A Study to Evaluate the Efficacy and Safety Study of Povorcitinib in Participants With Inadequately Controlled Moderate to Severe Asthma

Conditions

• Moderate to Severe Asthma

Eligibility Criteria

Sex

ALL

Age

18 Years - 65 Years

Healthy Volunteers

Not accepted

Interventions

• povorcitinib — DRUG
  povorcitinib
• placebo — OTHER
  placebo
• ICS-LABA — DRUG
  Background Therapy

Study Details

The study is being conducted to evaluate the effect of 3 dosing regimens of povorcitinib on pulmonary function

Key Dates

Start date

Jul 11, 2023

Status verified

Apr 2026

Primary completion

Jun 15, 2026

Completion

Jan 31, 2027

Study Design

Enrollment

240 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Placebo Comparator: Inhaled Corticoseroid Long Acting Beta-Agonist(ICS-LABA) + placebo
  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
• Experimental: ICS-LABA + povorcitinib Dose 1
  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
• Experimental: ICS-LABA + povorcitinib Dose 2
  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
• Experimental: ICS-LABA + povorcitinib Dose 3
  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

Primary Outcome Measure

Absolute change in pre-bronchodilator forced expiratory volume in the first 1 second (pre-BD FEV1) [ Time Frame: Baseline ; Week 24 ]

Central Contacts

• Incyte Corporation Call Center (US)
  1.855.463.3463
  [email protected]
• Incyte Corporation Call Center (ex-US)
  +800 00027423
  [email protected]

Locations (26)

Find similar trials in Birmingham, AL

Related Studies

• Leveraging Pharmacogenomics in Asthma for Predication, Mechanism and Endotyping
  PHASE4 · Recruiting · University of California, San Diego · Scottsdale, Arizona
• CHEST: A Collaboration With Community HEalth Centers to Implement SmarT for Asthma
  PHASE4 · Recruiting · Washington University School of Medicine · St Louis, Missouri