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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 14 months
Awards & highlights

Study Summary

This trial tests 3 different doses of a drug to see how it improves lung function.

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.Check my eligibility
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.See study design
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
Select...
My lung function improved significantly after using a bronchodilator.
Select...
I've had at least 2 severe asthma attacks in the last year but none in the past month.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Absolute change in pre-bronchodilator forced expiratory volume in the first 1 second (pre-BD FEV1)
Secondary outcome measures
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

Find a Location

Who is running the clinical trial?

Incyte CorporationLead Sponsor
365 Previous Clinical Trials
55,055 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

Frequently Asked Questions

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

Has the US Food and Drug Administration sanctioned ICS-LABA + povorcitinib Dose 2 for use?

"As per our team's assessment, ICS-LABA + povorcitinib Dose 2 received a score of two on the safety scale as this is only in its second stage. While some data exists to confirm risk mitigation, there are no reports available yet that prove efficacy."

Answered by AI

Are individuals aged fifty and above eligible to participate in the experiment?

"This trial has established parameters for patient recruitment, where the minimum age to participate is 18 and maximum age is 65. For those below the lower limit or above the upper limit of this range, there are 138 studies available for minors and 198 suitable clinical trials for seniors."

Answered by AI

What number of participants has been recruited for this clinical trial?

"The protocol of this clinical trial necessitates 240 qualified individuals. Those who meet the requirements can seek to join at any one of two sites, such as Kern Allergy Medical Clinic Inc in Bakersfield, California and Jonathan Corren MD Inc in Los Angeles, Florida."

Answered by AI

Who meets the criteria to be accepted into this research project?

"This research trial is enrolling 240 adults aged 18-65, suffering from asthma. As part of the selection criteria, they must have a pre-bronchodilator forced expiratory volume in 1 second (FEV1) less than 80% predicted according to central over read value at Visit 2; display historical post-BD reversibility of FEV1 ≥ 12% and ≥ 200 mL in FEV1 within the last year or be able to do so during screening; document two exacerbations requiring systemic corticosteroids treatment, hospitalization or emergency department visits; and score an Asthma Control Questionnaire 6 greater"

Answered by AI

How many healthcare facilities are participating in this experiment?

"Currently, 56 different clinical sites are hosting this trial. Some of these include Bakersfield, Los Angeles and Hialeah. To reduce travel time for those considering enrolling, it is recommended to choose the nearest site available."

Answered by AI

Are there openings available for subjects in this research endeavor?

"Per the information on clinicaltrials.gov, this study is currently in search of qualified participants. It was first posted on July 11th 2023 and has since been updated to reflect any changes as recently as July 27th 2023."

Answered by AI

Who else is applying?

What site did they apply to?
Jonathan Corren Md, Inc
Heuer Md Research Inc
Pioneer Clinical Research Ny
Other
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria

How responsive is this trial?

Typically responds via
Phone Call
Most responsive sites:
  1. Pioneer Clinical Research: < 48 hours
Average response time
  • < 2 Days
Recent research and studies
clinicaltrials.govStudy
A Study to Evaluate the Efficacy and Safety Study of Povorcitinib in Participants With Inadequately Controlled Moderate to Severe Asthma
2023. "A Study to Evaluate the Efficacy and Safety Study of Povorcitinib in Participants With Inadequately Controlled Moderate to Severe Asthma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05851443.
~99 spots leftby Dec 2024
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