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

ConditionSevere Asthma
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorKinaset Therapeutics Inc

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

  • Frevecitinib

    Drug

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

  • Placebo

    Drug

    Matching placebo to frevecitinib

Treatment groups

512 Participants
are divided into 4 treatment groups
Group A: Frevecitinib Dose 1Experimental treatment 1 intervention
Group B: Frevecitinib Dose 2Experimental treatment 1 intervention
Group C: Frevecitinib Dose 3Experimental treatment 1 intervention
Group D: Frevecitinib (KN-002) matching placeboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Pre-BD FEV1

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

Time frame
Week 12

Secondary outcomes

1

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.

Time frame
Week 12
2

Peak expiratory flow (PEF)

Change from baseline in Peak expiratory flow

Time frame
Week 12
3

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.

Time frame
Week 12
4

Daily asthma symptom score

Change from baseline in average daily asthma symptom scores

Time frame
Week 12

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Kinaset Therapeutics Inc

Lead sponsor

Source ClinicalTrials.gov
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