Frevecitinib for Severe Asthma

(PANAIRAMA Trial)

Not yet recruiting at 14 trial locations

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Kinaset Therapeutics Inc

Must be taking: ICS, LABA

Must not be taking: JAK inhibitors, Immunosuppressives

Disqualifiers: Smoking, Heart disease, Cancer, TB, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

What You Need to Know Before You Apply

What is the purpose of 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

Are You a Good Fit for This Trial?

Inclusion Criteria

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

I have had at least one asthma attack in the past year while on strong inhaler treatment.

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).

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Frevecitinib or placebo over a 12-week period

12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Frevecitinib

How Is the Trial Designed?

Group I: Frevecitinib Dose 3 Experimental Treatment 1 Intervention

Drug: Frevecitinib

Group II: Frevecitinib Dose 2 Experimental Treatment 1 Intervention

Drug: Frevecitinib

Group III: Frevecitinib Dose 1 Experimental Treatment 1 Intervention

Drug: Frevecitinib

Group IV: Frevecitinib (KN-002) matching placebo Placebo Group 1 Intervention

Placebo

Who Is Running the Clinical Trial?

Kinaset Therapeutics Inc

Lead Sponsor

Trials

1

Recruited

120+