RecruitingPhase 2NCT05851443

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


Sponsor

Incyte Corporation

Enrollment

240 participants

Start Date

Jul 11, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

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


Eligibility

Min Age: 18 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new oral medication called povorcitinib — a drug that targets a specific immune signaling pathway (JAK1) — to see if it can reduce asthma attacks and improve breathing in people with moderate to severe asthma that is not adequately controlled by standard inhalers. **You may be eligible if...** - You have a confirmed asthma diagnosis requiring medium- to high-dose combination inhaler therapy for at least 12 months - Your lung function is below 80% of what's expected (pre-bronchodilator FEV1) - Your breathing improves with a bronchodilator (reliever inhaler), indicating reversible airflow limitation - You have had at least 2 asthma attacks in the past year requiring oral steroids or hospitalization **You may NOT be eligible if...** - You have another primary lung condition (like COPD) as a separate diagnosis - You are pregnant or breastfeeding - You have a history of certain serious infections (like tuberculosis) - You have significant heart, liver, or immune system problems - You are a current smoker with more than 10 pack-years of smoking history Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGpovorcitinib

povorcitinib

OTHERplacebo

placebo

DRUGICS-LABA

Background Therapy


Locations(83)

Allervie Clinical Research

Birmingham, Alabama, United States

Kern Allergy Medical Clinic, Inc

Bakersfield, California, United States

Integrated Research of Inland, Inc

Upland, California, United States

Qway Research

Hialeah, Florida, United States

Direct Helpers Research Center

Hialeah, Florida, United States

Care Research Inc

Miami, Florida, United States

Verus Clinical Research Corp

Miami, Florida, United States

Dr. de Armas Research Center, Llc

Miami, Florida, United States

Care Research Center, Inc

Miami, Florida, United States

Anderson Allergy and Asthma

Orlando, Florida, United States

Heuer Md Research Inc

Orlando, Florida, United States

Advanced Clinical Research Atlanta

Atlanta, Georgia, United States

Covenant Pulmonary Critical Care

East Point, Georgia, United States

Northshore Medical Group

Glenview, Illinois, United States

Henry Ford Hospital

Detroit, Michigan, United States

Aa Medical Research Center

Flint, Michigan, United States

Revive Research Institute

Southfield, Michigan, United States

Northwell Health Physician Partners

New Hyde Park, New York, United States

Pioneer Clinical Research Ny

New York, New York, United States

Montefiore Medical Center (Mmc)

The Bronx, New York, United States

Onsite Clinical Solutions, Llc Charlotte Central Office

Charlotte, North Carolina, United States

Temple University Hospital

Philadelphia, Pennsylvania, United States

Clinical Research of Rock Hill

Rock Hill, South Carolina, United States

Howland Allergy and Asthma Pllc Dba Orion Clinical Research

Austin, Texas, United States

Linq Research, Llc

Pearland, Texas, United States

Quality Assurance Research Center

San Antonio, Texas, United States

Fundacion Respirar

Buenos Aires, Argentina

Fundacion Cidea

Buenos Aires, Argentina

Mautalen Salud E Investigacion

Buenos Aires, Argentina

Care: Centro de Alergia Y Enfermedades Respiratorias

CABA, Argentina

INAER

Capitalfederal, Argentina

Centro de Medicina Respiratoria

Concepción del Uruguay, Argentina

Instituto de Medicina Respiratoria - Imer

Córdoba, Argentina

Fundacion Enfisema

Mar del Plata, Argentina

Centro Medico Dharma

Mendoza, Argentina

Polo de Salud Vistalba

Mendoza, Argentina

Fundacion Scherbovsky

Mendoza, Argentina

INSARES

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

Ierim Instituto de Enfermedades Respiratorias E Investigacion Medica

San Juan Bautista, Argentina

Ipr Instituto de Patologias Respiratorias

San Miguel de Tucumán, Argentina

Cimer - Centro Integral de Medicina Respiratoria Srl

San Miguel de Tucumán, Argentina

Iba Medica

Santa Fe, Argentina

Synergy Respiratory Care

Sherwood Park, Alberta, Canada

Centre For Lung Health

Vancouver, British Columbia, Canada

Dynamic Drug Advancement

Ajax, Ontario, Canada

Hamilton Allergy

Hamilton, Ontario, Canada

Ottawa Allergy Research Corporation

Ottawa, Ontario, Canada

S. Fikry Medicine Professional Corporation

Waterloo, Ontario, Canada

Dr. Syed Anees Medicine Professional Corporation

Windsor, Ontario, Canada

Pneumologische Gemeinschaftspraxis Kroker-Schaeben-Schmidt

Bendorf, Germany

Universitatsklinikum Bonn Aoer

Bonn, Germany

Ikf Pneumologie Frankfurt, Clinical Research Center Respiratory Diseases

Frankfurt am Main, Germany

Hannover Medical School

Hanover, Germany

Ikf Pneumologie Mainz

Mainz, Germany

Nihonbashi Medical and Allergy Clinic

Chūōku, Japan

Fukuwa Clinic

Chūōku, Japan

National Hospital Organization Fukuoka National Hospital

Fukuoka, Japan

Kishiwada City Hospital

Kishiwada, Japan

Kirigaoka Tsuda Hospital

Kitakyushu-shi, Japan

Tohno Chuo Clinic

Mizunami-shi, Japan

Kyosokai Amc Nishi-Umeda Clinic

Osaka, Japan

Lee Clinic

Osaka, 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, Japan

Allergy Clinic Homeo Medicus

Bialystok, Poland

Uniwersyteckie Centrum Kliniczne

Gdansk, Poland

Nzoz Atopia

Krakow, Poland

Szpital Specjalistyczny Cdt Medicus

Lubin, Poland

Ostrowieckie Centrum Medyczne Spka Cywilna Anna Olech-Cudzik Krzysztof Cudzik

Ostrowiec Świętokrzyski, Poland

Pim Mswia

Warsaw, Poland

Giromed Institute/ Clinica Tres Torrres

Barcelona, Spain

Hospital Clinic Barcelona Main

Barcelona, Spain

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NCT05851443


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