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

Incyte

Status and phase: Enrolling; Phase 2

Conditions: Moderate to Severe Asthma

Treatments: Drug: ICS-LABA; Other: placebo; Drug: povorcitinib

Study type: Interventional

Funder types: Industry

Identifiers

NCT05851443

INCB54707-208

Details and patient eligibility

About

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

Enrollment: 240 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Physician-diagnosed asthma requiring treatment with medium- to high-dose ICS-LABA for at least 12 months prior to screening.
• Pre-BD FEV1 < 80% predicted according to central over read value at Visit 2.
• Documented historical post-BD reversibility of FEV1 ≥ 12% and ≥ 200 mL in FEV1.
• 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
• ACQ-6 ≥ 1.5 at screening.

Exclusion criteria

• Maintenance use of asthma controllers other than ICS-LABA.
• Have undergone bronchial thermoplasty.
• Current smokers or participants with a smoking history of ≥ 10 pack-years and participants using vaping products, including electronic cigarettes.
• Women who are pregnant (or who are considering pregnancy) or breastfeeding.
• Current conditions or history of other diseases, as follows:
• Clinically important pulmonary disease other than asthma ,Thrombocytopenia, coagulopathy, or platelet dysfunction.
• Venous and arterial thrombosis, deep vein thrombosis, pulmonary embolism, moderate to severe heart failure (NYHA Class III or IV), cerebrovascular accident, myocardial infarction, coronary stenting, or CABG surgery.
• Diagnosis of other significant cardiovascular diseases, including but not limited to angina, peripheral arterial disease, or uncontrolled arrhythmias such as atrial fibrillation, supraventricular tachycardia, ventricular tachycardia, and forms of carditis.
• Recipient of an organ transplant that requires continued immunosuppression.
• Immunocompromised (eg, lymphoma, acquired immunodeficiency syndrome, Wiskott-Aldrich syndrome).
• Any malignancies or history of malignancies.
• Chronic or recurrent infectious disease.
• Receipt of any biologic drugs used for asthma < 12 weeks or 5 half-lives (if known), whichever is longer, prior to screening

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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240 participants in 4 patient groups, including a placebo group

Inhaled Corticoseroid Long Acting Beta-Agonist(ICS-LABA) + placebo

Placebo Comparator group

Description:

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

Treatment:

Other: placebo

Drug: ICS-LABA

ICS-LABA + povorcitinib Dose 1

Experimental group

Description:

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

Treatment:

Drug: povorcitinib

Drug: ICS-LABA

ICS-LABA + povorcitinib Dose 2

Experimental group

Description:

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

Treatment:

Drug: povorcitinib

Drug: ICS-LABA

ICS-LABA + povorcitinib Dose 3

Experimental group

Description:

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

Treatment:

Drug: povorcitinib

Drug: ICS-LABA