What side effects are associated with this type of intervention?

Common treatments for angioedema include antihistamines, corticosteroids, and epinephrine. Antihistamines can cause drowsiness, dry mouth, and dizziness. Corticosteroids may lead to weight gain, high blood pressure, and increased risk of infections. Epinephrine can cause anxiety, palpitations, and tremors. For treatments similar to Povorcitinib, which is a Janus Kinase (JAK) inhibitor, known side effects from other JAK inhibitors include upper respiratory tract infections, headache, nasopharyngitis, and injection site reactions. Serious but less common side effects may include increased risk of blood clots and cardiovascular events.

What prior FDA approvals exist?

The FDA has approved several treatments for Angioedema, particularly for hereditary angioedema (HAE). These include C1 esterase inhibitors (such as Berinert and Cinryze), kallikrein inhibitors (such as Ecallantide), and bradykinin receptor antagonists (such as Icatibant). While Janus Kinase (JAK) inhibitors like Povorcitinib are being studied for various inflammatory conditions, there is limited specific information on their approval for Angioedema. Current treatments focus on targeting the underlying pathways involved in HAE rather than JAK inhibition.

What other types of research exist?

Promising, novel alternatives to Povorcitinib for Angioedema patients in 2024 could include Pazopanib, a multi-kinase inhibitor, and Avapritinib, a selective KIT D816V inhibitor. Both have shown efficacy in related conditions and could be considered for their potential benefits.

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Tyrosine Kinase Inhibitor

Povorcitinib for Chronic Spontaneous Urticaria

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

CSU refractory to second-generation H1 antihistamines

Participants must have been on a stable dose of second-generation H1 antihistamine, and must agree to maintain the stable dose of second-generation H1 antihistamine throughout study

Must not have

Clearly defined underlying etiology for chronic urticarias other than CSU

Women who are pregnant (or who are considering pregnancy) or breastfeeding

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 weeks

Summary

This trial is testing a new medication called povorcitinib for adults with a chronic skin condition called CSU. These patients haven't found relief with standard treatments. The medication works by reducing the body's overactive immune response.

Who is the study for?

Adults with Chronic Spontaneous Urticaria (CSU) not responding well to standard antihistamines can join. They must have had CSU for at least 3 months, be on a stable dose of second-generation H1 antihistamine, and stick to their current treatment plan during the trial. People with other chronic itching diseases or who've used certain biologics recently can't participate.

What is being tested?

The trial is testing Povorcitinib's effectiveness and safety in adults whose CSU isn't controlled by usual treatments. Participants will either receive Povorcitinib or a placebo without knowing which one they're getting to compare results fairly.

What are the potential side effects?

Possible side effects of Povorcitinib may include issues related to blood clotting, heart problems, infections due to immune system suppression, allergic reactions, and potentially others not listed here.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My chronic hives don't improve with standard allergy pills.

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I have been taking a consistent dose of a second-generation antihistamine and will continue to do so.

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I have been diagnosed with chronic spontaneous urticaria for at least 3 months.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My chronic hives have a known cause other than chronic spontaneous urticaria.

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I am not pregnant, considering pregnancy, or breastfeeding.

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I have had an organ transplant and am on ongoing immunosuppressants.

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I have a long-lasting or frequently returning infection.

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I have a history of serious blood, heart, or circulation problems.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change from baseline in the urticaria activity score (UAS7)

Secondary study objectives

Proportion of participants who achieve UAS7 ≤ 6 (controlled disease) at Week 12

Proportion of participants with UAS7 = 0 at Week 12.

Time to first achievement of UAS7 ≤ 6 (controlled disease) during the PC period

Trial Design

4Treatment groups

Experimental Treatment

Group I: Povorcitinib Dose CExperimental Treatment1 Intervention

Participants will receive dose C of povorcitinib for a 12 week period, followed by dose C for an additional 24 week period.

Group II: Povorcitinib Dose BExperimental Treatment1 Intervention

Participants will receive dose B of povorcitinib for a 12 week period, followed by dose B for an additional 24 week period.

Group III: Povorcitinib Dose AExperimental Treatment1 Intervention

Participants will receive dose A of povorcitinib for a 12 week period, followed by dose A for an additional 24 week period.

Group IV: Placebo followed by Povorcitinib Dose A, B, or CExperimental Treatment2 Interventions

Participants will receive placebo for a 12 week period, followed by randomization to either Dose A, Dose B, or Dose C for an additional 24 week period.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Povorcitinib

2024

Completed Phase 1

~170

Placebo

1995

Completed Phase 3

~2670

0 / 8Eligibility 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

Angioedema treatments often target the underlying inflammatory pathways to reduce swelling and prevent attacks. Common treatments include antihistamines, which block histamine receptors to reduce allergic reactions, and corticosteroids, which suppress the immune system to decrease inflammation. For hereditary angioedema, C1 esterase inhibitors are used to regulate the complement system. JAK inhibitors like Povorcitinib work by blocking the Janus kinase pathways, which are involved in the signaling of various cytokines that contribute to inflammation. This is particularly important for Angioedema patients as it helps to control the excessive immune response and reduce the frequency and severity of angioedema episodes.

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