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

NCT05851443 | Recruiting Phase 2 DMC FDA Drug

• 2 other identifiers: INCB54707-2082022-502570-16-00
• Study Type: interventional
• Target: 240
• Locations: 7 countries
• Sites: 83

Brief Summary

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

Conditions

Moderate to Severe Asthma

Keywords

Asthma; Moderate to Severe; INCB54707; Povorcitinib; ICS-LABA

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Number of asthma exacerbations during the Placebo Controlled (PC) period

  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 post-BD FEV1 at week 24

  Baseline; Week 24

• Percent change from baseline in post-BD FEV1 at week 24

  Baseline; Week 24

Study Arms (4)

Inhaled Corticoseroid Long Acting Beta-Agonist(ICS-LABA) + placebo

PLACEBO COMPARATOR

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; Drug: ICS-LABA

ICS-LABA + povorcitinib Dose 1

EXPERIMENTAL

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: povorcitinib; Drug: ICS-LABA

ICS-LABA + povorcitinib Dose 2

EXPERIMENTAL

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: povorcitinib; Drug: ICS-LABA

ICS-LABA + povorcitinib Dose 3

EXPERIMENTAL

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: povorcitinib; Drug: ICS-LABA

Interventions

placebo OTHER

placebo

Inhaled Corticoseroid Long Acting Beta-Agonist(ICS-LABA) + placebo

ICS-LABA DRUG

Background Therapy

ICS-LABA + povorcitinib Dose 1; ICS-LABA + povorcitinib Dose 2; ICS-LABA + povorcitinib Dose 3; Inhaled Corticoseroid Long Acting Beta-Agonist(ICS-LABA) + placebo

povorcitinib DRUG

povorcitinib

Also known as: INCB54707

ICS-LABA + povorcitinib Dose 1; ICS-LABA + povorcitinib Dose 2; ICS-LABA + povorcitinib Dose 3

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Incyte Corporation: lead

Study Sites (83)

Allervie Clinical Research

Birmingham, Alabama, 35209, United States

COMPLETED

Kern Allergy Medical Clinic, Inc

Bakersfield, California, 93301, United States

RECRUITING

Integrated Research of Inland, Inc

Upland, California, 91786, United States

COMPLETED

Qway Research

Hialeah, Florida, 33010, United States

RECRUITING

Direct Helpers Research Center

Hialeah, Florida, 33012, United States

RECRUITING

Care Research Inc

Miami, Florida, 33130, United States

RECRUITING

Verus Clinical Research Corp

Miami, Florida, 33135, United States

RECRUITING

Dr. de Armas Research Center, Llc

Miami, Florida, 33174, United States

COMPLETED

Care Research Center, Inc

Miami, Florida, 33175, United States

COMPLETED

Anderson Allergy and Asthma

Orlando, Florida, 32806, United States

COMPLETED

Heuer Md Research Inc

Orlando, Florida, 32819, United States

COMPLETED

Advanced Clinical Research Atlanta

Atlanta, Georgia, 30309, United States

COMPLETED

Covenant Pulmonary Critical Care

East Point, Georgia, 30344, United States

COMPLETED

Northshore Medical Group

Glenview, Illinois, 60026, United States

COMPLETED

Henry Ford Hospital

Detroit, Michigan, 48202, United States

COMPLETED

Aa Medical Research Center

Flint, Michigan, 48504, United States

COMPLETED

Revive Research Institute

Southfield, Michigan, 48075, United States

COMPLETED

Northwell Health Physician Partners

New Hyde Park, New York, 11040, United States

COMPLETED

Pioneer Clinical Research Ny

New York, New York, 10016, United States

COMPLETED

Montefiore Medical Center (Mmc)

The Bronx, New York, 10461, United States

COMPLETED

Onsite Clinical Solutions, Llc Charlotte Central Office

Charlotte, North Carolina, 28277, United States

COMPLETED

Temple University Hospital

Philadelphia, Pennsylvania, 19140, United States

COMPLETED

Clinical Research of Rock Hill

Rock Hill, South Carolina, 29732, United States

COMPLETED

Howland Allergy and Asthma Pllc Dba Orion Clinical Research

Austin, Texas, 78759, United States

RECRUITING

Linq Research, Llc

Pearland, Texas, 77584, United States

RECRUITING

Quality Assurance Research Center

San Antonio, Texas, 78212, United States

COMPLETED

Fundacion Respirar

Buenos Aires, 01426, Argentina

RECRUITING

Fundacion Cidea

Buenos Aires, 1125 ABE, Argentina

RECRUITING

Mautalen Salud E Investigacion

Buenos Aires, C1128AAF, Argentina

RECRUITING

Care: Centro de Alergia Y Enfermedades Respiratorias

CABA, C1414AIF, Argentina

RECRUITING

INAER

Capitalfederal, C1425BEN, Argentina

RECRUITING

Centro de Medicina Respiratoria

Concepción del Uruguay, 03260, Argentina

RECRUITING

Instituto de Medicina Respiratoria - Imer

Córdoba, X5003DCE, Argentina

RECRUITING

Fundacion Enfisema

Mar del Plata, B7612ENA, Argentina

RECRUITING

Centro Medico Dharma

Mendoza, 05500, Argentina

RECRUITING

Polo de Salud Vistalba

Mendoza, 05509, Argentina

RECRUITING

Fundacion Scherbovsky

Mendoza, M5500AXR, Argentina

RECRUITING

INSARES

Mendoza, MENDOZA (5500), Argentina

RECRUITING

Centro Respiratorio Quilmes

Quilmes, 01878, Argentina

RECRUITING

Centro Respiratorio Infantil

Rosario, 02000, Argentina

RECRUITING

Instituto de Diagnostico Abc

Rosario, 02000, Argentina

RECRUITING

Instituto Especialidades de La Salud Rosario

Rosario, 02000, Argentina

RECRUITING

Instituto Medico de La Fundacion Estudios Clinicos

Rosario, S2000 DEJ, Argentina

RECRUITING

Centro Medico Respire

San Fernando, 01644, Argentina

RECRUITING

Ierim Instituto de Enfermedades Respiratorias E Investigacion Medica

San Juan Bautista, 01888, Argentina

RECRUITING

Ipr Instituto de Patologias Respiratorias

San Miguel de Tucumán, 04000, Argentina

RECRUITING

Cimer - Centro Integral de Medicina Respiratoria Srl

San Miguel de Tucumán, T4000 CBC, Argentina

RECRUITING

Iba Medica

Santa Fe, S3000ASF, Argentina

RECRUITING

Synergy Respiratory Care

Sherwood Park, Alberta, T8H 0N2, Canada

RECRUITING

Centre For Lung Health

Vancouver, British Columbia, V5Z 1M9, Canada

COMPLETED

Dynamic Drug Advancement

Ajax, Ontario, L1S2J5, Canada

RECRUITING

Hamilton Allergy

Hamilton, Ontario, L8S 1G5, Canada

WITHDRAWN

Ottawa Allergy Research Corporation

Ottawa, Ontario, K1H 1E4, Canada

COMPLETED

S. Fikry Medicine Professional Corporation

Waterloo, Ontario, N2J 1C4, Canada

RECRUITING

Dr. Syed Anees Medicine Professional Corporation

Windsor, Ontario, N8X 1T3, Canada

RECRUITING

Pneumologische Gemeinschaftspraxis Kroker-Schaeben-Schmidt

Bendorf, 56170, Germany

RECRUITING

Universitatsklinikum Bonn Aoer

Bonn, 53127, Germany

RECRUITING

Ikf Pneumologie Frankfurt, Clinical Research Center Respiratory Diseases

Frankfurt am Main, 60596, Germany

RECRUITING

Hannover Medical School

Hanover, 30625, Germany

RECRUITING

Ikf Pneumologie Mainz

Mainz, 55128, Germany

RECRUITING

Nihonbashi Medical and Allergy Clinic

Chūōku, 103-0022, Japan

COMPLETED

Fukuwa Clinic

Chūōku, 104-0031, Japan

RECRUITING

National Hospital Organization Fukuoka National Hospital

Fukuoka, 811-1394, Japan

RECRUITING

Kishiwada City Hospital

Kishiwada, 596-8501, Japan

RECRUITING

Kirigaoka Tsuda Hospital

Kitakyushu-shi, 802-0052, Japan

RECRUITING

Tohno Chuo Clinic

Mizunami-shi, 509-6134, Japan

RECRUITING

Kyosokai Amc Nishi-Umeda Clinic

Osaka, 530-0001, Japan

COMPLETED

Lee Clinic

Osaka, 531-0073, Japan

COMPLETED

Sakaide City Hospital

Sakaide-shi, 762-8550, Japan

RECRUITING

Idaimae Minami Yojo Int Clinic

Sapporo, 064-0804, Japan

COMPLETED

Tokyo Shinagawa Hospital

Shinagawa-ku, 140-8522, Japan

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

RECRUITING

Kaiseikai Kita Shin Yokohama Internal Medicine Clinic

Yokohama, 223-0059, Japan

COMPLETED

Allergy Clinic Homeo Medicus

Bialystok, 15-687, Poland

RECRUITING

Uniwersyteckie Centrum Kliniczne

Gdansk, 80-214, Poland

RECRUITING

Nzoz Atopia

Krakow, 31-142, Poland

RECRUITING

Szpital Specjalistyczny Cdt Medicus

Lubin, 59-300, Poland

COMPLETED

Ostrowieckie Centrum Medyczne Spka Cywilna Anna Olech-Cudzik Krzysztof Cudzik

Ostrowiec Świętokrzyski, 27-400, Poland

RECRUITING

Pim Mswia

Warsaw, 02-507, Poland

COMPLETED

Giromed Institute/ Clinica Tres Torrres

Barcelona, 08017, Spain

RECRUITING

Hospital Clinic Barcelona Main

Barcelona, 08036, Spain

RECRUITING

Related Links

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

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Central Study Contacts

Incyte Corporation Call Center (US)

CONTACT

1.855.463.3463; medinfo@incyte.com

Incyte Corporation Call Center (ex-US)

CONTACT

+800 00027423; eumedinfo@incyte.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 24, 2023
• First Posted: May 9, 2023
• Study Start: July 11, 2023
• Primary Completion (Estimated): June 15, 2026
• Study Completion (Estimated): January 31, 2027
• Last Updated: April 14, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Data will be shared after the primary publication or 2 years after the study has ended for market authorized products and indications.
• 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.

Locations

AR (22); DE (5); CA (7); US (26); PL (6); ES (2); JP (15)