Clinical trial • Phase II • Gastroenterology

AMLITELIMAB for Coeliac disease | Non-responsive celiac disease

Phase II trial of AMLITELIMAB for Coeliac disease | Non-responsive celiac disease.

Overview

Trial Therapeutic Area
Gastroenterology
Trial Disease
Coeliac disease | Non-responsive celiac disease
Trial Stage
Phase II
Drug Modality
Monoclonal antibody

Key dates

Initial CTIS Submission Date
13-05-2024
First CTIS Authorization Date
02-09-2024

Trial design

Randomised, placebo (amlitelimab matching placebo to test product); dose and schedule not specified in provided documents.-controlled Phase II trial in Greece, Belgium, Italy and others.

Randomised
Yes
Comparator
Placebo (Amlitelimab matching placebo to test product); dose and schedule not specified in provided documents.
Target Sample Size
442
Trial Duration For Participant
196

Eligibility

Recruits 442 adults.

Inclusion criteria

  • {"criterion_text":"- Participants must be 18 to 75 years of age inclusive, at the time of signing the informed consent.\n- Participants with physician-diagnosed celiac disease with documented history of biopsy-proven celiac disease confirmed by medical records or physician statement.\n- Participants who have self-reported attempt to maintain a GFD (and confirmed via questionnaire) for at least 12 consecutive months and must be willing to maintain their current diet for the duration of study participation.\n- Participants have an adequate comprehension of a GFD as assessed by the Investigator.\n- Participants willing to undergo all assessments in the protocol, including 2 esophagogastroduodenoscopies with duodenal biopsies.\n- Participants who completed CDSD with ≥ 75% compliance from screening until randomization.\n- During screening, participants must have at least one gastrointestinal symptom (i.e., diarrhea, abdominal pain, bloating, or nausea) of moderate or greater severity, as measured by the CDSD Gastrointestinal Domain, on at least 3 days out of any consecutive 7-day period considered by the investigator to be related to gluten exposure (i.e., due to celiac disease). The symptom can vary, but severity must be moderate or greater on three or more days. Participants must meet symptom criteria to undergo baseline esophagogastroduodenoscopy (EGD)."}

Exclusion criteria

  • {"criterion_text":"- A diagnosis of any severe complication of celiac disease, such as refractory celiac disease type 1 (RCD I) requiring immune suppressive medication, or type 2 (RCD II), enteropathy associated T-cell lymphoma (EATL), ulcerative jejunitis, or recent (within 12 months of screening) GI perforation.\n- Presence of other active inflammatory GI disorders, including but not limited to the following: inflammatory bowel disease, eosinophilic esophagitis, diverticulitis, helicobacter infection, gastroenteritis or colitis, and microscopic colitis (requiring treatment) in the 6 months before screening. A history of treated erosive esophagitis is not an exclusion. Abnormalities found during baseline EGD or biopsy that are consistent with an inflammatory GI disorder other than celiac disease are exclusionary.\n- Presence of other systemic autoimmune diseases including scleroderma, psoriatic or rheumatoid arthritis, and lupus. Participants with thyroid disease that has been well-controlled for at least 6 months, prior to screening, and participants with well-controlled type 1 diabetes (glycosylated hemoglobin < 9 % and no hospitalization or emergency room visit in the last 12 months for hyperglycemia or hypoglycemia) can be included per investigator judgement.\n- Known or suspected severe enteric infection (viral, bacterial, or parasitic) within 6 months before screening. Severe enteric infection is defined as requiring a visit to the emergency room, hospitalization, or treatment with antibiotics or anti-infectives due to infection. Non-enteric viral infections, either resolved or well-controlled are not exclusionary.\n- Any active or chronic infection including helminthic infection requiring systemic treatment within 4 weeks prior to screening (1 week in the event of superficial skin infections).\n- Known history of or suspected significant current immunosuppression or hyposplenism, including history of invasive opportunistic or invasive helminthic infections despite infection resolution or otherwise recurrent infections of abnormal frequency or prolonged duration.\n- Any malignancies or history of malignancies prior to enrollment (except for non-melanoma skin cancer that has been excised and completely cured for more than 5 years prior to enrollment).\n- History of solid organ or stem cell transplant.\n- Ongoing use, or use in the 3 months before screening, of medications known to cause villus abnormalities (eg, mycophenolate mofetil, azathioprine, methotrexate, olmesartan (other angiotensin receptor blockers are allowed), CTLA4 inhibitors, and PD-1/PD-L1 inhibitors).\n- Ongoing chronic use of non-steroidal anti-inflammatory drugs (NSAIDs) of more than 2 doses per week, except acetylsalicylic acid/aspirin ≤100 mg daily for prophylactic use.\n- Any ongoing treatment with systemic immunosuppressants, systemic corticosteroids, or use of oral budesonide in the 12 weeks before screening.\n- Ongoing use of over-the-counter digestive enzymes or supplements, other than lactase, including those for gluten digestion and oral pharmaceutical probiotic supplements. Probiotics in foods (e.g., yogurt) are permitted.\n- Concurrent participation in any other clinical study, including non-interventional studies.\n- Prior administration of investigational agents to treat celiac disease within 5 half-lives of any agent, or one year from any tolerogenic agent."}

Endpoints

Primary endpoints

  • {"endpoint_text":"- Change in Villus Height to Crypt Depth Ratio (Vh:Cd) from baseline to Week 28","definition_or_measurement_approach":"Measured as change in Villus Height to Crypt Depth Ratio (Vh:Cd) from baseline to Week 28 on duodenal biopsies (histological assessment)."}

Secondary endpoints

  • {"endpoint_text":"- Change in Celiac Disease Symptom Diary (CDSD) Gastrointestinal (GI) symptom severity score","definition_or_measurement_approach":"Measured by change in the CDSD GI symptom severity score recorded by participants (CDSD) between baseline and follow-up timepoints."}
  • {"endpoint_text":"- Percentage of participants who experienced treatment-emergent adverse events (TEAEs), including serious adverse events (SAEs) and adverse events of special interest (AESI) during the placebo-controlled treatment period and the long-term extension","definition_or_measurement_approach":"Proportion of participants with TEAEs, SAEs and AESIs recorded during the placebo-controlled period and long-term extension (safety reporting)."}
  • {"endpoint_text":"- Percentage of participants with potentially clinically significant abnormalities (PCSA) for vital signs and clinical laboratory assessments during the placebo-controlled treatment period and the long-term extension","definition_or_measurement_approach":"Proportion of participants with PCSA based on predefined thresholds in vital signs and laboratory assessments during treatment and extension."}
  • {"endpoint_text":"- Percentage of participants discontinued from study treatment due to TEAEs during the placebo-controlled treatment period and the long-term extension","definition_or_measurement_approach":"Proportion of participants who discontinued study treatment because of TEAEs during the placebo-controlled period and long-term extension."}
  • {"endpoint_text":"- Serum amlitelimab concentrations measured at prespecified timepoints","definition_or_measurement_approach":"Pharmacokinetic measurements of serum amlitelimab concentrations at prespecified sampling timepoints."}
  • {"endpoint_text":"- Incidence of anti-drug antibodies (ADAs) of amlitelimab","definition_or_measurement_approach":"Immunogenicity assessment: incidence of anti-drug antibodies detected by validated ADA assays."}

Recruitment

Digital Remote Recruitment
True, recruitment materials include digital marketing, social media graphics, web landing pages, online banners and other web/online trial-awareness assets (multiple localized versions).
Planned Sample Size
442
Recruitment Window Months
55
Consent Approach
Informed consent obtained from adult participants (participants must be 18–75 years). Subject information and informed consent forms (ICFs) and related documents are provided in multiple languages; available ICF/local materials include English, French, Dutch, Italian, Polish, Finnish, Czech, Spanish, German, Swedish, Slovak and Greek. Optional/partner/pregnancy and optional consent modules (e.g., optional DNA/RNA, optional gluten-challenge, partner/pregnancy information) are provided as separate documents.

Methods

  • Site-level printed materials: flyers, posters, postcards and study brochures (multiple language localisations) aimed at patients with non-responsive celiac disease.
  • HCP referral letters to engage healthcare professionals and gastroenterology clinics to refer eligible patients.
  • Participant letters and study brochures distributed via sites to potential participants.
  • Digital recruitment and awareness: digital marketing materials, trial-awareness web graphics, leaderboard banners, social media graphics, and web landing pages (country/local language versions).
  • Trust-builder sheets and informational materials to increase trial awareness and trust among patients.
  • Site-specific recruitment materials and advertisements (including social media adverts and print ads) tailored per country/language.

Geography

Total Number Of Sites
45
Total Number Of Participants
374

Greece

Earliest CTIS Part Ii Submission Date
28-05-2024
Latest Decision Or Authorization Date
17-04-2026
Processing Time Days
689
Number Of Sites
2
Number Of Participants
7

Sites

Site Name
Evangelismos S.A.
Department Name
Gastroenterology Department
Contact Person Name
Nikolaos Viazis
Contact Person Email
nikos.viazis@gmail.com
Site Name
Thoracic General Hospital Of Athens I Sotiria
Department Name
GI Unit, 3rd Academic dept. of Internal Medicine
Contact Person Name
Georgios Bamias
Contact Person Email
gbamias@med.uoa.gr

Belgium

Earliest CTIS Part Ii Submission Date
05-08-2024
Latest Decision Or Authorization Date
20-04-2026
Processing Time Days
623
Number Of Sites
2
Number Of Participants
20

Sites

Site Name
Cliniques Universitaires Saint-Luc
Department Name
Hépato-gastroentérologie
Contact Person Name
Pierre Deprez
Contact Person Email
pdeprez@saintluc.uclouvain.be
Site Name
UZ Leuven
Department Name
Campus Gasthuisberg Maag-, darm- en leverziekten
Contact Person Name
Lucas Wauters
Contact Person Email
lucas.wauters@uzleuven.be

Italy

Earliest CTIS Part Ii Submission Date
12-08-2024
Latest Decision Or Authorization Date
20-04-2026
Processing Time Days
616
Number Of Sites
3
Number Of Participants
10

Sites

Site Name
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico
Department Name
Unità di Gastroenterologia ed Endoscopia
Contact Person Name
Luca Elli
Contact Person Email
luca.elli@policlinico.mi.it
Site Name
Azienda Ospedaliera di Padova
Department Name
Department of Surgery, Oncology and Gastroenterology,
Contact Person Name
Fabiana Zingone
Contact Person Email
fabiana.zingone@unipd.it
Site Name
Azienda Ospedaliero Universitaria Pisana
Department Name
UO Gastroenterologia
Contact Person Name
Maria Gloria Mumolo
Contact Person Email
g.mumolo@int.med.unipi.it

Poland

Earliest CTIS Part Ii Submission Date
19-08-2024
Latest Decision Or Authorization Date
21-04-2026
Processing Time Days
610
Number Of Sites
4
Number Of Participants
55

Sites

Site Name
Panstwowy Instytut Medyczny Ministerstwa Spraw Wewnetrznych I Administracji
Department Name
Klinika Gastroenterologii i Chorób Wewnętrznych
Contact Person Name
Grazyna Rydzewska - Wyszkowska
Site Name
Solumed Sp. z o.o. sp.k.
Contact Person Name
Magdalena Andrzejewska
Contact Person Email
office@solumed.pl
Site Name
Futuremeds Sp. z o.o.
Contact Person Name
Szymon Wieczorek
Site Name
Krakowskie Centrum Medyczne Sp. z o.o.
Contact Person Name
Przemyslaw Borowy

Finland

Earliest CTIS Part Ii Submission Date
13-08-2024
Latest Decision Or Authorization Date
17-04-2026
Processing Time Days
612
Number Of Sites
4
Number Of Participants
48

Sites

Site Name
Pirkanmaan hyvinvointialue
Department Name
TAYS tutkimuspalvelut
Contact Person Name
Juha Taavela
Contact Person Email
juha.taavela@tuni.fi
Site Name
Clinical Research Services Turku CRST Oy
Contact Person Name
Max Kiugel
Contact Person Email
max.kiugel@crst.fi
Site Name
Pihlajalinna Laeaekaerikeskukset Oy
Contact Person Name
Oskari Korhonen
Site Name
CRST Helsinki Oy
Contact Person Name
Zsofia Lovro
Contact Person Email
zsofia.lovro@crst.fi

Czechia

Earliest CTIS Part Ii Submission Date
13-08-2024
Latest Decision Or Authorization Date
20-04-2026
Processing Time Days
615
Number Of Sites
5
Number Of Participants
63

Sites

Site Name
Endohope Havirov s.r.o.
Contact Person Name
Evzen Machytka
Contact Person Email
machytka@endohope.cz
Site Name
Nemocnice Milosrdnych Sester Sv. Karla Boromejskeho V Praze
Department Name
Interni oddeleni
Contact Person Name
Robert Mudr
Contact Person Email
robertmudr@seznam.cz
Site Name
Vojenska Nemocnice Brno
Department Name
Interni oddeleni
Contact Person Name
David Stepek
Contact Person Email
DStepek@vnbrno.cz
Site Name
GASTRO JeKa s.r.o.
Contact Person Name
Ondrej Jelinek
Contact Person Email
ondra.jelinek@cmail.cz
Site Name
Univerzita Karlova 2 Lekarska Fakulta
Department Name
Interni oddeleni
Contact Person Name
Iva Hoffmanova
Contact Person Email
iva.hoffmanova@fnmotol.cz

Spain

Earliest CTIS Part Ii Submission Date
27-08-2024
Latest Decision Or Authorization Date
20-04-2026
Processing Time Days
601
Number Of Sites
9
Number Of Participants
70

Sites

Site Name
Futuremeds Spain S.L. (Madrid)
Department Name
Medicina Interna
Contact Person Name
Ana Maria Moreno Collado
Contact Person Email
emag@futuremeds.com
Site Name
Futuremeds Spain S.L. (Chiclana De La Frontera)
Department Name
Medicina Interna
Contact Person Name
Ana Maria Moreno Collado
Contact Person Email
emag@futuremeds.com
Site Name
Hospital Universitario Virgen De La Victoria
Department Name
Aparato Digestivo
Contact Person Name
Raul-Jesus Andrade-Bellido
Contact Person Email
andrade@uma.es
Site Name
Futuremeds Spain S.L. (Sevilla)
Contact Person Name
Ana Maria Moreno Collado
Contact Person Email
emag@futuremeds.com
Site Name
Futuremeds Spain S.L. (Sevilla - alternate)
Department Name
Medicina Interna
Contact Person Name
Ana Maria Moreno Collado
Contact Person Email
emag@futuremeds.com
Site Name
Hospital Universitari Vall D Hebron
Department Name
Aparato Digestivo
Contact Person Name
Beatriz Lobo
Contact Person Email
beatriz.lobo@vallhebron.cat
Site Name
El Hospital Universitario De Gran Canaria Dr. Negrin
Department Name
Servicio de Aparato Digestivo
Contact Person Name
Daniel Sebastian Ceballos Santos
Contact Person Email
dcebsan@gobiernodecanarias.org
Site Name
Hospital Universitario Ramon Y Cajal
Department Name
Aparato Digestivo
Contact Person Name
Laura Crespo Perez
Contact Person Email
lcreper@yahoo.es
Site Name
University Hospital Virgen Del Rocio S.L.
Department Name
Aparato Digestivo
Contact Person Name
Angeles Pizarro
Contact Person Email
apizarromo@gmail.com

Germany

Earliest CTIS Part Ii Submission Date
26-08-2024
Latest Decision Or Authorization Date
20-04-2026
Processing Time Days
602
Number Of Sites
5
Number Of Participants
17

Sites

Site Name
Charite Universitaetsmedizin Berlin KöR
Department Name
Medizinische Klinik fur Gastroenterologie, Infektiologie und Rheumatologie
Contact Person Name
Michael Schumann
Contact Person Email
michael.schumann@charite.de
Site Name
Klinische Forschung Berlin-Mitte GmbH
Contact Person Name
Hartmut Tischner
Contact Person Email
hartmut.tischner@pratia.com
Site Name
Studiengesellschaft BSF UG (haftungsbeschraenkt)
Department Name
Gastroenterology
Contact Person Name
Lars Fechner
Contact Person Email
Lars.Fechner@sigal-sms.de
Site Name
Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz KöR
Department Name
Institut für Translationale Immunolgie
Contact Person Name
Detlef Schuppan
Site Name
Universitaetsklinikum Leipzig AöR
Department Name
Klinik und Poliklinik für Onkologie, Gastroentreologie, Hepatologie und Pneumologie
Contact Person Name
Charlotte Ackmann

France

Earliest CTIS Part Ii Submission Date
28-05-2024
Latest Decision Or Authorization Date
17-04-2026
Processing Time Days
689
Number Of Sites
2
Number Of Participants
17

Sites

Site Name
Assistance Publique Hopitaux De Paris
Department Name
Hepato-gastroenterologie et Endoscopies Digestives
Contact Person Name
Christophe Cellier
Contact Person Email
christophe.cellier@aphp.fr
Site Name
Centre Hospitalier Universitaire De Nice
Department Name
Unite de Recherche Clinique Gastroenterologie et Nutrition Clinique
Contact Person Name
Stephane Schneider
Contact Person Email
schneider.s@chu-nice.fr

Sweden

Earliest CTIS Part Ii Submission Date
07-08-2024
Latest Decision Or Authorization Date
17-04-2026
Processing Time Days
618
Number Of Sites
4
Number Of Participants
36

Sites

Site Name
CTC Clinical Trial Consultants AB (Linkoping)
Contact Person Name
Per Hellstrom
Contact Person Email
per.hellstrom@ctc-ab.se
Site Name
CTC Clinical Trial Consultants AB (Uppsala)
Contact Person Name
Per Hellstrom
Contact Person Email
per.hellstrom@ctc-ab.se
Site Name
CTC Clinical Trial Consultants AB (Moelndal)
Contact Person Name
Per Hellstrom
Contact Person Email
per.hellstrom@ctc-ab.se
Site Name
Ersta Sjukhus-Ersta Hospital
Department Name
Medicinkliniken, Gastromedicin FoU-enhet
Contact Person Name
Hetzel Olenia Diaz Tartera

Netherlands

Earliest CTIS Part Ii Submission Date
13-08-2024
Latest Decision Or Authorization Date
21-04-2026
Processing Time Days
616
Number Of Sites
2
Number Of Participants
11

Sites

Site Name
Stichting Amsterdam UMC
Department Name
stomach liver intestine department
Contact Person Name
Gerhard Bouma
Contact Person Email
g.bouma@amsterdamumc.nl
Site Name
Rijnstate Ziekenhuis Stichting
Department Name
stomach liver intestine department
Contact Person Name
Jordy Burger
Contact Person Email
jburger@rijnstate.nl

Slovakia

Earliest CTIS Part Ii Submission Date
16-08-2024
Latest Decision Or Authorization Date
17-04-2026
Processing Time Days
609
Number Of Sites
3
Number Of Participants
20

Sites

Site Name
Fakultna Nemocnica Nitra
Department Name
Interna klinika
Contact Person Name
Juraj Duris
Contact Person Email
duris.juraj@gmail.com
Site Name
Endomed s.r.o.
Department Name
Gastroenterologicka ambulancia a IBD centrum
Contact Person Name
Miroslav Fedurco
Contact Person Email
fedurco@endomed.sk
Site Name
Accout Center s.r.o.
Contact Person Name
Frantisek Horvath
Contact Person Email
fhorvath.studie@gmail.com

Sponsor

Primary sponsor

Full Name
Sanofi-Aventis Recherche & Developpement
Organisation Type
Pharmaceutical company
Country Of Registered Address
France

Contract research organisations

Name
Endpoint Clinical Inc.
Responsibilities
sponsorDuties code 3; listed as third party contact (email: etroll@endpointclinical.com)
Name
PPD Development LP
Responsibilities
sponsorDuties code 4; listed as third party contact (email: TamaraR.Jones@ppd.com)
Name
Bioclinica Inc.
Responsibilities
sponsorDuties code 7; listed as third party contact (email: Paul.Alouani@Clario.Com)
Name
Medidata Solutions Inc.
Responsibilities
sponsorDuties code 7; data/electronic data services (email: Elise.BROSSAUD@3ds.com)
Name
Fisher Clinical Services UK Limited
Responsibilities
sponsorDuties code 14; listed as third party (email: dennis.kadel@thermofisher.com)
Name
Clinigma ApS
Responsibilities
sponsorDuties code 7; listed as third party (email: jhk@clinigma.com)

Third parties

  • {"country":"United Kingdom","full_name":"ESMS Global Limited","duties_or_roles":"Centralized 24-Hour Emergency System: eSMS (sponsorDuties code 15)","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Endpoint Clinical Inc.","duties_or_roles":"sponsorDuties code 3","organisation_type":"Pharmaceutical company"}
  • {"country":"Finland","full_name":"Oriola Finland Oy","duties_or_roles":"sponsorDuties code 14","organisation_type":"Pharmaceutical company"}
  • {"country":"Poland","full_name":"Centrala Farmaceutyczna Cefarm S.A.","duties_or_roles":"sponsorDuties code 14","organisation_type":"Pharmaceutical company"}
  • {"country":"Germany","full_name":"Precision for Medicine GmbH","duties_or_roles":"sponsorDuties code 4","organisation_type":"Laboratory/Research/Testing facility"}
  • {"country":"United States","full_name":"Azenta US Inc.","duties_or_roles":"sponsorDuties code 4","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Medidata Solutions Inc.","duties_or_roles":"sponsorDuties code 7","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"France","full_name":"Quipment","duties_or_roles":"sponsorDuties code 14","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"Czechia","full_name":"PHOENIX lekarensky velkoobchod s.r.o.","duties_or_roles":"sponsorDuties code 14","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Bioclinica Inc.","duties_or_roles":"sponsorDuties code 7","organisation_type":"Laboratory/Research/Testing facility"}
  • {"country":"United States","full_name":"PPD Development LP","duties_or_roles":"sponsorDuties code 4","organisation_type":"Pharmaceutical company"}
  • {"country":"Italy","full_name":"Depo-pack S.r.l.","duties_or_roles":"sponsorDuties code 14","organisation_type":"Pharmaceutical company"}
  • {"country":"Denmark","full_name":"Clinigma ApS","duties_or_roles":"sponsorDuties code 7","organisation_type":"Pharmaceutical company"}
  • {"country":"Greece","full_name":"Bioiatriki Private Medical Polyclinic S.A.","duties_or_roles":"sponsorDuties code 4","organisation_type":"Hospital/Clinic/Other health care facility"}
  • {"country":"France","full_name":"Marken","duties_or_roles":"sponsorDuties code 14","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Rules Based Medicine Inc.","duties_or_roles":"sponsorDuties code 4","organisation_type":"Laboratory/Research/Testing facility"}
  • {"country":"Spain","full_name":"Alcura Health Espana S.A.","duties_or_roles":"sponsorDuties code 14","organisation_type":"Pharmaceutical company"}
  • {"country":"Spain","full_name":"Biomedal S.L.","duties_or_roles":"sponsorDuties code 4","organisation_type":"Pharmaceutical company"}
  • {"country":"Finland","full_name":"Jilab Oy","duties_or_roles":"sponsorDuties code 4","organisation_type":"Laboratory/Research/Testing facility"}
  • {"country":"France","full_name":"Inato","duties_or_roles":"sponsorDuties code 2","organisation_type":"Pharmaceutical company"}
  • {"country":"United Kingdom","full_name":"Fisher Clinical Services UK Limited","duties_or_roles":"sponsorDuties code 14","organisation_type":"Pharmaceutical company"}
  • {"country":"Germany","full_name":"MARKEN Germany GmbH","duties_or_roles":"sponsorDuties code 14","organisation_type":"Pharmaceutical company"}
  • {"country":"France","full_name":"Firalis","duties_or_roles":"sponsorDuties code 4","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Labcorp Central Laboratory Services LP","duties_or_roles":"sponsorDuties code 4","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Azenta US Inc. (additional address)","duties_or_roles":"sponsorDuties code 4","organisation_type":"Pharmaceutical company"}
  • {"country":"Spain","full_name":"Alcura Health Espana S.A. (additional address)","duties_or_roles":"sponsorDuties code 14","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Bioclinica Inc. (additional address)","duties_or_roles":"sponsorDuties code 7","organisation_type":"Laboratory/Research/Testing facility"}

Investigational products

Investigational Product Name
Amlitelimab
Active Substance
AMLITELIMAB
Modality
Monoclonal antibody
Routes Of Administration
SUBCUTANEOUS INJECTION
Route
SUBCUTANEOUS INJECTION
Authorisation Status
Authorised
Maximum Dose
Max daily dose 500 mg; max total dose 8500 mg
Investigational Product Name
Amlitelimab matching placebo to test product
Modality
Other

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