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Moderate to Severe AsthmaPhase 2NCT05851443

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

A Phase 2 study testing povorcitinib and ICS-LABA in people with Moderate to Severe Asthma, run by Incyte Corporation at 82 sites in 7 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial summary

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

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Moderate to Severe Asthma
What is being tested?
povorcitinib and ICS-LABA
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
247 participants
Where
82 sitesin 7 countries
Study dates
11 Jul 2023to 5 Jul 2027
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 13Show fewer
  • 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

Trial locations and contacts

82 sites in 7 countries.

82 sites in 7 countries

United States26 sites

  • Advanced Clinical Research Atlanta

    Atlanta, Georgia, 30309

  • Howland Allergy and Asthma Pllc Dba Orion Clinical Research

    Austin, Texas, 78759

  • Kern Allergy Medical Clinic, Inc

    Bakersfield, California, 93301

  • Allervie Clinical Research

    Birmingham, Alabama, 35209

  • Onsite Clinical Solutions, Llc Charlotte Central Office

    Charlotte, North Carolina, 28277

  • Henry Ford Hospital

    Detroit, Michigan, 48202

  • Covenant Pulmonary Critical Care

    East Point, Georgia, 30344

  • Aa Medical Research Center

    Flint, Michigan, 48504

  • Northshore Medical Group

    Glenview, Illinois, 60026

  • Qway Research

    Hialeah, Florida, 33010

  • Direct Helpers Research Center

    Hialeah, Florida, 33012

  • Care Research Inc

    Miami, Florida, 33130

  • Verus Clinical Research Corp

    Miami, Florida, 33135

  • Dr. de Armas Research Center, Llc

    Miami, Florida, 33174

  • Care Research Center, Inc

    Miami, Florida, 33175

  • Northwell Health Physician Partners

    New Hyde Park, New York, 11040

  • Pioneer Clinical Research Ny

    New York, New York, 10016

  • Anderson Allergy and Asthma

    Orlando, Florida, 32806

  • Heuer Md Research Inc

    Orlando, Florida, 32819

  • Linq Research, Llc

    Pearland, Texas, 77584

  • Temple University Hospital

    Philadelphia, Pennsylvania, 19140

  • Clinical Research of Rock Hill

    Rock Hill, South Carolina, 29732

  • Quality Assurance Research Center

    San Antonio, Texas, 78212

  • Revive Research Institute

    Southfield, Michigan, 48075

  • Montefiore Medical Center (Mmc)

    The Bronx, New York, 10461

  • Integrated Research of Inland, Inc

    Upland, California, 91786

Other trials in United States

Argentina22 sites

  • Fundacion Respirar

    Buenos Aires, 01426

  • Fundacion Cidea

    Buenos Aires, 1125 ABE

  • Mautalen Salud E Investigacion

    Buenos Aires, C1128AAF

  • Care: Centro de Alergia Y Enfermedades Respiratorias

    CABA, C1414AIF

  • INAER

    Capitalfederal, C1425BEN

  • Centro de Medicina Respiratoria

    Concepción del Uruguay, 03260

  • Instituto de Medicina Respiratoria - Imer

    Córdoba, X5003DCE

  • Fundacion Enfisema

    Mar del Plata, B7612ENA

  • Centro Medico Dharma

    Mendoza, 05500

  • Polo de Salud Vistalba

    Mendoza, 05509

  • Fundacion Scherbovsky

    Mendoza, M5500AXR

  • INSARES

    Mendoza, MENDOZA (5500)

  • Centro Respiratorio Quilmes

    Quilmes, 01878

  • Centro Respiratorio Infantil

    Rosario, 02000

  • Instituto de Diagnostico Abc

    Rosario, 02000

  • Instituto Especialidades de La Salud Rosario

    Rosario, 02000

  • Instituto Medico de La Fundacion Estudios Clinicos

    Rosario, S2000 DEJ

  • Centro Medico Respire

    San Fernando, 01644

  • Ierim Instituto de Enfermedades Respiratorias E Investigacion Medica

    San Juan Bautista, 01888

  • Ipr Instituto de Patologias Respiratorias

    San Miguel de Tucumán, 04000

  • Cimer - Centro Integral de Medicina Respiratoria Srl

    San Miguel de Tucumán, T4000 CBC

  • Iba Medica

    Santa Fe, S3000ASF

Other trials in Argentina

Japan15 sites

  • Nihonbashi Medical and Allergy Clinic

    Chūōku, 103-0022

  • Fukuwa Clinic

    Chūōku, 104-0031

  • National Hospital Organization Fukuoka National Hospital

    Fukuoka, 811-1394

  • Kishiwada City Hospital

    Kishiwada, 596-8501

  • Kirigaoka Tsuda Hospital

    Kitakyushu-shi, 802-0052

  • Tohno Chuo Clinic

    Mizunami-shi, 509-6134

  • Kyosokai Amc Nishi-Umeda Clinic

    Osaka, 530-0001

  • Lee Clinic

    Osaka, 531-0073

  • Sakaide City Hospital

    Sakaide-shi, 762-8550

  • Idaimae Minami Yojo Int Clinic

    Sapporo, 064-0804

  • Tokyo Shinagawa Hospital

    Shinagawa-ku, 140-8522

  • Takahashi Medical Clinic

    Tokyo, 185-0014

  • Kouwa Clinic

    Toshima-ku, 170-0003

  • Local Independent Administrative Institution Mie Prefectural General Medical Center

    Yokkaichi-shi, 510-8561

  • Kaiseikai Kita Shin Yokohama Internal Medicine Clinic

    Yokohama, 223-0059

Other trials in Japan

Canada6 sites

  • Dynamic Drug Advancement

    Ajax, Ontario, L1S2J5

  • Ottawa Allergy Research Corporation

    Ottawa, Ontario, K1H 1E4

  • Synergy Respiratory Care

    Sherwood Park, Alberta, T8H 0N2

  • Centre For Lung Health

    Vancouver, British Columbia, V5Z 1M9

  • S. Fikry Medicine Professional Corporation

    Waterloo, Ontario, N2J 1C4

  • Dr. Syed Anees Medicine Professional Corporation

    Windsor, Ontario, N8X 1T3

Other trials in Canada

Poland6 sites

  • Allergy Clinic Homeo Medicus

    Bialystok, 15-687

  • Uniwersyteckie Centrum Kliniczne

    Gdansk, 80-214

  • Nzoz Atopia

    Krakow, 31-142

  • Szpital Specjalistyczny Cdt Medicus

    Lubin, 59-300

  • Ostrowieckie Centrum Medyczne Spka Cywilna Anna Olech-Cudzik Krzysztof Cudzik

    Ostrowiec Świętokrzyski, 27-400

  • Pim Mswia

    Warsaw, 02-507

Other trials in Poland

Germany5 sites

  • Pneumologische Gemeinschaftspraxis Kroker-Schaeben-Schmidt

    Bendorf, 56170

  • Universitatsklinikum Bonn Aoer

    Bonn, 53127

  • Ikf Pneumologie Frankfurt, Clinical Research Center Respiratory Diseases

    Frankfurt am Main, 60596

  • Hannover Medical School

    Hanover, 30625

  • Ikf Pneumologie Mainz

    Mainz, 55128

Other trials in Germany

Spain2 sites

  • Giromed Institute/ Clinica Tres Torrres

    Barcelona, 08017

  • Hospital Clinic Barcelona Main

    Barcelona, 08036

Other trials in Spain

About this study

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

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

Being tested
povorcitinib, placebo, ICS-LABA
Keywords
Asthma, Moderate to Severe, INCB54707, Povorcitinib, ICS-LABA
Medical subject headings
Asthma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • povorcitinibDrug

    Also called INCB54707

    povorcitinib

  • placeboOther

    placebo

  • ICS-LABADrug

    Background Therapy

Study groups in NCT05851443
Study groupRoleWhat they receive
Inhaled Corticoseroid Long Acting Beta-Agonist(ICS-LABA) + placeboPlacebo comparatorParticipants 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
Receives: Other: placebo; Drug: ICS-LABA
ICS-LABA + povorcitinib Dose 1ExperimentalParticipants 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
Receives: Drug: povorcitinib; Drug: ICS-LABA
ICS-LABA + povorcitinib Dose 2ExperimentalParticipants 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
Receives: Drug: povorcitinib; Drug: ICS-LABA
ICS-LABA + povorcitinib Dose 3ExperimentalParticipants 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
Receives: Drug: povorcitinib; Drug: ICS-LABA

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: Baseline ; Week 24

Secondary outcomes (7)

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

    Defined as a worsening of asthma

    Measured: Up to 28 weeks

  2. Absolute change from baseline in pre-BD FEV1 at each visit

    Measured: Up to 14 months

  3. Percent change from baseline in pre-BD FEV1 at each visit

    Measured: Up to 14 months

  4. Absolute change from baseline in post-BD FEV1 at week 24

    Measured: Baseline; Week 24

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

    Measured: Baseline; Week 24

  6. Absolute change from baseline in pre-BD FVC at each visit

    Measured: Up to 14 months

  7. Percent change from baseline in pre-BD FVC at each visit

    Measured: Up to 14 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 May 2023
  2. Study start11 Jul 2023
  3. Primary completion20 Nov 2026 (estimated)
  4. Study completion5 Jul 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
247 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05851443
Sponsor's protocol ID
INCB54707-208
Other IDs
2022-502570-16-00
Status last verified
Jul 2026
First submitted
24 Apr 2023
Last updated
7 Jul 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: 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

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing povorcitinib and ICS-LABA in people with Moderate to Severe Asthma, run by Incyte Corporation at 82 sites in 7 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 7 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 82 sites in United States, Argentina, Japan, Canada, Poland and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Absolute change in pre-bronchodilator forced expiratory volume in the first 1 second (pre-BD FEV1) (time frame: Baseline ; Week 24). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05851443.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jul 2026.

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