Clinical trial • Phase II • Respiratory|Immunology
KT-621 for Uncontrolled moderate to severe eosinophilic asthma|Eosinophilic asthma
Phase II trial of KT-621 for Uncontrolled moderate to severe eosinophilic asthma|Eosinophilic asthma.
Overview
- Trial Therapeutic Area
- Respiratory|Immunology
- Trial Disease
- Uncontrolled moderate to severe eosinophilic asthma|Eosinophilic asthma
- Trial Stage
- Phase II
- Drug Modality
- Small molecule
Key dates
- Initial CTIS Submission Date
- 18-12-2025
- First CTIS Authorization Date
- 10-04-2026
Trial design
Randomised, placebo oral tablet matched to kt-621, administered daily (placebo arm). dose not specified in part i documentation; active comparator is multiple dose levels of kt-621 given once daily (described as x qd, y qd, z qd) but specific mg doses not stated.-controlled Phase II trial in Austria, Belgium, Germany and others.
- Randomised
- Yes
- Comparator
- Placebo oral tablet matched to KT-621, administered daily (placebo arm). Dose not specified in Part I documentation; active comparator is multiple dose levels of KT-621 given once daily (described as X QD, Y QD, Z QD) but specific mg doses not stated.
- Single Multiple Or Escalation Dose Combined
- Yes
- Target Sample Size
- 143
- Trial Duration For Participant
- 84
Eligibility
Recruits 143 isVulnerablePopulationSelected = true. Participants must be the legal age of consent in the jurisdiction and sign the informed consent form (ICF). Country- and purpose-specific ICFs (main ICF, prescreening ICF, pregnancy/newborn ICFs) are provided. No assent procedures for minors are described..
- Vulnerable Population
- isVulnerablePopulationSelected = true. Participants must be the legal age of consent in the jurisdiction and sign the informed consent form (ICF). Country- and purpose-specific ICFs (main ICF, prescreening ICF, pregnancy/newborn ICFs) are provided. No assent procedures for minors are described.
Inclusion criteria
- {"criterion_text":"- 9. Documented history of at least 1 asthma exacerbation requiring either treatment with systemic corticosteroids (intramuscular, intravenous, or oral) and/or hospitalization or an emergency/urgent medical care visit for acute asthma worsening within the past 52 weeks prior to Screening (V1).\n- 8. Absolute blood eosinophil count must be ≥0.30 x 10^9/L at Screening; up to 2 repeat assessments (3 total) are allowed during the screening period up to the Baseline visit (V2).\n- 10. Male or female assigned at birth, inclusive of all gender identities. Contraceptive use by participants or participant partners should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.\n- 1. Must be 18 years old (or the legal age of consent in the jurisdiction in which the study is taking place) to 75 years of age, inclusive, at the time of signing the ICF.\n- 2. Must have a physician diagnosis of asthma for ≥ 52 weeks prior to the Screening visit (V1), based on the Global Initiative for Asthma (GINA) 2024 guidelines.\n- 3. Must be on a stable regimen of medium- to high- 500 µg fluticasone propionate dry powder formulation or an equivalent total daily dose, in combination with a LABA. The regimen may include additional controller medication such as an LTRA and/or LAMA used for at least 12 weeks, at a stable dose and regimen, with no change in the dose or frequency of administration for at least 4 weeks prior to the Screening visit (V1) and between the Screening and Baseline visits (V2).\n- 4. Morning pre-bronchodilator FEV1 40 to 80% of predicted normal at the Screening visit (V1) and the Baseline visit (V2), prior to randomization; up to 2 repeat assessments (3 total) are allowed during the Screening period up to the Baseline visit.\n- 5. ACQ-5 score ≥ 1.5 at the Screening visit (V1) and at the Baseline visit (V2), prior to randomization.\n- 6. A FeNO level of ≥ 25 ppb at the Screening visit (v1) and the Baseline visit (V2); up to 2 repeat assessments (3 total) are allowed during the Screening period up to the Baseline visit.\n- 7. Demonstrated evidence of reversible airway obstruction by post-bronchodilator (albuterol/salbutamol) reversibility of FEV1 at Screening (15-30 min after administration of 2 to 4 puffs of albuterol/salbutamol); up to 2 repeat assessments (3 total) are allowed during the screening period up to the Baseline visit (V2)."}
Exclusion criteria
- {"criterion_text":"- 1. The presence of any clinically significant pulmonary disease other than asthma, including, but not limited to, active lung infection, chronic obstructive pulmonary disease (COPD), bronchiectasis, pulmonary fibrosis, cystic fibrosis, obesity associated hypoventilation syndrome, lung cancer, alpha 1 antitrypsin deficiency, or primary ciliary dyskinesia. Additionally, any pulmonary or systemic condition other than asthma that is associated with elevated peripheral eosinophil counts, such as allergic bronchopulmonary aspergillosis/mycosis, Churg Strauss syndrome, or hypereosinophilic syndrome.\n- 10. Has any medical or psychiatric condition which, in the opinion of the Investigator or the Sponsor's Medical Monitor, would place the participant at risk, interfere with participation in the study, or interfere with the interpretation of study results.\n- 11. Has a history of alcohol or drug abuse within 2 years of the Screening visit (V1).\n- 12. Current smokers of nicotine/tobacco as well as non-nicotine products, participants with smoking history of ≥10 pack years, and participants using vaping products, including electronic cigarettes. Former smokers with a smoking history of < 10 pack years and users of vaping or e-cigarette products must have stopped for at least 26 weeks prior to the Screening visit (V1).\n- 13. Has any cancer or a history of cancers within the last 5 years (except curatively treated with surgical excised squamous cell carcinoma, basal cell carcinoma, or carcinoma in situ of the skin or cervix).\n- 2. An asthma exacerbation, requiring either treatment with systemic corticosteroids (intramuscular, intravenous, or oral) and/or hospitalization or an emergency/urgent medical care visit for acute asthma worsening, at any time from 4 weeks prior to the Screening visit (V1) up to and including the Baseline visit (V2).\n- 3. Has had any of the following at Screening: a. Positive human immunodeficiency virus (HIV) antibody b. Positive hepatitis B (HBV) surface antigen (HBsAg) c. Positive total hepatitis B core antibody (HBcAb) d. Positive hepatitis C virus (HCV) antibody e. Have evidence of active or latent or inadequately treated infection with mycobacterium tuberculosis (TB)\n- 4. Has any of the following findings at the Screening visit (V1): a. Inadequate hematological function, as follows: i. Platelet count < 100 × 10^9/L (< 100,000/µL) ii. Hemoglobin < 9 g/dL iii. Absolute neutrophil count < 1.5 × 10^9/L (< 1,500/µL) b. Inadequate liver function, as follows: i. Aspartate aminotransferase (AST)/ alanine aminotransferase (ALT) > 2 × upper limit of normal (ULN) ii. Total bilirubin > 1.5 x ULN (participants with Gilbert's syndrome can be included with total bilirubin > 1.5 × ULN) as long as direct bilirubin is ≤ 1.5 x ULN)\n- 5, Known or suspected history of immunodeficiency disorder, including history of invasive opportunistic infections (eg, histoplasmosis, listeriosis, coccidioidomycosis, pneumocystosis, aspergillosis), despite infection resolution; or unusually frequent, recurrent or prolonged infections, per Investigator's judgment.\n- 6. Has a clinically significant history or evidence of any active or suspected parasitic infection within 4 weeks of the Baseline visit (V2) or has travelled within the 3 months before Baseline to areas of high parasitic exposure, as determined by local or international health guidelines or epidemiological data.\n- 7. Has had any major surgery within 8 weeks prior to the Screening visit (V1) or has any planned surgical or medical procedure planned during the study\n- 8. Has a chronic or acute infection, including upper or lower respiratory tract infection, requiring treatment with systemic antibiotics, antiparasitics, antifungals, or antivirals that were completed within 4 weeks of Baseline or during the Screening period.\n- 9. Has any other clinically significant disease, condition, or medical history that, in the opinion of the Investigator, would interfere with participant safety, study evaluations, and/or study procedures. Examples include, but are not limited to, participants with short life expectancy, participants with uncontrolled diabetes (hemoglobin A1c ≥9%), partecipants with cardiovascular conditions (eg, heart failure, uncontrolled hypertension), severe renal conditions (eg, participants on dialysis), hepatobiliary conditions (eg, Child Pugh class B or C), neurological conditions (eg, demyelinating diseases), active major autoimmune diseases (such as, but not limited to, lupus, inflammatory bowel disease, rheumatoid arthritis), and other severe endocrinological, gastrointestinal, metabolic, pulmonary, or lymphatic diseases."}
Endpoints
Primary endpoints
- {"endpoint_text":"- Change from baseline to Week 12 in pre-bronchodilator FEV1.","definition_or_measurement_approach":"Change from baseline to Week 12 in pre-bronchodilator FEV1 measured by spirometry (pre-bronchodilator FEV1 at Baseline and at Week 12)."}
Secondary endpoints
- {"endpoint_text":"- Change from baseline to Week 12 in post-bronchodilator FEV1.","definition_or_measurement_approach":"Measured by post-bronchodilator spirometry comparing Baseline to Week 12."}
- {"endpoint_text":"- Change from baseline to Week 12 in ACQ-5 score","definition_or_measurement_approach":"Change in ACQ-5 questionnaire score from Baseline to Week 12."}
- {"endpoint_text":"- Change from baseline to Week 12 in the AQLQ(S) Global Score","definition_or_measurement_approach":"Change in AQLQ(S) (Asthma Quality of Life Questionnaire - Standard) global score from Baseline to Week 12."}
- {"endpoint_text":"- Incidence of TEAEs","definition_or_measurement_approach":"Treatment-emergent adverse events collected and reported per safety monitoring procedures; incidence summarized."}
- {"endpoint_text":"- Incidence of treatment-emergent SAEs","definition_or_measurement_approach":"Serious adverse events collected during treatment period and reported per regulatory requirements."}
- {"endpoint_text":"- Plasma PK parameter estimates of KT-621 derived from plasma concentration time data","definition_or_measurement_approach":"PK parameters derived from plasma concentration vs time sampling and analysis."}
Recruitment
- Digital Remote Recruitment
- Yes
- Planned Sample Size
- 143
- Recruitment Window Months
- 21
- Consent Approach
- Informed consent is obtained from each participant (must be at or above the legal age of consent in the jurisdiction). Country- and language-specific informed consent forms are provided (main ICF, prescreening ICF, pregnancy/newborn ICFs). Consent materials are available in multiple languages aligned to participating countries (examples include English, German, French, Dutch, Italian, Spanish, Romanian, Polish, Slovak). No assent process for minors is described (participants must be ≥ legal age of consent).
Methods
- Social media posts (country-specific social posts documents available for Austria, Belgium, Germany, Italy, Spain, Romania, Poland, Slovakia).
- Trial information videos (country/language-specific Trial Information Video documents).
- Posters and recruitment brochures (country-specific materials).
- Patient invitation-to-trial letters (site-/country-specific invitation letters).
- Trial listings / trial listing documents for sites/countries.
- Prescreener and study microsite content (content creation noted: prescreener, study microsite, partner materials).
- ICF tools and pre-screening information materials to support recruitment and informed consent.
- GP letters (documented for Italy) and site-level patient outreach.
Geography
- Total Number Of Sites
- 45
- Total Number Of Participants
- 121
Austria
- Earliest CTIS Part Ii Submission Date
- 02-03-2026
- Latest Decision Or Authorization Date
- 19-04-2026
- Processing Time Days
- 48
- Number Of Sites
- 2
- Number Of Participants
- 10
Sites
- Site Name
- Medical University Of Vienna
- Department Name
- Klinische Abteilung für Pulmologie
- Principal Investigator Name
- Marco Idzko
- Principal Investigator Email
- marco.idzko@meduniwien.ac.at
- Contact Person Name
- Marco Idzko
- Contact Person Email
- marco.idzko@meduniwien.ac.at
- Site Name
- Klinik Hietzing
- Department Name
- Abteilung für Lungen- und Atmungserkrankungen
- Principal Investigator Name
- Robab Breyer- Kohansal
- Principal Investigator Email
- robab.breyer-kohansal@gesundheitsverbund.at
- Contact Person Name
- Robab Breyer- Kohansal
- Contact Person Email
- robab.breyer-kohansal@gesundheitsverbund.at
Belgium
- Earliest CTIS Part Ii Submission Date
- 30-03-2026
- Latest Decision Or Authorization Date
- 16-04-2026
- Processing Time Days
- 17
- Number Of Sites
- 5
- Number Of Participants
- 15
Sites
- Site Name
- Cliniques Universitaires Saint-Luc
- Department Name
- Pulmonology
- Principal Investigator Name
- Charles Pilette
- Principal Investigator Email
- charles.pilette@saintluc.uclouvain.be
- Contact Person Name
- Charles Pilette
- Contact Person Email
- charles.pilette@saintluc.uclouvain.be
- Site Name
- Az Maria Middelares Gent
- Department Name
- Pulmonology
- Principal Investigator Name
- Carole De Cock
- Principal Investigator Email
- carole.decock@mijnziekenhuis.be
- Contact Person Name
- Carole De Cock
- Contact Person Email
- carole.decock@mijnziekenhuis.be
- Site Name
- CHU Saint Pierre
- Department Name
- Pulmonology
- Principal Investigator Name
- Marie Bruyneel
- Principal Investigator Email
- marie.bruyneel@stpierre-bru.be
- Contact Person Name
- Marie Bruyneel
- Contact Person Email
- marie.bruyneel@stpierre-bru.be
- Site Name
- Centre Hospitalier Regional De La Citadelle
- Department Name
- Pulmonology
- Principal Investigator Name
- Hélène Simonis
- Principal Investigator Email
- helene.simonis@citadelle.be
- Contact Person Name
- Hélène Simonis
- Contact Person Email
- helene.simonis@citadelle.be
- Site Name
- Pneumocare
- Department Name
- Pneumocare Pulmonology
- Principal Investigator Name
- Jean-Benoit Martinot
- Principal Investigator Email
- martinot.j@respisom.be
- Contact Person Name
- Jean-Benoit Martinot
- Contact Person Email
- martinot.j@respisom.be
Germany
- Earliest CTIS Part Ii Submission Date
- 12-02-2026
- Latest Decision Or Authorization Date
- 10-04-2026
- Processing Time Days
- 57
- Number Of Sites
- 4
- Number Of Participants
- 9
Sites
- Site Name
- Lungenpraxis Hohenzollerndamm
- Department Name
- Research Center for Medical Studies (RCMS)
- Principal Investigator Name
- Björn Martens
- Principal Investigator Email
- dr.martens@lungenpraxishohenzollerndamm.de
- Contact Person Name
- Björn Martens
- Contact Person Email
- dr.martens@lungenpraxishohenzollerndamm.de
- Site Name
- Pneumologicum Halle
- Department Name
- Pneumologicum Halle
- Principal Investigator Name
- Peter-Uwe Haase
- Principal Investigator Email
- peteruwehaase@pneumologicumhalle.de
- Contact Person Name
- Peter-Uwe Haase
- Contact Person Email
- peteruwehaase@pneumologicumhalle.de
- Site Name
- Berufsausuebungsgemeinschaft Bag Prof. Dr. Med Gerhard Hoheisel Dr. Med Andreas Bonitz GbR
- Department Name
- Praxis für Pneumologie und Allergologie - Studienzentrum
- Principal Investigator Name
- Andreas Bonitz
- Principal Investigator Email
- andreas.bonitz@pneumologiepraxis-leipzig.de
- Contact Person Name
- Andreas Bonitz
- Contact Person Email
- andreas.bonitz@pneumologiepraxis-leipzig.de
- Site Name
- POIS Sachsen GmbH
- Department Name
- POIS Sachsen GmbH
- Principal Investigator Name
- Falk Brunner
- Principal Investigator Email
- f.brunner@pois-sachsen.de
- Contact Person Name
- Falk Brunner
- Contact Person Email
- f.brunner@pois-sachsen.de
Italy
- Earliest CTIS Part Ii Submission Date
- 23-01-2026
- Latest Decision Or Authorization Date
- 14-04-2026
- Processing Time Days
- 81
- Number Of Sites
- 6
- Number Of Participants
- 12
Sites
- Site Name
- IRCCS Ospedale Policlinico San Martino
- Department Name
- Clin Mal App Resp e Allergologia
- Principal Investigator Name
- Diego Bagnasco
- Principal Investigator Email
- dott.diegobagnasco@gmail.com
- Contact Person Name
- Diego Bagnasco
- Contact Person Email
- dott.diegobagnasco@gmail.com
- Site Name
- Azienda Universitaria Ospedaliera Consorziale Policlinico Bari
- Department Name
- UOC Respiratory System Diseases
- Principal Investigator Name
- Giovanna Elisiana
- Principal Investigator Email
- elisiana.carpagnano@uniba.it
- Contact Person Name
- Giovanna Elisiana
- Contact Person Email
- elisiana.carpagnano@uniba.it
- Site Name
- Azienda Socio Sanitaria Territoriale Santi Paolo E Carlo
- Department Name
- Respiratory Unit
- Principal Investigator Name
- Michele Mondoni
- Principal Investigator Email
- michele.mondoni@asstsantipaolocarlo.it
- Contact Person Name
- Michele Mondoni
- Contact Person Email
- michele.mondoni@asstsantipaolocarlo.it
- Site Name
- Azienda Ospedaliera Dei Colli
- Department Name
- U.O.C. Clinica Pneumologica
- Principal Investigator Name
- Andrea Bianco
- Principal Investigator Email
- Andrea.bianco@unicampania.it
- Contact Person Name
- Andrea Bianco
- Contact Person Email
- Andrea.bianco@unicampania.it
- Site Name
- Azienda Ospedaliero-Universitaria Sant Andre
- Department Name
- UOC Pneumologia
- Principal Investigator Name
- Alberto Ricci
- Principal Investigator Email
- alberto.ricci@uniroma1.it
- Contact Person Name
- Alberto Ricci
- Contact Person Email
- alberto.ricci@uniroma1.it
- Site Name
- Azienda Ospedaliera Policlinico Universitario Tor Vergata
- Department Name
- UOC di Malattie dell’Apparato Respiratorio
- Principal Investigator Name
- Paola Rogliani
- Principal Investigator Email
- paola.rogliani@uniroma2.it
- Contact Person Name
- Paola Rogliani
- Contact Person Email
- paola.rogliani@uniroma2.it
Romania
- Earliest CTIS Part Ii Submission Date
- 30-03-2026
- Latest Decision Or Authorization Date
- 17-04-2026
- Processing Time Days
- 18
- Number Of Sites
- 3
- Number Of Participants
- 9
Sites
- Site Name
- Spitalul Clinic De Boli Infectioase Si Pneumoftiziologie Victor Babes Craiova
- Department Name
- Ambulatoriul de pneumologie
- Principal Investigator Name
- Dragos NICOLOSU
- Principal Investigator Email
- nicolosud@yahoo.com
- Contact Person Name
- Dragos NICOLOSU
- Contact Person Email
- nicolosud@yahoo.com
- Site Name
- Theramed Healthcare S.R.L.
- Department Name
- Alergologie si Imunologie Clinica
- Principal Investigator Name
- Ioana-Octavia AGACHE
- Principal Investigator Email
- ibrumaru@unitbv.ro
- Contact Person Name
- Ioana-Octavia AGACHE
- Contact Person Email
- ibrumaru@unitbv.ro
- Site Name
- Neoclinic Concept S.R.L.
- Department Name
- Pneumologie
- Principal Investigator Name
- Stefan MIHAICUTA
- Principal Investigator Email
- Stefan.mihaicuta@umft.ro
- Contact Person Name
- Stefan MIHAICUTA
- Contact Person Email
- Stefan.mihaicuta@umft.ro
Spain
- Earliest CTIS Part Ii Submission Date
- 16-02-2026
- Latest Decision Or Authorization Date
- 13-04-2026
- Processing Time Days
- 56
- Number Of Sites
- 8
- Number Of Participants
- 18
Sites
- Site Name
- Hospital Universitario Marques De Valdecilla
- Department Name
- Pneumology
- Principal Investigator Name
- Juan Luis Garcia Rivero
- Principal Investigator Email
- jgarcianml@gmail.com
- Contact Person Name
- Juan Luis Garcia Rivero
- Contact Person Email
- jgarcianml@gmail.com
- Site Name
- Hospital Universitario Puerta Del Mar
- Department Name
- Pneumology
- Principal Investigator Name
- Aurelio Victor Arnedillo Muñoz
- Principal Investigator Email
- aureliov.arnedillo.sspa@juntadeandalucia.es
- Contact Person Name
- Aurelio Victor Arnedillo Muñoz
- Contact Person Email
- aureliov.arnedillo.sspa@juntadeandalucia.es
- Site Name
- Clinica Respira-Dr.Juanola
- Department Name
- Pneumology
- Principal Investigator Name
- Jordi Juanola Pla
- Principal Investigator Email
- Investigacion@respirahr.com
- Contact Person Name
- Jordi Juanola Pla
- Contact Person Email
- Investigacion@respirahr.com
- Site Name
- Hospital Universitario De Salamanca
- Department Name
- Alergology
- Principal Investigator Name
- Cristina Martin Garcia
- Principal Investigator Email
- cmartingarci@saludcastillayleon.es
- Contact Person Name
- Cristina Martin Garcia
- Contact Person Email
- cmartingarci@saludcastillayleon.es
- Site Name
- Hospital De Jerez De La Frontera
- Department Name
- Pneumology
- Principal Investigator Name
- Jose Gregorio Soto Campos
- Principal Investigator Email
- josesoto@separ.es
- Contact Person Name
- Jose Gregorio Soto Campos
- Contact Person Email
- josesoto@separ.es
- Site Name
- University Hospital Of Canary Islands
- Department Name
- Alergology
- Principal Investigator Name
- Ruperto Gonzalez Perez
- Principal Investigator Email
- citashuc.scs@gobiernodecanarias.org
- Contact Person Name
- Ruperto Gonzalez Perez
- Contact Person Email
- citashuc.scs@gobiernodecanarias.org
- Site Name
- Hospital Universitario Infanta Leonor
- Department Name
- Pneumology
- Principal Investigator Name
- Ismael Ali-Garcia
- Principal Investigator Email
- ismael.ali@salud.madrid.org
- Contact Person Name
- Ismael Ali-Garcia
- Contact Person Email
- ismael.ali@salud.madrid.org
- Site Name
- Hospital Universitario 12 De Octubre
- Department Name
- Alergology
- Principal Investigator Name
- Ismael Garcia Moguel
- Principal Investigator Email
- ismaelgmoguel@gmail.com
- Contact Person Name
- Ismael Garcia Moguel
- Contact Person Email
- ismaelgmoguel@gmail.com
Poland
- Earliest CTIS Part Ii Submission Date
- 23-01-2026
- Latest Decision Or Authorization Date
- 23-04-2026
- Processing Time Days
- 90
- Number Of Sites
- 13
- Number Of Participants
- 39
Sites
- Site Name
- Lekarze Specjalisci J. Malolepszy I Partnerzy
- Department Name
- NZOZ Lekarze Specjalisci J. Małolepszy i Partnerzy
- Principal Investigator Name
- Krzysztof Wytrychowski
- Principal Investigator Email
- ALERGOLODZY@OP.PL
- Contact Person Name
- Krzysztof Wytrychowski
- Contact Person Email
- ALERGOLODZY@OP.PL
- Site Name
- Homeo Medicus Szczesiul sp.j.
- Department Name
- NZOZ Homeo Medicus Poradnia Alergologiczna
- Principal Investigator Name
- Krzysztof Kowal
- Principal Investigator Email
- kowalkmd@umb.edu.pl
- Contact Person Name
- Krzysztof Kowal
- Contact Person Email
- kowalkmd@umb.edu.pl
- Site Name
- Santa Familia PTG Łódź
- Principal Investigator Name
- Mariola Jędrzejczak
- Principal Investigator Email
- mariola.jedrzejczak@ptg-network.com
- Contact Person Name
- Mariola Jędrzejczak
- Contact Person Email
- TOMASZ.BUDLEWSKI@PTG-NETWORK.COM
- Site Name
- Clinica Vitae Sp. z o.o.
- Principal Investigator Name
- Bogusława Cimoszko
- Principal Investigator Email
- b.cimoszko@clinicavitae.pl
- Contact Person Name
- Bogusława Cimoszko
- Contact Person Email
- b.cimoszko@clinicavitae.pl
- Site Name
- Uniwersytecki Szpital Kliniczny W Bialymstoku
- Department Name
- Klinika Alergologii i Chorob Wewnętrznych
- Principal Investigator Name
- Ziemowit Ziętkowski
- Principal Investigator Email
- klinika.alergologii@uskwb.pl
- Contact Person Name
- Ziemowit Ziętkowski
- Contact Person Email
- klinika.alergologii@uskwb.pl
- Site Name
- Alergologia Plus Sp. z o.o.
- Principal Investigator Name
- Michał Springer
- Principal Investigator Email
- poradnia@alergologiaplus.com
- Contact Person Name
- Michał Springer
- Contact Person Email
- poradnia@alergologiaplus.com
- Site Name
- Kiepury Clinic Malgorzata Jarnot Specjalistyczna Praktyka Ginekologiczno-Położnicza
- Principal Investigator Name
- Marta Frejowska-Reniecka
- Principal Investigator Email
- marciafre@op.pl
- Contact Person Name
- Marta Frejowska-Reniecka
- Contact Person Email
- marciafre@op.pl
- Site Name
- Bio Zdrowie Sp. z o.o.
- Principal Investigator Name
- Anna Płoszczuk
- Principal Investigator Email
- anna.ploszczuk@wp.pl
- Contact Person Name
- Anna Płoszczuk
- Contact Person Email
- anna.ploszczuk@wp.pl
- Site Name
- Umed Clinical Trials Sp. z o.o.
- Principal Investigator Name
- Marcelina Przemęcka
- Principal Investigator Email
- marcelina.przemecka@umed.lodz.pl
- Contact Person Name
- Marcelina Przemęcka
- Contact Person Email
- marcelina.przemecka@umed.lodz.pl
- Site Name
- Centermed Sp. z o.o.
- Department Name
- CenterMed Bandrowskiego
- Principal Investigator Name
- Małgorzata Żurowska-Gębala
- Principal Investigator Email
- mzurowska@centermed.pl
- Contact Person Name
- Małgorzata Żurowska-Gębala
- Contact Person Email
- mzurowska@centermed.pl
- Site Name
- Viltis Medica Sp. z o.o.
- Principal Investigator Name
- Agata Kot
- Principal Investigator Email
- agata.kot@viltismedica.pl
- Contact Person Name
- Agata Kot
- Contact Person Email
- agata.kot@viltismedica.pl
- Site Name
- Samodzielny Publiczny Zaklad Opieki Zdrowotnej Uniwersytecki Szpital Kliniczny Nr 1 Im. Norberta Barlickiego Uniwersytetu Medycznego W Lodzi
- Department Name
- Oddział Kliniczny Pulmonologii i Alergologii z Pododdziałem Chorób Wewnętrznych
- Principal Investigator Name
- Wojciech Piotrowski
- Principal Investigator Email
- wojciech.piotrowski@umed.lodz.pl
- Contact Person Name
- Wojciech Piotrowski
- Contact Person Email
- wojciech.piotrowski@umed.lodz.pl
- Site Name
- Centrum Medyczne Lucyna Andrzej Dymek s.c.
- Principal Investigator Name
- Andrzej Dymek
- Principal Investigator Email
- adymek@centrummedyczne.com
- Contact Person Name
- Andrzej Dymek
- Contact Person Email
- adymek@centrummedyczne.com
Slovakia
- Earliest CTIS Part Ii Submission Date
- 20-04-2026
- Latest Decision Or Authorization Date
- 21-04-2026
- Processing Time Days
- 1
- Number Of Sites
- 4
- Number Of Participants
- 9
Sites
- Site Name
- Nsp Sv. Jakuba N.O. Bardejov
- Principal Investigator Name
- Helena Lescisinova
- Principal Investigator Email
- lescisinova.h@gmail.com
- Contact Person Name
- Helena Lescisinova
- Contact Person Email
- lescisinova.h@gmail.com
- Site Name
- Plucna ambulancia Hrebenar s.r.o.
- Department Name
- Plucna ambulancia Hrebenar s.r.o.
- Principal Investigator Name
- Slavomir Hrebenar
- Principal Investigator Email
- slavomir.hrebenar@gmail.com
- Contact Person Name
- Slavomir Hrebenar
- Contact Person Email
- slavomir.hrebenar@gmail.com
- Site Name
- Alersa s.r.o.
- Department Name
- Ambulancia klinickej imunologie a alergologie
- Principal Investigator Name
- Daniela Safcakova
- Principal Investigator Email
- dsafcakova@gmail.com
- Contact Person Name
- Daniela Safcakova
- Contact Person Email
- dsafcakova@gmail.com
- Site Name
- Alian s.r.o.
- Department Name
- Ambulancia klinickej imunologie a alergologie
- Principal Investigator Name
- Maria Dzupinova
- Principal Investigator Email
- marika.dzupinova@centrum.sk
- Contact Person Name
- Maria Dzupinova
- Contact Person Email
- marika.dzupinova@centrum.sk
Sponsor
Primary sponsor
- Full Name
- Kymera Therapeutics Inc.
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- United States
Contract research organisations
- Name
- PPD Development LP
- Responsibilities
- codes:1,12,13,2,4,5,8,9
Third parties
- {"country":"United States","full_name":"Eresearchtechnology Inc.","duties_or_roles":"Spirometry, FeNO, ECG, eCOA, Central ECG Reader","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Proofpilot Inc.","duties_or_roles":"Content Creation: Prescreener, Study Microdite, Partner Materials","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"PPD Development LP","duties_or_roles":"codes:1,12,13,2,4,5,8,9","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Praxis Communications LLC","duties_or_roles":"Patient Recruitment / Retention","organisation_type":"Non-Pharmaceutical company"}
- {"country":"United States","full_name":"Medidata Solutions Inc.","duties_or_roles":"EDC (Kymera URL)","organisation_type":"Non-Pharmaceutical company"}
- {"country":"United States","full_name":"Digital Medical Technologies LLC","duties_or_roles":"code:7","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Greenphire LLC","duties_or_roles":"Payments","organisation_type":"Non-Pharmaceutical company"}
- {"country":"Germany","full_name":"PCI Pharma Services Germany GmbH","duties_or_roles":"Packaging and labeling","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Suvoda LLC","duties_or_roles":"code:3","organisation_type":"Non-Pharmaceutical company"}
Investigational products
- Investigational Product Name
- KT-621
- Active Substance
- KT-621
- Modality
- Small molecule
- Routes Of Administration
- ORAL USE
- Route
- ORAL
- Frequency
- Once daily
- Investigational Product Name
- Placebo oral tablet matched to KT-621
- Modality
- Other
- Frequency
- Once daily
- Combination Treatment
- Yes
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