Clinical trial • Phase III • Neurology

AMLENETUG for Multiple system atrophy

Phase III trial of AMLENETUG for Multiple system atrophy.

Overview

Trial Therapeutic Area
Neurology
Trial Disease
Multiple system atrophy
Trial Stage
Phase III
Drug Modality
Monoclonal antibody
Orphan Drug
Yes

Key dates

Initial CTIS Submission Date
04-11-2024
First CTIS Authorization Date
10-03-2025

Trial design

Randomised, open-label, active arms: amlenetug (high dose) and amlenetug (low dose) administered iv every 4 weeks ± 3 days; comparator/placebo arm: commercially available saline solution for infusion (placebo) administered iv every 4 weeks ± 3 days.-controlled Phase III trial in France, Italy, Spain and others.

Randomised
Yes
Open Label
Yes
Comparator
Active arms: amlenetug (high dose) and amlenetug (low dose) administered IV every 4 weeks ± 3 days; Comparator/placebo arm: commercially available saline solution for infusion (placebo) administered IV every 4 weeks ± 3 days.
Target Sample Size
245
Trial Duration For Participant
1148

Eligibility

Recruits 245 Participants are adults with a neurodegenerative disease and the protocol requires caregiver involvement. Consent handling: "The participant is able to read and understand the ICF."; "The participant has signed the trial specific ICF."; caregiver requirements: "The participant's caregiver is able to read and understand the Caregiver's Informed Consent Form." and "The participant's caregiver has signed the Caregiver's Informed Consent Form.". Multiple caregiver and participant ICF variants (biobanking, OLE, pregnant participant/partner, father of newborn) are provided..

Pregnancy Exclusion
The participant is pregnant, breastfeeding, intends to become pregnant, or is of childbearing potential and not willing to use adequate contraceptive methods.
Vulnerable Population
Participants are adults with a neurodegenerative disease and the protocol requires caregiver involvement. Consent handling: "The participant is able to read and understand the ICF."; "The participant has signed the trial specific ICF."; caregiver requirements: "The participant's caregiver is able to read and understand the Caregiver's Informed Consent Form." and "The participant's caregiver has signed the Caregiver's Informed Consent Form.". Multiple caregiver and participant ICF variants (biobanking, OLE, pregnant participant/partner, father of newborn) are provided.

Inclusion criteria

  • {"criterion_text":"- The participant is capable of communicating with site staff.\n- The participant had onset of motor MSA symptoms (i.e., parkinsonian and/or cerebellar) within 5 years prior to the Screening Visit in the judgement of the investigator.\n- The participant has an anticipated survival of >3 years, in the opinion of the investigator, at the Screening Visit.\n- The participant has an UMSARS Part I score lesser than/equal16 (omitting item 11 on sexual function) at the Screening Visit.\n- The participant has a cognitive performance score ≥22, evaluated by the MoCA at the Screening Visit. Add one point for an individual who has 12 years or less of formal education.\n- The participant has suitable peripheral venous access for IMP administration and blood sampling.\n- The man must: - have been surgically sterlised (bilateral surgical vasectomy or bilateral orchiectomy) prior to Screening Visit OR - remain sexually abstinent, when this is in line with his preferred and usual lifestyle OR - engage exclusively in same-sex relationships OR - engage in sexual relationships with a partner who is a woman of non-childbearing potential, defined as: - a woman who had her last natural menstruation ≥12 months prior to the screening Visit OR - a woman who was surgically sterlised (bilateral fallopian tubal ligation, bilateral salpingo-oophorectomy, or bilateral oophorectomy) or had hysterectomy prior to the screening visit - Bilateral fallopian tubal ligation is not considered a criterion for non clildbearing potential in GB OR - agree to avoid impregnating his partner, if the partner is considered to be of childbearing potential, from the Screening Visit until at least 5 months after the last dose of IMP by using contraception as specified below AND -not donate sperm from the Screening Visit until atleast 5 months after the last dose of IMP Contraception Methods to be used by Men and their partners who are woman of Childbearing Potential: - By the man: condom (to avoid the risk of drug exposure through the ejaculate [which also applies to a vasectomised male] to the sexual partner, including a pregnant partner) - By the woman of childbearing potential: contraception is recommended\n- The woman, if considered to be of childbearing potential* must: - remain sexually abstinent when this is in line with her preferred and usual lifestyle OR - engage exclusively in same-sex relationships OR - have a male partner who was surgically sterilised (bilateral surgical vasectomy or bilateral orchiectomy) prior to the Screening Visit OR - agree to avoid becoming pregnant from the Screening Visit until at least 5 months after the last dose of IMP by using a highly effective method of contraception as specified below AND - not donate ova from the Screening Visit until at least 5 months after the last dose of IMP Contraception Method: - Highly effective contraception is defined as one that results in a low failure rate (that is, - <1% per year) when used consistently and correctly, for example, combined (oestrogen- and progesterone-containing) hormonal contraception associated with inhibition of ovulation (oral, intra-vaginal, or transdermal), progesterone-only hormonal contraception associated with inhibition of ovulation (oral, injectable, implantable), intrauterine device, intrauterine hormone-releasing system. * The woman is considered to be of non-childbearing potential if she: - has not had her menses for ≥12 months without an alternative medical cause; if this needs to be confirmed, an FSH test can be used, unless the participant is taking hormonal replacement therapy or using hormonal contraception. OR - was surgically sterilised (bilateral fallopian tubal ligation, bilateral salpingo-oophorectomy, or bilateral oophorectomy) or had a hysterectomy prior to the Screening Visit - Bilateral fallopian tubal ligation is not considered a criterion for non-childbearing potential in GB.\n- The participant is able to read and understand the ICF.\n- The participant has signed the trial specific ICF.\n- The participant's caregiver is able to read and understand the Caregiver's Informed Consent Form.\n- The participant's caregiver has signed the Caregiver's Informed Consent Form.\n- The participant is ≥ 40 and lesser than/equal 75 years of age at the screening Visit.\n- The participant has a reliable caregiver who will be available throughout the trial to complete caregiver observer questionnaires when carer/ observer-reported outcomes are performed. A caregiver is defined as a person who spends approximately 3 hours or more with the participant per week and can inform on the participant's level of functioning.\n- The participant and participant's caregiver are willing and able to attend trial appointments within the specified time windows.\n- The participant has a diagnosis of clinically established MSA-P or MSA-C, or clinically probable MSA-P or MSA-C, according to the 2022 MDS criteria for diagnosis of MSA at the screening visit."}

Exclusion criteria

  • {"criterion_text":"- The participant is a member of the site staff or of their immediate families or is a subordinate (or immediate family member of a subordinate) to any of the site staff\n- The participant has evidence (clinically or on MRI) and/or history of any clinically significant disease or condition other than MSA, that is, in the investigator’s opinion, likely to affect CNS functioning, e.g., serious neurological disorder, other intracranial or systemic disease. Abnormalities (space-occupying lesions, vascular lesions, tumours, stroke, etc.) on MRI are to be discussed with the Lundbeck Medical Expert or the CRO Medical Monitor before the participant is enrolled\n- The participant has a current diagnosis of movement disorders that could mimic MSA, e.g., Parkinson’ disease, dementia with Lewy bodies, essential tremor, progressive supranuclear palsy, spinocerebellar ataxia, spastic paraparesis, corticobasal degeneration, or vascular, pharmacological, or post-encephalitic parkinsonism, per investigator discretion. Participants who have previously been incorrectly diagnosed with Parkinson’s disease will not be excluded\n- The participant has a history of neurosurgical procedures including deep brain stimulation that could, in the investigator’s opinion, interfere with the assessments of safety or efficacy.\n- The participant has a history of cancer, other than basal cell or Stage 1 squamous cell carcinoma of the skin or adequately treated cervical intraepithelial neoplasia, that has not been in remission for >5 years prior to the first dose of IMP\n- The participant has any other disorder for which the treatment takes priority over treatment of MSA or is likely to interfere with the trial treatment or impair treatment compliance.\n- The participant takes or has taken concomitant medication that is disallowed or allowed with restrictions (see Protocol), or it is anticipated that the participant will require treatment with at least one of these medications during the trial\n- The participant has an abnormal ECG that is considered clinically significant by the investigator at the Screening Visit, and that could, in the opinion of the investigator, interfere with the assessments of safety, or interfere with the conduct of the trial\n- The participant has one or more clinical laboratory test values outside the reference range, based on the blood and urine samples taken at the Screening Visit, or has a disease or takes medication that could, in the opinion of the investigator, interfere with the assessments of safety, or tolerability, or interfere with the conduct or interpretation of the trial.\n- The participant is at significant risk of suicide based on medical history, mental status, investigator judgement, or the C-SSRS (answer of ‘yes’ to suicidal ideation question 4 or 5 or any suicidal behaviour during the last 6 months prior to the Screening Visit)\n- The participant is, in the opinion of the investigator, unlikely to comply with the Clinical Trial Protocol or is unsuitable for any reason\n- The participant has previously been enrolled in this trial\n- The participant has previously been dosed with Lu AF82422\n- The participant has taken any active IMP within 3 months or 5 half-lives of that product, whichever is longer, prior to the first dose of IMP\n- The participant is pregnant, breastfeeding, intends to become pregnant, or is of childbearing potential and not willing to use adequate contraceptive methods.\n- The participant has a history of severe drug allergy, anaphylaxis or hypersensitivity or known or suspected hypersensitivity or intolerance to the IMP, or its excipients\n- The participant has 2 or more first degree relatives with a history of MSA\n- The participant, if of MSA-P subtype, has unexplained anosmia (not explained by other common causes such as allergic rhinitis or smoking, nasal structural lesions, or nasal surgery) on olfactory testing at the Screening Visit\n- The participant has contraindications for MRI scanning"}

Endpoints

Primary endpoints

  • {"endpoint_text":"- Please refer Protocol for information related to primary end points as considered company confidential information by the sponsor\n- Please refer Protocol for information related to primary end points as considered company confidential information by the sponsor","definition_or_measurement_approach":""}

Secondary endpoints

  • {"endpoint_text":"- Non-EU regional-specific : slowing in clinical progression, as assessed by changes from baseline up to Week 72 in UMSARS TS\n- Non-EU regional-specific : Change from baseline to Week 72 in UMSARS TS\n- EU regional-specific: Change from baseline to Week 72 in UMSARS TS\n- Global Endpoints: slowing in clinical progression, as assessed by changes from baseline up to Week 72 in UMSARS Part I score\n- Global Endpoints: slowing in clinical progression, as assessed by changes from baseline up to Week 72 in UMSARS Part II score\n- Global Endpoints: change from baseline to Week 72 in mUMSARS, UMSARS Part I and UMSARS Part II\n- Global Clinical Impression: Please refer to the protocol for relevant information as the sponsor considers this to be confidential company information\n- Global Clinical Impression: change from baseline to Week 72 in PGI-S score\n- Global Clinical Impression: change from baseline to Week 72 in OGI-S score\n- Global Disability: Please refer to the protocol for relevant information as the promoter considers this to be confidential company information\n- Functionality: change from baseline to Week 72 in SE-ADL score\n- Disease Milestones: change from baseline to Week 72 in UMSARS Part I item 1: Speech -  time-to-disability, as defined by the time it takes (from baseline) to reach a total of 2 points across 1 or more selected UMSARS Part I items (2. Swallowing; 4. Cutting; 5. Dressing; 6. Hygiene; 7. Walking) or death\n- Health-related Quality of Life: change from baseline to Week 72 in EQ-5D-5L domain and VAS scores\n- Health-related Quality of Life: change from baseline to Week 72 in MSA-QoL domain scores\n- Overall survival: combined clinical progression and survival: joint-rank score based on change from baseline in mUMSARS at Week 72 or time-to-death, whichever comes first\n- Overall survival: Please refer to the protocol for relevant information as the promoter considers this to be confidential company information\n- Clinical meaningfulness: response, defined as an absolute increase in mUMSARS score of <5, <7, and <9 points at Week 72\n- Clinical meaningfulness: response, defined as an absolute increase in UMSARS TS of <16, <21, and <26 points at Week 72\n- MRI biomarkers: percentage change from baseline to Week 72 in brain volume in brain ROIs; primary ROIs: pons and cerebellum; secondary ROIs: caudate nucleus, putamen, brain stem and total grey matter, as measured using vMRI\n- Pharmacokinetics: exposure to Lu AF82422 (expressed as plasma concentrations, AUC, and Cmax)\n- Safety placebo-controlled period: TEAEs (treatment-emergent adverse events)\n- Safety placebo-controlled period: actual values and changes from baseline and Week 72 to Week 144 in clinical safety laboratory test values, and vital signs\n- Safety placebo-controlled period: PCS clinical safety laboratory test values, vital signs, and weight changes\n- Safety placebo-controlled period: suicidal ideation and behaviour based on the C-SSRS\n- Safety OLE period: TEAEs (treatment-emergent adverse events)\n- Safety OLE period: actual values and changes from baseline and Week 72 to Week 144 in clinical safety laboratory test values, and vital signs\n- Safety OLE period: PCS clinical safety laboratory test values, and vital signs\n- Safety OLE period: suicidal ideation and behaviour based on the C-SSRS\n- Immunogenicity: development of anti-amlenetug antibodies (ADAs) and titration of ADA-positive samples during the placebo-controlled period and OLE","definition_or_measurement_approach":"Endpoints include UMSARS TS and parts I/II, mUMSARS changes from baseline to Week 72, PGI-S, OGI-S, SE-ADL, EQ-5D-5L, MSA-QoL, MRI volumetric measures (vMRI) in specified ROIs, pharmacokinetic measures (plasma concentrations, AUC, Cmax), TEAEs, clinical laboratory values and C-SSRS for suicidal ideation/behaviour; some endpoints refer to protocol for confidential details."}

Recruitment

Registry Or Advocacy Recruitment
True, K2_Advocacy_FP; K2_Advocacy FS_en_FP
Digital Remote Recruitment
True, methods include online postings, patient prescreener website materials, participant recruitment digital outreach documents and informational website materials (documents: K2_Online Posting, K2_Participant Recruitment Digital Outreach, K2_Patient Website_Prescreener, K2_Informational website).
Planned Sample Size
245
Recruitment Window Months
53
Consent Approach
Informed consent: participants must be able to read and understand and sign the trial-specific ICF ("The participant is able to read and understand the ICF."; "The participant has signed the trial specific ICF."). Caregiver consent: caregiver information and caregiver ICF required ("The participant's caregiver is able to read and understand the Caregiver's Informed Consent Form."; "The participant's caregiver has signed the Caregiver's Informed Consent Form."). Multiple ICF variants exist for OLE, biobanking, pregnant participant/partner and father of newborn. Consent documents available in multiple languages (English and language-specific ICFs and protocol synopses in Italian, Spanish, Polish, French, German as provided in the documents list).

Methods

  • Flyers, posters and brochures (site and patient-facing print materials) — multilingual (EN/IT/ES/PL/FR/DE) recruitment materials available (documents: K2_Flyer, K2_Poster, K2_Brochure and language-specific variants).
  • HCP outreach letters to healthcare professionals (K2_HCP Letter, country-specific HCP letters).
  • Online postings and digital outreach including Participant Recruitment Digital Outreach, Online Posting, Patient Website Prescreener, Informational website (K2_Online Posting, K2_Participant Recruitment Digital Outreach, K2_Informational website, K2_Patient Website_Prescreener).
  • Advocacy materials / fact sheets to patient advocacy groups (K2_Advocacy_FP, K2_Advocacy FS_en_FP).
  • Study visit guides and patient letters to support attendance (K2_Study Visit Guide, K2_Patient Letter).
  • Pre-screening via online prescreener (K2_Patient Website_Prescreener and Patient Website Prescreener documents).

Geography

Total Number Of Sites
34
Total Number Of Participants
140

France

Earliest CTIS Part Ii Submission Date
13-02-2025
Latest Decision Or Authorization Date
31-03-2026
Processing Time Days
411
Number Of Sites
8
Number Of Participants
30

Sites

Site Name
Centre Hospitalier Universitaire De Toulouse
Department Name
Neurology
Contact Person Name
Margherita Fabbri
Contact Person Email
fabbri.m@chu-toulouse.fr
Site Name
Centre Hospitalier Universitaire De Lille
Department Name
Department of Neurology and Movement Pathology
Contact Person Name
Caroline Moreau
Contact Person Email
caroline.moreau@chru-lille.fr
Site Name
Assistance Publique Hopitaux De Paris
Department Name
Neurology
Contact Person Name
David Grabli
Contact Person Email
david.grabli@aphp.fr
Site Name
Centre Hospitalier Universitaire De Montpellier
Department Name
Department of Neurology
Contact Person Name
Mahmoud Charif
Contact Person Email
m-charif@chu-montpellier.fr
Site Name
Centre Hospitalier Universitaire Grenoble Alpes
Department Name
Service de Neurologie
Contact Person Name
Elena Moro
Contact Person Email
emoro@chu-grenoble.fr
Site Name
Centre Hospitalier Universitaire De Rennes
Department Name
Department of Neurology
Contact Person Name
Sophie Drapier
Contact Person Email
sophie.drapier@chu-rennes.fr
Site Name
Centre Hospitalier Regional De Marseille
Department Name
Department of Neurology and Movement Pathology
Contact Person Name
Alexandre Eusebio
Contact Person Email
Alexandre.eusebio@ap-hm.fr
Site Name
Centre Hospitalier Universitaire De Bordeaux
Department Name
Department of Neurology for Neurodegenerative Diseases
Contact Person Name
Wassilios Meissner (NCI)

Italy

Earliest CTIS Part Ii Submission Date
13-02-2025
Latest Decision Or Authorization Date
17-03-2026
Processing Time Days
397
Number Of Sites
7
Number Of Participants
30

Sites

Site Name
Azienda Ospedaliera Universitaria San Giovanni Di Dio E Ruggi d'Aragona
Department Name
UOC program of “Experimental Neurology”
Contact Person Name
Maria Teresa Pellecchia
Contact Person Email
mpellecchia@unisa.it
Site Name
IRCCS Foundation Istituto Neurologico Carlo Besta
Department Name
Neurology Unit 1 (Parkinson and Movement Disorders)
Contact Person Name
Roberto Eleopra
Site Name
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Department Name
Neuroscienze, Organi di Senso e Torace
Contact Person Name
Anna Rita Bentivoglio
Site Name
Azienda Unita Sanitaria Locale Di Bologna
Department Name
IRCCS Istituto Delle Scienze Neurologiche LOC-100076813 Via Altura 3,40139 Bologna - Italy
Contact Person Name
Giovanna Calandra Buonaura
Contact Person Email
giovanna.calandra@unibo.it
Site Name
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico
Department Name
Neuroscienze e salute mentale
Contact Person Name
Alessio Barnaba Di Fonzo
Site Name
Azienda Ospedaliero Universitaria Pisana
Department Name
UO Neurologia
Contact Person Name
Roberto Ceravolo
Contact Person Email
roberto.ceravolo@unipi.it
Site Name
Azienda Ospedaliera Universita' Degli Studi Della Campania Luigi Vanvitelli
Department Name
I Clinica Neurologica e Neurofisiopatologia
Contact Person Name
Alessandro Tessitore

Spain

Earliest CTIS Part Ii Submission Date
27-02-2025
Latest Decision Or Authorization Date
20-03-2026
Processing Time Days
386
Number Of Sites
7
Number Of Participants
30

Sites

Site Name
University Hospital Virgen Del Rocio S.L.
Department Name
Neurology
Contact Person Name
Pablo Mir Rivera
Contact Person Email
pmir@us.es
Site Name
Hospital Clinic De Barcelona
Department Name
Neurology
Contact Person Name
Yaroslau Compta Hirnyj
Contact Person Email
ycompta@clinic.cat
Site Name
Hospital General Universitario De Elche
Department Name
Neurology
Contact Person Name
Eric Alejandro Freire Alvarez
Contact Person Email
dr.freyre@gmail.com
Site Name
Hospital Universitari Vall D Hebron
Department Name
Neurology
Contact Person Name
Jorge Hernandez Vara
Contact Person Email
jorge.hernandez@vallhebron.cat
Site Name
Hospital Universitario Y Politecnico La Fe
Department Name
Neurology
Contact Person Name
Irene Beatriz Martinez Torres
Contact Person Email
martinez_ire@gva.es
Site Name
Hospital De La Santa Creu I Sant Pau
Department Name
Neurology
Contact Person Name
Javier Pagonabarraga Mora
Contact Person Email
jpagonabarraga@santpau.cat
Site Name
Hospital Universitario De La Princesa
Department Name
Neurology
Contact Person Name
Lydia Lopez Manzanares
Contact Person Email
Lydia.lopez@salud.madrid.org

Germany

Earliest CTIS Part Ii Submission Date
28-02-2025
Latest Decision Or Authorization Date
19-03-2026
Processing Time Days
384
Number Of Sites
7
Number Of Participants
25

Sites

Site Name
Universitaetsklinikum Erlangen AöR
Department Name
Movement Disorders Outpatient Center, Department of Molecular Neuorolgy
Contact Person Name
Martin Regensburger
Site Name
curiositas ad sanum Studien und Beratungs GmbH
Contact Person Name
Johannes Schwarz
Contact Person Email
info@curiositas-ad-sanum.de
Site Name
Kliniken Beelitz GmbH
Department Name
Neurologisches Fachkrankenhaus für Bewegunsstoerungen / Parkinson
Contact Person Name
Doreen Gruber
Contact Person Email
gruber@kliniken-beelitz.de
Site Name
Universitaetsklinikum Duesseldorf AöR
Department Name
Centre for Movement Disorders and Neuromodulation
Contact Person Name
Alfons Schnitzler
Contact Person Email
alfons.schnitzler@hhu.de
Site Name
Klinikum der Universitaet Muenchen AöR
Department Name
Dept. of Neurology
Contact Person Name
Guenter Hoeglinger
Site Name
Universitaetsklinikum Tuebingen AöR
Department Name
Neurologische Ambulanz
Contact Person Name
Benjamin Roeben
Site Name
Universitaet Muenster
Department Name
Department of Neurology with Institute of Translational Neurology
Contact Person Name
Inga Claus
Contact Person Email
inga.claus@ukmuenster.de

Poland

Earliest CTIS Part Ii Submission Date
05-03-2025
Latest Decision Or Authorization Date
23-03-2026
Processing Time Days
383
Number Of Sites
5
Number Of Participants
25

Sites

Site Name
Neuro-Care Sp. z o.o. sp.k.
Department Name
not applicable/nie dotyczy
Contact Person Name
Gabriela Kłodowska
Contact Person Email
neuro-care@neuro-care.pl
Site Name
Neurologia Śląska Centrum Medyczne
Department Name
not applicable/nie dotyczy
Contact Person Name
Marek Śmiłowski
Site Name
Centrum Medyczne Neuromed Sp. z o.o.
Department Name
not applicable/nie dotyczy
Contact Person Name
Paweł Lisewski
Contact Person Email
lisewski.p@gmail.com
Site Name
Instytut Zdrowia Dr Boczarska-Jedynak Sp. z o.o. S.K.
Department Name
not applicable/nie dotyczy
Contact Person Name
Magdalena Boczarska-Jedynak
Contact Person Email
info@instytutboczarska.pl
Site Name
Niepubliczny Zaklad Opieki Zdrowotnej Neuromed M. I M. Nastaj. sp.p.
Department Name
not applicable/nie dotyczy
Contact Person Name
Marcin Nastaj
Contact Person Email
marcinnastaj@gmail.com

Sponsor

Primary sponsor

Full Name
H. Lundbeck A/S
Organisation Type
Pharmaceutical company
Country Of Registered Address
Denmark

Contract research organisations

Name
Icon Clinical Research Limited
Responsibilities
sponsorDuties codes: [1,12,13,14,2,3,4,5,6,8]
Name
Pharma Bio-Research Group
Responsibilities
sponsorDuties codes: [4]
Name
Almac Group Limited
Responsibilities
sponsorDuties codes: [14]
Name
WCG Clinical Inc.
Responsibilities
sponsorDuties codes: [7]

Third parties

  • {"country":"United Kingdom (Northern Ireland)","full_name":"Almac Group Limited","duties_or_roles":"sponsorDuties codes: [14]","organisation_type":"Pharmaceutical company"}
  • {"country":"Netherlands","full_name":"Pharma Bio-Research Group","duties_or_roles":"sponsorDuties codes: [4]","organisation_type":"Pharmaceutical company"}
  • {"country":"Ireland","full_name":"Icon Clinical Research Limited","duties_or_roles":"sponsorDuties codes: [1,12,13,14,2,3,4,5,6,8]","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Amprion Inc.","duties_or_roles":"sponsorDuties codes: [4]","organisation_type":"Laboratory/Research/Testing facility"}
  • {"country":"United States","full_name":"WCG Clinical Inc.","duties_or_roles":"sponsorDuties codes: [7]","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Azenta US Inc.","duties_or_roles":"sponsorDuties codes: [15] (Biobanking)","organisation_type":"Pharmaceutical company"}
  • {"country":"United Kingdom","full_name":"Ixico Technologies Limited","duties_or_roles":"sponsorDuties codes: [15] (Medical Imaging)","organisation_type":"Pharmaceutical company"}
  • {"country":"United Kingdom","full_name":"Medidata Solutions International Limited","duties_or_roles":"sponsorDuties codes: [7]","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Swarn Inc.","duties_or_roles":"sponsorDuties codes: [6]","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"United Kingdom","full_name":"Medical Equipment Supplies And Management Limited","duties_or_roles":"sponsorDuties codes: [15] (Ancilliary Supplies vendor)","organisation_type":"Pharmaceutical company"}

Investigational products

Investigational Product Name
Amlenetug 53 mg/ml solution for infusion
Active Substance
AMLENETUG
Modality
Monoclonal antibody
Routes Of Administration
INTRAVENOUS USE
Route
Intravenous
Orphan Designation
Yes
Frequency
Every 4 weeks ± 3 days

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