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

Last updated: March 24, 2025
Sponsor: Incyte Corporation
Overall Status: Active - Recruiting

Phase

2

Condition

Asthma

Treatment

ICS-LABA

povorcitinib

placebo

Clinical Study ID

NCT05851443
INCB54707-208
  • Ages 18-65
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Physician-diagnosed asthma requiring treatment with medium- to high-dose ICS-LABAfor 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 screeningbut not within the past 4 weeks prior to screening

  • ACQ-6 ≥ 1.5 at screening.

Exclusion

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 andparticipants 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, moderateto severe heart failure (NYHA Class III or IV), cerebrovascular accident, myocardialinfarction, coronary stenting, or CABG surgery.

  • Diagnosis of other significant cardiovascular diseases, including but not limited toangina, peripheral arterial disease, or uncontrolled arrhythmias such as atrialfibrillation, supraventricular tachycardia, ventricular tachycardia, and forms ofcarditis.

  • Recipient of an organ transplant that requires continued immunosuppression.

  • Immunocompromised (eg, lymphoma, acquired immunodeficiency syndrome, Wiskott-Aldrichsyndrome).

  • 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

Study Design

Total Participants: 240
Treatment Group(s): 3
Primary Treatment: ICS-LABA
Phase: 2
Study Start date:
July 11, 2023
Estimated Completion Date:
May 29, 2026

Connect with a study center

  • Fundacion Cidea

    Buenos Aires, 1125 ABE
    Argentina

    Active - Recruiting

  • Fundacion Respirar

    Buenos Aires, 01426
    Argentina

    Active - Recruiting

  • Fundacion Scherbovsky

    Buenos Aires, M5500AXR
    Argentina

    Active - Recruiting

  • INAER

    Buenos Aires, C1425BEN
    Argentina

    Site Not Available

  • Care: Centro de Alergia Y Enfermedades Respiratorias

    Caba, C1414AIF
    Argentina

    Active - Recruiting

  • Mautalen Salud E Investigacion

    Caba, 01128
    Argentina

    Active - Recruiting

  • INAER

    Capitalfederal, C1425BEN
    Argentina

    Active - Recruiting

  • Centro de Medicina Respiratoria

    Concepcion Del Uruguay, 03260
    Argentina

    Active - Recruiting

  • Instituto de Medicina Respiratoria - Imer

    Cordoba, X5003DCE
    Argentina

    Active - Recruiting

  • Ierim Instituto de Enfermedades Respiratorias E Investigacion Medica

    Florencio Varela, 01888
    Argentina

    Active - Recruiting

  • CIMEL

    Lanus ESTE, 01824
    Argentina

    Site Not Available

  • Fundacion Enfisema

    Mar Del Plata, 07600
    Argentina

    Active - Recruiting

  • Centro Medico Dharma

    Mendoza, M5500
    Argentina

    Active - Recruiting

  • Fundacion Scherbovsky

    Mendoza, M5500AXR
    Argentina

    Active - Recruiting

  • Office of Pedro Carlos Elias, Md

    Mendoza, 05500
    Argentina

    Active - Recruiting

  • Polo de Salud Vistalba

    Mendoza, 05509
    Argentina

    Active - Recruiting

  • Centro Respiratorio Quilmes

    Quilmes, 01878
    Argentina

    Active - Recruiting

  • Centro Respiratorio Infantil

    Rosario, 02000
    Argentina

    Active - Recruiting

  • Instituto Especialidades de La Salud Rosario

    Rosario, 02000
    Argentina

    Active - Recruiting

  • Instituto Medico de La Fundacion Estudios Clinicos

    Rosario, S2000 DEJ
    Argentina

    Active - Recruiting

  • Instituto de Diagnostico Abc

    Rosario, 02000
    Argentina

    Active - Recruiting

  • Centro Medico Respire

    San Fernando, 01644
    Argentina

    Active - Recruiting

  • Cimer - Centro Integral de Medicina Respiratoria Srl

    San Miguel de Tucuman, T4000 CBC
    Argentina

    Active - Recruiting

  • Ipr Instituto de Patologias Respiratorias

    San Miguel de Tucumán, 04000
    Argentina

    Active - Recruiting

  • Iba Medica

    Santa Fe, S3000ASF
    Argentina

    Active - Recruiting

  • Instituto Del Buen Aire

    Santa Fe, S3000ASF
    Argentina

    Site Not Available

  • Uclouvain - Institut de Recherche Irec

    Brussels, 01200
    Belgium

    Site Not Available

  • Chu St Pierre

    Bruxelles, 01000
    Belgium

    Site Not Available

  • Centre Hospitalier Universitaire (Chu) de Liege

    Liege, 04000
    Belgium

    Site Not Available

  • Synergy Respiratory Care

    Sherwood Park, Alberta T8H 0N2
    Canada

    Active - Recruiting

  • Centre For Lung Health

    Vancouver, British Columbia V5Z 1M9
    Canada

    Active - Recruiting

  • Dynamic Drug Advancement

    Ajax, Ontario L1S2J5
    Canada

    Active - Recruiting

  • Hamilton Allergy

    Hamilton, Ontario L8S 1G5
    Canada

    Site Not Available

  • Ottawa Allergy Research Corporation

    Ottawa, Ontario K1H 1E4
    Canada

    Active - Recruiting

  • Inspiration Research Limited

    Toronto, Ontario M5T 3A9
    Canada

    Site Not Available

  • S. Fikry Medicine Professional Corporation

    Waterloo, Ontario N2J 1C4
    Canada

    Active - Recruiting

  • Dr. Syed Anees Medicine Professional Corporation

    Windsor, Ontario N8X 1T3
    Canada

    Active - Recruiting

  • Pneumologische Gemeinschaftspraxis Kroker-Schaeben-Schmidt

    Bendorf, 56170
    Germany

    Active - Recruiting

  • Universitatsklinikum Bonn Aoer

    Bonn, 53105
    Germany

    Active - Recruiting

  • Ikf Pneumologie Frankfurt, Clinical Research Center Respiratory Diseases

    Frankfurt Am Main, 60596
    Germany

    Active - Recruiting

  • Hannover Medical School

    Hannover, 30625
    Germany

    Active - Recruiting

  • Pneumologische Gemeinschaftspraxis Kroker-Schaeben-Schmidt

    Koblenz, 56068
    Germany

    Site Not Available

  • Ikf Pneumologie Mainz

    Mainz, 55128
    Germany

    Active - Recruiting

  • Petrus-Krankenhaus - Klinik Fuer Innere Medizin I Pneumologie Allergologie Schlaf Und Intensivmediz

    Wuppertal, 42283
    Germany

    Site Not Available

  • Fukuwa Clinic

    Chuo-ku, 104-0031
    Japan

    Active - Recruiting

  • Nihonbashi Medical and Allergy Clinic

    Chuo-ku, 103-0022
    Japan

    Completed

  • National Hospital Organization Fukuoka National Hospital

    Fukuoka City, 811-1394
    Japan

    Active - Recruiting

  • Kishiwada City Hospital

    Kishiwada, 596-8501
    Japan

    Active - Recruiting

  • Kirigaoka Tsuda Hospital

    Kitakyushu-shi, 802-0052
    Japan

    Active - Recruiting

  • Tohno Chuo Clinic

    Mizunami-shi, 509-6134
    Japan

    Active - Recruiting

  • Kyosokai Amc Nishi-Umeda Clinic

    Osaka-shi, 530-0001
    Japan

    Completed

  • Lee Clinic

    Osaka-shi, 531-0073
    Japan

    Completed

  • Sakaide City Hospital

    Sakaide-shi, 762-8550
    Japan

    Active - Recruiting

  • Idaimae Minami Yojo Int Clinic

    Sapporo, 064-0804
    Japan

    Completed

  • Tokyo Shinagawa Hospital

    Shinagawa-ku, 140-8522
    Japan

    Active - Recruiting

  • Takahashi Medical Clinic

    Tokyo, 185-0014
    Japan

    Completed

  • Kouwa Clinic

    Toshima-ku, 170-0003
    Japan

    Completed

  • Local Independent Administrative Institution Mie Prefectural General Medical Center

    Yokkaichi-shi, 510-8561
    Japan

    Active - Recruiting

  • Kaiseikai Kita Shin Yokohama Internal Medicine Clinic

    Yokohama, 223-0059
    Japan

    Completed

  • Chungbuk National University Hospital

    Cheongju, 28644
    Korea, Republic of

    Site Not Available

  • Asan Medical Center

    Seoul, 05505
    Korea, Republic of

    Site Not Available

  • Hanyang University Seoul Hospital

    Seoul, 04763
    Korea, Republic of

    Site Not Available

  • Severance Hospital Yonsei University Health System

    Seoul, 04387
    Korea, Republic of

    Site Not Available

  • The Catholic University of Korea Seoul St. Mary'S Hospital

    Seoul, 06591
    Korea, Republic of

    Site Not Available

  • Allergy Clinic Homeo Medicus

    Bialystok, 15-687
    Poland

    Active - Recruiting

  • Uniwersyteckie Centrum Kliniczne

    Gdansk, 80-214
    Poland

    Active - Recruiting

  • Nzoz Atopia

    Krakow, 31-142
    Poland

    Active - Recruiting

  • Nzoz Atopia

    Kraków, 31-159
    Poland

    Site Not Available

  • Uniwersytecki Szpital Kliniczny Nr.1 Im. N. Barlickiego

    Lodz, 90-153
    Poland

    Site Not Available

  • Szpital Specjalistyczny Cdt Medicus

    Lubin, 59-300
    Poland

    Active - Recruiting

  • Ostrowieckie Centrum Medyczne Spka Cywilna Anna Olech-Cudzik Krzysztof Cudzik

    Ostrowiec Swietokrzyski, 27-400
    Poland

    Active - Recruiting

  • Pim Mswia

    Warszawa, 02-507
    Poland

    Completed

  • Giromed Institute/ Clinica Tres Torrres

    Barcelona, 08017
    Spain

    Active - Recruiting

  • Hospital Clinic Barcelona Main

    Barcelona, 08036
    Spain

    Active - Recruiting

  • Hospital de Basurto

    Bilbao, 48013
    Spain

    Site Not Available

  • Hospital General Universitario Gregorio Maranon

    Madrid, 28007
    Spain

    Site Not Available

  • Hospital Universitario Fundacion Jimenez Diaz

    Madrid, 28040
    Spain

    Site Not Available

  • Hospital Universitario Virgen de La Arrixaca

    Murcia, 30120
    Spain

    Site Not Available

  • Complejo Hospitalario Universitario de Santiago de Compostela

    Santiago de Compostela, 15706
    Spain

    Site Not Available

  • Allervie Clinical Research

    Birmingham, Alabama 35209
    United States

    Active - Recruiting

  • Kern Allergy Medical Clinic, Inc

    Bakersfield, California 93301
    United States

    Active - Recruiting

  • Jonathan Corren Md, Inc

    Los Angeles, California 90025
    United States

    Site Not Available

  • Integrated Research of Inland, Inc

    Upland, California 91786
    United States

    Completed

  • Direct Helpers Research Center

    Hialeah, Florida 33012
    United States

    Active - Recruiting

  • Qway Research

    Hialeah, Florida 33010
    United States

    Active - Recruiting

  • Care Research Center, Inc

    Miami, Florida 33175
    United States

    Completed

  • Care Research Inc

    Miami, Florida 33130
    United States

    Active - Recruiting

  • Dr. de Armas Research Center, Llc

    Miami, Florida 33174
    United States

    Completed

  • Verus Clinical Research Corp

    Miami, Florida 33135
    United States

    Active - Recruiting

  • Anderson Allergy and Asthma

    Orlando, Florida 32806
    United States

    Completed

  • Heuer Md Research Inc

    Orlando, Florida 32819
    United States

    Active - Recruiting

  • Advanced Clinical Research Atlanta

    Atlanta, Georgia 30309
    United States

    Active - Recruiting

  • Covenant Pulmonary Critical Care

    East Point, Georgia 30344
    United States

    Active - Recruiting

  • Northshore Medical Group

    Glenview, Illinois 60026
    United States

    Completed

  • University of Michigan Health Center-Allergy Specialty Clinic At Domino'S Farms

    Ann Arbor, Michigan 48106
    United States

    Site Not Available

  • Henry Ford Hospital

    Detroit, Michigan 48202
    United States

    Active - Recruiting

  • Aa Medical Research Center

    Flint, Michigan 48504
    United States

    Active - Recruiting

  • Revive Research Institute

    Lathrup Village, Michigan 48076
    United States

    Site Not Available

  • Revive Research Institute

    Southfield, Michigan 48075
    United States

    Active - Recruiting

  • Montefiore Medical Center (Mmc)

    Bronx, New York 10461
    United States

    Completed

  • Northwell Health Physician Partners

    New Hyde Park, New York 11040
    United States

    Active - Recruiting

  • Pioneer Clinical Research Ny

    New York, New York 10016
    United States

    Active - Recruiting

  • Onsite Clinical Solutions, Llc Charlotte Central Office

    Charlotte, North Carolina 28277
    United States

    Active - Recruiting

  • Temple University Hospital

    Philadelphia, Pennsylvania 19140
    United States

    Completed

  • Clinical Research of Rock Hill

    Rock Hill, South Carolina 29732
    United States

    Active - Recruiting

  • Howland Allergy and Asthma Pllc Dba Orion Clinical Research

    Austin, Texas 78759
    United States

    Active - Recruiting

  • Linq Research, Llc

    Pearland, Texas 77584
    United States

    Active - Recruiting

  • Quality Assurance Research Center

    San Antonio, Texas 78207
    United States

    Active - Recruiting

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