Study on the Effects of Povorcitinib for Adults with Moderate to Severe Asthma Not Well Controlled

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What is this study about?

This clinical trial is focused on studying the effects of a medication called Povorcitinib (also known by its code name INCB054707) in adults who have moderate to severe asthma that is not well controlled. Asthma is a condition where the airways in the lungs become inflamed and narrow, making it difficult to breathe. The purpose of the study is to evaluate how different doses of Povorcitinib affect lung function in these patients.

Participants in the study will be randomly assigned to receive either Povorcitinib or a placebo, which is a substance with no active medication. The study is designed to be double-blind, meaning neither the participants nor the researchers will know who is receiving the actual medication or the placebo. This helps ensure that the results are not biased. The treatment will be administered in the form of tablets taken orally, and the study will last for a period of time during which the effects on lung function and the safety of the medication will be closely monitored.

The study aims to provide valuable information on the potential benefits and safety of Povorcitinib for people with inadequately controlled asthma. By exploring different dosing regimens, researchers hope to find the most effective way to improve breathing and reduce asthma symptoms in patients who have not found relief with their current treatments. The results of this study could lead to new treatment options for those struggling with this challenging condition.

1 initial assessment

Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes a review of medical history and current asthma condition.

A negative urine pregnancy test is required for women of childbearing potential.

2 baseline evaluation

A baseline evaluation is performed to measure lung function. This involves a test called FEV1, which measures how much air you can exhale in one second.

The baseline evaluation helps determine the starting point for measuring changes in lung function throughout the study.

3 randomization and treatment assignment

Participants are randomly assigned to receive either Povorcitinib or a placebo. This ensures that the study results are unbiased.

The medication is provided in tablet form and is taken orally.

4 treatment phase

During the treatment phase, Povorcitinib is administered in one of three dosing regimens. The specific dosage and frequency are determined by the study protocol.

Participants continue their regular asthma medication regimen, which includes medium- to high-dose inhaled corticosteroids and long-acting beta-agonists (ICS-LABA).

5 monitoring and follow-up

Regular monitoring is conducted to assess lung function and overall health. This includes periodic FEV1 tests and tracking of asthma symptoms.

Participants are required to report any asthma exacerbations, which are episodes of worsening asthma symptoms.

6 end of treatment evaluation

At the end of the treatment period, a final evaluation is conducted to measure changes in lung function from the baseline.

The primary focus is on the absolute change in pre-BD FEV1 at Week 24.

7 study completion

Upon completion of the study, participants may receive information about the overall study results.

The study is estimated to conclude by June 28, 2025.

Who Can Join the Study?

Must be able to understand and willing to sign a written consent form for the study.
Must agree to use birth control methods as outlined in the study protocol.
Must be willing and able to follow the study rules and procedures.
Women of childbearing potential must have a negative urine pregnancy test.
Must have taken their asthma medication (ICS-LABA) at least 11 times in the morning or evening in the last 14 days before the study starts.
Must have a lung function test result (FEV1) that is less than 80% of what is expected for their age and size, before using a bronchodilator, at specific visits.
Must have an asthma control test score (ACQ-6) of 1.5 or higher at the start of the study.
Must meet at least one of the following conditions in the week before the study starts:
- More than 2 days with asthma symptoms during the day or night.
- Used rescue medication on more than 2 days.
- Had at least 1 night waking up due to asthma.
Must be between 18 and 65 years old at the time of signing the consent form.
Must have asthma diagnosed by a doctor that requires treatment with medium- to high-dose ICS-LABA for at least 12 months before the study.
Must have been on a stable daily dose of medium- or high-dose ICS and a LABA for at least 3 months before the study.
Must agree to continue using a stable dose of medium- to high-dose ICS-LABA throughout the study.
Must have a documented history of lung function improvement (FEV1) of at least 12% and 200 mL after using a bronchodilator within 12 months before the study or at a specific visit.
Must have had at least 2 asthma flare-ups in the 12 months before the study but not in the 4 weeks before the study.
Must have an asthma control test score (ACQ-6) of 1.5 or higher at the time of screening.

Who Cannot Join the Study?

Patients who do not have moderate to severe asthma that is not well controlled.
Patients who are not within the specified age range for the study.
Patients who are not part of the specified clinical trial group.
Patients who are not male or female, as both genders are included in the study.
Patients who are considered part of a vulnerable population, which means they might need special protection or care.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Medizinische Hochschule Hannover	Hanover	Germany

Other Sites

Site Name	City	Country
Giromed Institute S.L.P.	Barcelona	Spain
IKF Pneumologie GmbH & Co. KG	Frankfurt	Germany
Universidade De Santiago De Compostela	Santiago De Compostela	Spain
Rheinische Friedrich-Wilhelms-Universitaet Bonn	Bonn	Germany
Fundacio De Recerca Clinic Barcelona-Institut D’Investigacions Biomediques August Pi I Sunyer	Barcelona	Spain
Centrum Diagnostyczno Terapeutyczne Medicus Sp. z o.o.	Lubin	Poland
Poradnia Alergologiczna NZOZ Homeo Medicus	Bialystok	Poland
Pmjmgwkuv Ilavonqf Mlvskudc Megziheayaap Smqlb Wpypdockuetx I Ayumdcivcnhgj	Warsaw	Poland
Oswkbaaktqod Coytbzd Miomboiy Alnf Oeepv Cqazfs Kcpeztxpb Clukdx sauy	Ostrowiec Swietokrzyski	Poland
Uqqkqyuqxtssod Ctbgtzf Kqmtzdsst	Gdansk	Poland
Krua Gopz	Bendorf	Germany
Nhfs Ppzidnet Sqpwpgfcwnzogpd Avfchg Gvzpszk Jtstiwvnmpfytqi	Cracow	Poland

Trial status

Country	Status	Recruitment Start
Germany	Not recruiting	31.07.2024
Poland	Not recruiting	31.07.2024
Spain	Not recruiting	31.07.2024

Trial locations

Investigated drugs:

Povorcitinib

Povorcitinib is a medication being studied for its potential to help people with moderate to severe asthma that is not well controlled with current treatments. The trial is exploring different dosing regimens to see how it affects lung function, which is crucial for people with asthma. The goal is to determine if this medication can improve breathing and overall respiratory health in participants.

Asthma – Asthma is a chronic respiratory condition characterized by inflammation and narrowing of the airways, leading to difficulty in breathing. It often presents with symptoms such as wheezing, coughing, shortness of breath, and chest tightness. The severity of asthma can vary, with some individuals experiencing mild symptoms and others having more severe episodes. Asthma can be triggered by various factors, including allergens, exercise, cold air, and stress. Over time, if not managed properly, asthma can lead to frequent exacerbations, which are episodes of worsening symptoms. These exacerbations may require medical intervention, such as the use of systemic corticosteroids or emergency care.

Trial ID:

2022-502570-16-01

Protocol code:

INCB 54707-208

NCT ID:

NCT05851443

Trial Phase:

Therapeutic exploratory (Phase II)

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Study on the Effects of Povorcitinib for Adults with Moderate to Severe Asthma Not Well Controlled

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