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

Moderate to Severe Asthma Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05851443
• Other study ID #: INCB54707-208
• Status: Recruiting
• Phase: Phase 2
• Start date: July 11, 2023
• Est. completion date: August 8, 2025

Study information

• Verified date: May 2024
• Source: Incyte Corporation
• Contact: Incyte Corporation Call Center (US)
• Phone: 1.855.463.3463
• Email: medinfo[@]incyte.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 240
• Est. completion date: August 8, 2025
• Est. primary completion date: December 20, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Asthma
• Moderate to Severe Asthma

Intervention

Drug:
• povorcitinib
povorcitinib

Other:
• placebo
placebo

Drug:
• ICS-LABA
Background Therapy

Locations

Country	Name	City	State
Argentina	Fundacion Cidea	Buenos Aires
Argentina	Fundacion Respirar	Buenos Aires
Argentina	Fundacion Scherbovsky	Buenos Aires
Argentina	INAER	Buenos Aires
Argentina	Mautalen Salud E Investigacion	Caba
Argentina	Instituto de Medicina Respiratoria - Imer	Cordoba
Argentina	Ierim Instituto de Enfermedades Respiratorias E Investigacion Medica	Florencio Varela
Argentina	Centro Medico Dharma	Mendoza
Argentina	Polo de Salud Vistalba	Mendoza
Argentina	Centro Respiratorio Quilmes	Quilmes
Argentina	Centro Respiratorio Infantil	Rosario
Argentina	Instituto de Diagnostico Abc	Rosario
Argentina	Instituto Especialidades de La Salud Rosario	Rosario
Argentina	Instituto Medico de La Fundacion Estudios Clinicos	Rosario
Argentina	Centro Medico Respire	San Fernando
Argentina	Cimer - Centro Integral de Medicina Respiratoria Srl	San Miguel de Tucuman
Argentina	Ipr Instituto de Patologias Respiratorias	San Miguel de Tucumán
Argentina	Instituto Del Buen Aire	Santa Fe
Belgium	Uclouvain - Institut de Recherche Irec	Brussels
Belgium	Chu St Pierre	Bruxelles
Belgium	Centre Hospitalier Universitaire (Chu) de Liege	Liege
Canada	Dynamic Drug Advancement	Ajax	Ontario
Canada	Hamilton Allergy	Hamilton	Ontario
Canada	Ottawa Allergy Research Corporation	Ottawa	Ontario
Canada	Synergy Respiratory Care	Sherwood Park	Alberta
Canada	Inspiration Research Limited	Toronto	Ontario
Canada	Centre For Lung Health	Vancouver	British Columbia
Canada	S. Fikry Medicine Professional Corporation	Waterloo	Ontario
Canada	Dr. Syed Anees Medicine Professional Corporation	Windsor	Ontario
Germany	Universitatsklinikum Bonn Aoer	Bonn
Germany	Ikf Pneumologie Frankfurt, Clinical Research Center Respiratory Diseases	Frankfurt Am Main
Germany	Hannover Medical School	Hannover
Germany	Pneumologische Gemeinschaftspraxis Kroker-Schaeben-Schmidt	Koblenz
Germany	Ikf Pneumologie Mainz	Mainz
Germany	Petrus-Krankenhaus - Klinik Fuer Innere Medizin I Pneumologie Allergologie Schlaf Und Intensivmediz	Wuppertal
Japan	Fukuwa Clinic	Chuo-ku
Japan	Nihonbashi Medical and Allergy Clinic	Chuo-ku
Japan	National Hospital Organization Fukuoka National Hospital	Fukuoka City
Japan	Kishiwada City Hospital	Kishiwada
Japan	Kirigaoka Tsuda Hospital	Kitakyushu-shi
Japan	Tohno Chuo Clinic	Mizunami-shi
Japan	Kyosokai Amc Nishi-Umeda Clinic	Osaka-shi
Japan	Lee Clinic	Osaka-shi
Japan	Sakaide City Hospital	Sakaide-shi
Japan	Idaimae Minami Yojo Int Clinic	Sapporo
Japan	Tokyo Shinagawa Hospital	Shinagawa-ku
Japan	Takahashi Medical Clinic	Tokyo
Japan	Kouwa Clinic	Toshima-ku
Japan	Local Independent Administrative Institution Mie Prefectural General Medical Center	Yokkaichi-shi
Japan	Kaiseikai Kita Shin Yokohama Internal Medicine Clinic	Yokohama
Korea, Republic of	Chungbuk National University Hospital	Cheongju
Korea, Republic of	Asan Medical Center	Seoul
Korea, Republic of	Hanyang University Seoul Hospital	Seoul
Korea, Republic of	Severance Hospital Yonsei University Health System	Seoul
Korea, Republic of	The Catholic University of Korea Seoul St. Mary'S Hospital	Seoul
Poland	Allergy Clinic Homeo Medicus	Bialystok
Poland	Uniwersyteckie Centrum Kliniczne	Gdansk
Poland	Nzoz Atopia	Kraków
Poland	Uniwersytecki Szpital Kliniczny Nr.1 Im. N. Barlickiego	Lodz
Poland	Szpital Specjalistyczny Cdt Medicus	Lubin
Poland	Ostrowieckie Centrum Medyczne Spka Cywilna Anna Olech-Cudzik Krzysztof Cudzik	Ostrowiec Swietokrzyski
Poland	Pim Mswia	Warszawa
Spain	Giromed Institute/ Clinica Tres Torrres	Barcelona
Spain	Hospital Clinic Barcelona Main	Barcelona
Spain	Hospital de Basurto	Bilbao
Spain	Hospital General Universitario Gregorio Maranon	Madrid
Spain	Hospital Universitario Fundacion Jimenez Diaz	Madrid
Spain	Hospital Universitario Virgen de La Arrixaca	Murcia
Spain	Complejo Hospitalario Universitario de Santiago de Compostela	Santiago de Compostela
United States	Advanced Clinical Research Atlanta	Atlanta	Georgia
United States	Howland Allergy and Asthma Pllc Dba Orion Clinical Research	Austin	Texas
United States	Kern Allergy Medical Clinic, Inc	Bakersfield	California
United States	Allervie Clinical Research	Birmingham	Alabama
United States	Montefiore Medical Center (Mmc)	Bronx	New York
United States	Onsite Clinical Solutions, Llc Charlotte Central Office	Charlotte	North Carolina
United States	Henry Ford Hospital	Detroit	Michigan
United States	Covenant Pulmonary Critical Care	East Point	Georgia
United States	Aa Medical Research Center	Flint	Michigan
United States	Northshore Medical Group	Glenview	Illinois
United States	Direct Helpers Research Center	Hialeah	Florida
United States	Qway Research	Hialeah	Florida
United States	Revive Research Institute	Lathrup Village	Michigan
United States	Jonathan Corren Md, Inc	Los Angeles	California
United States	Care Research Center, Inc	Miami	Florida
United States	Care Research Inc	Miami	Florida
United States	Dr. de Armas Research Center, Llc	Miami	Florida
United States	Verus Clinical Research Corp	Miami	Florida
United States	Northwell Health Physician Partners	New Hyde Park	New York
United States	Pioneer Clinical Research Ny	New York	New York
United States	Anderson Allergy and Asthma	Orlando	Florida
United States	Heuer Md Research Inc	Orlando	Florida
United States	Linq Research, Llc	Pearland	Texas
United States	Temple University Hospital	Philadelphia	Pennsylvania
United States	Clinical Research of Rock Hill	Rock Hill	South Carolina
United States	Quality Assurance Research Center	San Antonio	Texas
United States	Integrated Research of Inland, Inc	Upland	California

Sponsors (1)

Lead Sponsor	Collaborator
Incyte Corporation

Countries where clinical trial is conducted

United States,  Argentina,  Belgium,  Canada,  Germany,  Japan,  Korea, Republic of,  Poland,  Spain, 

Outcome

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