POVORCITINIB for Asthma

Inclusion criteria

• {"criterion_text":"- Ability to comprehend and willingness to sign a written ICF for the study.\n- Agreement to use contraception (see Appendix A of the Protocol).\n- Willing and able to comply with the study protocol and procedures.\n- Negative urine pregnancy test (WOCBP only).\n- Inclusion Criteria No. 13 described in Protocol Section 5.1 “Inclusion Criteria”.\n- Minimum compliance with ICS-LABA doses as captured in the daily eDiary during the run-in period by having at least any 11 morning and/or any 11 evening dosing days completed in the last 14 days prior to D1/BL.\n- Pre-BD FEV1 < 80% predicted according to central overread value at either Visit 3 or D1/BL.\n- ACQ-6 ≥ 1.5 at D1/BL.\n- Fulfilment of at least 1 of the following conditions over the 7 days prior to D1/BL: a. > 2 days with a daytime or nighttime symptom score ≥ 1. b. Rescue medication use on > 2 days. c. ≥ 1 nocturnal awakening due to asthma.\n- Women and men 18 to 65 years of age at the time of signing the ICF.\n- Physician-diagnosed asthma requiring treatment with medium- to high-dose ICS-LABA for at least 12 months prior to screening.\n- Documented treatment with a stable daily dose of medium-dose or high-dose ICS and a LABA for at least 3 months prior to screening (see Appendix F of the Protocol).\n- Agreement to use a medium- to high-dose ICS-LABA at a stable dose from screening through the duration of the study (see Appendix F of the Protocol).\n- Pre-BD FEV1 < 80% predicted according to central overread value at Visit 2.\n- Documented historical post-BD reversibility of FEV1 ≥ 12% and ≥ 200 mL in FEV1 within 12 months prior to screening OR Post-BD reversibility of FEV1 ≥ 12% and ≥ 200 mL in FEV1 according to central overread value at Visit 2.\n- At least 2 documented asthma exacerbations within 12 months prior to screening but not within the past 4 weeks prior to screening (see Protocol Section 8.1.6.2).\n- ACQ-6 ≥ 1.5 at screening."}

Exclusion criteria

• {"criterion_text":"- Experience 1 asthma exacerbation during screening/run-in. (see Section 5.4.1 of the protocol).\n- At the screening visit, any of the laboratory abnormalities defined in Table 7 of the protocol.\n- Evidence of infection with Mycobacterium tuberculosis (ie, TB) as defined in Section 8.3.5.2 of the protocol.\n- Women who are pregnant (or who are considering pregnancy) or breastfeeding.\n- Active HIV or acquired immunodeficiency syndrome. Active HIV is defined as a confirmed positive anti-HIV antibody test (see Section 8.3.5.3 of the protocol).\n- Exclusion Criteria No. 9 described in Protocol Section 5.2 “Exclusion Criteria”.\n- Undergone significant trauma or major surgery (per investigator's assessment) within 30 days prior to screening.\n- Planned or expected major surgery during the initial 24 weeks of treatment with study drug (ie, during the PC period of the study).\n- History of clinically significant (per investigator's judgment) drug or alcohol abuse within 6 months prior to screening.\n- Exclusion Criteria No. 15 described in Protocol Section 5.2 “Exclusion Criteria”.\n- Exclusion Criteria No. 16 described in Protocol Section 5.2 “Exclusion Criteria”.\n- Acute upper or lower respiratory infections requiring antibiotics or antiviral medication within 4 weeks prior to screening.\n- Concurrent enrollment in another clinical study.\n- Evidence of HBV or HCV infection or risk of reactivation (see Section 8.3.5.4 of the protocol).\n- Known hypersensitivity or severe reaction to povorcitinib or excipients of povorcitinib (refer to the IB) and/or other products in the same class.\n- Any condition, laboratory result, or result of screening assessments that would, in the investigator's and sponsor's (or designee's) judgment, interfere with full participation in the study, including administration of study drug and attending required study visits, pose a significant risk to the participant, or interfere with interpretation of study data.\n- The following participants are excluded in France: vulnerable populations according to article L.1121-6 of the French Public Health Code and adults under legal protection or who are unable to express their consent per article L.1121-8 of the French Public Health Code.\n- A screening 12-lead ECG that demonstrates clinically significant abnormalities requiring treatment or that is indicative of serious underlying heart disease or criteria associated with QT/QTcF abnormalities.\n- Experience more than 1 asthma exacerbation during screening/run-in.\n- Inability to use acceptable inhaler technique or to perform PEF and spirometry assessments.\n- Maintenance use of asthma controllers other than ICS-LABA (see Section 6.6.7 of the protocol).\n- Receipt or initiation of medical treatment or procedures used for asthma management.\n- Have undergone bronchial thermoplasty.\n- Current smokers or participants with a smoking history of ≥ 10 pack-years and participants using vaping products, including electronic cigarettes. Note: Former smokers with a smoking history of <10 pack-years and users of vaping or e-cigarette products must have stopped for at least 6 months prior to screening to be eligible."}

Primary endpoints

• {"endpoint_text":"- Absolute change from baseline in pre-BD FEV1 at Week 24","definition_or_measurement_approach":"Absolute change from baseline in pre-bronchodilator (pre-BD) FEV1 at Week 24 (pre-BD FEV1 measured by spirometry)."}

Secondary endpoints

• {"endpoint_text":"- Number of asthma exacerbations during the PC period, defined as a worsening of asthma that leads to any of the following: − Use of systemic CS for at least 3 consecutive days; a single depo-injectable dose of CS will be considered equivalent to a 3-day course of systemic CS","definition_or_measurement_approach":"Number of asthma exacerbations during the placebo-controlled (PC) period; exacerbation defined as worsening of asthma leading to use of systemic corticosteroids for ≥3 consecutive days (a single depo-injectable dose equivalent to a 3-day systemic CS course)."}
• {"endpoint_text":"- An emergency department or urgent care visit (defined as evaluation and treatment for < 24 hours in an emergency department or urgent care center) due to asthma that required use of systemic CS (as noted above)","definition_or_measurement_approach":"Event defined as ED/urgent care evaluation and treatment for <24 hours due to asthma that required systemic corticosteroids."}
• {"endpoint_text":"- An inpatient hospitalization (defined as admission to an inpatient facility and/or evaluation and treatment in a healthcare facility for ≥ 24 hours) due to asthma","definition_or_measurement_approach":"Event defined as inpatient admission or evaluation/treatment in a healthcare facility for ≥24 hours due to asthma."}

Methods

• Doctor-to-doctor contact / Dr-to-Dr emails (documents: K2_Recruitment material doctor to doctor mail; K2_Recruitment material_Dr to dr_email_ES) — HCP-targeted communications
• Patient brochures and patient-facing recruitment materials (documents: K2_ Recruitment material patient brochure; K1_Patient Brochure; K2_Recruitment material_Brochure_ES) — patient-targeted printed/digital brochures
• Advertisements (document: K1_Advertisement) — recruitment advertisement material
• Patient engagement platform materials (PatientGo) and related policies (documents: K1_PatientGo_Reimbursement Policy_Redacted; L2_Other subject information material_PatientGO Supplemental ICF; L2_Other subject information material_PatientGO Reimbursement Policy) — patient-facing digital platform documented

Spain

Earliest CTIS Part Ii Submission Date

22-02-2024

Latest Decision Or Authorization Date

27-05-2024

Processing Time Days

95

Number Of Sites

3

Number Of Participants

28

Germany

Earliest CTIS Part Ii Submission Date

22-02-2024

Latest Decision Or Authorization Date

28-05-2024

Processing Time Days

96

Number Of Sites

5

Number Of Participants

28

Poland

Earliest CTIS Part Ii Submission Date

26-04-2024

Latest Decision Or Authorization Date

31-05-2024

Processing Time Days

35

Number Of Sites

6

Number Of Participants

28

Primary sponsor

Full Name

Incyte Corp.

Organisation Type

Pharmaceutical company

Country Of Registered Address

United States

Contract research organisations

Name

Syneos Health Netherlands B.V.

Responsibilities

sponsorDuties codes: 1,10,11,12,5,6,7

Name

Suvoda LLC

Responsibilities

sponsorDuties codes: 3

Third parties

• {"country":"Netherlands","full_name":"Syneos Health Netherlands B.V.","duties_or_roles":"sponsorDuties codes: 1,10,11,12,5,6,7","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Suvoda LLC","duties_or_roles":"sponsorDuties codes: 3","organisation_type":"Non-Pharmaceutical company"}