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Povorcitinib for Asthma

Recruiting in Palo Alto (17 mi)

+92 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Recruiting

Sponsor: Incyte Corporation

Must be taking: ICS-LABA

Must not be taking: Biologic drugs

Disqualifiers: Smoking, Pregnancy, Heart failure, others

Prior Safety Data

Trial Summary

What is the purpose of this trial?

This trial is testing a medication called povorcitinib to see if it can help people with lung function problems. The study is looking at three different doses to find out which one works best. The goal is to improve how well the lungs work.

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.

Research Team

Eligibility Criteria

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.

See 2 more

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.

See 9 more

Trial Timeline

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

Treatment Details

Interventions

ICS-LABA (Drug)
Placebo (Other)
Povorcitinib (Tyrosine Kinase Inhibitor)

Trial OverviewThe 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.

Participant Groups

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