Study of Three Doses of Frevecitinib (KN-002) in Adults with Severe Asthma Not Controlled by Medium‑to‑High Dose Inhaled Steroid/LABA Therapy

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What is this study about?

The study focuses on severe asthma, a form of asthma that remains uncontrolled despite use of medium to high dose ICS/LABA therapy. The investigational medicine is an inhaled powder containing the active substance frevecitinib, delivered by inhalation. Participants will receive one of three dose strengths of this powder or a matching placebo powder that contains no active drug.

The purpose of the trial is to evaluate the clinical efficacy of frevecitinib. Over a period of about three months, participants will take the study medication each day and attend clinic visits at the start of the study and at weeks 2, 4, 8 and 12. During these visits lung function will be measured using tests such as FEV1, which records how much air can be forced out of the lungs in one second, and symptom questionnaires will be completed.

Safety will be monitored throughout the study with regular checks of blood tests, heart rhythm recordings (ECG), blood pressure, and reports of any adverse events. Participants will continue their regular asthma inhalers while using the study powder, and any changes in rescue inhaler use or asthma symptoms will be recorded.

1 baseline visit and randomization

you attend the first clinic visit after joining the study. during this visit, basic health information is recorded and tests are done to confirm eligibility.

the study team explains that you will be randomly assigned to receive either frevecitinib inhalation powder (known as kn-002) or a matching placebo inhalation powder.

2 receive study medication

you are given a supply of hard‑capsule inhalation powder. the capsule contains either frevecitinib or only inactive ingredients (placebo).

the capsule is designed to be inhaled using a specific device; instructions for correct use are provided in writing.

3 daily inhalation of study medication

you take the inhalation powder once each day, at the same time each day, as instructed by the study team.

the exact amount of active drug in each capsule is determined by the study protocol; the label shows the dose as 0 mg because the dose is defined by the capsule content rather than a numeric milligram value.

4 use of rescue inhaler

you keep a short‑acting bronchodilator containing salbutamol for relief of sudden breathing symptoms.

the rescue inhaler is taken by inhalation only when you feel shortness of breath or wheezing, following the normal instructions for salbutamol use.

5 clinic visit at week 2

you return to the clinic two weeks after starting the study medication.

the visit includes a lung function test (pre‑bronchodilator forced expiratory volume in one second, or fev1), measurement of peak flow, a short questionnaire about asthma control, and a blood sample for safety checks and drug level testing.

6 clinic visit at week 4

you attend a second follow‑up visit four weeks after starting treatment.

the same set of assessments as at week 2 is repeated: lung function test, peak flow, questionnaires, and blood sampling.

7 clinic visit at week 8

you have a third follow‑up visit eight weeks after the first dose.

again, lung function, peak flow, asthma questionnaires, and safety blood tests are performed.

8 final visit at week 12 (end of treatment)

you attend the last scheduled visit twelve weeks after beginning the study medication.

comprehensive assessments are done, including lung function, peak flow, quality‑of‑life questionnaires, safety laboratory tests, electrocardiogram, and a final blood sample for drug level and pharmacokinetic analysis.

the study medication is stopped after this visit.

9 continuous safety monitoring

throughout the twelve‑week period you are asked to report any new symptoms, side effects, or health problems to the study team, either by phone or during clinic visits.

all reported events are recorded and evaluated for seriousness and possible relation to the study medication.

Who Can Join the Study?

Be able to read and understand the study information, sign the consent form, and agree to follow the study rules.
Be judged by the doctor as able to follow the study instructions.
Be between 18 and 75 years old when you sign the consent form.
Have a body‑mass index (BMI) and weight that fall within the range required by the study.
Have a doctor‑confirmed diagnosis of asthma for at least one year before the screening visit.
Have been using a prescribed asthma controller medicine that includes a medium‑ or high‑dose inhaled corticosteroid (ICS) plus a long‑acting beta‑agonist (LABA) for at least six months, and the doses must have stayed the same for at least four weeks before screening and during the run‑in period. Any other asthma medicines you take must also have been stable for at least four weeks.
Show a pre‑bronchodilator FEV1 (a lung‑function test) that is at least 40 % and no more than 80 % of the predicted normal value.
Show a post‑bronchodilator improvement in FEV1 of at least 12 % and at least 200 mL after using a short‑acting inhaler (such as albuterol). One repeat test is allowed if the first result is close to the limit.
Have an ACQ‑6 (asthma control questionnaire) score of 1.5 or higher during the screening visits.
Meet any additional study‑specific requirements defined by the investigators.
Have had at least one asthma flare‑up (exacerbation) in the past 12 months while on medium‑ or high‑dose ICS/LABA, which required a course of oral or injected steroids for at least three days, an emergency‑room visit lasting more than 24 hours, or a hospital stay with steroid treatment.
If you are receiving allergy‑specific immunotherapy, you must have been on a stable maintenance schedule for at least two months before screening and continue it throughout the study.
Have a recent chest X‑ray or other lung imaging (within the past three months) that shows no other active lung disease besides asthma.
Be able to use your inhaler, peak‑flow meter, and spirometry equipment correctly, be able to generate a peak inspiratory flow (PIF) of at least 60 L/min with the study device, and have taken at least 70 % of your usual asthma controller doses and 80 % of the required electronic diary (ePRO) entries during the two weeks before randomization.
Women who could become pregnant and are sexually active with a male partner who is not sterilized must use a highly effective method of contraception from the time you sign the consent until 16 weeks after the last study dose.
Men who are not sterilized and are sexually active with a woman who could become pregnant must use a male condom plus spermicide from the first day of the study until 92 days after the last dose.

Who Cannot Join the Study?

Current smoker (any tobacco, nicotine, cigarettes, e‑cigarettes, vaping, or marijuana) or a smoking history of 10 or more pack years (calculated as cigarettes per day ÷ 20 × years smoked); former smokers with less than 10 pack years must have quit at least 6 months before screening.
Uncontrolled illness that could make the study unsafe or affect results, such as recent angina (chest pain), heart attack (myocardial infarction), stroke or mini‑stroke (TIA) within the past year, or any history of blood clots in the lungs (pulmonary embolism) or elsewhere, or a genetic tendency to clot.
Any other lung disease that might interfere with the study, for example COPD (chronic obstructive pulmonary disease), cystic fibrosis, pulmonary fibrosis, bronchiectasis, allergic bronchopulmonary aspergillosis, or Churg‑Strauss syndrome.
Significant abnormal results in blood tests, urine tests, physical exam, or vital signs that could put you at risk or affect the study’s findings.
Active liver disease, such as yellowing of the skin (jaundice) or liver enzymes (AST, ALT) or bilirubin more than twice the normal limit; very high alkaline phosphatase is allowed only if it is proven not to come from the liver, and isolated high bilirubin is allowed if you have a known condition called Gilbert’s syndrome.
History of cancer: you may join if you had only basal cell skin cancer or early‑stage cervical cancer and finished curative treatment at least 12 months ago; other cancers are allowed only if treatment was finished and you have been cancer‑free for at least 5 years.
Having a respiratory tract infection (RTI) that has not fully healed by screening, or getting an RTI during screening or on the first day of the study; you could be re‑screened after you recover.
Any serious infection or use of systemic (whole‑body) antibiotics, anti‑parasitic, or antiviral medicines on the first day of the study.
Active tuberculosis (TB) or a positive QFT‑G blood test for TB, unless you have no TB symptoms, no recent exposure, a clear chest X‑ray, and have completed treatment for latent TB.
Positive test for hepatitis B surface antigen or hepatitis C antibody, or a history of hepatitis B or C; vaccination against hepatitis B is acceptable, and a positive hepatitis C antibody is allowed if a follow‑up test shows no active virus.
Positive test for human immunodeficiency virus (HIV) or taking HIV medicines (antiretrovirals).
Known allergy to any part of the study drug or any drug allergy that the doctor thinks makes participation unsafe.
Use of 5‑lipoxygenase inhibitors (e.g., zileuton) within 15 days before screening and during the study.
Use of roflumilast or azithromycin within 15 days before screening and during the study.
Use of oral or topical JAK inhibitors or any immunosuppressive medicines (such as methotrexate, cyclosporine, azathioprine, long‑acting steroid injections, or experimental anti‑inflammatory drugs) within 3 months before screening and during the study.
Receiving immune‑boosting blood products (immunoglobulin) or any blood transfusion within 30 days before screening and during the study.
Taking any other experimental non‑biologic drug within 30 days or five drug half‑lives (the time it takes for half the drug to leave the body), whichever is longer, before screening and during the study.
Being on regular daily oral steroids (corticosteroids) within 4 weeks before screening or during the study.
Having a short course (burst) of systemic steroids, even with a taper, within 15 days before screening or during the study.
Receiving injectable monoclonal antibody treatments for asthma or other conditions within the required time before screening: mepolizumab 4 months, benralizumab 6 months, omalizumab 6 months, reslizumab 6 months, dupilumab 6 months, tezepelumab 6 months, or other antibodies 5 half‑lives.
Being pregnant, breastfeeding, or planning to breastfeed.
Having a history of chronic alcohol or drug abuse within the past 12 months.
Planning a surgery that needs general anesthesia or an overnight hospital stay (more than one day) while the study is ongoing.
Receiving any live or weakened (attenuated) vaccines within 15 days before screening.
Having undergone bronchial thermoplasty (a procedure that uses heat to treat severe asthma).
Having a prolonged heart‑rate‑corrected QT interval (QTcF) greater than 470 milliseconds on the screening ECG, which indicates a risk of abnormal heart rhythms.

Where you can join this trial?

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Other Sites

Site Name	City	Country
Lungenpraxis Hohenzollerndamm / RCMS	Berlin	Germany
Michał Bogacki – DOBROSTAN	Wroclaw	Poland
Fagjhbif Nfpolorea Bruc	Brno	Czechia
Mbegfysnr sbjhbv	Jindřichův Hradec	Czechia
Piepc pkfszv anzipquca sqfywr	Prague	Czechia
Pitlqkultse Vascfczyq sjixfv	Varnsdorf	Czechia
Ssevpelrn Gxad	Hanover	Germany
Prwh Sokxosb Gdmd	Leipzig	Germany
Scvoiafpvupjo Bbjcuxnrwttczzqene Cnrqvrfj Siaewspjyr Uim Lxpzktt Sktgrpn Gze	Berlin	Germany
Axchvb Nhzut Hjbhbsxn	Athens	Greece
Alolcj Mqjotwx Cwtqsx Swuf	Paleo Faliro	Greece
Tgvrft Cmzjtv Sgjz	Thessaloniki	Greece
Grxcwg Nyqozcaywm Tlyzpmiexypjm Gzlubq Pkfoqnwcgnvl	Thessaloniki	Greece
Lrtotpr Sinutkpbdia Jp Mhxxhwfywd I Puuaevwnf	Wroclaw	Poland
Poptfp Gaydpbiw Givbvd Mtkyoqn Kcikravx sbcf	Sosnowiec	Poland
Awovcmckc Navm Jctkbzwo Dhckdlkpg Alygjoqpn Dqiradwgz Srwwgo Jcimr	Radom	Poland
Mhg Hbtaqicf So zta	Makow Podhalanski	Poland
Sreamxnkn Sco z ophc	Piaseczno	Poland
Tttvx Prcvcvufpvn Nuycqkldder Cprzkbc Mqrtuiwl Shp z omuj	Nowa Sol	Poland
Dasyjoxhkpa Arv Chnckfmexyib Cwabqs Cspmdb Ljwm	Sofia	Bulgaria
Uzzidjnthj Fflpi moycosrxuixr hclmebiq fhk anqfyp tcadwvjqa Sijfb Sbt Jbdh Kubdlckal Egd	Sofia	Bulgaria
Mbonoom Cxlsel Plyjdsogsi Epaj	Haskovo	Bulgaria
Ataafkkmi Mueybsu Cqhvac Orz	Dupnitsa	Bulgaria
Khwt Rwjmrp Kmicho Ea Rprspjsefpdnwv	Edeleny	Hungary
Silqlimu Cnnbdp Dh Bnzk Igzgoeddmnt Sx Pklsgrzsjakirlxfr Vgkrez Bfkst Cimcuet	Craiova	Romania

Trial status

Country	Status	Recruitment Start
Bulgaria	Not yet recruiting	01.08.2026
Czechia	Not yet recruiting	01.08.2026
Germany	Not yet recruiting	01.08.2026
Greece	Not yet recruiting	01.08.2026
Hungary	Not yet recruiting	01.08.2026
Poland	Not yet recruiting	01.08.2026
Romania	Not yet recruiting	01.08.2026

Trial locations

Investigated Drugs:

Salbutamol Sulfate

KN-002 (frevecitinib) is an experimental inhaled medicine being tested to see if it can improve control of severe asthma. It is taken as a dry‑powder capsule that the patient inhales, allowing the drug to reach the airways directly. In this study the medicine is given in three different strengths, but the exact doses are not listed here. The purpose of KN-002 is to reduce inflammation and airway narrowing that are not fully controlled by the usual inhaled steroids and long‑acting bronchodilators.

Salbutamol is a well‑known rescue inhaler that helps open the airways quickly when a person experiences asthma symptoms such as wheezing or shortness of breath. In this trial participants continue to use salbutamol as needed, so it serves as background therapy to provide immediate relief while the study drug (KN-002) is being evaluated for its longer‑term benefits.

Investigated Diseases:

Asthma

Severe asthma – Severe asthma is a long‑lasting condition in which the airways become overly sensitive and inflamed. This causes frequent episodes of wheezing, chest tightness, shortness of breath, and coughing. In severe cases, symptoms are present most days and can interfere with normal activities. Over time the airway narrowing can become more persistent, leading to increased limitation of airflow and more frequent flare‑ups.

Trial ID:

2023-509125-41-00

Protocol code:

KN-002/2/001

Trial Phase:

Therapeutic exploratory (Phase II)

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Study of Three Doses of Frevecitinib (KN-002) in Adults with Severe Asthma Not Controlled by Medium‑to‑High Dose Inhaled Steroid/LABA Therapy

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?