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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 weeks

Awards & highlights

Study Summary

This trial will test if a new drug can help people with chronic spontaneous urticaria (hives) that isn't well-controlled with existing treatments.

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.Check my eligibility

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.See study design

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

Select...

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

Select...

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.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change from baseline in the urticaria activity score (UAS7)

Secondary outcome measures

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

Placebo

1995

Completed Phase 3

~2670

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Incyte CorporationLead Sponsor

365 Previous Clinical Trials

55,159 Total Patients Enrolled

Media Library

Povorcitinib (Tyrosine Kinase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT05936567 — Phase 2

Angioedema Research Study Groups: Povorcitinib Dose B, Povorcitinib Dose C, Placebo followed by Povorcitinib Dose A, B, or C, Povorcitinib Dose A

Angioedema Clinical Trial 2023: Povorcitinib Highlights & Side Effects. Trial Name: NCT05936567 — Phase 2

Povorcitinib (Tyrosine Kinase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05936567 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there still vacancies for patients to join this experiment?

"As per information found on clinicaltrials.gov, this research project is actively seeking patients and has been since July 31st 2023 when it was first posted; the data was last edited by researchers on August 11th of the same year."

Answered by AI

What is the current scope of this medical study in our state's health centers?

"Currently, 39 sites are participating in this trial, including the Center For Dermatology and Plastic Surgery in Scottsdale, Arkansas Research Trials in North Little Rock, First Oc Dermatology in Fountain Valley - among other clinical locations."

Answered by AI

To what degree could Povorcitinib Dose A pose a hazard to individuals?

"Due to the Phase 2 status of this medication, our team at Power assigned a score of 2 on safety. Thus far, there is evidence indicating its security but no data supporting efficacy."

Answered by AI

What is the present size of this research program's participant pool?

"Affirmative, clinicaltrials.gov data suggest that this trial is actively enrolling patients. The protocol was initially advertised on July 31st 2023 and the information has since been updated on August 11th of the same year. 136 participants are required from 39 different sites for this study to reach its goals."

Answered by AI

Is there a minimum age requirement to participate in this medical experiment?

"Patients aged 18-65 are eligible to participate in this trial. For those below the age of consent, there exist an additional 16 trials, and for patients over 65 years old there is a supplementary 45 medical studies available."

Answered by AI

Who can participate in this clinical experimentation?

"This medical trial is in search of 136 individuals aged 18 to 65 with a current diagnosis of angioedema. Furthermore, the applicants must have had CSU for at least 3 months prior to screening and be resistant to second-generation H1 antihistamines; they must also agree to remain on stable doses throughout the study period. Additionally, full willingness and capability regarding compliance with Protocols are essential prerequisites for inclusion into this research project."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Study Evaluating the Efficacy and Safety of Povorcitinib in Adults With Chronic Spontaneous Urticaria

2023. "Study Evaluating the Efficacy and Safety of Povorcitinib in Adults With Chronic Spontaneous Urticaria". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05936567.

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