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
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
Site Name
Studienzentrum Dr. Keller
Principal Investigator Name
Claus Keller
Principal Investigator Email
ckeller-studien@praxis-ckeller.de
Contact Person Name
Claus Keller
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
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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