A Phase 2 Clinical Study to Evaluate the Efficacy and Safety of Frevecitinib (KN-002) in Patients With Severe Asthma (PANAIRAMA)

A Phase 2 Randomized Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Three Doses of Frevecitinib (KN-002) in Patients With Severe Asthma

A Phase 2 Dose Ranging Study to Evaluate the Efficacy and Safety of Frevecitinib (KN-002) Over a 12-Week Treatment Period in Patients With Severe Asthma Not Controlled With Medium to High Dose ICS/LABA

Study Overview

• Status: Not yet recruiting
• Conditions: Severe Asthma
• Intervention / Treatment: Drug: Frevecitinib; Drug: Placebo

Detailed Description

A Phase 2 Randomized Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Three Doses of Frevecitinib (KN-002) in Patients With Severe Asthma Not Adequately Controlled With Medium to High Dose ICS/LABA Therapy

• Study Type: Interventional
• Enrollment (Estimated): 512
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • California
    • Lancaster, California, United States, 93534
      • Research Site
    • San Jose, California, United States, 95117
      • Research Site
  • Florida
    • Brandon, Florida, United States, 33511
      • Research Site
    • Miami, Florida, United States, 33137
      • Research Site
    • Tampa, Florida, United States, 33607
      • Research Site
  • Illinois
    • Chicago, Illinois, United States, 60612
      • Research Site
  • Missouri
    • Kansas City, Missouri, United States, 66160
      • Research Site
    • St Louis, Missouri, United States, 63141
      • Research Site
  • North Carolina
    • Charlotte, North Carolina, United States, 28277
      • Research Site
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15213
      • Research Site
  • South Carolina
    • Rock Hill, South Carolina, United States, 29732
      • Research Site
  • Texas
    • Dallas, Texas, United States, 75225
      • Research Site
    • Houston, Texas, United States, 77099
      • Research Site
    • San Antonio, Texas, United States, 78258
      • Research Site
  • Virginia
    • Williamsburg, Virginia, United States, 23188
      • Research Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

Capable of understanding the written informed consent, provides signed and witnessed written informed consent prior to any study-related procedures, and agrees to comply with protocol requirements.

Body mass index between 18 to 40 kg/m2 and weight ≥40 kg at screening.

Documented physician-diagnosed asthma for at least 12 months prior to screening.

Has received a physician-prescribed asthma controller regimen with medium dose or high dose ICS plus LABA, with or without additional controller medications for at least 6 months prior to screening and the dose of ICS and additional controller(s) must be stable for at least 4 weeks prior to screening and throughout the screening/run-in period.

Has a pre-bronchodilator FEV1 value of ≥40% and ≤80%, predicted, at screening and at Day 1.

Has a post-bronchodilator reversibility of FEV1 ≥12% and ≥200 mL documented during screening (15 to 30 min after administration of 4 puffs of albuterol/salbutamol).

Has an ACQ-6 score of ≥1.5 during screening (ie, Visit 1 and Visit 2).

Has a documented history of at least 1 asthma exacerbation in the 12 months prior to the screening visit, while using medium to high dose ICS/LABA therapy

Acceptable inhaler, peak flow meter, and spirometry techniques during the screening/run-in period.

≥80% compliance with required use of the ePRO device within the last 14 days of the screening/run-in period.

Females of childbearing potential who are sexually active with a non-sterilized male partner must use a highly effective method of contraception from the time informed consent is obtained and must agree to continue using such precautions throughout the study and continue using such precautions for 16 weeks after the final dose of study treatment.

Exclusion Criteria:

Current smokers or participants with a smoking history of ≥10 pack years

Participants with a current history of angina or history of myocardial infarction, stroke, or TIAs within the past 12 months from screening are disallowed.

Participants with a history of pulmonary embolic or thrombotic events, or genetic or autoimmune (eg anti-phospholipid syndrome) predisposition for thrombosis are disallowed.

Any concomitant respiratory disease that, in the opinion of the investigator and/or medical monitor, will interfere with the evaluation of the investigational product or interpretation of participant safety or study results

Any clinically relevant abnormal findings in hematology, clinical chemistry, coagulation, or urinalysis (laboratory results from visit), physical examination, vital signs during the screening/run-in period which, in the opinion of the investigator, may put the participant at risk because of his/her participation in the study

Evidence of active liver disease including jaundice or AST, ALT, or bilirubin greater than twice the upper limit of normal.

History of cancer

Participants with a respiratory tract infection that has not fully resolved by screening, or who experience an RTI during screening or at Day 1.

Evidence of a clinically significant infection or receiving treatment with systemic antibiotic, anti-parasitic, or antiviral medications at Day 1.

Known history of active TB or a positive QFT-G test for TB during screening.

A positive hepatitis B surface antigen, or hepatitis C virus antibody serology at screening, or a positive medical history for hepatitis B or C.

A positive human immunodeficiency virus test at screening or participant taking antiretroviral medications, as determined by medical history and/or participants verbal report.

History of sensitivity to any component of the investigational product formulation or a history of drug or other allergy that, in the opinion of the investigator or medical monitor contraindicates their participation.

Use of oral or topical JAK inhibitors for any reason or use of immunosuppressive medication (eg, methotrexate, troleandomycin, oral gold, cyclosporine, azathioprine, intramuscular long-acting depot glucocorticoid, or any experimental anti-inflammatory therapy) within 3 months prior to screening and throughout the study.

Receipt of any investigational nonbiologic agent within 30 days or 5 half-lives prior to screening, whichever is longer and throughout the study.

Prescription of regular daily oral corticosteroids within 4 weeks prior to screening or during the screening/run-in period and throughout the study.

Systemic glucocorticoid burst including taper within 15 days prior to screening or during the screening/run-in period and throughout the study.

Prescription of concomitant parenteral monoclonal antibody therapy for the management of asthma or any other condition within a specified period prior to the screening visit

Pregnant, breastfeeding, or lactating females.

History of chronic alcohol or drug abuse within 12 months prior to screening, as determined by the investigator.

Planned surgical procedures requiring general anesthesia or in-patient status for >1 day during the conduct of the study.

Receipt of any live or attenuated vaccines within 15 days prior to screening.

Participants who have undergone bronchial thermoplasty.

Prolonged QTcF >470 ms at screening or baseline.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Frevecitinib Dose 1; Drug: Frevecitinib	Drug: Frevecitinib; Frevecitinib (KN-002) delivered via a dry powder inhaler (DPI)
Experimental: Frevecitinib Dose 2; Drug: Frevecitinib	Drug: Frevecitinib; Frevecitinib (KN-002) delivered via a dry powder inhaler (DPI)
Experimental: Frevecitinib Dose 3; Drug: Frevecitinib	Drug: Frevecitinib; Frevecitinib (KN-002) delivered via a dry powder inhaler (DPI)
Placebo Comparator: Frevecitinib (KN-002) matching placebo; Placebo	Drug: Placebo; Matching placebo to frevecitinib

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pre-BD FEV1	Change from baseline in pre-bronchodilator forced expiratory volume in 1 second	Week 12

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
ACQ-6	Change from baseline in Asthma Control Questionnaire 6 which includes 6 questions about asthma symptoms and rescue medication use with responses between 0 and 6 with a higher score reflecting greater level of uncontrolled disease.	Week 12
Peak expiratory flow (PEF)	Change from baseline in Peak expiratory flow	Week 12
AQLQ	Change from baseline in Asthma Quality of Life Questionnaire which includes 32 items and 4 domains. A global score is calculated ranging from 1 to 7 and a score by domain. Higher scores indicate better quality of life.	Week 12
Daily asthma symptom score	Change from baseline in average daily asthma symptom scores	Week 12
CompEx	Rate and time to first CompEx event. CompEx Asthma is an exacerbation related endpoint that captures acute worsening events via evaluation of measures including symptoms, peak expiratory flow, severe asthma exacerbation events and rescue medication use	Week 12
Pharmacokinetics (PK)	Levels of frevecitinib (KN-002) in plasma	Week 12
Change from baseline in fractional exhaled nitric oxide (FeNO)	FeNO measures provide an assessment of airway inflammation	Week 12

Collaborators and Investigators

• Sponsor: Kinaset Therapeutics Inc

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): November 30, 2027
• Study Completion (Estimated): November 30, 2027

Study Registration Dates

• First Submitted: April 8, 2026
• First Submitted That Met QC Criteria: April 8, 2026
• First Posted (Actual): April 15, 2026

Study Record Updates

• Last Update Posted (Actual): April 20, 2026
• Last Update Submitted That Met QC Criteria: April 15, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: KN-002 frevecitinib Phase 2 dose ranging; JAK JANUS kinase
• Additional Relevant MeSH Terms: Immune System Diseases; Respiratory Tract Diseases; Lung Diseases; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Asthma
• Other Study ID Numbers: KN-002/2/001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No