Clinical trial • Phase II • Immunology | Neurology
EMPASIPRUBART for AChR-Ab Seropositive Generalized Myasthenia Gravis | Myasthenia gravis
Phase II trial of EMPASIPRUBART for AChR-Ab Seropositive Generalized Myasthenia Gravis | Myasthenia gravis.
Overview
- Trial Therapeutic Area
- Immunology | Neurology
- Trial Disease
- AChR-Ab Seropositive Generalized Myasthenia Gravis | Myasthenia gravis
- Trial Stage
- Phase II
- Drug Modality
- Monoclonal antibody | Other antibody
- Orphan Drug
- Yes
Key dates
- Initial CTIS Submission Date
- 15-10-2025
- First CTIS Authorization Date
- 18-02-2026
Trial design
open-label, efgartigimod iv (monotherapy) versus efgartigimod iv + empasiprubart (argx-117) iv (add-on); dosing and schedule not specified in the public record-controlled Phase II trial across 19 sites in Italy, Spain, Belgium and others.
- Open Label
- Yes
- Comparator
- Efgartigimod IV (monotherapy) versus Efgartigimod IV + Empasiprubart (ARGX-117) IV (add-on); dosing and schedule not specified in the public record
- Target Sample Size
- 18
Eligibility
Recruits 18 Vulnerable population considerations present. The registry shows isVulnerablePopulationSelected=true and subject information / informed consent forms include specific pregnancy and newborn / pregnant participant and partner ICFs (e.g. files titled "Pregnant_Participant_ICF", "Pregnancy-and-Birth-ICF", and country-specific pregnancy ICFs). Consent is obtained from adult participants (minimum age 18 as per inclusion criteria); separate ICFs for pregnancy and partner information are provided..
- Vulnerable Population
- Vulnerable population considerations present. The registry shows isVulnerablePopulationSelected=true and subject information / informed consent forms include specific pregnancy and newborn / pregnant participant and partner ICFs (e.g. files titled "Pregnant_Participant_ICF", "Pregnancy-and-Birth-ICF", and country-specific pregnancy ICFs). Consent is obtained from adult participants (minimum age 18 as per inclusion criteria); separate ICFs for pregnancy and partner information are provided.
Inclusion criteria
- {"criterion_text":"- MP Main inclusion criteria:\n- o\tIs at least 18 years of age and the local legal age of consent for clinical studies\n- o\tHas been diagnosed with MG consistent with MG's clinical features and with symptom severity appropriate for currently enrolling ISAs, per the investigator’s clinical judgment\n- o\tIf receiving MG therapy, including nonsteroidal immunosuppressive drugs (NSIDs), corticosteroids, or acetylcholinesterase (AChE) inhibitors either in combination or alone, the participant should receive a stable dosage before master protocol screening\n- ISA 1 Main inclusion criteria:\n- - Is seropositive for anti-acetylcholine receptor antibodies (AChR-Ab).\n- - Has confirmed diagnosis of gMG and is Myasthenia Gravis Foundation of America (MGFA) Class II, III, IVa, or IVb.\n- - Has documented immunization against encapsulated bacterial pathogens (Neisseria meningitidis and Streptococcus pneumoniae) within 5 years of ISA screening or is willing to receive immunization at least 14 days before the first study drug administration."}
Exclusion criteria
- {"criterion_text":"- MP Main exclusion criteria: - Known autoimmune disease or any medical condition other than the indication under study that would interfere with an accurate assessment of clinical symptoms of MG or puts the participant at undue risk. - Is MGFA (Myasthenia Gravis Foundation of America) Class V\n- ISA 1 Main exclusion criteria: - Clinical diagnosis of systemic lupus erythematosus (SLE). - Any known complement deficiency. - Current administration of a complement inhibitor or received zilucoplan or eculizumab <2 months or ravulizumab <6 months before the first study drug administration. - Patients proven to be refractory to efgartigimod (ie, not achieving a clinically meaningful improvement in total Myasthenia Gravis Activities of Daily Living (MG-ADL) score defined as an improvement of ≥2 points)."}
Endpoints
Primary endpoints
- {"endpoint_text":"- MP - 1.\t Incidence, severity, and relatedness of AEs and SAEs","definition_or_measurement_approach":"Assessment of incidence, severity, and relatedness of adverse events (AEs) and serious adverse events (SAEs) as recorded during the study (safety monitoring)."}
- {"endpoint_text":"- MP - 2.\t Clinically meaningful changes in vital signs, ECGs, and laboratory parameters","definition_or_measurement_approach":"Assessment of clinically meaningful changes from baseline in vital signs, ECGs and laboratory parameters."}
- {"endpoint_text":"- ISA 1 - 1. Incidence, severity, and relatedness of adverse events and serious adverse events in parts A and B","definition_or_measurement_approach":"Assessment of incidence, severity, and relatedness of AEs and SAEs in protocol parts A and B."}
- {"endpoint_text":"- ISA 1 - 2. Clinically meaningful changes in vital signs, electrocardio grams, and laboratory parameters in parts A and B","definition_or_measurement_approach":"Assessment of clinically meaningful changes from baseline in vital signs, electrocardiograms and laboratory parameters in parts A and B."}
Secondary endpoints
- {"endpoint_text":"- MP - 1. Change in MG disease severity as measured by change from baseline in Myasthenia Gravis Activities of Daily Living (MG-ADL) total score or Myasthenia Gravis Impairment Index (MGII) total score","definition_or_measurement_approach":"Change from baseline in MG-ADL total score or MGII total score."}
- {"endpoint_text":"- MP - 2. Proportion of participants reaching minimal symptom expression (MSE) and other percentage improvements at variable time points.","definition_or_measurement_approach":"Proportion achieving minimal symptom expression (MSE) and other percentage improvements at specified time points."}
- {"endpoint_text":"- ISA1 - 1. Myasthenia Gravis Activities of Daily Living (MG-ADL) total score change from baseline at week 18 in part B (cycle 2 day 29) compared with MG-ADL total score change from baseline at week 4 in part A","definition_or_measurement_approach":"Comparison of MG-ADL change from baseline at week 18 in part B vs change at week 4 in part A (timepoint-specified change from baseline)."}
- {"endpoint_text":"- ISA 1 - 2. Proportion of participants reaching minimal symptom expression (MSE) at any point in part B cycles 1 and 2, and part B cycles 1 or 2","definition_or_measurement_approach":"Proportion of participants who reach MSE at any point during part B cycles 1 and 2 or in cycles 1 or 2."}
- {"endpoint_text":"- ISA 1 - 3. MG-ADL total score actual values and changes from baseline over time in part B compared with part A","definition_or_measurement_approach":"Longitudinal MG-ADL actual values and change-from-baseline comparisons between part B and part A."}
- {"endpoint_text":"- ISA 1 - 4. Quantitative Myasthenia Gravis (QMG) total score change from baseline at week 18 in part B (cycle 2 day 29) compared with QMG total score change from baseline at week 4 in part A","definition_or_measurement_approach":"Comparison of QMG total score change from baseline at specified timepoints (week 18 part B vs week 4 part A)."}
- {"endpoint_text":"- ISA 1 - 5. QMG total score actual values and changes from baseline over time in part B compared with part A","definition_or_measurement_approach":"Longitudinal QMG actual values and change-from-baseline comparisons between part B and part A."}
- {"endpoint_text":"- ISA 1 - 6. Proportion of participants who have a 50% MG-ADL total score improvement in part B cycles 1 and 2","definition_or_measurement_approach":"Proportion of participants achieving a 50% improvement in MG-ADL total score during part B cycles 1 and 2."}
- {"endpoint_text":"- ISA 1 - 7. Proportion of participants who have positive patient acceptable symptom state (PASS) in part B cycles 1 and 2, and part B cycles 1 or 2","definition_or_measurement_approach":"Proportion of participants achieving a positive patient acceptable symptom state (PASS) in specified part B cycles."}
Recruitment
- Planned Sample Size
- 52
- Recruitment Window Months
- 23
- Consent Approach
- Informed consent is obtained from adult participants (minimum age 18). Subject information and ICF documents are provided per country and language (multiple country-specific ICFs listed: Italian, Spanish, English, French, Dutch, German, Greek, Polish, etc.). There are specific ICFs for pregnancy/partner and for optional future research where applicable.
Methods
- Doctor-to-patient letters (K2 / Doctor Letter documents) — channel: letter via treating physicians; target audience: patients with Myasthenia Gravis; country-specific versions available (e.g. ITA, ESP, BE, DEU, GRC, PL, NLD).
- HCP cards / HCP-Card documents — channel: healthcare professional outreach; target audience: neurologists and treating clinicians; country-specific versions available (e.g. ITA, BE, DEU, GRC, PL, NLD).
- Patient brochures, flyers and patient letters (K2 / Patient-Brochure, Patient-Flyer, Patient-Letter documents) — channel: printed materials for patients; target audience: potential participant patients; country/language-specific materials available (e.g. ITA, ESP, BE English/French/Dutch, DEU, GRC Greek, PL Polish, NLD).
- Recruitment arrangements (K1 documents) — channel: formal recruitment arrangement documents submitted per country; country-specific K1 documents present for Italy, Spain, Belgium, Germany, Greece, Poland, Netherlands.
Geography
- Total Number Of Sites
- 19
- Total Number Of Participants
- 52
Italy
- Earliest CTIS Part Ii Submission Date
- 13-01-2026
- Latest Decision Or Authorization Date
- 23-02-2026
- Processing Time Days
- 41
- Number Of Sites
- 5
- Number Of Participants
- 6
Sites
- Site Name
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Department Name
- Neurology
- Principal Investigator Name
- Raffaele Iorio
- Principal Investigator Email
- Raffaele.iorio@policlinicogemelli.it
- Contact Person Name
- Raffaele Iorio
- Contact Person Email
- Raffaele.iorio@policlinicogemelli.it
- Site Name
- Azienda Socio Sanitaria Territoriale Papa Giovanni Xxiii
- Department Name
- SC Neurology
- Principal Investigator Name
- Giorgia Camera
- Principal Investigator Email
- gcamera@asst-pg23.it
- Contact Person Name
- Giorgia Camera
- Contact Person Email
- gcamera@asst-pg23.it
- Site Name
- IRCCS Foundation Istituto Neurologico Carlo Besta
- Department Name
- UOC Neurology IV- Neuroimmunology and Neuromuscular Diseases
- Principal Investigator Name
- Carlo Giuseppe Antozzi
- Principal Investigator Email
- carlo.antozzi@istituto-besta.it
- Contact Person Name
- Carlo Giuseppe Antozzi
- Contact Person Email
- carlo.antozzi@istituto-besta.it
- 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
- Contact Person Email
- francesco.habetswallner@aocardarelli.it
- Site Name
- Azienda Ospedaliero-Universitaria Sant Andre
- Department Name
- UOC Neurology
- Principal Investigator Name
- Stefania Morino
- Principal Investigator Email
- stefania.morino@ospedalesantandrea.it
- Contact Person Name
- Stefania Morino
- Contact Person Email
- stefania.morino@ospedalesantandrea.it
Spain
- Earliest CTIS Part Ii Submission Date
- 13-01-2026
- Latest Decision Or Authorization Date
- 20-02-2026
- Processing Time Days
- 38
- Number Of Sites
- 2
- Number Of Participants
- 4
Sites
- Site Name
- Hospital De La Santa Creu I Sant Pau
- Department Name
- Neurology
- Principal Investigator Name
- Elena Cortés Vicente
- Principal Investigator Email
- ecortes@santpau.cat
- Contact Person Name
- Elena Cortés Vicente
- Contact Person Email
- ecortes@santpau.cat
- Site Name
- Hospital Universitario Regional De Malaga
- Department Name
- Neurology
- Principal Investigator Name
- Guillermina Garcia Martin
- Principal Investigator Email
- guille.garcia.eecc@gmail.com
- Contact Person Name
- Guillermina Garcia Martin
- Contact Person Email
- guille.garcia.eecc@gmail.com
Belgium
- Earliest CTIS Part Ii Submission Date
- 12-01-2026
- Latest Decision Or Authorization Date
- 18-02-2026
- Processing Time Days
- 37
- Number Of Sites
- 2
- Number Of Participants
- 3
Sites
- Site Name
- UZ Leuven
- Department Name
- Neurology
- Principal Investigator Name
- Kristl Claeys
- Principal Investigator Email
- kristl.claeys@uzleuven.be
- Contact Person Name
- Kristl Claeys
- Contact Person Email
- kristl.claeys@uzleuven.be
- Site Name
- Centre Hospitalier Regional De La Citadelle
- Department Name
- Neurology
- Principal Investigator Name
- Margaux Poleur
- Principal Investigator Email
- margaux.poleur@citadelle.be
- Contact Person Name
- Margaux Poleur
- Contact Person Email
- margaux.poleur@citadelle.be
Germany
- Earliest CTIS Part Ii Submission Date
- 15-01-2026
- Latest Decision Or Authorization Date
- 24-02-2026
- Processing Time Days
- 40
- Number Of Sites
- 2
- Number Of Participants
- 4
Sites
- Site Name
- Charite Universitaetsmedizin Berlin KöR
- Department Name
- Department of Neurology, Neuroscience Clinical Research Center
- Principal Investigator Name
- Sarah Hoffmann
- Principal Investigator Email
- sarah.hoffmann@charite.de
- Contact Person Name
- Sarah Hoffmann
- Contact Person Email
- sarah.hoffmann@charite.de
- Site Name
- Universitaetsmedizin Goettingen
- Department Name
- Department of Neurology
- Principal Investigator Name
- Jana Zschüntzsch
- Principal Investigator Email
- j.zschuentzsch@med.uni-goettingen.de
- Contact Person Name
- Jana Zschüntzsch
- Contact Person Email
- j.zschuentzsch@med.uni-goettingen.de
Greece
- Earliest CTIS Part Ii Submission Date
- 29-10-2025
- Latest Decision Or Authorization Date
- 24-02-2026
- Processing Time Days
- 118
- Number Of Sites
- 2
- Number Of Participants
- 8
Sites
- Site Name
- Eginitio Hospital
- Department Name
- Neurology Department
- Principal Investigator Name
- Vasiliki Zouvelou
- Principal Investigator Email
- vzouvelu@med.uoa.gr
- Contact Person Name
- Vasiliki Zouvelou
- Contact Person Email
- vzouvelu@med.uoa.gr
- Site Name
- University General Hospital Of Thessaloniki Ahepa
- Department Name
- Clinical Νeurophysiology
- Principal Investigator Name
- Marianthi Arnaoutoglou
- Principal Investigator Email
- marnaout@auth.gr
- Contact Person Name
- Marianthi Arnaoutoglou
- Contact Person Email
- marnaout@auth.gr
Poland
- Earliest CTIS Part Ii Submission Date
- 13-01-2026
- Latest Decision Or Authorization Date
- 22-02-2026
- Processing Time Days
- 40
- Number Of Sites
- 5
- Number Of Participants
- 25
Sites
- Site Name
- Medicover Integrated Clinical Services Sp. z o.o.
- Department Name
- MICS Centrum Medyczne Bydgoszcz
- Principal Investigator Name
- Łukasz Rzepiński
- Principal Investigator Email
- lukasz.rzepinski@mics.medicover.com
- Contact Person Name
- Łukasz Rzepiński
- Contact Person Email
- lukasz.rzepinski@mics.medicover.com
- Site Name
- Uniwersyteckie Centrum Kliniczne Warszawskiego Uniwersytetu Medycznego
- Department Name
- Centralny Szpital Kliniczny, Klinika Neurologii
- Principal Investigator Name
- Anna Kostera-Pruszczyk
- Principal Investigator Email
- anna.kostera-pruszczyk@wum.edu.pl
- Contact Person Name
- Anna Kostera-Pruszczyk
- Contact Person Email
- anna.kostera-pruszczyk@wum.edu.pl
- Site Name
- Samodzielny Publiczny Zaklad Opieki Zdrowotnej Szpital Uniwersytecki W Krakowie
- Department Name
- Zespół Poradni Specjalistycznych - Botaniczna 3, Poradnia Neurologiczna
- Principal Investigator Name
- Agnieszka Słowik
- Principal Investigator Email
- neurologiabk@su.krakow.pl
- Contact Person Name
- Agnieszka Słowik
- Contact Person Email
- neurologiabk@su.krakow.pl
- Site Name
- Neurologia Śląska Centrum Medyczne
- Principal Investigator Name
- Marek Śmiłowski
- Principal Investigator Email
- marek.smilowski@neurologiaslaska.pl
- Contact Person Name
- Marek Śmiłowski
- Contact Person Email
- marek.smilowski@neurologiaslaska.pl
- Site Name
- Krakowska Akademia Neurologii Sp. z o.o.
- Principal Investigator Name
- Andrzej Szczudlik
- Principal Investigator Email
- andrzej.szczudlik@neurologia.org.pl
- Contact Person Name
- Andrzej Szczudlik
- Contact Person Email
- andrzej.szczudlik@neurologia.org.pl
Netherlands
- Earliest CTIS Part Ii Submission Date
- 20-01-2026
- Latest Decision Or Authorization Date
- 20-02-2026
- Processing Time Days
- 31
- Number Of Sites
- 1
- Number Of Participants
- 2
Sites
- Site Name
- Leids Universitair Medisch Centrum (LUMC)
- Department Name
- Neurology
- Principal Investigator Name
- Jan Verschuuren
- Principal Investigator Email
- Myasthenie@Lumc.nl
- Contact Person Name
- Jan Verschuuren
- Contact Person Email
- Myasthenie@Lumc.nl
Sponsor
Primary sponsor
- Full Name
- Argenx
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- Belgium
Contract research organisations
- Name
- Pharmaceutical Product Development LLC (PPD)
- Responsibilities
- sponsorDuties codes include 4; vendor management and patient recruitment duties referenced (e.g. PPD Development LP duties include vendor management, patient recruitment)
- Name
- PPD Development LP
- Responsibilities
- sponsorDuties: 1, 11, 12, 13, 15 (Vendor management, Patient recruitment), 2, 5
- Name
- PPD International Holdings LLC / PPD Global Ltd.
- Responsibilities
- project management, monitoring/regulatory, site services
- Name
- Almac Clinical Services LLC / Almac Clinical Services Limited / Almac Clinical Services (Ireland) / Almac Pharmaceutical Services Pte. Ltd.
- Responsibilities
- logistics and shipment; sample handling (sponsorDuties codes: 14; 15 (Shipment))
- Name
- IQVIA Limited
- Responsibilities
- Pharmacovigilance; other study management responsibilities
- Name
- SGS Belgium / SGS France
- Responsibilities
- data safety monitoring, eCRF / IxRS, laboratory/service provisioning
- Name
- Endpoint Clinical Inc.
- Responsibilities
- audit and site oversight (sponsorDuties code: 3)
- Name
- Drug Development Solutions Limited
- Responsibilities
- laboratory/service provisioning (sponsorDuties code: 4)
Third parties
- {"country":"Poland","full_name":"Synexus Polska Sp. z o.o.","duties_or_roles":"PPD Home care Service (sponsorDuties code 15 / value: PPD Home care Service)","organisation_type":"Hospital/Clinic/Other health care facility"}
- {"country":"United States","full_name":"Pharmaceutical Product Development LLC","duties_or_roles":"sponsorDuties codes: 4","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Almac Clinical Services LLC","duties_or_roles":"sponsorDuties codes: 14; 15 (Shipment)","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Endpoint Clinical Inc.","duties_or_roles":"sponsorDuties codes: 3","organisation_type":"Pharmaceutical company"}
- {"country":"Ireland","full_name":"SAFIRA Clinical Research Limited","duties_or_roles":"sponsorDuties codes: 15 (eCOA consulting)","organisation_type":"Health care"}
- {"country":"France","full_name":"SGS France","duties_or_roles":"sponsorDuties codes: 4","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Almac Clinical Services LLC (additional address)","duties_or_roles":"sponsorDuties codes: 14; 15 (Shipment)","organisation_type":"Pharmaceutical company"}
- {"country":"United Kingdom","full_name":"The Doctors Laboratory Limited","duties_or_roles":"sponsorDuties codes: 4","organisation_type":"Laboratory/Research/Testing facility"}
- {"country":"United Kingdom (Northern Ireland)","full_name":"Almac Clinical Services Limited","duties_or_roles":"sponsorDuties codes: 14; 15 (Shipment)","organisation_type":"Pharmaceutical company"}
- {"country":"Singapore","full_name":"Almac Pharmaceutical Services Pte. Ltd.","duties_or_roles":"sponsorDuties codes: 14; 15 (Shipment)","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Almac Clinical Services LLC (other addresses)","duties_or_roles":"sponsorDuties codes: 14; 15 (Shipment)","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"PPD Development LP","duties_or_roles":"sponsorDuties codes: 1, 11, 12, 13, 15 (Vendor management, Patient recruitment), 2, 5","organisation_type":"Pharmaceutical company"}
- {"country":"Belgium","full_name":"SGS Belgium","duties_or_roles":"sponsorDuties codes: 10; 15 (Data Safety monitoring Board, eCRF / IxRS); 6; 7","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Almac Clinical Services LLC (25 Fretz Road)","duties_or_roles":"sponsorDuties codes: 14; 15 (Shipment)","organisation_type":"Pharmaceutical company"}
- {"country":"United Kingdom","full_name":"Drug Development Solutions Limited","duties_or_roles":"sponsorDuties codes: 4","organisation_type":"Pharmaceutical company"}
- {"country":"Belgium","full_name":"PPD International Holdings LLC","duties_or_roles":"sponsorDuties codes: 4","organisation_type":"Pharmaceutical company"}
- {"country":"Greece","full_name":"PPD Global Ltd.","duties_or_roles":"sponsorDuties codes: 15 (Project management duties and monitoring/regulatory)","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Advarra Inc.","duties_or_roles":"sponsorDuties codes: 15 (Investigator Site portal)","organisation_type":"Non-Pharmaceutical company"}
- {"country":"Ireland","full_name":"Almac Clinical Services (Ireland) Limited","duties_or_roles":"sponsorDuties codes: 14; 15 (Shipment)","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Eresearchtechnology Inc.","duties_or_roles":"sponsorDuties codes: 15 (Respiratory, Cardiac safety; ECG Machine, Ancillaries & eCOA Services)","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Scout Clinical","duties_or_roles":"sponsorDuties codes: 15 (Participant travel reimbursment)","organisation_type":"Hospital/Clinic/Other health care facility"}
- {"country":"Germany","full_name":"Azenta Germany GmbH","duties_or_roles":"sponsorDuties codes: 15 (Long Term sample Storage)","organisation_type":"Pharmaceutical company"}
- {"country":"United Kingdom","full_name":"IQVIA Limited","duties_or_roles":"sponsorDuties codes: 15 (Pharmacovigilance); 8","organisation_type":"Pharmaceutical company"}
- {"country":"Switzerland","full_name":"Celerion Switzerland AG","duties_or_roles":"sponsorDuties codes: 4","organisation_type":"Pharmaceutical company"}
- {"country":"Finland","full_name":"SYRINX Bioanalytics Oy","duties_or_roles":"sponsorDuties codes: 4","organisation_type":"Pharmaceutical company"}
Investigational products
- Investigational Product Name
- ARGX-117
- Active Substance
- EMPASIPRUBART
- Modality
- Monoclonal antibody
- Routes Of Administration
- IV INFUSION
- Route
- IV INFUSION
- Authorisation Status
- Authorised
- Investigational Product Name
- ARGX-113
- Active Substance
- EFGARTIGIMOD ALFA
- Modality
- Other antibody
- Routes Of Administration
- IV INFUSION
- Route
- IV INFUSION
- Authorisation Status
- Authorised
- Orphan Designation
- Yes
- Maximum Dose
- Max daily dose 1200 mg; max total dose 33600 mg
- Combination Treatment
- Yes
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