Povorcitinib for Asthma

Recruiting at 96 trial locations

Overseen By Incyte Corporation Call Center (ex-US)

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Incyte Corporation

Must be taking: ICS-LABA

Must not be taking: Biologic drugs

Disqualifiers: Smoking, Pregnancy, Heart failure, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 24 weeks

240 Participants Needed

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. ^{1 2 3 4 5}

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. ^{1 2 6 7 8}

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

I've had at least 2 severe asthma attacks in the last year but none in the past month.

Your ACQ-6 score is 1.5 or higher during screening.

I have asthma treated with strong inhalers for at least a year.

Exclusion Criteria

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

I have a condition that weakens my immune system.

I use asthma control medication that is not a combination of ICS and LABA.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive stable background therapy with ICS-LABA in combination with povorcitinib or placebo once daily for 24 weeks

24 weeks

Extension

Participants continue to take the same dose of povorcitinib during the extension period

28 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

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?

Group I: ICS-LABA + povorcitinib Dose 3 Experimental Treatment 2 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 2 Experimental Treatment 2 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 1 Experimental Treatment 2 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) + placebo Placebo Group 2 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

Who Is Running the Clinical Trial?

Incyte Corporation

Lead Sponsor

Trials

408

Recruited

66,800+

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-trial

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 ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT05851443

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 ...

4. afp.com afp.com/en/infos/incyte-announces-new-24-week-phase-3-data-stop-hs-clinical-trial-program-povorcitinib

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.pdf

Efficacy 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 ...

6. incytemi.com incytemi.com/pipeline/resource/NCT05851443?utm_source=linkedin&utm_medium=paidsocial&utm_campaign=infl-auto&utm_id=paidsocialgvy2

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-evaluating

Incyte 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 ( ...

8. healio.com healio.com/news/dermatology/20250317/new-data-support-efficacy-safety-of-povorcitinib-for-hidradenitis-suppurativa

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 ...