Clinical trial • Phase II/III • Neurology|Rare Disease

NIPOCALIMAB for Chronic inflammatory demyelinating polyneuropathy

Phase II/III trial of NIPOCALIMAB for Chronic inflammatory demyelinating polyneuropathy.

Overview

Trial Therapeutic Area
Neurology|Rare Disease
Trial Disease
Chronic inflammatory demyelinating polyneuropathy
Trial Stage
Phase II/III
Drug Modality
Monoclonal antibody|Other antibody

Key dates

Initial CTIS Submission Date
22-03-2024
First CTIS Authorization Date
13-05-2024

Trial design

Randomised, open-label, placebo (saline, 0.9% sodium chloride solution for injection); standard of care ivig (privigen 100 mg/ml solution for infusion) - doses/schedules not specified in provided metadata.-controlled Phase II/III trial in France, Italy, Portugal and others.

Randomised
Yes
Open Label
Yes
Comparator
Placebo (Saline, 0.9% Sodium Chloride Solution for Injection); Standard of care IVIg (Privigen 100 mg/ml solution for infusion) - doses/schedules not specified in provided metadata.
Target Sample Size
116

Eligibility

Recruits 116 Vulnerable population selection flag is set in the trial record. Participants must be adults (≥18) and consent is required from the participant; specific details on assent/consent handling for vulnerable subgroups are not available in the provided metadata..

Vulnerable Population
Vulnerable population selection flag is set in the trial record. Participants must be adults (≥18) and consent is required from the participant; specific details on assent/consent handling for vulnerable subgroups are not available in the provided metadata.

Inclusion criteria

  • {"criterion_text":"-Adults ≥18 years of age at the time of consent and as applicable, must also meet the legal age of consent and in the jurisdiction in which the study is taking place."}
  • {"criterion_text":"-Diagnosed with CIDP according to criteria of the EAN/PNS 2021, progressing or relapsing forms. CIDP diagnosis to be adjudicated by independent committee during screening period."}
  • {"criterion_text":"-INCAT disability score between 2 and 9 at the Run-In Baseline visit for participants entering Run-In, or Stage A Baseline visit for participants directly entering Stage A. Participants with an INCAT score of 2 at trial entry must have this score exclusively from the leg disability score."}

Exclusion criteria

  • {"criterion_text":"-Has a history of severe and/or uncontrolled hepatic (e.g. viral/alcoholic/ autoimmune hepatitis/cirrhosis and or metabolic liver disease), gastrointestinal, renal, pulmonary, cardiovascular, psychiatric, neurological or musculoskeletal disorder, hypertension and/ or any other medical or uncontrolled autoimmune disorder(s) (e.g. diabetes mellitus) or clinically significant abnormalities in screening laboratory that might interfere with the patient's full participation in the study, or might jeopardize the safety of the participant or the validity of the study results. Note: Any condition for which, in the opinion of the investigator, participation would not be in the best interest of the participants (e.g., compromise well-being) or that could prevent, limit, or confound the protocol-specified assessments."}
  • {"criterion_text":"-Pure sensory CIDP or CISP (EAN/PNS definition)."}
  • {"criterion_text":"-Polyneuropathy of other causes, including the following: Multifocal motor neuropathy (MMN); Monoclonal gammopathy of uncertain significance with antimyelin associated glycoprotein (anti-MAG) immunoglobulin M (IgM) antibodies; Hereditary motor neuropathy; Hereditary neuropathy with liability to pressure palsies (HNPP); Polyneuropathy, organomegaly, endocrinopathy, monoclonal protein and skin change syndromes; Lumbosacral radiculoplexus neuropathy; Polyneuropathy most likely due to diabetes mellitus; Polyneuropathy most likely due to systemic illnesses; Drug- or toxin-induced polyneuropathy. Note: A concomitant polyneuropathy of other causes (e.g. a mild, stable diabetic polyneuropathy) is not necessarily exclusionary if CIDP is confirmed as the main diagnosis, as determined by the investigator and confirmed by the adjudication committee."}

Endpoints

Primary endpoints

  • {"endpoint_text":"-Time to first occurrence of a relapse event, where relapse is defined by the deterioration in either adjusted INCAT disability score relative to Stage B baseline or the switch to IVIg or other SoC as a result of investigator-assessed lack of efficacy as confirmed by an independent RAC","definition_or_measurement_approach":"Relapse defined as deterioration in adjusted INCAT disability score relative to Stage B baseline OR switch to IVIg or other standard-of-care due to investigator-assessed lack of efficacy, confirmed by an independent Relapse Adjudication Committee (RAC). Time-to-event analysis."}

Secondary endpoints

  • {"endpoint_text":"-Time to initial confirmed ECI","definition_or_measurement_approach":"Time from baseline to initial confirmed Evidence of Clinical Improvement (ECI)."}
  • {"endpoint_text":"-Percentage of responders as determined by ECI","definition_or_measurement_approach":"Proportion of participants meeting ECI criteria as defined by protocol."}
  • {"endpoint_text":"-Change from Stage A baseline over time in adjusted INCAT disability score","definition_or_measurement_approach":"Longitudinal change from Stage A baseline in adjusted INCAT disability score."}
  • {"endpoint_text":"-Change from Stage A baseline over time in MRC Muscle Grading Scale Sum score","definition_or_measurement_approach":"Longitudinal change from Stage A baseline in Medical Research Council (MRC) muscle strength sum score."}
  • {"endpoint_text":"-Change from Stage A baseline over time in I-RODS centile score","definition_or_measurement_approach":"Longitudinal change from Stage A baseline in I-RODS centile score (Inflammatory Rasch-built Overall Disability Scale)."}
  • {"endpoint_text":"-Change from Stage A baseline over time in mean grip strength (dominant hand)","definition_or_measurement_approach":"Longitudinal change from Stage A baseline in mean grip strength measured in the dominant hand."}
  • {"endpoint_text":"-Change from Stage A baseline over time in mean grip strength (non-dominant hand)","definition_or_measurement_approach":"Longitudinal change from Stage A baseline in mean grip strength measured in the non-dominant hand."}
  • {"endpoint_text":"-Time to first adjusted INCAT disability score deterioration relative to Stage B baseline","definition_or_measurement_approach":"Time-to-event: first deterioration in adjusted INCAT disability score compared to Stage B baseline."}
  • {"endpoint_text":"-Time to first switch to IVIg or other SoC as a result of investigator-assessed lack of efficacy as confirmed by an independent RAC relative to Stage B baseline","definition_or_measurement_approach":"Time-to-event: first switch to IVIg or other standard-of-care due to investigator-assessed lack of efficacy, confirmed by independent RAC, relative to Stage B baseline."}
  • {"endpoint_text":"-Change from Stage B baseline over time in adjusted INCAT disability score","definition_or_measurement_approach":"Longitudinal change from Stage B baseline in adjusted INCAT disability score."}
  • {"endpoint_text":"-Change from Stage B baseline over time in MRC Muscle Grading Scale Sum score","definition_or_measurement_approach":"Longitudinal change from Stage B baseline in MRC muscle grading sum score."}
  • {"endpoint_text":"-Change from Stage B baseline over time in I-RODS centile score","definition_or_measurement_approach":"Longitudinal change from Stage B baseline in I-RODS centile score."}
  • {"endpoint_text":"-Change from Stage B baseline over time in mean grip strength (dominant hand)","definition_or_measurement_approach":"Longitudinal change from Stage B baseline in mean grip strength (dominant hand)."}
  • {"endpoint_text":"-Change from Stage B baseline over time in mean grip strength (non-dominant hand)","definition_or_measurement_approach":"Longitudinal change from Stage B baseline in mean grip strength (non-dominant hand)."}
  • {"endpoint_text":"-Binary response endpoint satisfying all 4 conditions: (1) an improved adjusted INCAT disability score compared to Stage B baseline, (2) not relapsing, (3) not switching to SoC, (4) not discontinuing treatment","definition_or_measurement_approach":"Composite binary responder endpoint requiring all four specified conditions relative to Stage B baseline."}
  • {"endpoint_text":"-Percentage of participants with TEAEs and SAEs","definition_or_measurement_approach":"Proportion of participants experiencing treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs)."}
  • {"endpoint_text":"-Change in ECG, vital signs and clinical laboratory values over time","definition_or_measurement_approach":"Assessment of longitudinal changes in ECG, vital signs and laboratory values."}
  • {"endpoint_text":"-Incidence of clinically significant ECG, vital signs and clinical laboratory abnormalities","definition_or_measurement_approach":"Incidence of clinically significant abnormalities in ECG, vital signs and laboratory tests."}
  • {"endpoint_text":"-Percentage of participants with suicidal ideation or suicidal behavior based on the C-SSRS","definition_or_measurement_approach":"Proportion of participants with suicidal ideation or behavior as measured by the Columbia-Suicide Severity Rating Scale (C-SSRS)."}
  • {"endpoint_text":"-Serum nipocalimab concentrations over time in participants receiving active study intervention","definition_or_measurement_approach":"Pharmacokinetic assessment: serum concentrations of nipocalimab over time."}
  • {"endpoint_text":"-Incidence and titers of ADA to nipocalimab and the presence of NAb to nipocalimab","definition_or_measurement_approach":"Immunogenicity assessment: incidence and titers of anti-drug antibodies (ADA) and presence of neutralizing antibodies (NAb) to nipocalimab."}
  • {"endpoint_text":"-Changes in total serum IgG concentrations over time","definition_or_measurement_approach":"Longitudinal assessment of total serum IgG concentrations."}

Recruitment

Digital Remote Recruitment
True - e-mail communication materials are present (e.g. L2_S491_SC_PFD_E-mail Communication and other electronic participant communications referenced in recruitment documents).
Planned Sample Size
116
Recruitment Window Months
90
Consent Approach
Informed consent is obtained from participants who are adults (≥18 years). Subject information and informed consent forms (L1_SIS-ICF_Main and related ICF documents, including pregnancy/withdrawal/privacy forms) are provided in the trial documentation. Specific assent procedures for minors are not applicable (minors excluded); exact language lists and age-specific consent form details are not available in the provided metadata.

Methods

  • Print advertisements (K2_Print-Ad-Color templates listed in recruitment documents)
  • Participant materials: flyer, brochure, poster (K2_Participant-Flyer / Participant-Brochure / Participant-Poster)
  • Dear Participant Letter (K2_Dear-Participant-Letter)
  • Advocacy / outreach text materials (K2_Advocacy-Outreach-Text)
  • Recruitment and informed consent process documentation (K1_Recruit-ICF process)

Geography

Total Number Of Sites
43
Total Number Of Participants
116

France

Earliest CTIS Part Ii Submission Date
12-04-2024
Latest Decision Or Authorization Date
11-06-2024
Processing Time Days
61
Number Of Sites
9
Number Of Participants
5

Sites

Site Name
Centre Hospitalier Universitaire De Nice
Department Name
Système Nerveux Périphérique & Muscle
Principal Investigator Name
Sabrina Sacconi
Principal Investigator Email
sacconi.s@chu-nice.fr
Contact Person Name
Sabrina Sacconi
Contact Person Email
sacconi.s@chu-nice.fr
Site Name
Centre Hospitalier Universitaire De Nimes
Department Name
Neurologie
Principal Investigator Name
Giovanni Castelnovo
Principal Investigator Email
giovanni.castelnovo@chu-nimes.fr
Contact Person Name
Giovanni Castelnovo
Site Name
Hospital Pierre Wertheimer
Department Name
Neurologie
Principal Investigator Name
Juliette Svahn
Principal Investigator Email
juliette.svahn@chu-lyon.fr
Contact Person Name
Juliette Svahn
Contact Person Email
juliette.svahn@chu-lyon.fr
Site Name
Centre Hospitalier Regional De Marseille
Department Name
Centre de reference des maladies neuromusculaires rares et de la SLA
Principal Investigator Name
Shahram Attarian
Principal Investigator Email
shahram.attarian@ap-hm.fr
Contact Person Name
Shahram Attarian
Contact Person Email
shahram.attarian@ap-hm.fr
Site Name
Les Hopitaux Universitaires De Strasbourg
Department Name
Neurologie
Principal Investigator Name
Jérôme De Seze
Principal Investigator Email
Jerome.DESEZE@chru-strasbourg.fr
Contact Person Name
Jérôme De Seze
Site Name
Assistance Publique Hopitaux De Paris
Department Name
Neurologie
Principal Investigator Name
Karine Viala
Principal Investigator Email
karine.viala@aphp.fr
Contact Person Name
Karine Viala
Contact Person Email
karine.viala@aphp.fr
Site Name
Fondation A De Rothschild
Department Name
Neurologie
Principal Investigator Name
Antoine Gueguen
Principal Investigator Email
agueguen@for.paris
Contact Person Name
Antoine Gueguen
Contact Person Email
agueguen@for.paris
Site Name
Assistance Publique Hopitaux De Paris (Le Kremlin-Bicetre)
Department Name
Neurologie
Principal Investigator Name
Andoni Echaniz-Laguna
Principal Investigator Email
andoni.echaniz-laguna@aphp.fr
Contact Person Name
Andoni Echaniz-Laguna
Contact Person Email
andoni.echaniz-laguna@aphp.fr
Site Name
Centre Hospitalier Universitaire De Bordeaux
Department Name
Neurologie
Principal Investigator Name
Gwendal Le Masson
Principal Investigator Email
gwendal.le-masson@chu-bordeaux.fr
Contact Person Name
Gwendal Le Masson

Italy

Earliest CTIS Part Ii Submission Date
12-04-2024
Latest Decision Or Authorization Date
29-05-2024
Processing Time Days
413
Number Of Sites
11
Number Of Participants
5

Sites

Site Name
Casa Di Cura Igea S.p.A.
Department Name
Dipartimento di Scienze Neuroriabilitative
Principal Investigator Name
Elda Judica
Principal Investigator Email
e.judica@casadicuraigea.it
Contact Person Name
Elda Judica
Contact Person Email
e.judica@casadicuraigea.it
Site Name
IRCCS Ospedale Policlinico San Martino
Department Name
Clinica neurologica
Principal Investigator Name
Angelo Schenone
Principal Investigator Email
aschenone@neurologia.unige.it
Contact Person Name
Angelo Schenone
Contact Person Email
aschenone@neurologia.unige.it
Site Name
Humanitas Mirasole S.p.A.
Department Name
UO Malattie Neuromuscolari e Neuroimmunologiche
Principal Investigator Name
Giuseppe Liberatore
Principal Investigator Email
giuseppe.liberatore@humanitas.it
Contact Person Name
Giuseppe Liberatore
Site Name
Azienda Ospedaliero-Universitaria Policlinico G. Rodolico-San Marco Di Catania
Department Name
UO clinica neurologica
Principal Investigator Name
Francesco Patti
Principal Investigator Email
patti@unict.it
Contact Person Name
Francesco Patti
Contact Person Email
patti@unict.it
Site Name
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Department Name
UOC Neurologia
Principal Investigator Name
Marco Luigetti
Principal Investigator Email
marco.luigetti@policlinicogemelli.it
Contact Person Name
Marco Luigetti
Site Name
Azienda Ospedaliera Di Rilievo Nazionale Antonio Cardarelli
Department Name
UOC Neurofisiopatologia
Principal Investigator Name
Francesco Habetswallner
Principal Investigator Email
francesco.habetswallner@aocardarelli.it
Contact Person Name
Francesco Habetswallner
Site Name
IRCCS Foundation Istituto Neurologico Carlo Besta
Department Name
Unità Neurologia – SC Neurologia 3 - Neuralgologia
Principal Investigator Name
Eleonora Dalla Bella
Principal Investigator Email
Eleonora.dallabella@istituto-besta.it
Contact Person Name
Eleonora Dalla Bella
Site Name
Fondazione Istituto Neurologico Nazionale Casimiro Mondino
Department Name
U.O. Neuroncologia
Principal Investigator Name
Luca Diamanti
Principal Investigator Email
Luca.diamandi@mondino.it
Contact Person Name
Luca Diamanti
Contact Person Email
Luca.diamandi@mondino.it
Site Name
Azienda Ospediera Policlinico Universitario Tor Vergata
Department Name
UOS Studio e Terapia delle Neuropatie Disimmuni
Principal Investigator Name
Girolama Marfia
Principal Investigator Email
marfia@med.uniroma2.it
Contact Person Name
Girolama Marfia
Contact Person Email
marfia@med.uniroma2.it
Site Name
Azienda Ospedaliero-Universitaria San Luigi Gonzaga
Department Name
SSD Patologie Neurologiche Specialistiche
Principal Investigator Name
Marinella Clerico
Principal Investigator Email
Marinella.clerico@unito.it
Contact Person Name
Marinella Clerico
Contact Person Email
Marinella.clerico@unito.it
Site Name
Azienda Ospedaliero Universitaria Pisana
Department Name
UO Neurologia
Principal Investigator Name
Gabriele Siciliano
Principal Investigator Email
g.siciliano@med.unipi.it
Contact Person Name
Gabriele Siciliano
Contact Person Email
g.siciliano@med.unipi.it

Portugal

Earliest CTIS Part Ii Submission Date
12-04-2024
Latest Decision Or Authorization Date
13-05-2024
Processing Time Days
31
Number Of Sites
3
Number Of Participants
6

Sites

Site Name
Centro Hospitalar Universitario Sao Joao E.P.E.
Department Name
Neurology
Principal Investigator Name
Luis Braz
Principal Investigator Email
luis.braz@chsj.min-saude.pt
Contact Person Name
Luis Braz
Contact Person Email
luis.braz@chsj.min-saude.pt
Site Name
Unidade Local De Saude De Almada-Seixal E.P.E.
Department Name
Neurology
Principal Investigator Name
Pedro Pereira
Principal Investigator Email
gacic@hgo.min-saude.pt
Contact Person Name
Pedro Pereira
Contact Person Email
gacic@hgo.min-saude.pt
Site Name
CCAB Centro Clinico Academico Braga Associacao
Department Name
Neurology
Principal Investigator Name
Ricardo Maré
Principal Investigator Email
2ca@ccabraga.org
Contact Person Name
Ricardo Maré
Contact Person Email
2ca@ccabraga.org

Greece

Earliest CTIS Part Ii Submission Date
12-04-2024
Latest Decision Or Authorization Date
10-06-2024
Processing Time Days
425
Number Of Sites
3
Number Of Participants
6

Sites

Site Name
General Hospital Of Thessaloniki Papageorgiou
Department Name
Neurology Clinic
Principal Investigator Name
Athanasios Tichalas
Principal Investigator Email
atichalas@yahoo.com
Contact Person Name
Athanasios Tichalas
Contact Person Email
atichalas@yahoo.com
Site Name
University General Hospital Of Thessaloniki Ahepa
Department Name
1st Department of Neurology
Principal Investigator Name
Vasilios Kimiskidis
Principal Investigator Email
kimiskid@auth.gr
Contact Person Name
Vasilios Kimiskidis
Contact Person Email
kimiskid@auth.gr
Site Name
University General Hospital Attikon
Department Name
B’ Neurology Clinic
Principal Investigator Name
Georgios Tsivgoulis
Principal Investigator Email
gtsivou@med.uoa.gr
Contact Person Name
Georgios Tsivgoulis
Contact Person Email
gtsivou@med.uoa.gr

Germany

Earliest CTIS Part Ii Submission Date
12-04-2024
Latest Decision Or Authorization Date
21-05-2024
Processing Time Days
410
Number Of Sites
8
Number Of Participants
10

Sites

Site Name
Martha-Maria Krankenhaus Halle-Doelau gGmbH
Department Name
Department of Neurology
Principal Investigator Name
Frank Hoffmann
Principal Investigator Email
frank.hoffmann@martha-maria.de
Contact Person Name
Frank Hoffmann
Contact Person Email
frank.hoffmann@martha-maria.de
Site Name
Universitaetsklinikum Leipzig AöR
Department Name
Studienambulanz Neurologie
Principal Investigator Name
Petra Baum
Principal Investigator Email
Petra.Baum@medizin.uni-leipzig.de
Contact Person Name
Petra Baum
Site Name
Medizinische Hochschule Hannover
Department Name
Klinik für Neurologie
Principal Investigator Name
Thomas Skripuletz
Principal Investigator Email
skripuletz.thomas@mh-hannover.de
Contact Person Name
Thomas Skripuletz
Site Name
Medizinische Versorgungszentren St. Josefs-Krankenhaus Potsdam GmbH
Department Name
Neurology
Principal Investigator Name
Alexander Gawlitza
Principal Investigator Email
a.gawlitza@alexianer.de
Contact Person Name
Alexander Gawlitza
Contact Person Email
a.gawlitza@alexianer.de
Site Name
Universitaetsmedizin Goettingen
Department Name
Dept. of Neurology, University Medical Center Göttingen (UMG)
Principal Investigator Name
Jana Zschüntzsch
Principal Investigator Email
j.zschuentzsch@med.uni-goettingen.de
Contact Person Name
Jana Zschüntzsch
Site Name
Deutsches Zentrum Fuer Neurodegenerative Erkrankungen e.V.
Department Name
Department of Neurology, University of Ulm, and Department of Neurological Rehabilitation
Principal Investigator Name
Angela Rosenbohm
Principal Investigator Email
angela.rosenbohm@uni-ulm.de
Contact Person Name
Angela Rosenbohm
Contact Person Email
angela.rosenbohm@uni-ulm.de
Site Name
Juedisches Krankenhaus Berlin Stiftung Des Buergerlichen Rechts
Department Name
Klinik für Neurologie
Principal Investigator Name
Juliane Klehmet
Principal Investigator Email
juliane.klehmet@charite.de
Contact Person Name
Juliane Klehmet
Contact Person Email
juliane.klehmet@charite.de
Site Name
Katholisches Klinikum Bochum gGmbH
Department Name
Neurologische Universitätsklinik am St. Josef Hospital
Principal Investigator Name
Kalliopi Pitarokoili
Principal Investigator Email
kalliopi.pitarokoili@ruhr-uni-bochum.de
Contact Person Name
Kalliopi Pitarokoili

Poland

Earliest CTIS Part Ii Submission Date
12-04-2024
Latest Decision Or Authorization Date
13-05-2024
Processing Time Days
397
Number Of Sites
2
Number Of Participants
6

Sites

Site Name
Clinical Research Center Sp. z o.o. Medic-R sp.k.
Principal Investigator Name
Artur Drużdż
Principal Investigator Email
artur.druzdz@cr-center.pl
Contact Person Name
Artur Drużdż
Contact Person Email
artur.druzdz@cr-center.pl
Site Name
Clinirem Sp. z o.o.
Department Name
Galen Clinic
Principal Investigator Name
Urszula Chyrchel-Paszkiewicz
Principal Investigator Email
pgluchyrchel@gmail.com
Contact Person Name
Urszula Chyrchel-Paszkiewicz
Contact Person Email
pgluchyrchel@gmail.com

Czechia

Earliest CTIS Part Ii Submission Date
12-04-2024
Latest Decision Or Authorization Date
14-05-2024
Processing Time Days
393
Number Of Sites
1
Number Of Participants
8

Sites

Site Name
Fakultni Nemocnice Hradec Kralove
Department Name
Neurologická klinika
Principal Investigator Name
Pavel Kunc
Principal Investigator Email
pavel.kunc@fnhk.cz
Contact Person Name
Pavel Kunc
Contact Person Email
pavel.kunc@fnhk.cz

Spain

Earliest CTIS Part Ii Submission Date
12-04-2024
Latest Decision Or Authorization Date
13-05-2024
Processing Time Days
397
Number Of Sites
6
Number Of Participants
14

Sites

Site Name
Hospital Universitari Vall D Hebron
Department Name
Neurology
Principal Investigator Name
María Salvado Figueras
Principal Investigator Email
maria.salvado@vhir.org
Contact Person Name
María Salvado Figueras
Contact Person Email
maria.salvado@vhir.org
Site Name
Hospital Universitario Donostia
Department Name
Neurology
Principal Investigator Name
Roberto Fernández Torron
Principal Investigator Email
roberto.fernandeztorron@osakidetza.eus
Contact Person Name
Roberto Fernández Torron
Site Name
Hospital General Universitario Dr. Balmis
Department Name
Neurology
Principal Investigator Name
Carmen Díaz Marin
Principal Investigator Email
ensayosneralicante@gmail.com
Contact Person Name
Carmen Díaz Marin
Contact Person Email
ensayosneralicante@gmail.com
Site Name
Hospital Clinico San Carlos
Department Name
Neurology
Principal Investigator Name
Lucía Galán Dávila
Principal Investigator Email
lgaland@salud.madrid.org
Contact Person Name
Lucía Galán Dávila
Contact Person Email
lgaland@salud.madrid.org
Site Name
Hospital Universitario Virgen De La Macarena
Department Name
Neurology
Principal Investigator Name
Eva María Martínez Fernández
Principal Investigator Email
evam.martinez.sspa@juntadeandalucia.es
Contact Person Name
Eva María Martínez Fernández
Site Name
Hospital Universitario Basurto
Department Name
Neurology
Principal Investigator Name
Solange Kapetanovic Garcia
Principal Investigator Email
solange.kapetanovicgarcia@osakidetza.eus
Contact Person Name
Solange Kapetanovic Garcia

Sponsor

Primary sponsor

Full Name
Janssen Cilag International
Organisation Type
Pharmaceutical company
Country Of Registered Address
Belgium

Contract research organisations

Name
Icon Clinical Research Limited
Responsibilities
Multiple sponsor duties (codes: 1,12,13,14,2,4,5,6,8,9) - per sponsor duties list
Name
PRA Hellas CRO A.E.
Responsibilities
Local/regional CRO activities (codes: 12,2,8)
Name
Bioclinica Inc.
Responsibilities
Adjudication
Name
Iqvia Inc.
Responsibilities
Clinical Outcome Assessments / Rater Services

Third parties

  • {"country":"Switzerland","full_name":"MindMaze SA","duties_or_roles":"Provider of Gait Assessment (code 15 / value: Provider of Gait Assessment)","organisation_type":"Pharmaceutical company"}
  • {"country":"Ireland","full_name":"Icon Clinical Research Limited","duties_or_roles":"Codes: 1,12,13,14,2,4,5,6,8,9 (multiple sponsor duties codes listed)","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Bioclinica Inc.","duties_or_roles":"Adjudication (code 15 / value: Adjudication)","organisation_type":"Laboratory/Research/Testing facility"}
  • {"country":"Greece","full_name":"PRA Hellas CRO A.E.","duties_or_roles":"Codes: 12,2,8","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Almac Clinical Services LLC","duties_or_roles":"Drug Destruction (code 15 / value: Drug Destruction)","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Labcorp Central Laboratory Services LP","duties_or_roles":"Code: 4","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"The Andwin Corp.","duties_or_roles":"Vigorimeter (code 15 / value: Vigorimeter)","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Meeting Protocol Worldwide LP","duties_or_roles":"patient reimbursement and Investigator meeting planning (code 15 / value: patient reimbursement and Investigator meeting planning)","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Ancillare LP","duties_or_roles":"Ancillary supplies (code 15 / value: Ancillary supplies)","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Iqvia Inc.","duties_or_roles":"Clinical Outcome Assessments / Rater Services (code 15 / value: Clinical Outcome Assessments / Rater Services)","organisation_type":"Pharmaceutical company"}
  • {"country":"United Kingdom","full_name":"Imperial Clinical Research Services International Limited","duties_or_roles":"printing services (code 15 / value: printing services)","organisation_type":"Hospital/Clinic/Other health care facility"}
  • {"country":"United States","full_name":"Medidata Solutions Inc.","duties_or_roles":"EDC (code 15 / value: EDC)","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"United States","full_name":"4g Clinical LLC","duties_or_roles":"Code: 3","organisation_type":"Non-Pharmaceutical company"}

Investigational products

Investigational Product Name
JNJ-80202135
Active Substance
NIPOCALIMAB
Modality
Monoclonal antibody
Routes Of Administration
Solution for infusion / Intravenous use
Route
Intravenous
Authorisation Status
Not authorised (investigational product; no marketing authorisation number listed)
Investigational Product Name
Privigen 100 mg/ml solution for infusion
Active Substance
HUMAN NORMAL IMMUNOGLOBULIN
Modality
Other antibody
Routes Of Administration
Intravenous use / Solution for infusion
Route
Intravenous
Authorisation Status
Authorised (marketing authorisation EU/1/08/446/001)
Investigational Product Name
Saline, 0.9% Sodium Chloride Solution for Injection
Modality
Other
Authorisation Status
Not specified (placebo/control)

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