FrexalimAB in Preservation of Endogenous insULIN Secretion Compared to Placebo in adUlts and Adolescents on Top of inSulin Therapy (FABULINUS)

PHASE2RecruitingINTERVENTIONAL
Enrollment

192

Participants

Timeline

Start Date

December 11, 2023

Primary Completion Date

April 30, 2027

Study Completion Date

October 27, 2028

Conditions
Type 1 Diabetes Mellitus
Interventions
DRUG

Frexalimab

Intravenous (IV) Infusion at Day 1 and subcutaneous (SC) Injection from W2 to W102

DRUG

Placebo

IV Infusion at Day 1 and SC Injection from W2 to W102

DRUG

Insulin

SC injection, dose and frequency will be established and/or adjusted by investigator

Trial Locations (74)

1089

RECRUITING

Investigational Site Number : 3480004, Budapest

1090

RECRUITING

Investigational Site Number : 0560002, Brussels

2730

RECRUITING

Investigational Site Number : 2080005, Herlev

3000

RECRUITING

Investigational Site Number : 0560001, Leuven

4400

RECRUITING

Investigational Site Number : 3480002, Nyíregyháza

8000

RECRUITING

Investigational Site Number : 3480006, Székesfehérvár

8230

RECRUITING

Investigational Site Number : 3480001, Balatonfüred

14203

RECRUITING

University at Buffalo - Downtown Campus- Site Number : 8400004, Buffalo

19104

RECRUITING

The Children's Hospital of Philadelphia Site Number : 8400005, Philadelphia

20132

RECRUITING

IRCCS Ospedale San Raffaele-Site Number : 3800006, Milan

21100

RECRUITING

Azienda Socio Sanitaria Territoriale Dei Sette Laghi - Ospedale Filippo del Ponte-Site Number : 3800002, Varese

23758

RECRUITING

Investigational Site Number : 2760002, Oldenburg in Holstein

27514

RECRUITING

University of North Carolina at Chapel Hill- Site Number : 8400001, Chapel Hill

28100

RECRUITING

Azienda Ospedaliero-Universitaria Maggiore Della Carità-Site Number : 3800001, Novara

RECRUITING

Investigational Site Number : 3800005, Novara

29010

RECRUITING

Investigational Site Number : 7240004, Málaga

30173

RECRUITING

Investigational Site Number : 2760001, Hanover

32610

RECRUITING

University of Florida College of Medicine- Site Number : 8400010, Gainesville

32803

RECRUITING

AdventHealth Orlando- Site Number : 8400002, Orlando

33011

RECRUITING

Investigational Site Number : 7240005, Oviedo

33136

RECRUITING

University of Miami Hospital- Site Number : 8400013, Miami

33520

RECRUITING

Investigational Site Number : 2460003, Tampere

37126

RECRUITING

Azienda Ospedaliera Universitaria Integrata Verona - Centro regionale di Diabetologia Pediatrica-Site Number : 3800004, Verona

40024

RECRUITING

Investigational Site Number : 2500005, Mont-de-Marsan

41009

RECRUITING

Investigational Site Number : 7240003, Seville

44800

RECRUITING

Investigational Site Number : 2500003, Saint-Herblain

45229

RECRUITING

Cincinnati Children's Hospital Medical Center- Site Number : 8400019, Cincinnati

46010

RECRUITING

Investigational Site Number : 7240006, Valencia

50139

RECRUITING

Azienda Ospedaliera Universitaria Meyer IRCCS-Site Number : 3800003, Florence

60020

RECRUITING

Investigational Site Number : 3800008, Torette

60077

RECRUITING

NorthShore University HealthSystem - Skokie- Site Number : 8400007, Skokie

75390

RECRUITING

University of Texas - Southwestern Medical Center- Site Number : 8400011, Dallas

75679

RECRUITING

Investigational Site Number : 2500006, Paris

80131

RECRUITING

Azienda Ospedaliera Universitaria 'Federico II'-Site Number : 3800009, Naples

80262

RECRUITING

University of Colorado- Site Number : 8400003, Denver

83404

RECRUITING

Rocky Mountain Diabetes and Osteoporosis Center- Site Number : 8400009, Idaho Falls

89075

RECRUITING

Investigational Site Number : 2760004, Ulm

91106

RECRUITING

Investigational Site Number : 2500004, Corbeil-Essonnes

94158

RECRUITING

University of California San Francisco - Mission Bay- Site Number : 8400012, San Francisco

95300

RECRUITING

Investigational Site Number : 2500007, Pontoise

98101

RECRUITING

Benaroya Research Institute at Virginia Mason- Site Number : 8400016, Seattle

02215

RECRUITING

Joslin Diabetes Center - Boston- Site Number : 8400015, Boston

V5Y 3W2

RECRUITING

Investigational Site Number : 1240001, Vancouver

N6A 5W9

RECRUITING

Investigational Site Number : 1240007, London

H3T 1C5

RECRUITING

Investigational Site Number : 1240005, Montreal

H4A 3J1

RECRUITING

Investigational Site Number : 1240004, Montreal

H4A 3T2

RECRUITING

Investigational Site Number : 1240003, Montreal

708 52

RECRUITING

Investigational Site Number : 2030003, Ostrava

100 34

RECRUITING

Investigational Site Number : 2030002, Prague

150 06

RECRUITING

Investigational Site Number : 2030001, Prague

401 11

RECRUITING

Investigational Site Number : 2030004, Ústí nad Labem

01307

RECRUITING

Investigational Site Number : 2760003, Dresden

00165

RECRUITING

Investigational Site Number : 3800007, Rome

02-117

RECRUITING

Investigational Site Number : 6160004, Warsaw

02-507

RECRUITING

Investigational Site Number : 6160001, Warsaw

04-746

ACTIVE_NOT_RECRUITING

Investigational Site Number : 6160007, Warsaw

40-752

RECRUITING

Investigational Site Number : 6160002, Katowice

15-274

RECRUITING

Investigational Site Number : 6160008, Bialystok

92-213

RECRUITING

Investigational Site Number : 6160005, Lodz

71-252

RECRUITING

Investigational Site Number : 6160009, Szczecin

02-091

RECRUITING

Investigational Site Number : 6160006, Warsaw

08035

RECRUITING

Investigational Site Number : 7240001, Barcelona

08950

RECRUITING

Investigational Site Number : 7240002, Esplugues de Llobregat

01009

RECRUITING

Investigational Site Number : 7240007, Vitoria-Gasteiz

171 64

RECRUITING

Investigational Site Number : 7520002, Solna

113 65

RECRUITING

Investigational Site Number : 7520001, Stockholm

118 83

RECRUITING

Investigational Site Number : 7520003, Stockholm

CB2 2QQ

RECRUITING

Investigational Site Number : 8260001, Cambridge

B15 2TH

RECRUITING

Investigational Site Number : 8260003, Birmingham

B4 6NH

RECRUITING

Investigational Site Number : 8260007, Birmingham

G51 4TF

RECRUITING

Investigational Site Number : 8260010, Glasgow

LE5 4PW

RECRUITING

Investigational Site Number : 8260004, Leicester

HA1 3UJ

RECRUITING

Investigational Site Number : 8260006, Harrow

DD1 9SY

RECRUITING

Investigational Site Number : 8260009, Dundee

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Sanofi

INDUSTRY