Actively Recruiting
FrexalimAB in Preservation of Endogenous insULIN Secretion Compared to Placebo in adUlts and Adolescents on Top of inSulin Therapy (FABULINUS)
Led by Sanofi · Updated on 2026-04-08
192
Participants Needed
80
Research Sites
359 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a randomized, parallel group, double-blind Phase 2 study with a 52-week blinded extension evaluating the safety and efficacy of 3 dose levels of frexalimab in comparison with placebo in participants with newly diagnosed T1D on insulin treatment. Study details include: Screening period: at least 3 weeks and up to 5 weeks Double-blind treatment period (104 weeks): * Main treatment period: 52 weeks * Blinded extension: 52 weeks Optional Open Label Extension: 104 weeks Safety follow-up: up to 26 weeks The treatment duration will be up to 104 weeks, the total study duration will be up to 135 weeks.
CONDITIONS
Official Title
FrexalimAB in Preservation of Endogenous insULIN Secretion Compared to Placebo in adUlts and Adolescents on Top of inSulin Therapy (FABULINUS)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants diagnosed with Type 1 Diabetes according to American Diabetes Association criteria
- Started insulin treatment no more than 90 days before screening
- Currently receiving insulin therapy via multiple daily injections or continuous infusion
- Positive for at least one Type 1 Diabetes autoantibody (GAD-65, IA-2, ZnT8, or Insulin)
- Random C-peptide level at screening of 0.2 nmol/L or higher
- Up to date with local vaccination schedule; vaccinations must be completed at least 28 days prior for non-live vaccines and 3 months prior for live vaccines
- Use of contraception consistent with local regulations for men and women participating in clinical studies
You will not qualify if you...
- Serious infections requiring hospitalization or intravenous antibiotics within 30 days before screening
- History of invasive opportunistic infections regardless of resolution
- Evidence of active or latent tuberculosis
- Clinically significant unstable or severe medical conditions that could affect safety
- History of low antibody levels (hypogammaglobulinemia)
- Severe allergies or hypersensitivity to humanized monoclonal antibodies
- Other autoimmune diseases requiring biologic or systemic corticosteroid treatment
- History or risk of blood clots, heart attack, stroke, or related disorders
- Diabetes types other than autoimmune Type 1 Diabetes
- Cancer treated or untreated within the past 5 years
- Use of systemic corticosteroids longer than 7 days within 1 month prior to screening
- Use of biologic treatments within 3 months or five half-lives prior to randomization
- Receipt of live vaccines within 3 months prior to randomization
- Receipt of non-live vaccines within 28 days prior to randomization
- Use of medications incompatible with the investigational drug
- Immunosuppressive therapy within 12 weeks prior to randomization
- Previous treatment with immunomodulatory drugs like Thymoglobulin or teplizumab
- Use of diabetes drugs other than insulin within 2 weeks prior to screening
- Abnormal laboratory tests at screening
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 80 locations
1
University of California San Francisco - Mission Bay- Site Number : 8400012
San Francisco, California, United States, 94158
Actively Recruiting
2
University of Colorado - Anschutz Medical Campus- Site Number : 8400003
Aurora, Colorado, United States, 80045
Actively Recruiting
3
University of Florida College of Medicine- Site Number : 8400010
Gainesville, Florida, United States, 32610
Actively Recruiting
4
University of Miami Hospital- Site Number : 8400013
Miami, Florida, United States, 33136
Actively Recruiting
5
AdventHealth Orlando- Site Number : 8400002
Orlando, Florida, United States, 32803
Actively Recruiting
6
Rocky Mountain Diabetes and Osteoporosis Center- Site Number : 8400009
Idaho Falls, Idaho, United States, 83404
Actively Recruiting
7
NorthShore University Health System - Endeavor Health Medical Group - Skokie - Woods Drive- Site Number : 8400007
Skokie, Illinois, United States, 60077
Actively Recruiting
8
Joslin Diabetes Center - Boston- Site Number : 8400015
Boston, Massachusetts, United States, 02215
Actively Recruiting
9
University at Buffalo - Downtown Campus- Site Number : 8400004
Buffalo, New York, United States, 14203
Actively Recruiting
10
University of North Carolina at Chapel Hill- Site Number : 8400001
Chapel Hill, North Carolina, United States, 27514
Actively Recruiting
11
Cincinnati Children's Hospital Medical Center- Site Number : 8400019
Cincinnati, Ohio, United States, 45229
Actively Recruiting
12
The Children's Hospital of Philadelphia Site Number : 8400005
Philadelphia, Pennsylvania, United States, 19104
Actively Recruiting
13
University of Texas - Southwestern Medical Center- Site Number : 8400011
Dallas, Texas, United States, 75390
Actively Recruiting
14
Benaroya Research Institute at Virginia Mason- Site Number : 8400016
Seattle, Washington, United States, 98101
Actively Recruiting
15
Investigational Site Number : 0400002
Graz, Austria, 8036
Actively Recruiting
16
Investigational Site Number : 0400004
Linz, Austria, 4020
Actively Recruiting
17
Investigational Site Number : 0400001
Vienna, Austria, 1090
Actively Recruiting
18
Investigational Site Number : 0560002
Brussels, Belgium, 1090
Actively Recruiting
19
Investigational Site Number : 0560001
Leuven, Belgium, 3000
Actively Recruiting
20
Investigational Site Number : 1240001
Vancouver, British Columbia, Canada, V5Y 3W2
Actively Recruiting
21
Investigational Site Number : 1240007
London, Ontario, Canada, N6A 5W9
Actively Recruiting
22
Investigational Site Number : 1240005
Montreal, Quebec, Canada, H3T 1C5
Actively Recruiting
23
Investigational Site Number : 1240004
Montreal, Quebec, Canada, H4A 3J1
Actively Recruiting
24
Investigational Site Number : 1240003
Montreal, Quebec, Canada, H4A 3T2
Actively Recruiting
25
Investigational Site Number : 2030003
Ostrava, Czechia, 708 52
Actively Recruiting
26
Investigational Site Number : 2030002
Prague, Czechia, 100 34
Actively Recruiting
27
Investigational Site Number : 2030001
Prague, Czechia, 150 06
Actively Recruiting
28
Investigational Site Number : 2080005
Herlev, Denmark, 2730
Actively Recruiting
29
Investigational Site Number : 2460001
Helsinki, Finland, 00290
Actively Recruiting
30
Investigational Site Number : 2460004
Oulu, Finland, 90220
Actively Recruiting
31
Investigational Site Number : 2460003
Tampere, Finland, 33520
Actively Recruiting
32
Investigational Site Number : 2460002
Turku, Finland, 20521
Actively Recruiting
33
Investigational Site Number : 2500004
Corbeil-Essonnes, France, 91106
Actively Recruiting
34
Investigational Site Number : 2500005
Mont-de-Marsan, France, 40024
Actively Recruiting
35
Investigational Site Number : 2500006
Paris, France, 75679
Actively Recruiting
36
Investigational Site Number : 2500007
Pontoise, France, 95300
Actively Recruiting
37
Investigational Site Number : 2500003
Saint-Herblain, France, 44800
Actively Recruiting
38
Investigational Site Number : 2760003
Dresden, Germany, 01307
Actively Recruiting
39
Investigational Site Number : 2760001
Hanover, Germany, 30173
Actively Recruiting
40
Investigational Site Number : 2760002
Oldenburg in Holstein, Germany, 23758
Actively Recruiting
41
Investigational Site Number : 2760004
Ulm, Germany, 89081
Actively Recruiting
42
Investigational Site Number : 3480001
Balatonfüred, Hungary, 8230
Actively Recruiting
43
Investigational Site Number : 3480004
Budapest, Hungary, 1089
Actively Recruiting
44
Investigational Site Number : 3480002
Nyíregyháza, Hungary, 4400
Actively Recruiting
45
Investigational Site Number : 3480003
Nyíregyháza, Hungary, 4400
Actively Recruiting
46
Investigational Site Number : 3480006
Székesfehérvár, Hungary, 8000
Actively Recruiting
47
AOU delle Marche - Ospedale G. Salesi-Site Number : 3800008
Torette, Ancona, Italy, 60020
Actively Recruiting
48
Azienda Ospedaliera Universitaria Meyer IRCCS-Site Number : 3800003
Florence, Firenze, Italy, 50139
Active, Not Recruiting
49
IRCCS Ospedale San Raffaele-Site Number : 3800006
Milan, Milano, Italy, 20132
Actively Recruiting
50
Azienda Ospedaliera Universitaria 'Federico II'-Site Number : 3800009
Naples, Napoli, Italy, 80131
Active, Not Recruiting
51
Ospedale Pediatrico Bambin Gesu IRCCS-Site Number : 3800007
Rome, Roma, Italy, 00165
Active, Not Recruiting
52
Azienda Ospedaliero-Universitaria Maggiore Della Carità-Site Number : 3800001
Novara, Italy, 28100
Actively Recruiting
53
Azienda Socio Sanitaria Territoriale Dei Sette Laghi - Ospedale Filippo del Ponte-Site Number : 3800002
Varese, Italy, 21100
Completed
54
Azienda Ospedaliera Universitaria Integrata Verona - Centro regionale di Diabetologia Pediatrica-Site Number : 3800004
Verona, Italy, 37126
Actively Recruiting
55
Investigational Site Number : 6160005
Lodz, Lódzkie, Poland, 92-213
Actively Recruiting
56
Investigational Site Number : 6160006
Warsaw, Masovian Voivodeship, Poland, 02-097
Actively Recruiting
57
Investigational Site Number : 6160004
Warsaw, Masovian Voivodeship, Poland, 02-117
Actively Recruiting
58
Investigational Site Number : 6160001
Warsaw, Masovian Voivodeship, Poland, 02-507
Actively Recruiting
59
Investigational Site Number : 6160007
Warsaw, Masovian Voivodeship, Poland, 04-746
Actively Recruiting
60
Investigational Site Number : 6160008
Bialystok, Podlaskie Voivodeship, Poland, 15-274
Actively Recruiting
61
Investigational Site Number : 6160002
Katowice, Silesian Voivodeship, Poland, 40-752
Actively Recruiting
62
Investigational Site Number : 6160009
Szczecin, West Pomeranian Voivodeship, Poland, 71-252
Actively Recruiting
63
Investigational Site Number : 7050001
Ljubljana, Slovenia, 1000
Actively Recruiting
64
Investigational Site Number : 7240001
Barcelona, Barcelona [Barcelona], Spain, 08035
Actively Recruiting
65
Investigational Site Number : 7240002
Esplugues de Llobregat, Barcelona [Barcelona], Spain, 08950
Actively Recruiting
66
Investigational Site Number : 7240005
Oviedo, Principality of Asturias, Spain, 33011
Actively Recruiting
67
Investigational Site Number : 7240003
Seville, Sevilla, Spain, 41009
Actively Recruiting
68
Investigational Site Number : 7240004
Málaga, Spain, 29010
Actively Recruiting
69
Investigational Site Number : 7240006
Valencia, Spain, 46010
Actively Recruiting
70
Investigational Site Number : 7240007
Vitoria-Gasteiz, Álava, Spain, 01009
Actively Recruiting
71
Investigational Site Number : 7520002
Solna, Sweden, 171 64
Actively Recruiting
72
Investigational Site Number : 7520001
Stockholm, Sweden, 113 65
Actively Recruiting
73
Investigational Site Number : 7520003
Stockholm, Sweden, 118 83
Actively Recruiting
74
Investigational Site Number : 8260001
Cambridge, Cambridgeshire, United Kingdom, CB2 2QQ
Active, Not Recruiting
75
Investigational Site Number : 8260009
Dundee, Dundee City, United Kingdom, DD1 9SY
Actively Recruiting
76
Investigational Site Number : 8260003
Birmingham, England, United Kingdom, B15 2TH
Actively Recruiting
77
Investigational Site Number : 8260007
Birmingham, England, United Kingdom, B4 6NH
Active, Not Recruiting
78
Investigational Site Number : 8260010
Glasgow, Glasgow City, United Kingdom, G51 4TF
Active, Not Recruiting
79
Investigational Site Number : 8260004
Leicester, Leicestershire, United Kingdom, LE5 4PW
Actively Recruiting
80
Investigational Site Number : 8260006
Harrow, London, City of, United Kingdom, HA1 3UJ
Active, Not Recruiting
Research Team
T
Trial Transparency email recommended (Toll free number for US & Canada)
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
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