A Phase 2a/b Study of the Efficacy and Safety of Subcutaneous Amlitelimab in Adults With Nonresponsive Celiac Disease

PHASE2RecruitingINTERVENTIONAL
Enrollment

204

Participants

Timeline

Start Date

August 29, 2024

Primary Completion Date

August 4, 2026

Study Completion Date

April 10, 2029

Conditions
Coeliac DiseaseCeliac Disease
Interventions
DRUG

Amlitelimab

Pharmaceutical form: Injection solution Route of administration: SC injection

DRUG

Placebo

Pharmaceutical form: Injection solution Route of administration: SC injection

DIETARY_SUPPLEMENT

SIGE

Pharmaceutical form: Capsule Route of administration: Oral

DIETARY_SUPPLEMENT

Gluten-free product (GFP)

Pharmaceutical form: Capsule Route of administration: Oral

Trial Locations (111)

1006

RECRUITING

Investigational Site Number : 0320007, Buenos Aires

1128

RECRUITING

Investigational Site Number : 0320001, Buenos Aires

1200

RECRUITING

Investigational Site Number : 0560002, Brussels

1878

RECRUITING

Investigational Site Number : 0320010, Quilmes

2000

RECRUITING

Investigational Site Number : 0320005, Rosario

2560

RECRUITING

Investigational Site Number : 0360002, Sydney

3000

RECRUITING

Investigational Site Number : 0560001, Leuven

3128

ACTIVE_NOT_RECRUITING

Investigational Site Number : 0360005, Melbourne

4000

RECRUITING

Investigational Site Number : 0320002, San Miguel de Tucumán

4558

RECRUITING

Investigational Site Number : 0320012, Maroochydore

4740

RECRUITING

Investigational Site Number : 0360001, Mackay

5000

RECRUITING

Investigational Site Number : 0320003, Córdoba

11139

RECRUITING

Investigational Site Number : 7240009, Chiclana de la Frontera

12203

RECRUITING

Investigational Site Number : 2760004, Berlin

20520

RECRUITING

Investigational Site Number : 2460001, Turku

23220

RECRUITING

Clinical Research Partners - Richmond - Forest Avenue- Site Number : 8400011, Richmond

27310

RECRUITING

Investigational Site Number : 7920003, Gaziantep

27612

RECRUITING

M3-Emerging Medical Research- Site Number : 8400008, Raleigh

28003

RECRUITING

Investigational Site Number : 7240007, Madrid

28034

RECRUITING

Investigational Site Number : 7240003, Madrid

28211

RECRUITING

Ospedale Maggiore Policlinico Milano-Site Number : 3800002, Charlotte

29010

RECRUITING

Investigational Site Number : 7240004, Málaga

31792

RECRUITING

Archbold Memorial Hospital- Site Number : 8400044, Thomasville

33016

RECRUITING

Wellness Clinical Research - Miami Lakes - 8181 Northwest 154th Street- Site Number : 8400040, Miami Lakes

33070

RECRUITING

Investigational Site Number : 7920001, Mersin

33076

RECRUITING

Centre Hospitalier Universitaire de Bordeaux - Hopital Pellegrin Tripode- Site Number : 8400006, Bordeaux

33520

RECRUITING

Investigational Site Number : 2460003, Tampere

33609

RECRUITING

GCP Clinical Research- Site Number : 8400007, Tampa

34102

RECRUITING

GI Pros- Site Number : 8400034, Naples

34899

RECRUITING

Investigational Site Number : 7920006, Istanbul

35128

RECRUITING

Azienda Ospedaliera di Padova-Site Number : 3800004, Padua

37211

RECRUITING

Quality Medical Research- Site Number : 8400018, Nashville

37421

RECRUITING

ClinSearch - Chattanooga - Shallowford Road- Site Number : 8400012, Chattanooga

41012

RECRUITING

Investigational Site Number : 7240008, Seville

41013

RECRUITING

Investigational Site Number : 7240002, Seville

45519

RECRUITING

Gastroenterology Associates of Western Michigan, P.L.C.- Site Number : 8400004, Wyoming

55131

RECRUITING

Investigational Site Number : 2760002, Mainz

55905

RECRUITING

Mayo Clinic Hospital Rochester- Site Number : 8400049, Rochester

56126

RECRUITING

Ospedale di Cisanello-Site Number : 3800003, Pisa

63110

RECRUITING

Washington University- Site Number : 8400025, St Louis

63290

RECRUITING

Investigational Site Number : 7920005, Sanliurfa

67000

RECRUITING

Investigational Site Number : 7920002, Zonguldak

67502

RECRUITING

Hutchinson Clinic- Site Number : 8400020, Hutchinson

70210

RECRUITING

Investigational Site Number : 0320009, Kuopio

75015

RECRUITING

Investigational Site Number : 2500001, Paris

77090

RECRUITING

MedCare Pharma - Houston - Cypress Creek Parkway- Site Number : 8400016, Houston

77375

RECRUITING

DM Clinical Research - Tomball- Site Number : 8400042, Tomball

77584

RECRUITING

LinQ Research, LLC- Site Number : 8400028, Pearland

78613

RECRUITING

Advanced Research Institute- Site Number : 8400030, Cedar Park

80218

RECRUITING

Advanced Research Institute - Denver- Site Number : 8400048, Denver

84088

RECRUITING

Velocity Clinical Research - Salt Lake City- Site Number : 8400023, West Jordan

84092

RECRUITING

Advanced Research Institute - Sandy- Site Number : 8400046, Sandy City

89511

RECRUITING

Advanced Research Institute- Site Number : 8400036, Reno

90720

RECRUITING

United Gastroenterologists - Los Alamitos- Site Number : 8400014, Los Alamitos

91006

RECRUITING

FOMAT Medical Research - inSite Digestive Health Care - Arcadia- Site Number : 8400052, Arcadia

93012

RECRUITING

Ventura County Gastroenterology Medical Group- Site Number : 8400010, Camarillo

93534

RECRUITING

Om Research - Lancaster - 15th Street West- Site Number : 8400001, Lancaster

98405

RECRUITING

GI Alliance- Site Number : 8400033, Tacoma

1834111

RECRUITING

Investigational Site Number : 3760002, Afula

2687000

RECRUITING

Investigational Site Number : 1520005, Talcahuano

4070038

RECRUITING

Investigational Site Number : 1520006, Concepción

4731001

RECRUITING

Investigational Site Number : 3760007, Ramat HaSharon

4941492

RECRUITING

Investigational Site Number : 3760003, Petah Tikva

7500010

RECRUITING

Investigational Site Number : 1520007, Santiago

7610001

RECRUITING

Investigational Site Number : 3760001, Rehovot

7620001

RECRUITING

Investigational Site Number : 1520004, Santiago

8330034

RECRUITING

Investigational Site Number : 1520001, Santiago

8457108

RECRUITING

Investigational Site Number : 3760006, Beersheba

9103102

RECRUITING

Investigational Site Number : 3760004, Jerusalem

02111

RECRUITING

Boston Specialists- Site Number : 8400051, Boston

01201

RECRUITING

Berkshire Medical Center, Inc.- Site Number : 8400017, Pittsfield

07018

RECRUITING

Sanmora Bespoke Clinical Research Solutions- Site Number : 8400015, East Orange

07728

RECRUITING

Allied Health Clinical Research Organization, LLC- Site Number : 8400053, Freehold

02818

RECRUITING

Velocity Clinical Research - Providence- Site Number : 8400002, East Greenwich

B1642DSF

RECRUITING

Investigational Site Number : 0320008, San Isidro

29055-450

RECRUITING

Centro de Diagnostico e Pesquisa da Osteoporose do Espirito Santo- Site Number : 8400013, Vitória

41253-190

RECRUITING

Hospital Sao Rafael- Site Number : 0760005, Salvador

41820-020

RECRUITING

Centro de Pesquisas da Clínica IBIS- Site Number : 0760006, Salvador

72145-450

RECRUITING

Chronos Pesquisa Clínica- Site Number : 0760002, Brasília

90035-902

RECRUITING

Hospital Moinhos de Vento- Site Number : 0760004, Porto Alegre

90610-000

RECRUITING

Hospital São Lucas da PUCRS - Porto Alegre - Avenida Ipiranga- Site Number : 0760001, Porto Alegre

09090-790

RECRUITING

Praxis Pesquisa Medica- Site Number : 0760008, Santo André

V6Z 2K5

RECRUITING

Investigational Site Number : 1240001, Vancouver

V8V 3P9

RECRUITING

Investigational Site Number : 1240002, Victoria

636 00

RECRUITING

Investigational Site Number : 2030002, Brno

736 01

RECRUITING

Investigational Site Number : 2030006, Havířov

339 01

RECRUITING

Investigational Site Number : 2030005, Klatovy

118 33

RECRUITING

Investigational Site Number : 2030001, Prague

150 06

RECRUITING

Investigational Site Number : 2030003, Prague

00180

RECRUITING

Investigational Site Number : 2460002, Helsinki

06202

RECRUITING

Investigational Site Number : 2500002, Nice

06108

RECRUITING

Investigational Site Number : 2760001, Halle

106 76

RECRUITING

Investigational Site Number : 3000001, Athens

115 27

RECRUITING

Investigational Site Number : 3000002, Athens

1081 HV

RECRUITING

Investigational Site Number : 5280001, Amsterdam

6815 AD

RECRUITING

Investigational Site Number : 5280002, Arnhem

60-529

RECRUITING

Investigational Site Number : 6160004, Poznan

31-501

RECRUITING

Investigational Site Number : 6160001, Krakow

50-088

RECRUITING

Investigational Site Number : 6160005, Wroclaw

02-507

RECRUITING

Investigational Site Number : 6160002, Warsaw

040 13

RECRUITING

Investigational Site Number : 7030001, Košice

950 01

RECRUITING

Investigational Site Number : 7030003, Nitra

936 01

RECRUITING

Investigational Site Number : 7030004, Šahy

08035

RECRUITING

Investigational Site Number : 7240006, Barcelona

582 16

RECRUITING

Investigational Site Number : 7522001, Linköping

431 53

RECRUITING

Investigational Site Number : 7521001, Mölndal

116 91

RECRUITING

Investigational Site Number : 7520003, Stockholm

752 37

RECRUITING

Investigational Site Number : 7520001, Uppsala

07100

RECRUITING

Investigational Site Number : 7920004, Antalya

OX3 9DU

RECRUITING

Investigational Site Number : 8260001, Oxford

S5 7AU

RECRUITING

Investigational Site Number : 8260002, Sheffield

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Sanofi

INDUSTRY