Clinical trial • Phase III • Musculoskeletal

SECUKINUMAB for Polymyalgia rheumatica

Phase III trial of SECUKINUMAB for Polymyalgia rheumatica. open-label, none/not specified-controlled. 167 participants.

Overview

Trial Therapeutic Area
Musculoskeletal
Trial Disease
Polymyalgia rheumatica
Trial Stage
Phase III
Drug Modality
Monoclonal antibody

Key dates

Initial CTIS Submission Date
27-02-2024
First CTIS Authorization Date
17-06-2024

Trial design

open-label, none/not specified-controlled Phase III trial across 64 sites in Czechia, Germany, Hungary and others.

Open Label
Yes
Comparator
None/Not specified
Target Sample Size
167
Trial Duration For Participant
728

Eligibility

Recruits 167 Vulnerable population selected in source record; no detailed description of consent/assent handling for vulnerable populations is provided in the available data..

Vulnerable Population
Vulnerable population selected in source record; no detailed description of consent/assent handling for vulnerable populations is provided in the available data.

Inclusion criteria

  • {"criterion_text":"- Participants who have completed 52-week Treatment Period as per protocol in a Novartis study of secukinumab in PMR patients (the “core study\" - Study CAIN457C22301), AND • \twho have experienced a relapse during the treatment-free follow-up period of the core \tstudy, AND • \twho have not been on rescue treatment. Relapse is defined as recurrence of symptoms of PMR or as detection of signs and symptoms of a new-onset GCA that requires an increase of GC dose, re-initiation of GC treatment, or other changes in treatment of PMR.\n- The participant would potentially derive benefit from secukinumab, and the benefit outweighs the risk, based on the investigator’s judgement."}

Exclusion criteria

  • {"criterion_text":"- Use of prohibited medications as specified in Section 6.8.2\n- History of ongoing, chronic or recurrent infectious disease (i.e., human immunodeficiency virus (HIV), hepatitis B (HBV), hepatitis C (HCV), active tuberculosis infection (TB))\n- History of lymphoproliferative disease or any known malignancy or history of malignancy of any organ system within the past 5 years (except for basal cell carcinoma or actinic keratosis that have been treated with no evidence of recurrence in the past 3 months carcinoma in situ of the cervix or non-invasive malignant colon polyps that have been removed).\n- Live vaccinations (e.g., monkey pox vaccine, oral polio vaccine, varicella/zoster vaccines) within 6 weeks prior to Baseline\n- Subjects whose participation in the extension study could expose them to an undue safety risk including but not limited to below: • \tCurrent severe progressive or uncontrolled disease which in the judgment of the \tinvestigator renders the subject unsuitable for the study. • \tUnderlying conditions (including, but not limited to metabolic, hematologic, renal, \thepatic, pulmonary, neurologic, endocrine, cardiac, infectious or gastrointestinal, such \tas active inflammatory bowel disease), which in the opinion of the investigator \tsignificantly immunocompromises the patient and/or places the patient at \tunacceptable risk for receiving an immunomodulatory therapy."}

Endpoints

Primary endpoints

  • {"endpoint_text":"- Incidence of adverse events (AEs) and serious adverse events (SAEs)","definition_or_measurement_approach":"As assessed by occurrence of adverse events/serious adverse events (AEs/SAEs)"}

Recruitment

Planned Sample Size
167
Recruitment Window Months
44
Consent Approach
Informed consent obtained using adult main ICF documents (multiple languages). Separate ICFs exist for pregnant participants and for optional assessments. No information on assent or minor consent procedures is provided in the available documents.

Geography

Total Number Of Sites
64
Total Number Of Participants
182

Czechia

Earliest CTIS Part Ii Submission Date
28-05-2024
Latest Decision Or Authorization Date
18-06-2024
Processing Time Days
21
Number Of Sites
8
Number Of Participants
26

Sites

Site Name
MuDr. Zuzana Urbanova
Department Name
1607: Revmatologie
Contact Person Name
Zuzana Urbanova
Contact Person Email
urbarevma@centrum.cz
Site Name
L.K.N. Arthrocentrum s.r.o.
Department Name
1608: Revmatologie
Contact Person Name
Libor Novosad
Contact Person Email
libor.novosad@email.cz
Site Name
PV-Medical s.r.o.
Department Name
1605: Revmatologická ambulance
Contact Person Name
Petr Vítek
Contact Person Email
pv.medical@seznam.cz
Site Name
MuDr. Zuzana Stejfova
Department Name
1606: Revmatologie
Contact Person Name
Zuzana Stejfova
Contact Person Email
Stejfalova.zuzana@seznam.cz
Site Name
Medical Plus s.r.o.
Department Name
1604: Revmatologická ambulance
Contact Person Name
Eva Dokoupilova
Contact Person Email
evadokoupil@gmail.com
Site Name
Revmatologicky Ustav
Department Name
1601: Department of Experimental Rheumatology
Contact Person Name
Michal Tomcik
Contact Person Email
tomcik@revma.cz
Site Name
Revmatologie s.r.o.
Department Name
1602: Revmatologická ambulance
Contact Person Name
Leona Prochazkova
Site Name
PV-Medical s.r.o.
Department Name
1605: Revmatologická ambulance
Contact Person Name
Petr Vítek
Contact Person Email
pv.medical@seznam.cz

Germany

Earliest CTIS Part Ii Submission Date
15-05-2024
Latest Decision Or Authorization Date
18-06-2024
Processing Time Days
34
Number Of Sites
9
Number Of Participants
19

Sites

Site Name
Rheumazentrum Ratingen
Department Name
1915: Rheumatology
Contact Person Name
Siegfried Wassenberg
Contact Person Email
wassenberg@rhzr.de
Site Name
Rheumatologische Schwerpunktpraxis Erlangen
Department Name
1912: Rheumatology
Contact Person Name
Stefan Kleinert
Contact Person Email
stefan.kleinert@pgrn.de
Site Name
Medical Center - University Of Freiburg
Department Name
1904: Clinic for Rheumatology and Clinical Immunology Department Internal Medicine
Contact Person Name
Stephanie Finzel
Site Name
Rheumatologische Schwerpunktpraxis Dr. Jochen Walter
Department Name
1918; Rheumatology
Contact Person Name
Jochen Walter
Contact Person Email
j.walter@rheuma.sh
Site Name
Universitaetsklinikum Wuerzburg AöR
Department Name
1905: Med. Klinik und Poliklinik II / Rheumatology / Clinical Immunology
Principal Investigator Name
Marc Thomas Schmalzing
Principal Investigator Email
Schmalzing_M@ukw.de
Contact Person Name
Marc Thomas Schmalzing
Contact Person Email
Schmalzing_M@ukw.de
Site Name
St. Elisabeth Gruppe GmbH Katholische Kliniken Rhein-Ruhr
Department Name
1903: Rheumazentrum Ruhrgebiet
Contact Person Name
Ioana Andreica
Site Name
Immanuel-Krankenhaus GmbH
Department Name
1907: Rheumatologie und Klinische Immunologie
Contact Person Name
Hans Bastian
Site Name
Charite Universitaetsmedizin Berlin KöR
Department Name
1908: Rheumatology and Clinical Immunology
Principal Investigator Name
Frank Buttgereit
Principal Investigator Email
frank.buttgereit@charite.de
Contact Person Name
Frank Buttgereit
Contact Person Email
frank.buttgereit@charite.de
Site Name
Technische Universitaet Dresden
Department Name
1906: Medizinische Klinik und Poliklinik III (Rheumatologie)
Contact Person Name
Anne Kathrin Tausche

Hungary

Earliest CTIS Part Ii Submission Date
26-04-2024
Latest Decision Or Authorization Date
19-06-2024
Processing Time Days
54
Number Of Sites
3
Number Of Participants
16

Sites

Site Name
University Of Szeged
Department Name
2001: Reumatologiai es Immunologiai Klinika
Principal Investigator Name
Attila Balog
Principal Investigator Email
balog.attila@med.u-szeged.hu
Contact Person Name
Attila Balog
Contact Person Email
balog.attila@med.u-szeged.hu
Site Name
Vital-Medicina Kft.
Department Name
2004 :VITAL MEDICAL CENTER Reumatológia
Contact Person Name
Edit Drescher
Contact Person Email
drescher@invitel.hu
Site Name
Revita Kft.
Department Name
2003: Revita Reumatológiai Rendelő
Principal Investigator Name
Regina Cseuz
Principal Investigator Email
recseuz@gmail.com
Contact Person Name
Regina Cseuz
Contact Person Email
recseuz@gmail.com

Poland

Earliest CTIS Part Ii Submission Date
10-05-2024
Latest Decision Or Authorization Date
19-06-2024
Processing Time Days
40
Number Of Sites
5
Number Of Participants
8

Sites

Site Name
Klinika Reuma Park Sp. z o.o. S.K.
Department Name
2307: NA
Principal Investigator Name
Paula Śliwińska-Stańczyk
Principal Investigator Email
stanczyki@post.pl
Contact Person Name
Paula Śliwińska-Stańczyk
Contact Person Email
stanczyki@post.pl
Site Name
Reumed Sp. z o.o.
Department Name
2305: NA
Principal Investigator Name
Marcin Mazurek
Principal Investigator Email
mamazurek@tlen.pl
Contact Person Name
Marcin Mazurek
Contact Person Email
mamazurek@tlen.pl
Site Name
Rheuma Medicus Sp. z o.o.
Department Name
2301: Rheuma Medicus Sp. z o.o.
Principal Investigator Name
Maria Rell-Bakalarska
Principal Investigator Email
rejestracja@rheuma-medicus.pl
Contact Person Name
Maria Rell-Bakalarska
Contact Person Email
rejestracja@rheuma-medicus.pl
Site Name
Narodowy Instytut Geriatrii Reumatologii I Rehabilitacji Im Prof. Dr Hab. Med. Eleonory Reicher
Department Name
2303: Centrum Wsparcia Badań Klinicznych
Principal Investigator Name
Jolanta Nałęcz-Janik
Principal Investigator Email
jolanta.nalecz-janik@spartanska.pl
Contact Person Name
Jolanta Nałęcz-Janik
Site Name
Szpital Specjalistyczny Nr I W Bytomiu SPZOZ
Department Name
2302: Oddział Rumatologii i Rehabilitacji
Principal Investigator Name
Aleksandra Zoń-Giebel
Principal Investigator Email
sreumatologia@szpital1.bytom.pl
Contact Person Name
Aleksandra Zoń-Giebel

France

Earliest CTIS Part Ii Submission Date
06-06-2024
Latest Decision Or Authorization Date
19-06-2024
Processing Time Days
13
Number Of Sites
17
Number Of Participants
41

Sites

Site Name
Assistance Publique Hopitaux De Paris
Department Name
1804 : Rhumatologie
Principal Investigator Name
Bruno FAUTREL
Principal Investigator Email
bruno.fautrel@aphp.fr
Contact Person Name
Bruno FAUTREL
Contact Person Email
bruno.fautrel@aphp.fr
Site Name
HIA Sainte Anne
Department Name
1815 :Rhumatologie
Principal Investigator Name
Audrey CAMBON
Principal Investigator Email
cambon.audrey@intradef.gouv.fr
Contact Person Name
Audrey CAMBON
Contact Person Email
cambon.audrey@intradef.gouv.fr
Site Name
Centre Hospitalier Universitaire D'Angers
Department Name
1813 :Rhumatologie
Principal Investigator Name
Erick LEGRAND
Principal Investigator Email
erlegrand@chu-angers.fr
Contact Person Name
Erick LEGRAND
Contact Person Email
erlegrand@chu-angers.fr
Site Name
Centre Hospitalier Regional Universitaire De Tours
Department Name
1812 :Rhumatologie
Principal Investigator Name
Philippe GOUPILLE
Principal Investigator Email
philippe.goupille@univ-tours.fr
Contact Person Name
Philippe GOUPILLE
Site Name
Centre Hospitalier Universitaire De Dijon
Department Name
1814 :Rhumatologie
Principal Investigator Name
André RAMON
Principal Investigator Email
andre.ramon@chu-dijon.fr
Contact Person Name
André RAMON
Contact Person Email
andre.ramon@chu-dijon.fr
Site Name
Centre Hospitalier Universitaire De Nantes
Department Name
1807 :Rhumatologie
Principal Investigator Name
Benoît LEGOFF
Principal Investigator Email
benoit.legoff@chu-nantes.fr
Contact Person Name
Benoît LEGOFF
Contact Person Email
benoit.legoff@chu-nantes.fr
Site Name
Les Hopitaux Universitaires De Strasbourg
Department Name
1805 :Rhumatologie
Principal Investigator Name
Jacques-Eric GOTTENBERG
Principal Investigator Email
jacques-eric.gottenberg@chru-strasbourg.fr
Contact Person Name
Jacques-Eric GOTTENBERG
Site Name
Centre Hospitalier Regional Et Universitaire De Brest
Department Name
1803 : Rhumatologie
Principal Investigator Name
Alain SARAUX
Principal Investigator Email
alain.saraux@chu-brest.fr
Contact Person Name
Alain SARAUX
Contact Person Email
alain.saraux@chu-brest.fr
Site Name
Centre Hospitalier Universitaire De Montpellier
Department Name
1809 :Rhumatologie
Principal Investigator Name
Jacques MOREL
Principal Investigator Email
j-morel@chu-montpellier.fr
Contact Person Name
Jacques MOREL
Contact Person Email
j-morel@chu-montpellier.fr
Site Name
Centre Hospitalier Et Universitaire De Limoges
Department Name
1817 :Rhumatologie
Principal Investigator Name
Pascale VERGNE-SALLE
Principal Investigator Email
pascale.vergne-salle@chu-limoges.fr
Contact Person Name
Pascale VERGNE-SALLE
Site Name
Centre Hospitalier Le Mans
Department Name
1802: Rhumatologie
Principal Investigator Name
Guillaume DIREZ
Principal Investigator Email
gdirez@ch-lemans.fr
Contact Person Name
Guillaume DIREZ
Contact Person Email
gdirez@ch-lemans.fr
Site Name
Centre Hospitalier Universitaire De Toulouse
Department Name
1806 :Rhumatologie
Principal Investigator Name
Adeline RUYSSEN-WITRAND
Principal Investigator Email
ruyssen-witrand.a@chu-toulouse.fr
Contact Person Name
Adeline RUYSSEN-WITRAND
Site Name
Centre Hospitalier Pasteur
Department Name
1818 :Rhumatologie
Principal Investigator Name
Laurent MESSER
Principal Investigator Email
laurent.messer@ch-colmar.fr
Contact Person Name
Laurent MESSER
Contact Person Email
laurent.messer@ch-colmar.fr
Site Name
Centre Hospitalier Du Pays D Aix Centre Hospitalier Intercommunal Aix-Pertuis
Department Name
1816 :Rhumatologie
Principal Investigator Name
François VIDAL
Principal Investigator Email
fvidal@ch-aix.fr
Contact Person Name
François VIDAL
Contact Person Email
fvidal@ch-aix.fr
Site Name
Centre Hospitalier Sud Francilien
Department Name
1808 :Rhumatologie
Principal Investigator Name
Pascal HILLIQUIN
Principal Investigator Email
pascal.hilliquin@chsf.fr
Contact Person Name
Pascal HILLIQUIN
Contact Person Email
pascal.hilliquin@chsf.fr
Site Name
Centre Hospitalier De Cholet
Department Name
1810 :Rhumatologie
Principal Investigator Name
Charles LESKE
Principal Investigator Email
charles.leske@ch-cholet.fr
Contact Person Name
Charles LESKE
Contact Person Email
charles.leske@ch-cholet.fr
Site Name
Centre Hospitalier Universitaire Reims
Department Name
1811 :Rhumatologie
Principal Investigator Name
Jean-Hugues SALMON
Principal Investigator Email
jhsalmon@chu-reims.fr
Contact Person Name
Jean-Hugues SALMON
Contact Person Email
jhsalmon@chu-reims.fr

Belgium

Earliest CTIS Part Ii Submission Date
25-04-2025
Latest Decision Or Authorization Date
09-05-2025
Processing Time Days
14
Number Of Sites
2
Number Of Participants
4

Sites

Site Name
UZ Leuven
Department Name
1501: General Internal medicine
Principal Investigator Name
Albrecht Betrains
Principal Investigator Email
Albrechtbetrains@uzleuven.be
Contact Person Name
Albrecht Betrains
Contact Person Email
Albrechtbetrains@uzleuven.be
Site Name
Centre hospitalier universitaire de Liege
Department Name
1502: Rheumatology
Principal Investigator Name
Clio Ribbens
Principal Investigator Email
clio.ribbens@chuliege.be
Contact Person Name
Clio Ribbens
Contact Person Email
clio.ribbens@chuliege.be

Denmark

Earliest CTIS Part Ii Submission Date
20-05-2024
Latest Decision Or Authorization Date
17-06-2024
Processing Time Days
28
Number Of Sites
3
Number Of Participants
13

Sites

Site Name
Sanos A/S
Department Name
1705: SANOS Gandrup
Principal Investigator Name
Cecilie Rovsing
Principal Investigator Email
cec@sanosclinic.com
Contact Person Name
Cecilie Rovsing
Contact Person Email
cec@sanosclinic.com
Site Name
Esbjerg Og Grindsted Sygehus
Department Name
1701: Afsnit for Gigt-og Bindevævssygdomme
Principal Investigator Name
Philip Rask Lage-Hansen
Principal Investigator Email
Stavros.Chrysidis@rsyd.dk
Contact Person Name
Philip Rask Lage-Hansen
Contact Person Email
Stavros.Chrysidis@rsyd.dk
Site Name
Lillebaelt Hospital
Department Name
1704: Reumatologisk Afsnit - Intern Medicin
Principal Investigator Name
Myriam Liz Grana
Principal Investigator Email
Myriam.Liz.Grana@rsyd.dk
Contact Person Name
Myriam Liz Grana
Contact Person Email
Myriam.Liz.Grana@rsyd.dk

Netherlands

Earliest CTIS Part Ii Submission Date
05-06-2024
Latest Decision Or Authorization Date
19-06-2024
Processing Time Days
14
Number Of Sites
3
Number Of Participants
4

Sites

Site Name
Universitair Medisch Centrum Groningen
Department Name
2201: Rheumatology
Principal Investigator Name
Liesbeth Brouwer
Principal Investigator Email
e.brouwer@umcg.nl
Contact Person Name
Liesbeth Brouwer
Contact Person Email
e.brouwer@umcg.nl
Site Name
Ziekenhuisgroep Twente Stichting
Department Name
2203: Rheumatology
Principal Investigator Name
Edgar Colin
Principal Investigator Email
e.colin@zgt.nl
Contact Person Name
Edgar Colin
Contact Person Email
e.colin@zgt.nl
Site Name
Maasstad Ziekenhuis Stichting
Department Name
2204: Rheumatology
Principal Investigator Name
Radjesh Bisoendial
Principal Investigator Email
BisoendialR@maasstadziekenhuis.nl
Contact Person Name
Radjesh Bisoendial

Spain

Earliest CTIS Part Ii Submission Date
08-05-2024
Latest Decision Or Authorization Date
17-06-2024
Processing Time Days
40
Number Of Sites
7
Number Of Participants
27

Sites

Site Name
Hospital Universitario Basurto
Department Name
2406: Reumatología
Principal Investigator Name
Maria Rosa Expósito Molinero
Principal Investigator Email
mariaexpositomolinero@osakidetza.eus
Contact Person Name
Maria Rosa Expósito Molinero
Site Name
Complexo Hospitalario Universitario A Coruna
Department Name
2402: Reumatología
Principal Investigator Name
Francisco Javier Blanco Garcia
Principal Investigator Email
fblagar@sergas.es
Contact Person Name
Francisco Javier Blanco Garcia
Contact Person Email
fblagar@sergas.es
Site Name
Hospital De La Santa Creu I Sant Pau
Department Name
2403: Reumatología
Principal Investigator Name
Patricia Moya Alvarado
Principal Investigator Email
pmoyaA@santpau.cat
Contact Person Name
Patricia Moya Alvarado
Contact Person Email
pmoyaA@santpau.cat
Site Name
University Hospital Virgen Del Rocio S.L.
Department Name
2407: Reumatología
Principal Investigator Name
Elena Alonso Blanco-Morales
Contact Person Name
Elena Alonso Blanco-Morales
Site Name
Hospital General Universitario Gregorio Maranon
Department Name
2409: Reumatología
Principal Investigator Name
Juan Molina Collada
Principal Investigator Email
juan.molina@salud.madrid.org
Contact Person Name
Juan Molina Collada
Contact Person Email
juan.molina@salud.madrid.org
Site Name
Parc Tauli Hospital Universitari
Department Name
2401: Reumatología
Principal Investigator Name
Marta Arévalo Salaet
Principal Investigator Email
marevalo@tauli.cat
Contact Person Name
Marta Arévalo Salaet
Contact Person Email
marevalo@tauli.cat
Site Name
Hospital Clinico Universitario De Valencia
Department Name
2404: Reumatología
Principal Investigator Name
Isabel De La Morena Barrio
Principal Investigator Email
delaeme84@gmail.com
Contact Person Name
Isabel De La Morena Barrio
Contact Person Email
delaeme84@gmail.com

Italy

Earliest CTIS Part Ii Submission Date
16-05-2024
Latest Decision Or Authorization Date
17-06-2024
Processing Time Days
32
Number Of Sites
7
Number Of Participants
24

Sites

Site Name
Azienda USL IRCCS Di Reggio Emilia
Department Name
2103: S.C. Reumatologia
Principal Investigator Name
Chiara Marvisi
Principal Investigator Email
chiara.marvisi@ausl.re.it
Contact Person Name
Chiara Marvisi
Contact Person Email
chiara.marvisi@ausl.re.it
Site Name
Ospedale Galeazzi S.p.A.
Department Name
2108: U.O. Reumatologia
Principal Investigator Name
Piercarlo Sarzi Puttini
Principal Investigator Email
piercarlo.sarziputtini@unimi.it
Contact Person Name
Piercarlo Sarzi Puttini
Site Name
Asst Centro Specialistico Ortopedico Traumatologico Gaetano Pini Cto
Department Name
2102: U.O.C. Reumatologia Clinica
Principal Investigator Name
Roberto Caporali
Principal Investigator Email
roberto.caporali@unimi.it
Contact Person Name
Roberto Caporali
Contact Person Email
roberto.caporali@unimi.it
Site Name
Ospedale San Raffaele S.r.l.
Department Name
2107: U.O. di Immunologia, Reumatologia, Allergologia e Malattie Rare
Principal Investigator Name
Lorenzo Dagna
Principal Investigator Email
dagna.lorenzo@unisr.it
Contact Person Name
Lorenzo Dagna
Contact Person Email
dagna.lorenzo@unisr.it
Site Name
Hospital Santa Maria Della Misericordia
Department Name
2105: S.C. Interaziendale di Reumatologia Dip. Medicina e Chirurgia
Principal Investigator Name
Elena Bartoloni Bocci
Principal Investigator Email
elena.bartolonibocci@unipg.it
Contact Person Name
Elena Bartoloni Bocci
Contact Person Email
elena.bartolonibocci@unipg.it
Site Name
Central Hospital Of Bolzano
Department Name
2101: Ambulatorio Reumatologico Servizio Aziendale di Reumatologia
Principal Investigator Name
Peter Matzneller
Principal Investigator Email
peter.matzneller@sabes.it
Contact Person Name
Peter Matzneller
Contact Person Email
peter.matzneller@sabes.it
Site Name
Fondazione IRCCS Policlinico San Matteo
Department Name
2106: SC Reumatologia
Principal Investigator Name
Francesca Bobbio Pallavicini
Principal Investigator Email
f.bobbiopallavicini@smatteo.pv.it
Contact Person Name
Francesca Bobbio Pallavicini

Sponsor

Primary sponsor

Full Name
Novartis Pharma AG
Organisation Type
Pharmaceutical company
Country Of Registered Address
Switzerland

Contract research organisations

Name
Parexel International (IRL) Limited
Responsibilities
code: 12
Name
IQVIA Limited
Responsibilities
code: 1
Name
Icon Clinical Research Limited
Responsibilities
code: 1
Name
Syneos Health Inc.
Responsibilities
code: 1
Name
Scout Clinical
Responsibilities
Participant Reimbursement Management

Third parties

  • {"country":"Ireland","full_name":"Parexel International (IRL) Limited","duties_or_roles":"code: 12","organisation_type":"Pharmaceutical company"}
  • {"country":"United Kingdom","full_name":"IQVIA Limited","duties_or_roles":"code: 1","organisation_type":"Pharmaceutical company"}
  • {"country":"Poland","full_name":"Eco-Abc Sp. z o. o.","duties_or_roles":"Destruction of the investigational medicinal products","organisation_type":"Pharmaceutical company"}
  • {"country":"Ireland","full_name":"Icon Clinical Research Limited","duties_or_roles":"code: 1","organisation_type":"Pharmaceutical company"}
  • {"country":"Hungary","full_name":"Opt-X-Pense Kft.","duties_or_roles":"Patient compensation","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"United States","full_name":"Syneos Health Inc.","duties_or_roles":"code: 1","organisation_type":"Pharmaceutical company"}
  • {"country":"Poland","full_name":"Statmed Sp. z o.o.","duties_or_roles":"Compensation for patients travel to the clinical site","organisation_type":"Pharmaceutical company"}
  • {"country":"Italy","full_name":"Opis S.r.l.","duties_or_roles":"TMF Archive","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Scout Clinical","duties_or_roles":"Participant Reimbursement Management","organisation_type":"Hospital/Clinic/Other health care facility"}
  • {"country":"Denmark","full_name":"Specific Pharma A/S","duties_or_roles":"code: 14","organisation_type":"Pharmaceutical company"}
  • {"country":"Hungary","full_name":"ADR Logistics Kft.","duties_or_roles":"code: 14","organisation_type":"Pharmaceutical company"}

Investigational products

Investigational Product Name
SECUKINUMAB
Active Substance
SECUKINUMAB
Modality
Monoclonal antibody
Routes Of Administration
SUBCUTANEOUS
Route
SUBCUTANEOUS
Maximum Dose
300 mg

Related trials

Other published trials that may interest you.