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

April 10, 2026 updated by: Incyte Corporation

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

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

240

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Incyte Corporation Call Center (US)
  • Phone Number: 1.855.463.3463
  • Email: medinfo@incyte.com

Study Contact Backup

  • Name: Incyte Corporation Call Center (ex-US)
  • Phone Number: +800 00027423
  • Email: eumedinfo@incyte.com

Study Locations

  • Argentina
      • Buenos Aires, Argentina, 01426
        • Recruiting
        • Fundación Respirar
      • Buenos Aires, Argentina, 1125 ABE
        • Recruiting
        • Fundacion Cidea
      • Buenos Aires, Argentina, C1128AAF
        • Recruiting
        • Mautalen Salud e Investigacion
      • CABA, Argentina, C1414AIF
        • Recruiting
        • CARE: Centro de Alergia y Enfermedades Respiratorias
      • Capitalfederal, Argentina, C1425BEN
        • Recruiting
        • InAER
      • Concepción del Uruguay, Argentina, 03260
        • Recruiting
        • Centro de Medicina Respiratoria
      • Córdoba, Argentina, X5003DCE
        • Recruiting
        • Instituto de Medicina Respiratoria - Imer
      • Mar del Plata, Argentina, B7612ENA
        • Recruiting
        • Fundacion Enfisema
      • Mendoza, Argentina, 05509
        • Recruiting
        • Polo de Salud Vistalba
      • Mendoza, Argentina, M5500AXR
        • Recruiting
        • Fundacion Scherbovsky
      • Mendoza, Argentina, MENDOZA (5500)
        • Recruiting
        • INSARES
      • Mendoza, Argentina, 05500
        • Recruiting
        • Centro Medico Dharma
      • Quilmes, Argentina, 01878
        • Recruiting
        • Centro Respiratorio Quilmes
      • Rosario, Argentina, 02000
        • Recruiting
        • Instituto de Diagnostico abc
      • Rosario, Argentina, S2000 DEJ
        • Recruiting
        • Instituto Medico de La Fundacion Estudios Clinicos
      • Rosario, Argentina, 02000
        • Recruiting
        • Centro Respiratorio Infantil
      • Rosario, Argentina, 02000
        • Recruiting
        • Instituto Especialidades de la Salud Rosario
      • San Fernando, Argentina, 01644
        • Recruiting
        • Centro Médico Respire
      • San Juan Bautista, Argentina, 01888
        • Recruiting
        • IERIM Instituto de Enfermedades Respiratorias e Investigacion Medica
      • San Miguel de Tucumán, Argentina, 04000
        • Recruiting
        • Ipr Instituto de Patologias Respiratorias
      • San Miguel de Tucumán, Argentina, T4000 CBC
        • Recruiting
        • Cimer - Centro Integral de Medicina Respiratoria Srl
      • Santa Fe, Argentina, S3000ASF
        • Recruiting
        • Iba Medica
  • Canada
    • Alberta
      • Sherwood Park, Alberta, Canada, T8H 0N2
        • Recruiting
        • Synergy Respiratory Care
    • British Columbia
      • Vancouver, British Columbia, Canada, V5Z 1M9
        • Completed
        • Centre for Lung Health
    • Ontario
      • Ajax, Ontario, Canada, L1S2J5
        • Recruiting
        • Dynamic Drug Advancement
      • Hamilton, Ontario, Canada, L8S 1G5
        • Withdrawn
        • Hamilton Allergy
      • Ottawa, Ontario, Canada, K1H 1E4
        • Completed
        • Ottawa Allergy Research Corporation
      • Waterloo, Ontario, Canada, N2J 1C4
        • Recruiting
        • S. Fikry Medicine Professional Corporation
      • Windsor, Ontario, Canada, N8X 1T3
        • Recruiting
        • Dr. Syed Anees Medicine Professional Corporation
  • Germany
      • Bendorf, Germany, 56170
        • Recruiting
        • Pneumologische Gemeinschaftspraxis Kroker-Schaeben-Schmidt
      • Bonn, Germany, 53127
        • Recruiting
        • Universitatsklinikum Bonn Aoer
      • Frankfurt am Main, Germany, 60596
        • Recruiting
        • IKF Pneumologie Frankfurt, Clinical Research Center Respiratory Diseases
      • Hanover, Germany, 30625
        • Recruiting
        • Hannover Medical School
      • Mainz, Germany, 55128
        • Recruiting
        • IKF Pneumologie Mainz
  • Japan
      • Chūōku, Japan, 104-0031
        • Recruiting
        • Fukuwa Clinic
      • Chūōku, Japan, 103-0022
        • Completed
        • Nihonbashi Medical and Allergy Clinic
      • Fukuoka, Japan, 811-1394
        • Recruiting
        • National Hospital Organization Fukuoka National Hospital
      • Kishiwada, Japan, 596-8501
        • Recruiting
        • Kishiwada City Hospital
      • Kitakyushu-shi, Japan, 802-0052
        • Recruiting
        • Kirigaoka Tsuda Hospital
      • Mizunami-shi, Japan, 509-6134
        • Recruiting
        • Tohno Chuo Clinic
      • Osaka, Japan, 530-0001
        • Completed
        • Kyosokai Amc Nishi-Umeda Clinic
      • Osaka, Japan, 531-0073
        • Completed
        • Lee Clinic
      • Sakaide-shi, Japan, 762-8550
        • Recruiting
        • Sakaide City Hospital
      • Sapporo, Japan, 064-0804
        • Completed
        • Idaimae Minami Yojo Int Clinic
      • Shinagawa-ku, Japan, 140-8522
        • Recruiting
        • Tokyo Shinagawa Hospital
      • Tokyo, Japan, 185-0014
        • Completed
        • Takahashi Medical Clinic
      • Toshima-ku, Japan, 170-0003
        • Completed
        • Kouwa Clinic
      • Yokkaichi-shi, Japan, 510-8561
        • Recruiting
        • Local Independent Administrative Institution Mie Prefectural General Medical Center
      • Yokohama, Japan, 223-0059
        • Completed
        • Kaiseikai Kita Shin Yokohama Internal Medicine Clinic
  • Poland
      • Bialystok, Poland, 15-687
        • Recruiting
        • Allergy Clinic Homeo Medicus
      • Gdansk, Poland, 80-214
        • Recruiting
        • Uniwersyteckie Centrum Kliniczne
      • Krakow, Poland, 31-142
        • Recruiting
        • Nzoz Atopia
      • Lubin, Poland, 59-300
        • Completed
        • Szpital Specjalistyczny Cdt Medicus
      • Ostrowiec Świętokrzyski, Poland, 27-400
        • Recruiting
        • Ostrowieckie Centrum Medyczne Spka Cywilna Anna Olech-Cudzik Krzysztof Cudzik
      • Warsaw, Poland, 02-507
        • Completed
        • Pim Mswia
  • Spain
      • Barcelona, Spain, 08036
        • Recruiting
        • Hospital Clinic Barcelona Main
      • Barcelona, Spain, 08017
        • Recruiting
        • Giromed Institute/ Clinica Tres Torrres
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35209
        • Completed
        • Allervie Clinical Research
    • California
      • Bakersfield, California, United States, 93301
        • Recruiting
        • Kern Allergy Medical Clinic, Inc
      • Upland, California, United States, 91786
        • Completed
        • Integrated Research of Inland, Inc
    • Florida
      • Hialeah, Florida, United States, 33012
        • Recruiting
        • Direct Helpers Research Center
      • Hialeah, Florida, United States, 33010
        • Recruiting
        • Qway Research
      • Miami, Florida, United States, 33174
        • Completed
        • Dr. de Armas Research Center, Llc
      • Miami, Florida, United States, 33175
        • Completed
        • Care Research Center, Inc
      • Miami, Florida, United States, 33130
        • Recruiting
        • Care Research Inc
      • Miami, Florida, United States, 33135
        • Recruiting
        • Verus Clinical Research Corp
      • Orlando, Florida, United States, 32806
        • Completed
        • Anderson Allergy and Asthma
      • Orlando, Florida, United States, 32819
        • Completed
        • Heuer Md Research Inc
    • Georgia
      • Atlanta, Georgia, United States, 30309
        • Completed
        • Advanced Clinical Research Atlanta
      • East Point, Georgia, United States, 30344
        • Completed
        • Covenant Pulmonary Critical Care
    • Illinois
      • Glenview, Illinois, United States, 60026
        • Completed
        • Northshore Medical Group
    • Michigan
      • Detroit, Michigan, United States, 48202
        • Completed
        • Henry Ford Hospital
      • Flint, Michigan, United States, 48504
        • Completed
        • AA Medical Research Center
      • Southfield, Michigan, United States, 48075
        • Completed
        • Revive Research Institute
    • New York
      • New Hyde Park, New York, United States, 11040
        • Completed
        • Northwell Health Physician Partners
      • New York, New York, United States, 10016
        • Completed
        • Pioneer Clinical Research NY
      • The Bronx, New York, United States, 10461
        • Completed
        • Montefiore Medical Center (MMC)
    • North Carolina
      • Charlotte, North Carolina, United States, 28277
        • Completed
        • Onsite Clinical Solutions, Llc Charlotte Central Office
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19140
        • Completed
        • Temple University Hospital
    • South Carolina
      • Rock Hill, South Carolina, United States, 29732
        • Completed
        • Clinical Research of Rock Hill
    • Texas
      • Austin, Texas, United States, 78759
        • Recruiting
        • Howland Allergy and Asthma Pllc Dba Orion Clinical Research
      • Pearland, Texas, United States, 77584
        • Recruiting
        • LinQ Research, LLC
      • San Antonio, Texas, United States, 78212
        • Completed
        • Quality Assurance Research Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Inhaled Corticoseroid Long Acting Beta-Agonist(ICS-LABA) + placebo
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
Other: placebo
placebo
Drug: ICS-LABA
Background Therapy
Experimental: ICS-LABA + povorcitinib Dose 1
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
Drug: ICS-LABA
Background Therapy
Drug: povorcitinib
povorcitinib
Other Names:
  • INCB54707
Experimental: ICS-LABA + povorcitinib Dose 2
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
Drug: ICS-LABA
Background Therapy
Drug: povorcitinib
povorcitinib
Other Names:
  • INCB54707
Experimental: ICS-LABA + povorcitinib Dose 3
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
Drug: ICS-LABA
Background Therapy
Drug: povorcitinib
povorcitinib
Other Names:
  • INCB54707

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Absolute change in pre-bronchodilator forced expiratory volume in the first 1 second (pre-BD FEV1)
Time Frame: Baseline ; Week 24
To assess the effect of povorcitinib on lung function (pre-BD FEV1) between baseline and week 24
Baseline ; Week 24

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of asthma exacerbations during the Placebo Controlled (PC) period
Time Frame: Up to 28 weeks
Defined as a worsening of asthma
Up to 28 weeks
Absolute change from baseline in pre-BD FEV1 at each visit
Time Frame: Up to 14 months
Up to 14 months
Percent change from baseline in pre-BD FEV1 at each visit
Time Frame: Up to 14 months
Up to 14 months
Absolute change from baseline in pre-BD FVC at each visit
Time Frame: Up to 14 months
Up to 14 months
Percent change from baseline in pre-BD FVC at each visit
Time Frame: Up to 14 months
Up to 14 months
Absolute change from baseline in post-BD FEV1 at week 24
Time Frame: Baseline; Week 24
Baseline; Week 24
Percent change from baseline in post-BD FEV1 at week 24
Time Frame: Baseline; Week 24
Baseline; Week 24

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Incyte Corporation

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 11, 2023

Primary Completion (Estimated)

June 15, 2026

Study Completion (Estimated)

January 31, 2027

Study Registration Dates

First Submitted

April 24, 2023

First Submitted That Met QC Criteria

May 8, 2023

First Posted (Actual)

May 9, 2023

Study Record Updates

Last Update Posted (Actual)

April 14, 2026

Last Update Submitted That Met QC Criteria

April 10, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • INCB54707-208
  • 2022-502570-16-00 (Registry Identifier: EU CT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD 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 Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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