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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 belowSelect...
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.
Select...
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:Select...
My chronic hives have a known cause other than chronic spontaneous urticaria.
Select...
I am not pregnant, considering pregnancy, or breastfeeding.
Select...
I have had an organ transplant and am on ongoing immunosuppressants.
Select...
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
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
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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Find a Location
Who is running the clinical trial?
Incyte CorporationLead Sponsor
393 Previous Clinical Trials
63,821 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have no cancer history, except for treated skin cancer or cervical pre-cancer.My chronic hives have a known cause other than chronic spontaneous urticaria.I am not pregnant, considering pregnancy, or breastfeeding.I have had an organ transplant and am on ongoing immunosuppressants.My chronic hives don't improve with standard allergy pills.I have been taking a consistent dose of a second-generation antihistamine and will continue to do so.I have been diagnosed with chronic spontaneous urticaria for at least 3 months.I have not taken anti-IgE medication like omalizumab in the last 8 weeks.I have a history of serious blood, heart, or circulation problems.I have a long-lasting or frequently returning infection.I have a skin or systemic condition that causes chronic itching or symptoms like hives or swelling.I am willing and able to follow the study's rules and procedures.
Research Study Groups:
This trial has the following groups:- Group 1: Placebo followed by Povorcitinib Dose A, B, or C
- Group 2: Povorcitinib Dose B
- Group 3: Povorcitinib Dose C
- Group 4: Povorcitinib Dose A
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.