512 Participants NeededMy employer runs this trial

Frevecitinib for Severe Asthma

(PANAIRAMA Trial)

Recruiting at 14 trial locations
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: Kinaset Therapeutics Inc
Must be taking: ICS, LABA
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests Frevecitinib, a new drug, to evaluate its effectiveness and safety for people with severe asthma. It targets individuals who continue to experience symptoms despite using medium to high doses of inhaled corticosteroids (ICS) and long-acting beta-agonists (LABA). Participants will join one of several groups, each receiving a different dose of Frevecitinib or a placebo (an inactive substance). Suitable candidates have had asthma for at least a year and experience frequent asthma attacks despite current treatments. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group of people.

Do I need to stop my current medications for the trial?

The trial requires that you continue your current asthma medications, like medium to high dose ICS/LABA, as they must be stable before and during the trial. However, you cannot use certain medications like oral corticosteroids or immunosuppressive drugs during the study.

Is there any evidence suggesting that Frevecitinib is likely to be safe for humans?

Research has shown that frevecitinib, a new treatment for asthma, was safe in earlier studies. In Phase 1b trials, this inhaled medicine reduced airway inflammation with minimal impact on the rest of the body. This indicates it is generally well-tolerated when used correctly. By targeting lung problems directly, the drug lowers the risk of side effects elsewhere in the body. These findings provide promising safety evidence for those considering joining a trial.12345

Why do researchers think this study treatment might be promising?

Researchers are excited about Frevecitinib for severe asthma because it offers a novel approach compared to standard treatments like inhaled corticosteroids and bronchodilators. Frevecitinib works by targeting specific pathways involved in inflammation, potentially providing more precise control over asthma symptoms. This targeted action could lead to improved outcomes for patients who don't respond well to existing therapies. Additionally, the study is exploring different dosages, which may help tailor treatments to individual needs, enhancing both effectiveness and safety.

What evidence suggests that Frevecitinib might be an effective treatment for severe asthma?

Research has shown that Frevecitinib, an inhaled treatment, could benefit people with severe asthma. Early studies found that it reduces airway swelling, a major issue in asthma, while having fewer effects on the rest of the body. In these studies, patients experienced less airway swelling, indicating potential for improved breathing and fewer asthma attacks. The treatment targets specific lung areas crucial in asthma. Although more research is needed, these early results offer hope for those whose asthma isn't well-managed by regular treatments.12346

Are You a Good Fit for This Trial?

This trial is for adults with severe asthma that isn't well controlled despite using medium to high doses of inhaled steroids and long-acting bronchodilators. Participants must have had at least one asthma attack in the past year, be able to use study devices properly, and meet certain lung function criteria.

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).
See 7 more

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

Trial Overview

The study is testing different doses of a new drug called Frevecitinib compared to a placebo (inactive treatment) over 12 weeks to see if it helps people with severe asthma who aren't responding well enough to standard treatments.

How Is the Trial Designed?

4

Treatment groups

Experimental Treatment

Placebo Group

Group I: Frevecitinib Dose 3Experimental Treatment1 Intervention
Group II: Frevecitinib Dose 2Experimental Treatment1 Intervention
Group III: Frevecitinib Dose 1Experimental Treatment1 Intervention
Group IV: Frevecitinib (KN-002) matching placeboPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Kinaset Therapeutics Inc

Lead Sponsor

Trials
1
Recruited
120+

Citations

A Phase 2 Dose Ranging Clinical Study to Evaluate the ...

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

NCT07532265 | A Phase 2 Clinical Study to Evaluate the ...

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

9.4.24

A Phase 2b clinical study evaluating frevecitinib in patients with asthma not adequately controlled on medium to high dose ICS/LABA is planned to begin in 2025.

FDA Accepts New Drug Application for Frevecitinib in Asthma

Early Data Supports Targeted Lung Delivery – Phase 1b results showed frevecitinib reduced airway inflammation while minimizing systemic exposure ...

FDA Clears IND for Frevecitinib Asthma Inhaler

Frevecitinib, an inhaled JAK inhibitor, targets severe asthma with minimal systemic exposure, showing promise in Phase 1 trials. Kinaset ...

Biologics in the treatment of severe asthma in children and ...

This review will focus on relevant updates to the literature since 2024, highlighting new indications for use, predictors of response, safety data, real-world ...