Clinical trial • Phase III • Respiratory
CAMLIPIXANT for Refractory chronic cough | Unexplained chronic cough
Phase III trial of CAMLIPIXANT for Refractory chronic cough | Unexplained chronic cough.
Overview
- Trial Therapeutic Area
- Respiratory
- Trial Disease
- Refractory chronic cough | Unexplained chronic cough
- Trial Stage
- Phase III
- Drug Modality
- Small molecule
Key dates
- Initial CTIS Submission Date
- 19-07-2024
- First CTIS Authorization Date
- 08-08-2024
Trial design
Randomised, open-label, placebo — tablets (appearance described as "tablets are oval, biconvex, plain and white to off white"); dose and schedule not specified in the record.-controlled Phase III trial in Germany, Slovakia, Czechia and others.
- Randomised
- Yes
- Open Label
- Yes
- Comparator
- Placebo — tablets (appearance described as "Tablets are oval, biconvex, plain and white to off white"); dose and schedule not specified in the record.
- Target Sample Size
- 723
- Trial Duration For Participant
- 168
Eligibility
Recruits 723 Vulnerable population selected; participants must be capable of understanding the written informed consent (participants must be able to understand and provide written informed consent)..
- Pregnancy Exclusion
- A female participant is eligible to participate if she is not pregnant, not breastfeeding, and at least 1 of the following conditions applies: Not a woman of childbearing potential (WOCBP) OR A WOCBP who agrees to the contraceptive guidance
- Vulnerable Population
- Vulnerable population selected; participants must be capable of understanding the written informed consent (participants must be able to understand and provide written informed consent).
Inclusion criteria
- {"criterion_text":"- 1. Between 18 and 80 years of age inclusive\n- 2. Capable of understanding the written informed consent\n- 3. Diagnosis of Refractory chronic cough (including unexplained chronic cough) for ≥ 1 year prior to Screening\n- 4. Participants must meet the cough frequency criteria\n- 5. A female participant is eligible to participate if she is not pregnant, not breastfeeding, and at least 1 of the following conditions applies: Not a woman of childbearing potential (WOCBP) OR A WOCBP who agrees to the contraceptive guidance"}
Exclusion criteria
- {"criterion_text":"- 1. Current smoker or vaper or current use of tobacco smoke, cannabis smoke, or nicotine vapors or Individuals who have given up smoking or vaping within the past 6 months, or those with > 20 pack-year smoking history \n- 2. Diagnosis of chronic obstructive pulmonary disease, bronchiectasis, chronic bronchitis, cystic fibrosis, pulmonary sarcoidosis, idiopathic pulmonary fibrosis, or uncontrolled asthma\n- 3. History of upper and/or lower respiratory tract infection or significant change in pulmonary status within 28 days of Screening \n- 4. Severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) infection at Screening\n- 5. Medical history of malignancy and treatment completed ≤ 5 years prior to Screening\n- 6. History of a diagnosis of drug or alcohol dependency or abuse within the last 3 years\n- 7. Positive serological test for human immunodeficiency virus (HIV), hepatitis B, or hepatitis C at Screening\n- 8. Previous participation in an investigational study of BLU-5937"}
Endpoints
Primary endpoints
- {"endpoint_text":"- 24-hour cough frequency at Week 24 by a cough monitor in adult participants\n- Incidence of AEs and SAEs up to Week 24\n- Incidence of AEMIs up to Week 24\n- Incidence of study treatment discontinuations due to AEs and SAEs leading to study withdrawal up to Week 24\n- Changes from Baseline in vital signs at Week 24, clinical laboratory values at Week 24\n- Changes from Baseline in ECG values at Week 24","definition_or_measurement_approach":"24-hour cough frequency at Week 24 measured by a cough monitor; safety endpoints measured as incidence counts up to Week 24 (AEs, SAEs, AEMIs, treatment discontinuations); changes from Baseline in vital signs, clinical laboratory values and ECG values assessed at Week 24 compared with baseline."}
Secondary endpoints
- {"endpoint_text":"- CS-VAS\n- Change from Baseline in CS-VAS at Week 24\n- CS-VAS response at Week 24\n- Objective cough frequency recording\n- Awake cough frequency at Week 24\n- 24-hour cough response from Baseline at Week 24\n- LCQ\n- Change from Baseline in the LCQ total score at Week 24\n- LCQ response at Week 24","definition_or_measurement_approach":"CS-VAS: patient-reported cough severity visual analogue scale (change and response at Week 24); Objective cough frequency recording and awake cough frequency measured by cough monitor; 24-hour cough response measured versus Baseline at Week 24; LCQ = Leicester Cough Questionnaire total score change and response at Week 24."}
Recruitment
- Digital Remote Recruitment
- Yes
- Planned Sample Size
- 723
- Recruitment Window Months
- 48
- Consent Approach
- Written informed consent obtained from adult participants who must be capable of understanding the written informed consent. Subject information and informed consent forms (L1 SIS and ICF and language-specific versions) are provided; ICFs and patient-facing documents exist in country/language-specific versions (examples include DEU, POL, SVK, CZE). No minors/assent procedures are indicated.
Methods
- Pre-screening website content (K2_Patient_Pre_Screening_Website and country-specific versions)
- Referral hub (K2_Referral_Hub_content)
- Patient brochure and patient study guide (K2_Patient Brochure, K2_Patient Study Guide) provided to potential participants
- Site recruitment materials, patient flyers and posters (K2_Site_Recruitment_Material, K2_Patient_Flyer, K2_Patient_Poster)
- Inbound/outbound call scripts and appointment scheduling call scripts for phone-based recruitment (K2_DTP_Inbound/Outbound Call Script, Schedule Appointment Call Script)
- Participant emails and Clinician/Patient video storyboard content (K2_Patient Study Overview Video Storyboard, Participant Journey Emails)
- Use of ClinCard/Greenphire reimbursement and travel support materials (K2_Greenphire ClinCard templates and travel guides)
- Site network recruitment via CRO/site vendors (documents reference multiple site recruitment toolkits and site-specific materials)
Geography
- Total Number Of Sites
- 44
- Total Number Of Participants
- 723
Germany
- Earliest CTIS Part Ii Submission Date
- 05-08-2024
- Latest Decision Or Authorization Date
- 15-08-2024
- Processing Time Days
- 10
- Number Of Sites
- 25
- Number Of Participants
- 140
Sites
- Site Name
- Zentrum Fuer Ambulante Pneumologische Forschung Marburg GbR
- Department Name
- ambulante pneumologische Forschung
- Contact Person Name
- Silke Mronga
- Contact Person Email
- Mronga@studienzentrum-marburg.de
- Site Name
- Klinische Forschung Dresden GmbH
- Department Name
- Klinische Forschung Dresden GmbH
- Contact Person Name
- Peter Heymer
- Contact Person Email
- info-dresden@pratia.com
- Site Name
- Klinische Forschung Berlin-Mitte GmbH
- Department Name
- Klinische Forschung Berlin-Mitte GmbH
- Contact Person Name
- Hans Peter Gmünder
- Contact Person Email
- hans.peter.gmuender@pratia.com
- Site Name
- Pneumologicum Halle
- Department Name
- Pneumologicum Halle
- Contact Person Name
- Peter-Uwe Haase
- Contact Person Email
- peteruwehaase@aol.com
- Site Name
- Universitaetsklinikum Frankfurt AöR
- Department Name
- Zentrum der Inneren Medizin: Medizinische Klinik I
- Contact Person Name
- Wolfgang Gleiber
- Contact Person Email
- wolfgang.gleiber@kgu.de
- Site Name
- Klinische Forschung Karlsruhe GmbH
- Department Name
- Klinische Forschung Karlsruhe GmbH
- Contact Person Name
- Alla Reimer
- Contact Person Email
- Alla.reimer@pratia.com
- Site Name
- Pneumologicum im Suedstadtforum Dr. Alexander Schulz Dr. Martin Hoffmann Dr. Henning Geldmacher PD Dr. Hendrik Suhling Fachaerzte fuer Innere Medizin Pneumologie Partnerschaftsgesellschaft
- Department Name
- Pneumologicum im Südstadtforum
- Contact Person Name
- Martin Hoffmann
- Contact Person Email
- hoffmann@pneumologicum.de
- Site Name
- Pneumologisches Forschungsinstitut Hohegeest GbR
- Department Name
- Pneumologisches Forschungsinstitut
- Contact Person Name
- Wolfgang Zachgo
- Contact Person Email
- wz@mikloweit-zachgo.de
- Site Name
- Thoraxklinik Heidelberg gGmbH
- Department Name
- Pneumologie und Beatmungsmedizin
- Contact Person Name
- Franziska Trudzinski
- Contact Person Email
- Franziska.Trudzinski@med.uniheidelberg.de
- Site Name
- Klinische Forschung Hamburg GmbH
- Department Name
- Klinische Forschung Hamburg GmbH
- Contact Person Name
- Michael Froer
- Contact Person Email
- michael.froer@pratia.com
- Site Name
- GEKA Gesellschaft fuer Experimentelle und Klinische Atemwegsforschung mbH
- Department Name
- Zentrum für Rhinologie und Allergologie
- Contact Person Name
- Jan Hagemann
- Contact Person Email
- Jan.Hagemann@allergiezentrum.org
- Site Name
- Pneumo Studien Darmstadt GmbH
- Department Name
- Pneumostudien Darmstadt
- Principal Investigator Name
- Andreas Forster
- Principal Investigator Email
- forster@pneumostudien-darmstadt.de
- Contact Person Name
- Andreas Forster
- Contact Person Email
- forster@pneumostudien-darmstadt.de
- Site Name
- Ballenberger Freytag Wenisch Institut fuer klinische Forschung GmbH
- Department Name
- Institut für klinische Forschung
- Contact Person Name
- Sabine Ballenberger
- Contact Person Email
- ballenberger@bfw-institut.de
- Site Name
- Siteworks GmbH
- Department Name
- Siteworks - Zentrum für Klinische Studien Bochum
- Contact Person Name
- Annemone Köchel
- Contact Person Email
- koechel@siteworks-research.de
- Site Name
- Medaimun GmbH
- Department Name
- Medaimun GmbH
- Contact Person Name
- Stefan Zielen
- Contact Person Email
- S.zielen@medaimun.de
- Site Name
- Pneumologisches Studienzentrum München-West
- Department Name
- Pneumologisches Studienzentrum München-West
- Contact Person Name
- Rainald Fischer
- Contact Person Email
- rainald.fischer@gmail.com
- Site Name
- IKF Pneumologie GmbH & Co. KG
- Department Name
- IKF Pneumologie GmbH & Co. KG
- Principal Investigator Name
- Marc Oliver Kornmann
- Principal Investigator Email
- kornmann@ikf-pneumologie.de
- Contact Person Name
- Marc Oliver Kornmann
- Contact Person Email
- kornmann@ikf-pneumologie.de
- Site Name
- Medizentrum Essen Borbeck
- Department Name
- Medizentrum Essen Borbeck
- Principal Investigator Name
- Axel Schaefer
- Principal Investigator Email
- axel.schaefer@mzeb.de
- Contact Person Name
- Axel Schaefer
- Contact Person Email
- axel.schaefer@mzeb.de
- Site Name
- Klinische Forschung Hannover-Mitte GmbH
- Department Name
- Klinische Forschung Hannover-Mitte GmbH
- Principal Investigator Name
- Jan Wagner
- Principal Investigator Email
- Jan.wagner@pratia.com
- Contact Person Name
- Jan Wagner
- Contact Person Email
- Jan.wagner@pratia.com
- Site Name
- Siteworks GmbH (Schleswig)
- Department Name
- RespiRatio affiliated to Lungenpraxis Schleswig
- Principal Investigator Name
- Andreas Deimling
- Principal Investigator Email
- info@siteworks-research.de
- Contact Person Name
- Andreas Deimling
- Contact Person Email
- info@siteworks-research.de
- Site Name
- Velocity Clinical Research Germany GmbH
- Department Name
- Velocity Clinical Research Germany GmbH
- Principal Investigator Name
- Nakul Modi
- Principal Investigator Email
- klanderholm@velocityclinical.com
- Contact Person Name
- Nakul Modi
- Contact Person Email
- klanderholm@velocityclinical.com
- Site Name
- Pneumologisches Studienzentrum MVZ dieLungenaerzte
- Department Name
- Pneumologisches Studienzentrum MVZ dieLungenaerzte
- Principal Investigator Name
- Markus Becker
- Principal Investigator Email
- becker@lungenaerzte-mitte.de
- Contact Person Name
- Markus Becker
- Contact Person Email
- becker@lungenaerzte-mitte.de
- Site Name
- Lungenzentrum Maingau
- Department Name
- Lungenzentrum Maingau
- Principal Investigator Name
- Peter Kardos
- Principal Investigator Email
- kardos@lungenzentrum-maingau.de
- Contact Person Name
- Peter Kardos
- Contact Person Email
- kardos@lungenzentrum-maingau.de
Slovakia
- Earliest CTIS Part Ii Submission Date
- 05-08-2024
- Latest Decision Or Authorization Date
- 08-08-2024
- Processing Time Days
- 3
- Number Of Sites
- 7
- Number Of Participants
- 33
Sites
- Site Name
- Plucna ambulancia Hrebenar s.r.o.
- Department Name
- Pneumologicko-ftizeologicka ambulancia
- Principal Investigator Name
- Slavomir Hrebenar
- Principal Investigator Email
- tapch@centrum.sk
- Contact Person Name
- Slavomir Hrebenar
- Contact Person Email
- tapch@centrum.sk
- Site Name
- Nsp Sv. Jakuba N.O. Bardejov
- Department Name
- Pneumologicka ftizeologicka ambulancia
- 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
- Zeleznicne zdravotnictvo Kosice s.r.o.
- Department Name
- Pneumologicko-ftizeologicka ambulancia
- Principal Investigator Name
- Martin Orolin
- Principal Investigator Email
- m_orolin@yahoo.com
- Contact Person Name
- Martin Orolin
- Contact Person Email
- m_orolin@yahoo.com
- Site Name
- AlergoImuno centrum s.r.o.
- Department Name
- Ambulancia klinickej imunologie a alergologie
- Principal Investigator Name
- Ivan Hlinka
- Principal Investigator Email
- hlinka@centrum.sk
- Contact Person Name
- Ivan Hlinka
- Contact Person Email
- hlinka@centrum.sk
- Site Name
- PNEUMO-MED s.r.o.
- Department Name
- Pneumologicko-ftizeologicka ambulancia
- Principal Investigator Name
- Katarina Vircikova
- Principal Investigator Email
- vircikal@orangemail.sk
- Contact Person Name
- Katarina Vircikova
- Contact Person Email
- vircikal@orangemail.sk
- Site Name
- Inspiro s.r.o.
- Department Name
- Pneumologicko-ftizeologicka ambulancia
- Principal Investigator Name
- Alexander Golubov
- Principal Investigator Email
- agolubov0904@gmail.com
- Contact Person Name
- Alexander Golubov
- Contact Person Email
- agolubov0904@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@gmail.com
- Contact Person Name
- Maria Dzupinova
- Contact Person Email
- marika.dzupinova@gmail.com
Czechia
- Earliest CTIS Part Ii Submission Date
- 05-08-2024
- Latest Decision Or Authorization Date
- 03-09-2024
- Processing Time Days
- 29
- Number Of Sites
- 6
- Number Of Participants
- 44
Sites
- Site Name
- Fakultni Nemocnice Brno
- Department Name
- Klinika nemocí plícních a tuberkulózy
- Principal Investigator Name
- Kristián Brat
- Principal Investigator Email
- brat.kristian@fnbrno.cz
- Contact Person Name
- Kristián Brat
- Contact Person Email
- brat.kristian@fnbrno.cz
- Site Name
- MUDr. I. Cierna Peterova s.r.o.
- Department Name
- MUDr. I. Čierná-Peterová s.r.o.
- Principal Investigator Name
- Ivana Čierná - Peterová
- Principal Investigator Email
- trnbrnl@gmai.com
- Contact Person Name
- Ivana Čierná - Peterová
- Contact Person Email
- trnbrnl@gmai.com
- Site Name
- D A W O N spol. s r.o.
- Department Name
- Plícní ambulance
- Principal Investigator Name
- Romana Davidová
- Principal Investigator Email
- omanadavidova@seznam.cz
- Contact Person Name
- Romana Davidová
- Contact Person Email
- omanadavidova@seznam.cz
- Site Name
- University Hospital Olomouc
- Department Name
- Klinika plicnich nemoci a tuberkulozy
- Principal Investigator Name
- Jaromír Zatloukal
- Principal Investigator Email
- jaromir.zatloukal@fnol.cz
- Contact Person Name
- Jaromír Zatloukal
- Contact Person Email
- jaromir.zatloukal@fnol.cz
- Site Name
- MUDr. Jaroslav Mareš - TBC a respir. nemoci
- Department Name
- Plícní ordinace
- Principal Investigator Name
- Jaroslav Mareš
- Principal Investigator Email
- mares245@tiscali.cz
- Contact Person Name
- Jaroslav Mareš
- Contact Person Email
- mares245@tiscali.cz
- Site Name
- MUDr. Ilona Pavlisova s.r.o.
- Department Name
- Plícní ordinace
- Principal Investigator Name
- Ilona Pavlišová
- Principal Investigator Email
- pavlisova.i@seznam.cz
- Contact Person Name
- Ilona Pavlišová
- Contact Person Email
- pavlisova.i@seznam.cz
Poland
- Earliest CTIS Part Ii Submission Date
- 09-10-2025
- Latest Decision Or Authorization Date
- 31-10-2025
- Processing Time Days
- 22
- Number Of Sites
- 6
- Number Of Participants
- 40
Sites
- Site Name
- Alergo Med Osrodek Badan Klinicznych Sp. z o.o.
- Department Name
- Alergo Med
- Principal Investigator Name
- Bernadetta Majorek-Olechowska
- Principal Investigator Email
- bernadettaolechowska@gmail.com
- Contact Person Name
- Bernadetta Majorek-Olechowska
- Contact Person Email
- bernadettaolechowska@gmail.com
- Site Name
- Centrum Innowacyjnych Terapii Sp. z o.o.
- Department Name
- Centrum Innowacyjnych Terapii Sp.Z o.o.
- Principal Investigator Name
- Luiza Jonczak
- Principal Investigator Email
- rafal.szurnicki@citrials.pl
- Contact Person Name
- Luiza Jonczak
- Contact Person Email
- rafal.szurnicki@citrials.pl
- Site Name
- Centrum Zdrowia MDM
- Department Name
- Centrum Zdrowia MDM
- Principal Investigator Name
- Marta Dabrowska
- Principal Investigator Email
- marta.dabrowska1@wum.edu.pl
- Contact Person Name
- Marta Dabrowska
- Contact Person Email
- marta.dabrowska1@wum.edu.pl
- Site Name
- Centrum Badan Klinicznych Piotr Napora Lekarze sp.p.
- Department Name
- Centrum Badan Klinicznych
- Principal Investigator Name
- Piotr Napora
- Principal Investigator Email
- szpital@cbk.wroc.pl
- Contact Person Name
- Piotr Napora
- Contact Person Email
- szpital@cbk.wroc.pl
- Site Name
- Prywatny Gabinet Lekarski Małgorzata Pawlukiewicz
- Department Name
- Prywatny Gabinet Lekarski Małgorzata Pawlukiewicz
- Principal Investigator Name
- Małgorzata Pawlukiewicz
- Principal Investigator Email
- pawlukiewiczj@gmail.com
- Contact Person Name
- Małgorzata Pawlukiewicz
- Contact Person Email
- pawlukiewiczj@gmail.com
- Site Name
- Samodzielny Publiczny Zaklad Opieki Zdrowotnej Uniwersytecki Szpital Kliniczny Nr 1 Im. Norberta Barlickiego Uniwersytetu Medycznego W Lodzi
- Department Name
- Uniwersytecki Szpital Kliniczny nr 1 im.Barlickiego
- Principal Investigator Name
- Piotr Kuna
- Principal Investigator Email
- wojciech.piotrowski@umed.lodz.pl
- Contact Person Name
- Piotr Kuna
- Contact Person Email
- wojciech.piotrowski@umed.lodz.pl
Sponsor
Primary sponsor
- Full Name
- Bellus Health Inc.
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- Canada
Contract research organisations
- Name
- Iqvia Rds Ireland Limited
- Responsibilities
- Site network, eCOA, patient study costs management and concierge; cough diary; equipment rental
- Name
- Syneos Health Clinique Inc.
- Responsibilities
- Pharmacokinetic analysis
- Name
- Sitero LLC
- Responsibilities
- IVRS/treatment randomisation and randomisation system
- Name
- Q Squared Solutions Limited
- Responsibilities
- Laboratory analyses (clinical chemistry, haematology, serology, pregnancy tests, SARS-CoV-2 tests, urine drug screen, urinalysis)
Third parties
- {"country":"United Kingdom","full_name":"Glaxosmithkline Research & Development Limited","duties_or_roles":"SUSAR reporting; (additional duty codes present but not specified)","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Cisys Inc.","duties_or_roles":"Eligibility criteria adjudication platform","organisation_type":"Pharmaceutical company"}
- {"country":"Ireland","full_name":"Iqvia Rds Ireland Limited","duties_or_roles":"Site network, eCOA, patient study costs management and concierge; cough diary; equipment rental; multiple operational roles","organisation_type":"Pharmaceutical company"}
- {"country":"United Kingdom","full_name":"Vitalograph Limited","duties_or_roles":"Measurement of recorded cough frequency","organisation_type":"Pharmaceutical company"}
- {"country":"United Kingdom","full_name":"Q Squared Solutions Limited","duties_or_roles":"Clinical chemistry, Clinical haematology, Serology/ endocrinology, serum pregnancy tests, SARS-CoV-2 tests, urine drug screen, urinalysis","organisation_type":"Non-Pharmaceutical company"}
- {"country":"Canada","full_name":"Syneos Health Clinique Inc.","duties_or_roles":"Pharmacokinetic analysis","organisation_type":"Hospital/Clinic/Other health care facility"}
- {"country":"United States","full_name":"Sitero LLC","duties_or_roles":"IVRS30 – treatment randomisation; other operational functions","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Greenphire LLC","duties_or_roles":"Patient reimbursements","organisation_type":"Non-Pharmaceutical company"}
Investigational products
- Investigational Product Name
- BLU-5937
- Active Substance
- CAMLIPIXANT
- Modality
- Small molecule
- Routes Of Administration
- Oral
- Route
- ORAL USE
- Maximum Dose
- 1111 mg
- Investigational Product Name
- Placebo (Tablets are oval, biconvex, plain and white to off white)
- Modality
- Other
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