What side effects are associated with this type of intervention?

Janus Kinase (JAK) inhibitors, such as tofacitinib and upadacitinib, are being explored for various inflammatory conditions, including asthma. Common side effects of JAK inhibitors include infections (e.g., upper respiratory infections, nasopharyngitis), headaches, nausea, and increased risk of venous thrombosis and pulmonary embolism. Other potential adverse effects include elevated liver enzymes and lipid levels, and a possible increased risk of malignancies. It is important for patients to discuss these risks with their healthcare provider to determine the most appropriate treatment plan.

What prior FDA approvals exist?

The FDA has approved several biologic treatments for asthma, particularly targeting severe cases with specific phenotypes. Notable examples include Mepolizumab, an IL-5 antagonist, and Dupilumab, which targets the IL-4 receptor alpha subunit. These treatments are designed to reduce inflammation and are used in patients with eosinophilic asthma or those who are dependent on oral corticosteroids. While Janus Kinase Inhibitors like Povorcitinib are being studied for their potential in asthma treatment, current FDA-approved treatments focus more on biologics targeting specific inflammatory pathways rather than Janus Kinase pathways.

What other types of research exist?

Promising novel alternatives to Povorcitinib for asthma patients include Baricitinib and Ruxolitinib, both of which are JAK inhibitors with potential utility in treating inflammatory conditions. Additionally, emerging therapies such as biologics targeting specific cytokines (e.g., IL-5, IL-4/IL-13) and small molecule inhibitors targeting other pathways involved in asthma pathogenesis may also be considered.

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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

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 14 months

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

0 / 12Eligibility criteria met

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.