina,

Fundacion Scherbovsky

Mendoza, Argentina, M5500AXR

RECRUITING

Argentina,

Dharma Medical Center

Mendoza, Argentina, M5500

RECRUITING

Argentina,

Insers

Mendoza, Argentina, MENDOZA (5500)

RECRUITING

Argentina,

Quilmes Respiratory Center

Quilmes, Argentina, 01878

RECRUITING

Argentina,

Children's Respiratory Center

Rosario, Argentina, 02000

RECRUITING

Argentina,

Abc Diagnostic Institute

Rosario, Argentina, 02000

RECRUITING

Argentina,

Rosario Health Specialties Institute

Rosario, Argentina, 02000

RECRUITING

Argentina,

Medical Institute of the Foundation Clinical Studies

Rosario, Argentina, S2000 WATER

RECRUITING

Argentina,

Respire Medical Center

San Fernando, Argentina, 01644

RECRUITING

Argentina,

Ierim Institute of Respiratory Diseases and Medical Research

Saint John the Baptist, Argentina, 01888

RECRUITING

Argentina,

Ipr Institute of Respiratory Pathologies

San Miguel de Tucumán, Argentina, 04000

RECRUITING

Argentina,

Cimer - Comprehensive Center for Respiratory Medicine Srl

San Miguel de Tucumán, Argentina, T4000 CBC

RECRUITING

Argentina,

Iba Medical

Santa Fe, Argentina, S3000ASF

RECRUITING

Canada, Alberta

Synergy Respiratory Care

Sherwood Park, Alberta, Canada, T8H 0N2

RECRUITING

Canada, British Columbia

Centre For Lung Health

Vancouver, British Columbia, Canada, V5Z 1M9

RECRUITING

Canada, Ontario

Dynamic Drug Advancement

Ajax, Ontario, Canada, L1S2J5

COMPLETED

Canada, Ontario

Ottawa Allergy Research Corporation

Ottawa, Ontario, Canada, K1H 1E4

RECRUITING

Canada, Ontario

S. Fikry Medicine Professional Corporation

Waterloo, Ontario, Canada, N2J 1C4

RECRUITING

Canada, Ontario

Dr. Syed Anees Medicine Professional Corporation

Windsor, Ontario, Canada, N8X 1T3

RECRUITING

Germany,

Pneumological group practice Kroker-Schaeben-Schmidt

Bendorf, Germany, 56170

RECRUITING

Germany,

University Clinic Bonn Aoer

Bonn, Germany, 53127

RECRUITING

Germany,

Ikf Pneumologie Frankfurt, Clinical Research Center Respiratory Diseases

Frankfurt am Main, Germany, 60596

RECRUITING

Germany,

Hannover Medical School

Hanover, Germany, 30625

RECRUITING

Germany,

Download music knowum

Mainz, Germany, 55128

COMPLETED

Japan,

Nihonbashi Medical and Allergy Clinic

Chūoku, Japan, 103-0022

RECRUITING

Japan,

Fukuwa Clinic

Chūoku, Japan, 104-0031

RECRUITING

Japan,

National Hospital Organization Fukuoka National Hospital

Fukuoka, Japan, 811-1394

RECRUITING

Japan,

Kishiwada City Hospital

Kishiwada, Japan, 596-8501

RECRUITING

Japan,

Kirigaoka Tsuda Hosupita L

Mr. Kitakyushu, Japan, 802-0052

RECRUITING

Japan,

Tohno Chuo Clinic

Mr. Mizunami, Japan, 509-6134

COMPLETED

Japan,

Action Committee AMC Nishi-Umeda Cini-c

Osaka, Japan, 530-0001

COMPLETED

Japan,

Lee Clinic

Osaka, Japan, 531-0073

RECRUITING

Japan,

Sakaide City Hospital

Sakai-yes, Japan, 762-8550

COMPLETED

Japan,

Faculty of Medicine Minami Seisho member t Cini

Sapporo, Japan, 064-0804

RECRUITING

Japan,

tokyo shinagawa supplementary pita l

The product is the work, Japan, 140-8522

COMPLETED

Japan,

Takahashi Medical Clinic

Tokyo, Japan, 185-0014

COMPLETED

Japan,

Kouwa Clinic

city ​​mark, Japan, 170-0003

RECRUITING

Japan,

Local Independent Administrative Institution Mie Prefectural General Medical Center

Mr. Yokkaichi, Japan, 510-8561

COMPLETED

Japan,

Revised meeting came New Yokohama Interna l Meji die Cini c

Yokohama, Japan, 223-0059

RECRUITING

Poland,

Allergy Clinic Homeo Doctor

Bialystok, Poland, 15-687

RECRUITING

Poland,

University Clinical Center

Gdansk, Poland, 80-214

RECRUITING

Poland,

Nzoz Atopia

Krakow, Poland, 31-142

RECRUITING

Poland,

Cdt Medicus Specialist Hospital

Lubin, Poland, 59-300

RECRUITING

Poland,

Ostrowiec Medical Center Spka Cywilna Anna Olech-Cudzik Krzysztof Cudzik

Ostrowiec Świętokrzyski, Poland, 27-400

COMPLETED

Poland,

Pim Mswia

Warsaw, Poland, 02-507

RECRUITING

Spain,

Giromed Institute/Tres Torres Clinic

Barcelona, Spain, 08017

RECRUITING

Spain,

Hospital Clinic Barcelona Main

Barcelona, Spain, 08036

NOT YET RECRUITING

Spain,

Santiago de Compostela University Hospital Complex

Santiago de Compostela, Spain, 15706