Povorcitinib for Asthma
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests povorcitinib, an experimental drug, to determine its effect on lung function in people with asthma. Researchers aim to evaluate how three different doses of this medication perform when combined with standard asthma treatments. Suitable candidates for this trial include individuals who have had asthma for over a year, regularly use inhaled medication, and have experienced at least two serious asthma flare-ups in the past year. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, providing participants an opportunity to contribute to the development of new asthma therapies.
Do I need to stop my current medications for the trial?
The trial requires that you stop using asthma controllers other than ICS-LABA (a combination of inhaled corticosteroids and long-acting beta-agonists). If you are using any biologic drugs for asthma, you must stop them at least 12 weeks before the trial or longer if specified by the drug's half-life.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that povorcitinib was well tolerated in past studies. For instance, trials for conditions like hidradenitis suppurativa (a skin condition) revealed no new safety concerns. Participants taking 45 mg and 75 mg doses experienced no unexpected issues. This suggests that povorcitinib might be safe to use, but its safety for asthma remains under investigation in this trial.12345
Why are researchers excited about this trial's treatments?
Researchers are excited about povorcitinib for asthma because it offers a new approach by targeting specific pathways involved in inflammation differently from standard treatments. Most asthma treatments, like inhaled corticosteroids and long-acting beta-agonists (ICS-LABA), focus on reducing symptoms and controlling inflammation through broad mechanisms. Povorcitinib, however, is a JAK inhibitor, which means it specifically blocks certain enzymes that play a crucial role in the inflammatory process. This targeted action has the potential to enhance asthma control and improve outcomes for patients who may not respond optimally to existing therapies.
What evidence suggests that this trial's treatments could be effective for asthma?
Research has shown that povorcitinib may improve lung function in people with asthma. In this trial, participants will receive different doses of povorcitinib combined with ICS-LABA, or a placebo with ICS-LABA. Earlier studies found that patients taking povorcitinib had better results than those taking a placebo, which contains no active medicine. Early findings suggest that different doses of povorcitinib could help people with moderate asthma breathe better. Researchers are studying this treatment because it targets specific pathways that might reduce inflammation and improve breathing. While more information is needed, early results are promising for those considering joining clinical trials.12678
Are You a Good Fit for This Trial?
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.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive stable background therapy with ICS-LABA in combination with povorcitinib or placebo once daily for 24 weeks
Extension
Participants continue to take the same dose of povorcitinib during the extension period
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- ICS-LABA
- Placebo
- Povorcitinib
Trial Overview
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.
How Is the Trial Designed?
4
Treatment groups
Experimental Treatment
Placebo Group
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
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
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
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 Clinic Near You
Who Is Running the Clinical Trial?
Incyte Corporation
Lead Sponsor
Steven Stein
Incyte Corporation
Chief Medical Officer since 2015
MD from University of Witwatersrand
Hervé Hoppenot
Incyte Corporation
Chief Executive Officer since 2014
MBA from ESSEC Business School
Citations
1.
investor.incyte.com
investor.incyte.com/news-releases/news-release-details/incyte-announces-new-24-week-phase-3-data-stop-hs-clinical-trialIncyte Announces New 24-Week Phase 3 Data from the ...
In addition, at Week 12, more patients treated with povorcitinib compared to placebo, achieved HiSCR75 (a ≥75% reduction from baseline in the ...
NCT05851443 | A Study to Evaluate the Efficacy and ...
The study is being conducted to evaluate the effect of 3 dosing regimens of povorcitinib on pulmonary function.
3.
theglobeandmail.com
theglobeandmail.com/investing/markets/stocks/INCY/pressreleases/35743883/incytes-promising-phase-2-study-on-povorcitinib-for-asthma-a-market-game-changer/Incyte's Promising Phase 2 Study on Povorcitinib for Asthma
The study aims to evaluate the effectiveness of different doses of povorcitinib on improving pulmonary function in individuals with moderate ...
Incyte Announces New 24-Week Phase 3 Data from the ...
In addition, at Week 12, more patients treated with povorcitinib compared to placebo, achieved HiSCR75 (a ≥75% reduction from baseline in the ...
5.
incytemi.com
incytemi.com/document/Poster/EADV%202024_Kwatra_40-Wk%20Results%20From%20Phase%202%20Povo%20in%20PN%20Study.pdfEfficacy and Safety of Oral Povorcitinib in Patients With ...
Patients not meeting the definition of a responder were considered as nonresponders. ‡ Data for study visits calculated as the average of the ...
ASTHMA
The efficacy and safety of the investigational compound and/or uses discussed have not been established. There is no guarantee that this ...
7.
investor.incyte.com
investor.incyte.com/news-releases/news-release-details/incyte-presents-new-late-breaking-data-phase-2-study-evaluatingIncyte Presents New Late-Breaking Data from Phase 2 ...
This randomized, double-blind, placebo-controlled Phase 2 clinical trial is designed to evaluate the safety and efficacy of povorcitinib ( ...
New data support efficacy, safety of povorcitinib for ...
Povorcitinib was considered well tolerated with no new safety signals. Newly released data from the phase 3 STOP-HS clinical trial program ...
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