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

NCT07532265 | Not Yet Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: KN-002/2/001
• Study Type: interventional
• Target: 512
• Locations: 1 country
• Sites: 15

Brief Summary

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

Conditions

Severe Asthma

Keywords

KN-002 frevecitinib Phase 2 dose ranging; JAK JANUS kinase

Outcome Measures

Primary Outcomes (1)

• Pre-BD FEV1

  Change from baseline in pre-bronchodilator forced expiratory volume in 1 second

  Week 12

Secondary Outcomes (7)

• ACQ-6

  Week 12

• Peak expiratory flow (PEF)

  Week 12

• AQLQ

  Week 12

• Daily asthma symptom score

  Week 12

• CompEx

  Week 12

Study Arms (4)

Frevecitinib Dose 1

EXPERIMENTAL

Drug: Frevecitinib

Drug: Frevecitinib

Frevecitinib Dose 2

EXPERIMENTAL

Drug: Frevecitinib

Drug: Frevecitinib

Frevecitinib Dose 3

EXPERIMENTAL

Drug: Frevecitinib

Drug: Frevecitinib

Frevecitinib (KN-002) matching placebo

PLACEBO COMPARATOR

Placebo

Drug: Placebo

Interventions

Frevecitinib DRUG

Frevecitinib (KN-002) delivered via a dry powder inhaler (DPI)

Frevecitinib Dose 1; Frevecitinib Dose 2; Frevecitinib Dose 3

Placebo DRUG

Matching placebo to frevecitinib

Frevecitinib (KN-002) matching placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Kinaset Therapeutics Inc: lead

Study Sites (15)

Research site

Lancaster, California, 93534, United States

Location

Research site

San Jose, California, 95117, United States

Location

Research site

Brandon, Florida, 33511, United States

Location

Research site

Miami, Florida, 33137, United States

Location

Research site

Tampa, Florida, 33607, United States

Location

Research site

Chicago, Illinois, 60612, United States

Location

Research site

Kansas City, Missouri, 66160, United States

Location

Research site

St Louis, Missouri, 63141, United States

Location

Research site

Charlotte, North Carolina, 28277, United States

Location

Research site

Pittsburgh, Pennsylvania, 15213, United States

Location

Research site

Rock Hill, South Carolina, 29732, United States

Location

Research site

Dallas, Texas, 75225, United States

Location

Research site

Houston, Texas, 77099, United States

Location

Research site

San Antonio, Texas, 78258, United States

Location

Research site

Williamsburg, Virginia, 23188, United States

Location

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 8, 2026
• First Posted: April 15, 2026
• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): November 30, 2027
• Study Completion (Estimated): November 30, 2027
• Last Updated: April 20, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (15)