Clinical trial • Phase II • Oncology|Respiratory|Rare Disease
TALADEGIB for Idiopathic pulmonary fibrosis
Phase II trial of TALADEGIB for Idiopathic pulmonary fibrosis.
Overview
- Trial Therapeutic Area
- Oncology|Respiratory|Rare Disease
- Trial Disease
- Idiopathic pulmonary fibrosis
- Trial Stage
- Phase II
- Drug Modality
- Small molecule
- Orphan Drug
- Yes
Key dates
- Initial CTIS Submission Date
- 25-10-2024
- First CTIS Authorization Date
- 03-03-2025
Trial design
Randomised, placebo drug product is available as a film-coated tablet containing no taladegib, provided as equivalent in size, color and shape to the active 25 mg and 100 mg taladegib tablets (placebo matching env-101 25 mg and 100 mg).-controlled Phase II trial in Germany, France, Austria and others.
- Randomised
- Yes
- Comparator
- Placebo drug product is available as a film-coated tablet containing no taladegib, provided as equivalent in size, color and shape to the active 25 mg and 100 mg taladegib tablets (placebo matching ENV-101 25 mg and 100 mg).
- Target Sample Size
- 218
- Trial Duration For Participant
- 168
Eligibility
Recruits 218 isVulnerablePopulationSelected = true. Subject information and informed consent form documents are listed for multiple countries and languages (country-specific ICFs). No explicit description of assent or special consent handling for minors is provided in the available CTIS data; inclusion criteria require adults (≥40 years)..
- Vulnerable Population
- isVulnerablePopulationSelected = true. Subject information and informed consent form documents are listed for multiple countries and languages (country-specific ICFs). No explicit description of assent or special consent handling for minors is provided in the available CTIS data; inclusion criteria require adults (≥40 years).
Inclusion criteria
- {"criterion_text":"- Patients ≥ 40 years old with an IPF diagnosis within the last 5 years based on 2022 international guidelines as confirmed by the Investigator.\n- A qualifying chest HRCT scan taken during Screening or within 30 days prior to Screening must be consistent with the diagnosis of IPF, as confirmed by central read/review.\n- Percent predicted FVC of ≥ 45% at the Screening Visit.\n- Percent predicted DLCO ≥ 25%, adjusted for hemoglobin (Hgb) at the Screening Visit.\n- Ability to perform spirometry tests.\n- Either stable treatment with SoC (i.e., antifibrotics) for at least 3 months prior to Day 1 or not treated with SoC for at least 8 weeks prior to Day 1."}
Exclusion criteria
- {"criterion_text":"- Evidence of other known causes of interstitial lung disease [e.g., domestic and occupational environmental exposures and drug toxicity].\n- Lung transplant expected within 12 months of the Screening Visit.\n- Evidence of clinically significant lung disease, other than IPF, including but not limited to asthma, chronic obstructive pulmonary disease (COPD), uncontrolled pulmonary hypertension and emphysema where computed tomography (CT)-assessed extent of emphysema is greater than extent of fibrosis, or clinically significant pulmonary abnormalities.\n- Forced expiratory volume in one second (FEV1)/FVC ratio <0.7 at the Screening Visit.\n- Acute exacerbation of IPF, in the opinion of the Investigator, within 3 months prior to Day 1"}
Endpoints
Primary endpoints
- {"endpoint_text":"- Change in ppFVC from baseline to Week 24, as compared to PBO.","definition_or_measurement_approach":"Change in percent predicted forced vital capacity (ppFVC) from baseline to Week 24 compared with placebo (PBO)."}
Secondary endpoints
- {"endpoint_text":"- Absolute change in FVC (mL) from baseline to Week 24, as compared to PBO.\n- Time to disease progression (absolute decline in ppFVC >10%, IPF related hospitalization, or death) up to Week 24, as compared to PBO.\n- Absolute change in L-PF Symptoms Cough domain score from baseline to Week 24, as compared to PBO.\n- Absolute change in L-PF Symptoms Dyspnea domain score from baseline to Week 24, as compared to PBO.\n- Absolute change in L-PF Symptoms Fatigue domain score from baseline to Week 24, as compared to PBO","definition_or_measurement_approach":"Absolute change in FVC measured in mL from baseline to Week 24; disease progression defined as absolute decline in ppFVC >10%, IPF-related hospitalization, or death up to Week 24; L-PF symptom domain scores assessed as change from baseline to Week 24 versus placebo."}
Recruitment
- Planned Sample Size
- 218
- Recruitment Window Months
- 17
- Consent Approach
- Informed consent obtained from participants (adults; inclusion criteria require ≥40 years). Country-specific subject information and informed consent form documents are provided in multiple languages (examples: German, French, Italian, English, Dutch) as listed in CTIS. No assent process for minors is described.
Methods
- Site-based recruitment at participating hospitals and university clinics listed in country trial sites (Germany, France, Austria, Italy, Ireland, Belgium).
- Third-party patient recruitment managed by Patient Enrollment Advisors, LLC (listed sponsor third party: 'Patient recruitment').
- Use of country-specific recruitment procedure documents (K1) for each participating Member State (documents listed in CTIS).
Geography
- Total Number Of Sites
- 31
- Total Number Of Participants
- 140
Germany
- Earliest CTIS Part Ii Submission Date
- 06-02-2025
- Latest Decision Or Authorization Date
- 04-03-2025
- Processing Time Days
- 26
- Number Of Sites
- 6
- Number Of Participants
- 26
Sites
- Site Name
- Lungenfachklinik Immenhausen
- Department Name
- #148
- Principal Investigator Name
- Peter Hammerl
- Principal Investigator Email
- hammerl@lungenfachklinik-Immenhausen.de
- Contact Person Name
- Peter Hammerl
- Contact Person Email
- hammerl@lungenfachklinik-Immenhausen.de
- Site Name
- Universitaet Leipzig
- Department Name
- #200; Klinik und Poliklinik für Onkologie, Gastroenterologie, Hepatologie und Pneumologie
- Principal Investigator Name
- Hubert Wirtz
- Principal Investigator Email
- hubert.wirtz@medizin.uni-leipzig.de
- Contact Person Name
- Hubert Wirtz
- Contact Person Email
- hubert.wirtz@medizin.uni-leipzig.de
- Site Name
- Medizinische Hochschule Hannover
- Department Name
- #152: Klinik für Pneumologie und Infektiologie
- Principal Investigator Name
- Benjamin Seeliger
- Principal Investigator Email
- seeliger.benjamin@mh-hannover.de
- Contact Person Name
- Benjamin Seeliger
- Contact Person Email
- seeliger.benjamin@mh-hannover.de
- Site Name
- Agaplesion Evangelisches Krankenhaus Mittelhessen gGmbH
- Department Name
- #149: Medizinische Klinik III - Pneumologische Klinik
- Principal Investigator Name
- Andreas Günther
- Principal Investigator Email
- andreas.guenther@innere.med.uni-giessen.de
- Contact Person Name
- Andreas Günther
- Contact Person Email
- andreas.guenther@innere.med.uni-giessen.de
- Site Name
- Evangelische Lungenklinik Berlin Krankenhausbetriebs gGmbH
- Department Name
- #173: Klinik für Pneumologie
- Principal Investigator Name
- Christian Grohé
- Principal Investigator Email
- christian.grohe@jsd.de
- Contact Person Name
- Christian Grohé
- Contact Person Email
- christian.grohe@jsd.de
- Site Name
- Universitaetsklinikum Essen AöR
- Department Name
- #189; Klinik für Pneumologie, Interstitielle Lungenerkrankungen
- Principal Investigator Name
- Francesco Bonella
- Principal Investigator Email
- francesco.bonella@rlk.uk-essen.de
- Contact Person Name
- Francesco Bonella
- Contact Person Email
- francesco.bonella@rlk.uk-essen.de
France
- Earliest CTIS Part Ii Submission Date
- 20-05-2025
- Latest Decision Or Authorization Date
- 04-06-2025
- Processing Time Days
- 15
- Number Of Sites
- 10
- Number Of Participants
- 60
Sites
- Site Name
- Assistance Publique Hopitaux De Paris
- Department Name
- #201: Pneumologie
- Principal Investigator Name
- David Montani
- Principal Investigator Email
- david.montani@aphp.fr
- Contact Person Name
- David Montani
- Contact Person Email
- david.montani@aphp.fr
- Site Name
- Centre Hospitalier Universitaire D'Angers
- Department Name
- #186: Médecine Respiratoire et du Sommeil
- Principal Investigator Name
- Frederic Gagnadoux
- Principal Investigator Email
- frgagnadoux@chu-angers.fr
- Contact Person Name
- Frederic Gagnadoux
- Contact Person Email
- frgagnadoux@chu-angers.fr
- Site Name
- Centre Hospitalier Universitaire De Dijon
- Department Name
- #184: Pneumologie
- Principal Investigator Name
- Philippe Bonniaud
- Principal Investigator Email
- philippe.bonniaud@chu-dijon.fr
- Contact Person Name
- Philippe Bonniaud
- Contact Person Email
- philippe.bonniaud@chu-dijon.fr
- Site Name
- Centre Hospitalier Universitaire De Nantes
- Department Name
- #198: Pneumologie
- Principal Investigator Name
- Stephanie Dirou
- Principal Investigator Email
- Stephanie.DIROU@chu-nantes.fr
- Contact Person Name
- Stephanie Dirou
- Contact Person Email
- Stephanie.DIROU@chu-nantes.fr
- Site Name
- Centre Hospitalier Universitaire De Rennes
- Department Name
- #182: Pneumologie
- Principal Investigator Name
- Stéphane Jouneau
- Principal Investigator Email
- stephane.jouneau@chu-rennes.fr
- Contact Person Name
- Stéphane Jouneau
- Contact Person Email
- stephane.jouneau@chu-rennes.fr
- Site Name
- Centre Hospitalier Regional Universitaire De Tours
- Department Name
- #199: Pneumologie
- Principal Investigator Name
- Sylvain Marchand-Adam
- Principal Investigator Email
- sylvain.marchand-adam@univ-tours.fr
- Contact Person Name
- Sylvain Marchand-Adam
- Contact Person Email
- sylvain.marchand-adam@univ-tours.fr
- Site Name
- GIE Groupe hospitalier Paris Saint-Joseph/Vinci
- Department Name
- #185: Pneumologie
- Principal Investigator Name
- Jean-Marc Naccache
- Principal Investigator Email
- jmnaccache@ghpsj.fr
- Contact Person Name
- Jean-Marc Naccache
- Contact Person Email
- jmnaccache@ghpsj.fr
- Site Name
- Centre Hospitalier Universitaire De Caen Normandie
- Department Name
- #183: Pneumologie
- Principal Investigator Name
- Aurelien Justet
- Principal Investigator Email
- Justet-a@chu-caen.fr
- Contact Person Name
- Aurelien Justet
- Contact Person Email
- Justet-a@chu-caen.fr
- Site Name
- Centre Hospitalier Universitaire De Montpellier
- Department Name
- #193: Maladies Respiratoires
- Principal Investigator Name
- Arnaud Bourdin
- Principal Investigator Email
- a-bourdin@chu-montpellier.fr
- Contact Person Name
- Arnaud Bourdin
- Contact Person Email
- a-bourdin@chu-montpellier.fr
- Site Name
- Centre Hospitalier Universitaire De Bordeaux
- Department Name
- #194: Maladies Respiratoires
- Principal Investigator Name
- Elodie Blanchard
- Principal Investigator Email
- elodie.blanchard@chu-bordeaux.fr
- Contact Person Name
- Elodie Blanchard
- Contact Person Email
- elodie.blanchard@chu-bordeaux.fr
Austria
- Earliest CTIS Part Ii Submission Date
- 17-01-2025
- Latest Decision Or Authorization Date
- 10-03-2025
- Processing Time Days
- 52
- Number Of Sites
- 2
- Number Of Participants
- 9
Sites
- Site Name
- Medical University Of Graz
- Department Name
- #158: Universitätsklinik, für Innere Medizin, Klinische Abteilung für Pulmonologie
- Principal Investigator Name
- Nikolaus Kneidinger
- Principal Investigator Email
- nikolaus.kneidinger@medunigraz.at
- Contact Person Name
- Nikolaus Kneidinger
- Contact Person Email
- nikolaus.kneidinger@medunigraz.at
- Site Name
- Medical University Of Vienna
- Department Name
- #120: 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
Italy
- Earliest CTIS Part Ii Submission Date
- 07-02-2025
- Latest Decision Or Authorization Date
- 07-03-2025
- Processing Time Days
- 28
- Number Of Sites
- 6
- Number Of Participants
- 30
Sites
- Site Name
- Azienda Ospedaliero-Universitaria Policlinico G. Rodolico-San Marco Di Catania
- Department Name
- #187: UOC Pneumologia
- Principal Investigator Name
- Carlo Vancheri
- Principal Investigator Email
- vancheri@unict.it
- Contact Person Name
- Carlo Vancheri
- Contact Person Email
- vancheri@unict.it
- Site Name
- Careggi University Hospital
- Department Name
- 160; SOD Pneumologia Interventistica
- Principal Investigator Name
- Sara Tomassetti
- Principal Investigator Email
- sara.tomassetti@unifi.it
- Contact Person Name
- Sara Tomassetti
- Contact Person Email
- sara.tomassetti@unifi.it
- Site Name
- Azienda Ospedaliera di Padova
- Department Name
- 153; UOC Pneumologia
- Principal Investigator Name
- Paolo Spagnolo
- Principal Investigator Email
- paolo.spagnolo@unipd.it
- Contact Person Name
- Paolo Spagnolo
- Contact Person Email
- paolo.spagnolo@unipd.it
- Site Name
- Multimedica S.p.A.
- Department Name
- #195: Pneumologia
- Principal Investigator Name
- Sergio Harari
- Principal Investigator Email
- sergio.harari@multimedica.it
- Contact Person Name
- Sergio Harari
- Contact Person Email
- sergio.harari@multimedica.it
- Site Name
- Azienda Ospedaliera Universitaria Citta Della Salute E Della Scienza Di Torino
- Department Name
- 153; SC Pneumologia U
- Principal Investigator Name
- Rocco Rinaldo
- Principal Investigator Email
- rocco.rinaldo@gmx.com
- Contact Person Name
- Rocco Rinaldo
- Contact Person Email
- rocco.rinaldo@gmx.com
- Site Name
- Azienda Unita Sanitaria Locale Della Romagna
- Department Name
- 172; U.O. Pneumologia
- Principal Investigator Name
- Claudia Ravaglia
- Principal Investigator Email
- claudia.ravaglia3@unibo.it
- Contact Person Name
- Claudia Ravaglia
- Contact Person Email
- claudia.ravaglia3@unibo.it
Ireland
- Earliest CTIS Part Ii Submission Date
- 03-02-2025
- Latest Decision Or Authorization Date
- 07-03-2025
- Processing Time Days
- 32
- Number Of Sites
- 4
- Number Of Participants
- 6
Sites
- Site Name
- Beaumont Hospital
- Department Name
- #191: Respiratory medicine
- Principal Investigator Name
- Killian Hurley
- Principal Investigator Email
- killianhurley@rcsi.com
- Contact Person Name
- Killian Hurley
- Contact Person Email
- killianhurley@rcsi.com
- Site Name
- Mater Misericordiae University Hospital
- Department Name
- #192: Pulmonology
- Principal Investigator Name
- Kate O’Reilly
- Principal Investigator Email
- koreilly@mater.ie
- Contact Person Name
- Kate O’Reilly
- Contact Person Email
- koreilly@mater.ie
- Site Name
- Cork University Hospital
- Department Name
- #190: Respiratory
- Principal Investigator Name
- Michael Henry
- Principal Investigator Email
- michael.henry@hse.ie
- Contact Person Name
- Michael Henry
- Contact Person Email
- michael.henry@hse.ie
- Site Name
- St Vincent's University Hospital
- Department Name
- #141: Respiratory
- Principal Investigator Name
- Michael Keane
- Principal Investigator Email
- michael.p.keane@ucd.ie
- Contact Person Name
- Michael Keane
- Contact Person Email
- michael.p.keane@ucd.ie
Belgium
- Earliest CTIS Part Ii Submission Date
- 03-02-2025
- Latest Decision Or Authorization Date
- 03-03-2025
- Processing Time Days
- 28
- Number Of Sites
- 3
- Number Of Participants
- 9
Sites
- Site Name
- Cliniques Universitaires Saint-Luc
- Department Name
- #170: Pneumologie
- Principal Investigator Name
- Antoine Froidure
- Principal Investigator Email
- antoine.froidure@uclouvain.be
- Contact Person Name
- Antoine Froidure
- Contact Person Email
- antoine.froidure@uclouvain.be
- Site Name
- Centre Hospitalier Universitaire Dinant Godinne Sainte-Elisabeth-UCL-Namur
- Department Name
- #159: Pneumologie
- Principal Investigator Name
- Caroline Dahlqvist
- Principal Investigator Email
- caroline.dahlqvist@uclouvain.be
- Contact Person Name
- Caroline Dahlqvist
- Contact Person Email
- caroline.dahlqvist@uclouvain.be
- Site Name
- Hopital Erasme
- Department Name
- #161: Gastroenterologie-oncologie
- Principal Investigator Name
- Benjamin Bondue
- Principal Investigator Email
- benjamin.bondue@hubruxelles.be
- Contact Person Name
- Benjamin Bondue
- Contact Person Email
- benjamin.bondue@hubruxelles.be
Sponsor
Primary sponsor
- Full Name
- Endeavor Biomedicines Inc.
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- United States
Contract research organisations
- Name
- Parexel International (IRL) Limited
- Responsibilities
- sponsorDuties codes: 1,10,12,2,5,8,9
- Name
- MEDPACE LABORATORIES
- Responsibilities
- sponsorDuties code: 4
Third parties
- {"country":"Belgium","full_name":"MEDPACE LABORATORIES","duties_or_roles":"sponsorDuties codes: 4","organisation_type":"Laboratory/Research/Testing facility"}
- {"country":"United States","full_name":"Voiant LLC","duties_or_roles":"sponsorDuties: 15 (Imaging)","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Medidata Solutions Inc.","duties_or_roles":"sponsorDuties: 15 (EDC and RTSM)","organisation_type":"Non-Pharmaceutical company"}
- {"country":"United States","full_name":"Patient Enrollment Advisors, LLC","duties_or_roles":"sponsorDuties: 15 (Patient recruitment)","organisation_type":"Industry"}
- {"country":"Ireland","full_name":"Parexel International (IRL) Limited","duties_or_roles":"sponsorDuties codes: 1,10,12,2,5,8,9","organisation_type":"Pharmaceutical company"}
- {"country":"Canada","full_name":"Axiom Real-Time Metrics Inc.","duties_or_roles":"sponsorDuties: 8","organisation_type":"Pharmaceutical company"}
- {"country":"Germany","full_name":"eResearchTechnology GmbH","duties_or_roles":"sponsorDuties: 15 (PFT (spirometry only)/ ECG)","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Cadence Travel Inc.","duties_or_roles":"sponsorDuties: 15 (Investigator Meetings)","organisation_type":"Non-Pharmaceutical company"}
- {"country":"United States","full_name":"Sherpa Clinical Packaging LLC","duties_or_roles":"sponsorDuties: 15 (IP Manufacturing and labeling)","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Biotrinity Consulting LLC","duties_or_roles":"sponsorDuties: 6","organisation_type":"Non-Pharmaceutical company"}
Investigational products
- Investigational Product Name
- Taladegib (25 mg strength)
- Active Substance
- TALADEGIB
- Modality
- Small molecule
- Routes Of Administration
- ORAL
- Route
- ORAL
- Authorisation Status
- Authorised
- Orphan Designation
- Yes
- Starting Dose
- 25 mg
- Dose Levels
- 25 mg
- Investigational Product Name
- Taladegib (100 mg strength)
- Active Substance
- TALADEGIB
- Modality
- Small molecule
- Routes Of Administration
- ORAL
- Route
- ORAL
- Authorisation Status
- Authorised
- Orphan Designation
- Yes
- Starting Dose
- 100 mg
- Dose Levels
- 100 mg
- Investigational Product Name
- Placebo (matching 25 mg tablet)
- Modality
- Other
- Routes Of Administration
- ORAL
- Route
- ORAL
- Starting Dose
- Placebo matching 25 mg
- Dose Levels
- Placebo
- Investigational Product Name
- Placebo (matching 100 mg tablet)
- Modality
- Other
- Routes Of Administration
- ORAL
- Route
- ORAL
- Starting Dose
- Placebo matching 100 mg
- Dose Levels
- Placebo
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