Clinical trial • Phase III • Respiratory
DEPEMOKIMAB for Eosinophilic asthma
Phase III trial of DEPEMOKIMAB for Eosinophilic asthma. open-label. 55 participants.
Overview
- Trial Therapeutic Area
- Respiratory
- Trial Disease
- Eosinophilic asthma
- Trial Stage
- Phase III
- Drug Modality
- Monoclonal antibody
Key dates
- Initial CTIS Submission Date
- 01-07-2025
- First CTIS Authorization Date
- 20-10-2025
Trial design
open-label Phase III trial across 36 sites in Germany, Greece, Belgium and others.
- Open Label
- Yes
- Target Sample Size
- 55
- Trial Duration For Participant
- 455
Eligibility
Recruits 55 Vulnerable population selected. Participants must be ≥18 and be capable of giving written informed consent. Subject information and consent documents are provided (Main ICF, Pregnant-Participant-ICF, Sub-Study ICF, Pre/Post-Bronchoscopy Patient Information Sheets, Future Research ICF). No procedures for assent of minors are described (study requires participants ≥18)..
- Pregnancy Exclusion
- 16. Participants who are pregnant or breastfeeding.
- Vulnerable Population
- Vulnerable population selected. Participants must be ≥18 and be capable of giving written informed consent. Subject information and consent documents are provided (Main ICF, Pregnant-Participant-ICF, Sub-Study ICF, Pre/Post-Bronchoscopy Patient Information Sheets, Future Research ICF). No procedures for assent of minors are described (study requires participants ≥18).
Inclusion criteria
- {"criterion_text":"- 1. Participants must be ≥18 years of age, at the time of signing the informed consent form (ICF)\n- 10. Participants who sign Informed Consent for biopsy sub study.\n- 11. Participants with post bronchodilator FEV1 ≥ 50% predicted\n- 12. Participants with no known increased risk for bleeding including: •\tNo history of easy bleeding, bruising or known bleeding diathesis •\tNo current anticoagulant and antiplatelet therapy •\tNo acetylsalicylic acid use within 2 weeks of the planned procedure •\tNormal screening platelet count\n- 13. Participants with no specific contraindication to bronchoscopy with endobronchial biopsy in the opinion of the investigator.\n- 14. No history of allergic reaction to local anesthesia or general anesthetic agent, which ever relevant to the procedure being performed.\n- 2. Documented clinical diagnosis of asthma for ≥2 years as per the National Heart, Lung, and Blood Institute guidelines[NHLBI, 2020], GINA guidelines [GINA, 2024], or joint guidance from the British Thoracic Society, National Institute for Health and Care Excellence, and Scottish Intercollegiate Guidelines Network [NICE, 2024] along with the following: •\tAn eosinophilic phenotype as evidenced by a blood eosinophil count of ≥300 cells/μL at screening or a documented history of blood eosinophil count ≥300 cells/μL within 3 months prior to screening. •\tExhaled nitric oxide (FeNO) measure of ≥25ppb recorded at screening. •\tPreviously confirmed history of ≥ 2 exacerbations requiring treatment with systemic corticosteroid (SCS; IM, IV, or oral), in the 12 months prior to screening, despite the use of medium to high dose ICS.\n- 3. Uncontrolled asthma indicated by ACQ5 > 1.5 recorded at screening.\n- 4. Persistent airflow obstruction as indicated by pre-bronchodilator FEV1 <80% predicted (GLI 2012) and recorded at screening.\n- 5. A well-documented requirement for regular treatment with medium or high dose ICS (in the 12 months prior to screening with or without maintenance OCS).\n- 6. Current treatment with at least one additional asthma controller medication, besides ICS, for at least 3 months [e.g., LABA, LAMA, leukotriene receptor antagonist (LTRA), or theophylline].\n- 7. Male or female. •\tMale Participants: No additional requirements for male participants.\n- 8. Female Participants: A female participant is eligible to participate if she is not pregnant or breastfeeding, and one of the following conditions applies: •\tIs a participant of non-childbearing potential (PONCBP) as defined in Section 10.4 (Appendix 4: Contraception and barrier guidance) OR •\tIs a participant of childbearing potential (POCBP) and using a contraceptive method that is highly effective (with a failure rate of <1% per year), with low user dependency, 14 days prior to and during the study intervention period and for at least 35 weeks after the last dose of study intervention. The investigator should evaluate the potential for contraceptive method failure (e.g., noncompliance, recently initiated) in relationship to the first dose of study intervention.\n- 9. A POCBP must have a negative highly sensitive pregnancy test (urine or serum as required by local regulations) within 24 hours before the first dose of study intervention (see Section 8.3.5 Pregnancy testing). •\tIf a urine test cannot be confirmed as negative (e.g., an ambiguous result), a serum pregnancy test is required. In such cases, the participant must be excluded from participation if the serum pregnancy result is positive. •\tAdditional requirements for pregnancy testing during and after the study intervention are located in Section 8.3.5. •\tThe investigator is responsible for review of medical history, menstrual history, and recent sexual activity to decrease the risk for inclusion of a participant with an early undetected pregnancy. Note: If the childbearing potential changes after start of the study or the risk of pregnancy changes (e.g., a female participant who is not heterosexually active becomes active), the participant must discuss this with the investigator, who should determine if a female participant must begin a highly effective method of contraception. If reproductive status is questionable, additional evaluation should be considered. •\tCapable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the ICF and in this protocol."}
Exclusion criteria
- {"criterion_text":"- 1. Presence of a known pre-existing, clinically important lung condition other than asthma. This includes (but is not limited to) current infection, bronchiectasis, pulmonary fibrosis, bronchopulmonary aspergillosis, or a history of lung cancer. Participants with current diagnoses of emphysema or chronic bronchitis (COPD other than asthma) are excluded.\n- 18. Participants who: -\thave occupational ionizing-radiation exposure exceeding 10 mSV over 3 years as documented with a dosimeter. -\thave been exposed to elevated ionizing radiation from research imaging studies, for example: ▪ \tParticipation in a research study with a single positron emission tomography scan in the past 3 years. ▪ \tParticipation in a research study with 2 or more CT scans in the past 3 years in the following anatomical regions: chest, abdomen, cardiac, or spine.\n- 2. Participants with other conditions that could lead to elevated eosinophils such as hyper eosinophilic syndromes including (but not limited to) Eosinophilic Granulomatosis with Polyangiitis (EGPA, formerly known as Churg-Strauss Syndrome) or eosinophilic esophagitis.\n- 19. Presence of metal objects that may interfere with chest CT quantification including presence of a cardiac pacemaker, defibrillator, metal prosthetic heart valve, metal projectile or metal weapon fragment (bullet, shrapnel, shotgun shot) or metal shoulder prosthesis.\n- 20. Evidence of clinically significant abnormality in the hematological, biochemical or urinalysis screen at screening (Visit 0), as judged by the investigator.\n- 3. Participants who developed an exacerbation within 4 weeks before screening. EXC#3\n- 4. Participants with a known, pre-existing parasitic infestation within 6 months prior to screening unless treated and evidenced to have been resolved.\n- 5. A known immunodeficiency (e.g. human immunodeficiency virus HIV), other than that explained by the use of CSs taken as therapy for asthma.\n- 6. A current malignancy or previous history of cancer in remission for less than 12 months prior to screening.\n- 7. Participants who have known, pre-existing, clinically significant cardiac, endocrine, autoimmune, metabolic, neurological, psychiatric, renal, gastrointestinal, hepatic, hematologic abnormalities or any other system abnormalities that are uncontrolled with standard treatment.\n- 8. Participants with current diagnosis of vasculitis.\n- 10. Participants who have received mAb therapy targeting IL-5/5R, IL-4R/IL-13, IL-33, IgE, or thymic stromal lymphpoietin (TSLP) within 12 months or 5 terminal phase half-lives of the drug, whichever is longer, prior to the screening. Authorized treatments for COVID-19 are permitted.\n- 9. Participants who have received a previous documented failure with anti-IL-5/5R therapy.\n- 11. Participants who have received treatment with an investigational drug within the past 30 days or 5 terminal phase half-lives of the drug whichever is longer, prior to the first dose of study intervention (this also includes investigational formulations of marketed products).\n- 12. Previously participated in any clinical study with biologic treatments for asthma (e.g., omalizumab, mepolizumab, dupilumab, reslizumab, benralizumab, other monoclonal antibodies (including Tezepelumab) or depemokimab and received study intervention (including placebo) within 12 months prior to the first dose of study intervention.\n- 13. A history (or suspected history) of alcohol misuse or substance abuse within 2 years prior to the first dose of study intervention.\n- 14. Current smokers or former smokers with a smoking history of 20 pack years (number of pack years = [number of cigarettes per day/20] x number of years smoked) and vapers.\n- 15. Participants with allergy/intolerance to a mAb or biologic or any of the excipients of depemokimab presented in Table 4.\n- 16. Participants who are pregnant or breastfeeding.\n- 17. Participants who have known evidence of lack of adherence to controller medications and/or ability to follow physician’s recommendations."}
Endpoints
Primary endpoints
- {"endpoint_text":"- Change from baseline in total mucus plug volume measured at TLC at Week 26","definition_or_measurement_approach":"Change from baseline at Week 26 measured at total lung capacity (TLC) using quantitative high-resolution CT (HRCT) imaging."}
Secondary endpoints
- {"endpoint_text":"- Change from baseline in airway wall thickness measured at TLC at Week 52.","definition_or_measurement_approach":"Change from baseline at Week 52 measured at total lung capacity (TLC) using quantitative high-resolution CT (HRCT) imaging."}
Recruitment
- Planned Sample Size
- 55
- Recruitment Window Months
- 27
- Consent Approach
- Adults (≥18) must provide written informed consent. Multiple subject information and informed consent forms are provided (Main ICF, country-specific Main ICFs in DE/GR/BE/ES/IT/FR, Pregnant-Participant-ICF, Sub-Study ICF, Future Research ICF). A separate consent is required for the biopsy sub-study; pre- and post-bronchoscopy patient information sheets are provided. ICFs are available in local languages as per country document listings.
Methods
- Use of patient-facing recruitment materials (patient flyers and posters) in local languages (titles present for DE, GR, BE, ES, IT, FR).
- GP letter template (country-specific GP letter templates listed for DE and IT) to inform referring physicians.
- Study-specific recruitment brochures and sub-study recruitment brochures (country-specific K1/K2 documents).
- Patient posters/flyers and posters targeted to asthma patients and clinic visitors (local-language versions per country).
- Clinic/site-based recruitment via participating hospital/clinic respiratory departments (site lists provided per country).
Geography
- Total Number Of Sites
- 36
- Total Number Of Participants
- 55
Germany
- Earliest CTIS Part Ii Submission Date
- 06-10-2025
- Latest Decision Or Authorization Date
- 04-03-2026
- Processing Time Days
- 149
- Number Of Sites
- 6
- Number Of Participants
- 11
Sites
- Site Name
- Thoraxklinik Heidelberg gGmbH
- Principal Investigator Name
- Frederik Trinkmann
- Principal Investigator Email
- frederik.trinkmann@med.uniheidelberg.de
- Contact Person Name
- Frederik Trinkmann
- Contact Person Email
- frederik.trinkmann@med.uniheidelberg.de
- Site Name
- Medical Center - University Of Freiburg
- Department Name
- Klinik für Pneumologie
- Principal Investigator Name
- Daiana Stolz
- Principal Investigator Email
- daiana.stolz@uniklinik-freiburg.de
- Contact Person Name
- Daiana Stolz
- Contact Person Email
- daiana.stolz@uniklinik-freiburg.de
- Site Name
- Studienzentrum Dr. Keller
- Principal Investigator Name
- Claus Keller
- Principal Investigator Email
- ckeller-studien@praxis-ckeller.de
- Contact Person Name
- Claus Keller
- Contact Person Email
- ckeller-studien@praxis-ckeller.de
- Site Name
- Universitaetsklinikum Bonn AöR
- Department Name
- Medizinische Klinik und Poliklinik II
- Principal Investigator Name
- Dirk Skowasch
- Principal Investigator Email
- dirk.skowasch@ukbonn.de
- Contact Person Name
- Dirk Skowasch
- Contact Person Email
- dirk.skowasch@ukbonn.de
- Site Name
- IKF Pneumologie GmbH & Co. KG
- Department Name
- Clinical Research Center Respiratory Diseases
- 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
- IKF Pneumologie GmbH & Co. KG
- Department Name
- Clinical Research Centre Respiratory Diseases
- Principal Investigator Name
- Stephanie Korn
- Principal Investigator Email
- korn@ikf-pneumologie.de
- Contact Person Name
- Stephanie Korn
- Contact Person Email
- korn@ikf-pneumologie.de
Greece
- Earliest CTIS Part Ii Submission Date
- 17-07-2025
- Latest Decision Or Authorization Date
- 26-02-2026
- Processing Time Days
- 224
- Number Of Sites
- 7
- Number Of Participants
- 7
Sites
- Site Name
- Geniko Nosokomeio Thessalonikis George Papanikolaou
- Department Name
- Pulmonary Clinic
- Principal Investigator Name
- Konstantinos Porpodis
- Principal Investigator Email
- kporpodis@yahoo.gr
- Contact Person Name
- Konstantinos Porpodis
- Contact Person Email
- kporpodis@yahoo.gr
- Site Name
- General University Hospital Of Patras
- Department Name
- Respiratory Medicine
- Principal Investigator Name
- Argyrios Tzouvelekis
- Principal Investigator Email
- atzouvelekis@upatras.gr
- Contact Person Name
- Argyrios Tzouvelekis
- Contact Person Email
- atzouvelekis@upatras.gr
- Site Name
- Athens Naval Hospital
- Department Name
- Pulmonary department
- Principal Investigator Name
- Nikolas Zias
- Principal Investigator Email
- nikoszias@gmail.com
- Contact Person Name
- Nikolas Zias
- Contact Person Email
- nikoszias@gmail.com
- Site Name
- Evangelismos S.A.
- Department Name
- Pulmonary and Respiratory Failure Department , A' Intentive Care Unit
- Principal Investigator Name
- Katsaounou Paraskevi
- Principal Investigator Email
- kpafili@elke.uoa.gr
- Contact Person Name
- Katsaounou Paraskevi
- Contact Person Email
- kpafili@elke.uoa.gr
- Site Name
- University General Hospital Of Ioannina
- Department Name
- Pulmonary Clinic
- Principal Investigator Name
- Konstantinos Kostikas
- Principal Investigator Email
- ktkostikas@gmail.com
- Contact Person Name
- Konstantinos Kostikas
- Contact Person Email
- ktkostikas@gmail.com
- Site Name
- University General Hospital Of Heraklion
- Department Name
- Pulmonary Clinic
- Principal Investigator Name
- Katerina Antoniou
- Principal Investigator Email
- kat.mich.antoniou@gmail.com
- Contact Person Name
- Katerina Antoniou
- Contact Person Email
- kat.mich.antoniou@gmail.com
- Site Name
- Thoracic General Hospital Of Athens I Sotiria
- Department Name
- Pulmonary Clinic
- Principal Investigator Name
- Bakakos Petros
- Principal Investigator Email
- petros44@hotmail.com
- Contact Person Name
- Bakakos Petros
- Contact Person Email
- petros44@hotmail.com
Belgium
- Earliest CTIS Part Ii Submission Date
- 17-07-2025
- Latest Decision Or Authorization Date
- 02-04-2026
- Processing Time Days
- 259
- Number Of Sites
- 5
- Number Of Participants
- 5
Sites
- Site Name
- Centre Hospitalier Regional De La Citadelle
- Department Name
- Pneumology Department
- 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
- Algemeen Ziekenhuis Groeninge
- Department Name
- Pulmonogy deparmtent
- Principal Investigator Name
- Mathias Leys
- Principal Investigator Email
- mathias.leys@azgroeninge.be
- Contact Person Name
- Mathias Leys
- Contact Person Email
- mathias.leys@azgroeninge.be
- Site Name
- Emmaues
- Department Name
- Pneumology Department
- Principal Investigator Name
- Muriel Lins
- Principal Investigator Email
- muriel.lins@emmaus.be
- Contact Person Name
- Muriel Lins
- Contact Person Email
- muriel.lins@emmaus.be
- Site Name
- Pneumocare
- Principal Investigator Name
- Jean-Benoît Martinot
- Principal Investigator Email
- martinot.j@respisom.be
- Contact Person Name
- Jean-Benoît Martinot
- Contact Person Email
- martinot.j@respisom.be
- Site Name
- Universitair Ziekenhuis Antwerpen
- Department Name
- respiratory deparment
- Principal Investigator Name
- Katrien Eger
- Principal Investigator Email
- katrien.eger@uza.be
- Contact Person Name
- Katrien Eger
- Contact Person Email
- katrien.eger@uza.be
Spain
- Earliest CTIS Part Ii Submission Date
- 03-10-2025
- Latest Decision Or Authorization Date
- 23-02-2026
- Processing Time Days
- 143
- Number Of Sites
- 7
- Number Of Participants
- 10
Sites
- Site Name
- Hospital Universitario Marques De Valdecilla
- Department Name
- Pneumology Department
- Principal Investigator Name
- Juan Luis García Rivero
- Principal Investigator Email
- juanluis.garcia@scsalud.es
- Contact Person Name
- Juan Luis García Rivero
- Contact Person Email
- juanluis.garcia@scsalud.es
- Site Name
- Bellvitge University Hospital
- Department Name
- Pneumology Department
- Principal Investigator Name
- Mariana Muñoz Esquerre
- Principal Investigator Email
- mmunoze@bellvitgehospital.cat
- Contact Person Name
- Mariana Muñoz Esquerre
- Contact Person Email
- mmunoze@bellvitgehospital.cat
- Site Name
- Hospital Clinic De Barcelona
- Department Name
- Pneumology Department
- Principal Investigator Name
- Ebymar Arismendi Núñez
- Principal Investigator Email
- earismen@clinic.cat
- Contact Person Name
- Ebymar Arismendi Núñez
- Contact Person Email
- earismen@clinic.cat
- Site Name
- University Hospital Son Espases
- Department Name
- Pneumology Department
- Principal Investigator Name
- Francisco de Borja García-Cosio Piqueras
- Principal Investigator Email
- borja.cosio@ssib.es
- Contact Person Name
- Francisco de Borja García-Cosio Piqueras
- Contact Person Email
- borja.cosio@ssib.es
- Site Name
- Hospital Vithas Xanit Internacional
- Department Name
- Pneumology Department
- Principal Investigator Name
- Gustavo de Luiz Martínez
- Principal Investigator Email
- neumologiaxanit@gmail.com
- Contact Person Name
- Gustavo de Luiz Martínez
- Contact Person Email
- neumologiaxanit@gmail.com
- Site Name
- Hospital Universitario Infanta Leonor
- Department Name
- Pneumology Department
- Principal Investigator Name
- Ismael Ali García
- Principal Investigator Email
- ismael.ali@salud.madrid.org
- Contact Person Name
- Ismael Ali García
- Contact Person Email
- ismael.ali@salud.madrid.org
- Site Name
- Hospital Universitario Dr Peset Aleixandre
- Department Name
- Pneumology Department
- Principal Investigator Name
- Eva Martinez Moragon
- Principal Investigator Email
- martinez_evamor@gva.es
- Contact Person Name
- Eva Martinez Moragon
- Contact Person Email
- martinez_evamor@gva.es
France
- Earliest CTIS Part Ii Submission Date
- 01-10-2025
- Latest Decision Or Authorization Date
- 06-03-2026
- Processing Time Days
- 156
- Number Of Sites
- 6
- Number Of Participants
- 12
Sites
- Site Name
- Centre Hospitalier Regional Et Universitaire De Brest
- Department Name
- Service Pneumologie
- Principal Investigator Name
- Raphaël LE MAO
- Principal Investigator Email
- raphael.lemao@chu-brest.fr
- Contact Person Name
- Raphaël LE MAO
- Contact Person Email
- raphael.lemao@chu-brest.fr
- Site Name
- Centre Hospitalier Universitaire De Montpellier
- Department Name
- Service Pneumologie – 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 Grenoble Alpes
- Department Name
- Service Pneumologie
- Principal Investigator Name
- Bruno DEGANO
- Principal Investigator Email
- bdegano@chu-grenoble.fr
- Contact Person Name
- Bruno DEGANO
- Contact Person Email
- bdegano@chu-grenoble.fr
- Site Name
- Centre Hospitalier Intercommunal Creteil
- Department Name
- Service Pneumologie
- Principal Investigator Name
- Amel BOUDJEMAA
- Principal Investigator Email
- amel.boudjemaa@chicreteil.fr
- Contact Person Name
- Amel BOUDJEMAA
- Contact Person Email
- amel.boudjemaa@chicreteil.fr
- Site Name
- Centre Hospitalier Universitaire Reims
- Department Name
- Service des Maladies Respiratoires et Allergiques
- Principal Investigator Name
- Jeanne-Marie PEROTIN-COLLARD
- Principal Investigator Email
- jmperotin-collard@chu-reims.fr
- Contact Person Name
- Jeanne-Marie PEROTIN-COLLARD
- Contact Person Email
- jmperotin-collard@chu-reims.fr
- Site Name
- Centre Hospitalier Universitaire De Bordeaux
- Department Name
- Service d’Explorations Fonctionnelles Respiratoire
- Principal Investigator Name
- Patrick BERGER
- Principal Investigator Email
- patrick.berger@chu-bordeaux.fr
- Contact Person Name
- Patrick BERGER
- Contact Person Email
- patrick.berger@chu-bordeaux.fr
Italy
- Earliest CTIS Part Ii Submission Date
- 30-09-2025
- Latest Decision Or Authorization Date
- 10-03-2026
- Processing Time Days
- 161
- Number Of Sites
- 5
- Number Of Participants
- 10
Sites
- Site Name
- IRCCS Ospedale Policlinico San Martino
- Department Name
- Clinica Malattie Apparato Respiratorio e Allergologia
- Principal Investigator Name
- Diego BAGNASCO
- Principal Investigator Email
- diego.bagnasco@hsanmartino.it
- Contact Person Name
- Diego BAGNASCO
- Contact Person Email
- diego.bagnasco@hsanmartino.it
- Site Name
- Azienda Ospedaliero Universitaria Careggi
- Department Name
- Severe Ashtma Unit- Dipartimento CardioToracoVascolare
- Principal Investigator Name
- Gianna CAMICIOTTOLI
- Principal Investigator Email
- gianna.camiciottoli@unifi.it
- Contact Person Name
- Gianna CAMICIOTTOLI
- Contact Person Email
- gianna.camiciottoli@unifi.it
- Site Name
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Department Name
- Dipartimento di Medicina Interna e Gastroenterologia
- Principal Investigator Name
- Cristiano CARUSO
- Principal Investigator Email
- cristiano.caruso@policlinicogemelli.it
- Contact Person Name
- Cristiano CARUSO
- Contact Person Email
- cristiano.caruso@policlinicogemelli.it
- Site Name
- Humanitas Mirasole S.p.A.
- Department Name
- Centro di Medicina Personalizzata, Asma e Allergologia
- Principal Investigator Name
- Enrico HEFFLER
- Principal Investigator Email
- enrico.heffler@hunimed.eu
- Contact Person Name
- Enrico HEFFLER
- Contact Person Email
- enrico.heffler@hunimed.eu
- Site Name
- Azienda Ospedaliero-Universitaria Policlinico G. Rodolico-San Marco Di Catania
- Department Name
- U.O.C Pneumologia
- Principal Investigator Name
- Carlo VANCHERI
- Principal Investigator Email
- vancheri@unict.it
- Contact Person Name
- Carlo VANCHERI
- Contact Person Email
- vancheri@unict.it
Sponsor
Primary sponsor
- Full Name
- Glaxosmithkline Research & Development Limited
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- United Kingdom
Contract research organisations
- Name
- PPD Global Ltd.
- Responsibilities
- code: 5
- Name
- PPD Global Limited
- Responsibilities
- codes: 1,10,12,13,2,4,5,6,7,8
- Name
- PPD Global Central Labs
- Responsibilities
- code: 4
- Name
- Scout Clinical
- Responsibilities
- Patient Travel and Reimbursement
Third parties
- {"country":"Greece","full_name":"PPD Global Ltd.","duties_or_roles":"code: 5","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Eresearchtechnology Inc.","duties_or_roles":"ECG, Forced Spirometry, FeNO, Oscillometry, Centralized Overread for ECG and forced Spirometry. eCoA","organisation_type":"Pharmaceutical company"}
- {"country":"United Kingdom","full_name":"PPD Global Limited","duties_or_roles":"codes: 1,10,12,13,2,4,5,6,7,8","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Glaxosmithkline LLC","duties_or_roles":"code: 4","organisation_type":"Pharmaceutical company"}
- {"country":"Belgium","full_name":"FluidDa","duties_or_roles":"Centralized Overread for HRCT","organisation_type":"Pharmaceutical company"}
- {"country":"Belgium","full_name":"PPD Global Central Labs","duties_or_roles":"code: 4","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Frontage Laboratories Inc.","duties_or_roles":"code: 4","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Glaxosmithkline LLC","duties_or_roles":"Long term storage of samples","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Scout Clinical","duties_or_roles":"Patient Travel and Reimbursement","organisation_type":"Hospital/Clinic/Other health care facility"}
- {"country":"United States","full_name":"Veeva Systems Inc.","duties_or_roles":"EDC database","organisation_type":"Non-Pharmaceutical company"}
Investigational products
- Investigational Product Name
- GSK3511294 (depemokimab) solution for injection
- Active Substance
- DEPEMOKIMAB
- Modality
- Monoclonal antibody
- Routes Of Administration
- Subcutaneous
- Route
- Subcutaneous
- Authorisation Status
- Investigational medicinal product (IMP); product record present (euMpNumber PRD5046670)
- Starting Dose
- 100 mg
- Dose Levels
- 100 mg
- Frequency
- Doses at Week 0 and Week 26 (two doses over 52-week treatment period)
- Maximum Dose
- 100 mg
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