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

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: Moderate to Severe Asthma
• Intervention / Treatment: Other: placebo; Drug: ICS-LABA; Drug: povorcitinib

• Study Type: Interventional
• Enrollment (Estimated): 240
• Phase: Phase 2

Contacts and Locations

• 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
    • Not yet recruiting
    • Fundación Respirar
  • Buenos Aires, Argentina, M5500AXR
    • Not yet recruiting
    • Fundacion Scherbovsky
  • Buenos Aires, Argentina, C1425BEN
    • Not yet recruiting
    • INAER
  • Buenos Aires, Argentina, 1125 ABE
    • Not yet recruiting
    • Fundacion Cidea
  • Caba, Argentina, 01128
    • Not yet recruiting
    • Mautalen Salud e Investigación
  • Cordoba, Argentina, X5003DCE
    • Not yet recruiting
    • Instituto de Medicina Respiratoria - Imer
  • Florencio Varela, Argentina, 01888
    • Not yet recruiting
    • Ierim Instituto de Enfermedades Respiratorias E Investigacion Medica
  • Mendoza, Argentina, 05509
    • Not yet recruiting
    • Polo de Salud Vistalba
  • Mendoza, Argentina, M5500
    • Not yet recruiting
    • Centro Medico Dharma
  • Quilmes, Argentina, 01878
    • Not yet recruiting
    • Centro Respiratorio Quilmes
  • Rosario, Argentina, 02000
    • Not yet recruiting
    • Instituto Especialidades de La Salud Rosario
  • Rosario, Argentina, S2000 DEJ
    • Not yet recruiting
    • Instituto Médico de la Fundación Estudios Clinicos
  • Rosario, Argentina, 02000
    • Not yet recruiting
    • Instituto de Diagnostico Abc
  • Rosario, Argentina, 02000
    • Not yet recruiting
    • Centro Respiratorio Infantil
  • San Fernando, Argentina, 01644
    • Not yet recruiting
    • Centro Medico Respire
  • San Miguel de Tucuman, Argentina, T4000 CBC
    • Not yet recruiting
    • Cimer - Centro Integral de Medicina Respiratoria Srl
  • San Miguel de Tucumán, Argentina, 04000
    • Not yet recruiting
    • Ipr Instituto de Patologias Respiratorias
  • Santa Fe, Argentina, S3000ASF
    • Not yet recruiting
    • Instituto Del Buen Aire
• Belgium
  • Brussels, Belgium, 01200
    • Not yet recruiting
    • Uclouvain - Institut de Recherche Irec
  • Bruxelles, Belgium, 01000
    • Not yet recruiting
    • Chu St Pierre
  • Liege, Belgium, 04000
    • Not yet recruiting
    • Centre Hospitalier Universitaire (Chu) de Liege
• Canada
  • Alberta
    • Sherwood Park, Alberta, Canada, T8H 0N2
      • Not yet recruiting
      • Synergy Respiratory Care
  • British Columbia
    • Vancouver, British Columbia, Canada, V5Z 1M9
      • Recruiting
      • Centre For Lung Health
  • Ontario
    • Ajax, Ontario, Canada, L1S2J5
      • Recruiting
      • Dynamic Drug Advancement
    • Hamilton, Ontario, Canada, L8S 1G5
      • Not yet recruiting
      • Hamilton Allergy
    • Ottawa, Ontario, Canada, K1H 1E4
      • Recruiting
      • Ottawa Allergy Research Corporation
    • Toronto, Ontario, Canada, M5T 3A9
      • Not yet recruiting
      • Inspiration Research Limited
    • Waterloo, Ontario, Canada, N2J 1C4
      • Recruiting
      • S. Fikry Medicine Professional Corporation
    • Windsor, Ontario, Canada, N8X 1T3
      • Recruiting
      • Dr. Syed Anees Medicine Professional Corporation
• Germany
  • Bonn, Germany, 53105
    • Not yet recruiting
    • Universitatsklinikum Bonn Aoer
  • Frankfurt Am Main, Germany, 60596
    • Not yet recruiting
    • Ikf Pneumologie Frankfurt, Clinical Research Center Respiratory Diseases
  • Hannover, Germany, 30625
    • Not yet recruiting
    • Hannover Medical School
  • Koblenz, Germany, 56068
    • Not yet recruiting
    • Pneumologische Gemeinschaftspraxis Kroker-Schaeben-Schmidt
  • Mainz, Germany, 55128
    • Not yet recruiting
    • Ikf Pneumologie Mainz
  • Wuppertal, Germany, 42283
    • Not yet recruiting
    • Petrus-Krankenhaus - Klinik Fuer Innere Medizin I Pneumologie Allergologie Schlaf Und Intensivmediz
• Japan
  • Chuo-ku, Japan, 104-0031
    • Recruiting
    • Fukuwa Clinic
  • Chuo-ku, Japan, 103-0022
    • Completed
    • Nihonbashi Medical and Allergy Clinic
  • Fukuoka City, 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-shi, Japan, 530-0001
    • Not yet recruiting
    • Kyosokai Amc Nishi-Umeda Clinic
  • Osaka-shi, Japan, 531-0073
    • Not yet recruiting
    • Lee Clinic
  • Sakaide-shi, Japan, 762-8550
    • Not yet 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
    • Not yet recruiting
    • 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
• Korea, Republic of
  • Cheongju, Korea, Republic of, 28644
    • Not yet recruiting
    • Chungbuk National University Hospital
  • Seoul, Korea, Republic of, 05505
    • Not yet recruiting
    • Asan Medical Center
  • Seoul, Korea, Republic of, 06591
    • Not yet recruiting
    • The Catholic University of Korea Seoul St. Mary'S Hospital
  • Seoul, Korea, Republic of, 04763
    • Not yet recruiting
    • Hanyang University Seoul Hospital
  • Seoul, Korea, Republic of, 04387
    • Not yet recruiting
    • Severance Hospital Yonsei University Health System
• Poland
  • Bialystok, Poland, 15-687
    • Not yet recruiting
    • Allergy Clinic Homeo Medicus
  • Gdansk, Poland, 80-214
    • Not yet recruiting
    • Uniwersyteckie Centrum Kliniczne
  • Kraków, Poland, 31-159
    • Not yet recruiting
    • Nzoz Atopia
  • Lodz, Poland, 90-153
    • Not yet recruiting
    • Uniwersytecki Szpital Kliniczny Nr.1 Im. N. Barlickiego
  • Lubin, Poland, 59-300
    • Not yet recruiting
    • Szpital Specjalistyczny Cdt Medicus
  • Ostrowiec Swietokrzyski, Poland, 27-400
    • Not yet recruiting
    • Ostrowieckie Centrum Medyczne Spka Cywilna Anna Olech-Cudzik Krzysztof Cudzik
  • Warszawa, Poland, 02-507
    • Not yet recruiting
    • Pim Mswia
• Spain
  • Barcelona, Spain, 08017
    • Not yet recruiting
    • Giromed Institute/ Clinica Tres Torrres
  • Barcelona, Spain, 08036
    • Not yet recruiting
    • Hospital Clinic Barcelona Main
  • Bilbao, Spain, 48013
    • Completed
    • Hospital de Basurto
  • Madrid, Spain, 28040
    • Not yet recruiting
    • Hospital Universitario Fundación Jiménez Díaz
  • Madrid, Spain, 28007
    • Not yet recruiting
    • Hospital General Universitario Gregorio Marañón
  • Murcia, Spain, 30120
    • Completed
    • Hospital Universitario Virgen de la Arrixaca
  • Santiago de Compostela, Spain, 15706
    • Not yet recruiting
    • Complejo Hospitalario Universitario De Santiago De Compostela
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35209
      • Recruiting
      • Allervie Clinical Research
  • California
    • Bakersfield, California, United States, 93301
      • Recruiting
      • Kern Allergy Medical Clinic, Inc
    • Los Angeles, California, United States, 90025
      • Not yet recruiting
      • Jonathan Corren Md, Inc
    • Upland, California, United States, 91786
      • Not yet recruiting
      • 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, 33125
      • Recruiting
      • Verus Clinical Research Corp
    • 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
    • Orlando, Florida, United States, 32819
      • Recruiting
      • Heuer Md Research Inc
    • Orlando, Florida, United States, 32806
      • Recruiting
      • Anderson Allergy and Asthma
  • Georgia
    • Atlanta, Georgia, United States, 30309
      • Recruiting
      • Advanced Clinical Research Atlanta
    • East Point, Georgia, United States, 30344
      • Recruiting
      • Covenant Pulmonary Critical Care
  • Illinois
    • Glenview, Illinois, United States, 60026
      • Recruiting
      • Northshore Medical Group
  • Michigan
    • Detroit, Michigan, United States, 48202
      • Not yet recruiting
      • Henry Ford Hospital
    • Flint, Michigan, United States, 48504
      • Recruiting
      • AA Medical Research Center
    • Lathrup Village, Michigan, United States, 48076
      • Recruiting
      • Revive Research Institute
  • New York
    • Bronx, New York, United States, 10461
      • Completed
      • Montefiore Medical Center (MMC)
    • New Hyde Park, New York, United States, 11040
      • Recruiting
      • Northwell Health Physician Partners
    • New York, New York, United States, 10016
      • Recruiting
      • Pioneer Clinical Research Ny
  • North Carolina
    • Charlotte, North Carolina, United States, 28277
      • Recruiting
      • Onsite Clinical Solutions, Llc Charlotte Central Office
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19140
      • Recruiting
      • Temple University Hospital
  • South Carolina
    • Rock Hill, South Carolina, United States, 29732
      • Recruiting
      • 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, 78207
      • Recruiting
      • Quality Assurance Research Center

Participation Criteria

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 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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

4

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)	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	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
Percent change from baseline in pre-BD FEV1 at each visit		Up to 14 months
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
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

Collaborators and Investigators

• Sponsor: Incyte Corporation

Study record dates

Study Major Dates

• Study Start (Actual): July 11, 2023
• Primary Completion (Estimated): December 20, 2024
• Study Completion (Estimated): August 8, 2025

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 19, 2024
• Last Update Submitted That Met QC Criteria: April 18, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Asthma; Moderate to Severe; Povorcitinib; INCB54707; ICS-LABA
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Immune System Diseases; Lung Diseases; Hypersensitivity, Immediate; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity; Asthma
• Other Study ID Numbers: INCB54707-208

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