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Tyrosine Kinase Inhibitor

Povorcitinib for Asthma

Verified Trial
Phase 2
Recruiting
Research Sponsored by Incyte Corporation
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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
Must not have
Maintenance use of asthma controllers other than ICS-LABA
Undergone bronchial thermoplasty
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 14 months
Awards & highlights

Summary

This trial is testing a medication called povorcitinib to see if it can help people with lung function problems. The study is looking at three different doses to find out which one works best. The goal is to improve how well the lungs work.

Who is the study for?
This trial is for people with moderate to severe asthma that's not well-controlled, despite using medium to high doses of ICS-LABA for at least a year. They should have had two serious asthma flare-ups in the past year but none in the last month. Pregnant or breastfeeding women, smokers, and those with other significant health issues like heart disease or immune problems can't join.
What is being tested?
The study tests three different doses of Povorcitinib on lung function compared to a placebo. Participants will continue their usual ICS-LABA treatment during the trial. The goal is to see if adding Povorcitinib improves breathing in people whose asthma isn't controlled by standard treatments.
What are the potential side effects?
Possible side effects of Povorcitinib may include respiratory symptoms, headaches, gastrointestinal discomforts such as nausea or diarrhea, potential allergic reactions, and an increased risk of infections due to its effect on the immune system.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My lung function improved significantly after using a bronchodilator.
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I've had at least 2 severe asthma attacks in the last year but none in the past month.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I use asthma control medication that is not a combination of ICS and LABA.
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I have undergone a procedure to treat my asthma.
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I currently smoke or have a history of smoking equivalent to 10 pack-years or more, or I use vaping products.
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I am not pregnant, considering pregnancy, or breastfeeding.
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I do not have serious lung problems, blood clotting issues, or platelet disorders besides asthma.
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I have not had serious heart issues, strokes, or blood clots.
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I do not have serious heart conditions like angina or uncontrolled heart rhythm problems.
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I have had an organ transplant and am on ongoing immunosuppressants.
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I have a condition that weakens my immune system.
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I have a long-lasting or frequently returning infection.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 14 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 14 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Absolute change in pre-bronchodilator forced expiratory volume in the first 1 second (pre-BD FEV1)
Secondary study objectives
Absolute change from baseline in post-BD FEV1 at week 24
Absolute change from baseline in pre-BD FEV1 at each visit
Absolute change from baseline in pre-BD FVC at each visit
+4 more

Trial Design

4Treatment groups
Experimental Treatment
Placebo Group
Group I: ICS-LABA + povorcitinib Dose 3Experimental Treatment2 Interventions
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
Group II: ICS-LABA + povorcitinib Dose 2Experimental Treatment2 Interventions
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
Group III: ICS-LABA + povorcitinib Dose 1Experimental Treatment2 Interventions
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
Group IV: Inhaled Corticoseroid Long Acting Beta-Agonist(ICS-LABA) + placeboPlacebo Group2 Interventions
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

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Asthma treatments primarily aim to reduce inflammation and relax airway muscles to improve breathing. Inhaled corticosteroids (ICS) reduce airway inflammation, while long-acting beta agonists (LABAs) relax the muscles around the airways, making it easier to breathe. Leukotriene receptor antagonists (LTRAs) block chemicals that cause inflammation and bronchoconstriction. Biologics, such as monoclonal antibodies, target specific molecules involved in the inflammatory process. Janus Kinase (JAK) inhibitors, like povorcitinib, work by blocking the JAK-STAT signaling pathway, which is involved in the immune response and inflammation. This is particularly important for asthma patients with severe or inadequately controlled symptoms, as it offers a targeted approach to reduce inflammation and improve lung function.

Find a Location

Who is running the clinical trial?

Incyte CorporationLead Sponsor
386 Previous Clinical Trials
57,613 Total Patients Enrolled

Media Library

Povorcitinib (Tyrosine Kinase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT05851443 — Phase 2
Asthma Research Study Groups: ICS-LABA + povorcitinib Dose 2, ICS-LABA + povorcitinib Dose 3, Inhaled Corticoseroid Long Acting Beta-Agonist(ICS-LABA) + placebo, ICS-LABA + povorcitinib Dose 1
Asthma Clinical Trial 2023: Povorcitinib Highlights & Side Effects. Trial Name: NCT05851443 — Phase 2
Povorcitinib (Tyrosine Kinase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05851443 — Phase 2
~28 spots leftby Dec 2024