Frexalimab in Preservation of Endogenous Insulin Secretion Compared to Placebo in Adults, Adolescents and Children on Top of Insulin Therapy (FABULINUS) (FABULINUS)

A Randomized, Double-blind, Placebo-controlled, Multi-center Phase 2b Study With a Blinded Extension and an Optional Open-label Extension-Assessing the Safety and Efficacy of Frexalimab, a CD40L-antagonist Monoclonal Antibody, for the Preservation of Pancreatic β-cell Function in Adults, Adolescents and Children With Newly Diagnosed Type 1 Diabetes on Insulin Therapy

This is a randomized, parallel group, double-blind Phase 2 study with a 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. Enrollment date of the participant must take into consideration this constraint)

Double-blind treatment period (104 weeks for Part A and Part B; 52 weeks for Part C):

Main treatment period: 52 weeks for Parts A and B, 26 weeks for Part C Blinded extension: 52 weeks (for Part A and Part B, 26 weeks for Part C) Optional OLE period: 104 weeks for all parts Safety follow-up: 26 weeks The treatment duration will be up to 104 weeks for Part A and Part B or 52 weeks for Part C, the total study duration will be up to 135 weeks for Part A and Part B or 83 weeks for Part C.

If participants enter the OLE period, the treatment duration will be up to 208 weeks for Part A and Part B or 156 weeks for Part C, and the total study duration will be 240 weeks approximately for Part A and Part B or 188 weeks for Part C.

Study Overview

• Status: Active, not recruiting
• Conditions: Type 1 Diabetes Mellitus
• Intervention / Treatment: Drug: Insulin; Drug: Frexalimab; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 197
• Phase: Phase 2

Contacts and Locations

Study Locations

• Austria
  • Graz, Austria, 8036
    • Investigational Site Number : 0400002
  • Linz, Austria, 4020
    • Investigational Site Number : 0400004
  • Vienna, Austria, 1090
    • Investigational Site Number : 0400001
• Belgium
  • Brussels, Belgium, 1090
    • Investigational Site Number : 0560002
  • Leuven, Belgium, 3000
    • Investigational Site Number : 0560001
• Canada
  • British Columbia
    • Vancouver, British Columbia, Canada, V5Y 3W2
      • Investigational Site Number : 1240001
  • Ontario
    • London, Ontario, Canada, N6a 4l6
      • Investigational Site Number : 1240007
  • Quebec
    • Montreal, Quebec, Canada, H4a 3j1
      • Investigational Site Number : 1240004
    • Montreal, Quebec, Canada, H3T 1C5
      • Investigational Site Number : 1240005
    • Montreal, Quebec, Canada, H4A 3T2
      • Investigational Site Number : 1240003
• Czechia
  • Ostrava, Czechia, 708 52
    • Investigational Site Number : 2030003
  • Prague, Czechia, 150 06
    • Investigational Site Number : 2030001
  • Prague, Czechia, 100 34
    • Investigational Site Number : 2030002
• Denmark
  • Herlev, Denmark, 2730
    • Investigational Site Number : 2080005
• Finland
  • Helsinki, Finland, 00029
    • Investigational Site Number : 2460001
  • Oulu, Finland, 90220
    • Investigational Site Number : 2460004
  • Tampere, Finland, 33520
    • Investigational Site Number : 2460003
  • Turku, Finland, 20521
    • Investigational Site Number : 2460002
• France
  • Corbeil-Essonnes, France, 91106
    • Investigational Site Number : 2500004
  • Mont-de-Marsan, France, 40024
    • Investigational Site Number : 2500005
  • Paris, France, 75679
    • Investigational Site Number : 2500006
  • Pontoise, France, 95300
    • Investigational Site Number : 2500007
  • Saint-Herblain, France, 44800
    • Investigational Site Number : 2500003
• Germany
  • Dresden, Germany, 01307
    • Investigational Site Number : 2760003
  • Hanover, Germany, 30173
    • Investigational Site Number : 2760001
  • Oldenburg in Holstein, Germany, 23758
    • Investigational Site Number : 2760002
  • Ulm, Germany, 89081
    • Investigational Site Number : 2760004
• Hungary
  • Balatonfüred, Hungary, 8230
    • Investigational Site Number : 3480001
  • Budapest, Hungary, 1089
    • Investigational Site Number : 3480004
  • Nyíregyháza, Hungary, 4400
    • Investigational Site Number : 3480003
  • Nyíregyháza, Hungary, 4400
    • Investigational Site Number : 3480002
  • Székesfehérvár, Hungary, 8000
    • Investigational Site Number : 3480006
• Italy
  • Novara, Italy, 28100
    • Azienda Ospedaliero-Universitaria Maggiore Della Carità-Site Number : 3800001
  • Varese, Italy, 21100
    • Azienda Socio Sanitaria Territoriale Dei Sette Laghi - Ospedale Filippo del Ponte-Site Number : 3800002
  • Verona, Italy, 37126
    • Azienda Ospedaliera Universitaria Integrata Verona - Centro regionale di Diabetologia Pediatrica-Site Number : 3800004
  • Ancona
    • Torette, Ancona, Italy, 60020
      • AOU delle Marche - Ospedale G. Salesi-Site Number : 3800008
  • Firenze
    • Florence, Firenze, Italy, 50139
      • Azienda Ospedaliera Universitaria Meyer IRCCS-Site Number : 3800003
  • Milano
    • Milan, Milano, Italy, 20132
      • IRCCS Ospedale San Raffaele-Site Number : 3800006
  • Napoli
    • Naples, Napoli, Italy, 80131
      • Azienda Ospedaliera Universitaria 'Federico II'-Site Number : 3800009
  • Roma
    • Rome, Roma, Italy, 00165
      • Ospedale Pediatrico Bambin Gesu IRCCS-Site Number : 3800007
• Poland
  • Lódzkie
    • Lodz, Lódzkie, Poland, 92-213
      • Investigational Site Number : 6160005
  • Masovian Voivodeship
    • Warsaw, Masovian Voivodeship, Poland, 02-097
      • Investigational Site Number : 6160006
    • Warsaw, Masovian Voivodeship, Poland, 02-117
      • Investigational Site Number : 6160004
    • Warsaw, Masovian Voivodeship, Poland, 04-746
      • Investigational Site Number : 6160007
  • Podlaskie Voivodeship
    • Bialystok, Podlaskie Voivodeship, Poland, 15-274
      • Investigational Site Number : 6160008
  • Silesian Voivodeship
    • Katowice, Silesian Voivodeship, Poland, 40-752
      • Investigational Site Number : 6160002
  • West Pomeranian Voivodeship
    • Szczecin, West Pomeranian Voivodeship, Poland, 71-252
      • Investigational Site Number : 6160009
• Slovenia
  • Ljubljana, Slovenia, 1000
    • Investigational Site Number : 7050001
• Spain
  • Málaga, Spain, 29010
    • Investigational Site Number : 7240004
  • Valencia, Spain, 46010
    • Investigational Site Number : 7240006
  • Barcelona [Barcelona]
    • Barcelona, Barcelona [Barcelona], Spain, 08035
      • Investigational Site Number : 7240001
    • Esplugues de Llobregat, Barcelona [Barcelona], Spain, 08950
      • Investigational Site Number : 7240002
  • Principality of Asturias
    • Oviedo, Principality of Asturias, Spain, 33011
      • Investigational Site Number : 7240005
  • Sevilla
    • Seville, Sevilla, Spain, 41009
      • Investigational Site Number : 7240003
  • Álava
    • Vitoria-Gasteiz, Álava, Spain, 01009
      • Investigational Site Number : 7240007
• Sweden
  • Solna, Sweden, 171 64
    • Investigational Site Number : 7520002
  • Stockholm, Sweden, 113 65
    • Investigational Site Number : 7520001
  • Stockholm, Sweden, 118 83
    • Investigational Site Number : 7520003
• United Kingdom
  • Cambridgeshire
    • Cambridge, Cambridgeshire, United Kingdom, CB2 2QQ
      • Investigational Site Number : 8260001
  • Dundee City
    • Dundee, Dundee City, United Kingdom, DD1 9SY
      • Investigational Site Number : 8260009
  • England
    • Birmingham, England, United Kingdom, B15 2TH
      • Investigational Site Number : 8260003
    • Birmingham, England, United Kingdom, B4 6NH
      • Investigational Site Number : 8260007
  • Glasgow City
    • Glasgow, Glasgow City, United Kingdom, G51 4TF
      • Investigational Site Number : 8260010
  • Leicestershire
    • Leicester, Leicestershire, United Kingdom, LE5 4PW
      • Investigational Site Number : 8260004
  • London, City of
    • Harrow, London, City of, United Kingdom, HA1 3UJ
      • Investigational Site Number : 8260006
• United States
  • California
    • San Francisco, California, United States, 94158
      • University of California San Francisco - Mission Bay- Site Number : 8400012
  • Colorado
    • Aurora, Colorado, United States, 80045
      • University of Colorado - Anschutz Medical Campus- Site Number : 8400003
  • Florida
    • Gainesville, Florida, United States, 32610
      • University of Florida College of Medicine- Site Number : 8400010
    • Miami, Florida, United States, 33136
      • University of Miami Hospital- Site Number : 8400013
    • Orlando, Florida, United States, 32803
      • AdventHealth Orlando- Site Number : 8400002
  • Idaho
    • Idaho Falls, Idaho, United States, 83404
      • Rocky Mountain Diabetes and Osteoporosis Center- Site Number : 8400009
  • Illinois
    • Skokie, Illinois, United States, 60077
      • NorthShore University Health System - Endeavor Health Medical Group - Skokie - Woods Drive- Site Number : 8400007
  • Massachusetts
    • Boston, Massachusetts, United States, 02215
      • Joslin Diabetes Center - Boston- Site Number : 8400015
  • New York
    • Buffalo, New York, United States, 14203
      • University at Buffalo - Downtown Campus- Site Number : 8400004
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27514
      • University of North Carolina at Chapel Hill- Site Number : 8400001
  • Ohio
    • Cincinnati, Ohio, United States, 45229
      • Cincinnati Children's Hospital Medical Center- Site Number : 8400019
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • The Children's Hospital of Philadelphia Site Number : 8400005
  • Texas
    • Dallas, Texas, United States, 75390
      • University of Texas - Southwestern Medical Center- Site Number : 8400011
  • Washington
    • Seattle, Washington, United States, 98101
      • Benaroya Research Institute at Virginia Mason- Site Number : 8400016

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Participants who meet the criteria of T1D according to American Diabetes Association
• Initiated exogenous insulin replacement therapy not longer than 90 days prior to screening visit at which random C-peptide will be assessed (V1).

• Receiving at least one of the following T1D standard of care (SOC), insulin hormone replacement therapy

  • one or multiple daily injections (MDI) of basal insulin, prandial insulin and/or premixed insulin, or
  • continuous subcutaneous insulin infusion (CSII)

• Participants must be positive for at least 1 of the following T1D autoantibodies confirmed by medical history and/or obtained at study screening:

  • Glutamic acid decarboxylase (GAD-65)
  • Insulinoma Antigen-2 (IA-2)
  • Zinc-transporter 8 (ZnT8) or
  • Insulin (if obtained not later than 10 days after exogenous insulin therapy initiation)
• Have random C-peptide levels ≥ 0.2 nmol/L determined at screening visit.
• Be vaccinated according to the local vaccination schedule. Any vaccinations should take place at least 28 days prior to randomization for non-live vaccines and at least 3 months prior to randomization for live vaccines.
• Contraceptive use by men and women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies
• Participants body weight at screening must be at least 20kg.

Exclusion Criteria:

• Serious systemic viral, bacterial or fungal infection (eg, pneumonia, pyelonephritis), infection requiring hospitalization or IV antibiotics or significant chronic viral (including history of recurrent or active herpes zoster, acute or active cytomegalovirus (CMV), Epstein-Barr Virus (EBV) as determined at screening), bacterial, or fungal infection (eg, osteomyelitis) 30 days before and during screening.
• Participants with a history of invasive opportunistic infections, such as, but not limited to histoplasmosis, listeriosis, coccidioidomycosis, candidiasis, pneumocystis jirovecii, and aspergillosis, regardless of resolution.
• Evidence of active or latent tuberculosis (TB) as documented by medical history and examination, chest X-rays (posterior anterior and lateral), and/or TB testing. Blood testing (eg, QuantiFERON® TB Gold test) is strongly preferred; if not available, any local approved TB test is allowed.
• Evidence of any clinically significant, severe or unstable, acute or chronically progressive, uncontrolled infection, medical or surgical condition (eg, but not limited to, cerebral, cardiac, pulmonary, renal, hepatic, gastrointestinal, neurologic, acquired or inherited bone/skeletal disorders including repeated bone fractures for unknown reason, juvenile osteoporosis, osteogenesis imperfecta, osteochondropathies, or any known immune deficiency), or any condition that may affect participant safety in the judgment of the Investigator (including vaccinations which are not updated based on local regulation).
• History or current hypogammaglobulinemia.
• History of a systemic hypersensitivity reaction or significant allergies, other than localized injection site reaction, to any humanized mAb. Clinically significant multiple or severe drug allergies, intolerance to topical corticosteroids, or severe post-treatment hypersensitivity reactions (including, but not limited to, erythema multiforme major, linear IgA dermatosis, toxic epidermal necrolysis, and exfoliative dermatitis).
• Has other autoimmune diseases (eg, rheumatoid arthritis [RA], polyarticular juvenile idiopathic arthritis [pJIA], psoriatic arthritis [PsA], ankylosing spondylitis [AS], MS, SLE), that require treatment with biologic drugs (mono or polyclonal antibodies) or systemic corticosteroid therapy (at discretion of investigator).
• History, clinical evidence, suspicion or significant risk for thromboembolic events, as well as myocardial infarction, stroke, antiphospholipid syndrome, other prothrombotic disorders and/or participants requiring antithrombotic treatment.
• Diabetes of forms other than autoimmune T1D that include but is not limited to genetic forms of diabetes, maturity-onset diabetes of the young (MODY), latent autoimmune diabetes of the adult (LADA), secondary to medications or surgery, type 2 diabetes by judgement of the investigator.
• History of malignancy of any organ system, treated or untreated, within 5 years of screening, regardless of whether there is evidence of local recurrence or metastases.
• Systemic corticosteroids (duration > 7 days), adrenocorticotropic hormone 1 month prior to screening.
• Any IV, IM or SC administered biologic treatments, < 3 months or < than 5 half-lives (whichever is longer), prior to randomization.
• Any live (attenuated or viral-vector) vaccine (including but not limited to varicella zoster, oral polio, nasal influenza, rabies) within 3 months prior to randomization.
• Any non-live (inactivated, mRNA, recombinant, conjugate, toxoid) vaccine administered less than 28 days prior to randomization.
• Other medications not compatible or interfering with IMP at discretion of investigator.
• Any immunosuppressive therapy within 12 weeks prior to randomization.
• Course of Thymoglobulin®, teplizumab or other immunomodulatory treatments at any time.
• Any drugs that may be used for treatment of T1D and type 2 diabetes other than insulin including but not limited to metformin, glucagon-like peptide 1 (GLP-1) agonists and sodium-glucose co-transporter-2 and 1 (SGLT2/1) inhibitor and verapamil within 2 weeks prior to screening.
• Abnormal laboratory test(s) at screening.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; Matching Placebo	Drug: Insulin; SC injection, dose and frequency will be established and/or adjusted by investigator; Drug: Placebo; IV Infusion at Day 1 SC Injection from W2 to W102 (part A and part B); SC Injection from W2 to W50(part C)
Experimental: Frexalimab Dose 1	Drug: Insulin; SC injection, dose and frequency will be established and/or adjusted by investigator; Drug: Frexalimab; IV Infusion at Day 1 SC Injection from W2 to W102 (part A and part B); SC Injection from W2 to W50(part C)
Experimental: Frexalimab Dose 2	Drug: Insulin; SC injection, dose and frequency will be established and/or adjusted by investigator; Drug: Frexalimab; IV Infusion at Day 1 SC Injection from W2 to W102 (part A and part B); SC Injection from W2 to W50(part C)
Experimental: Frexalimab Dose 3	Drug: Insulin; SC injection, dose and frequency will be established and/or adjusted by investigator; Drug: Frexalimab; IV Infusion at Day 1 SC Injection from W2 to W102 (part A and part B); SC Injection from W2 to W50(part C)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in mean 2h mixed meal tolerance test (MMTT) stimulated C-peptide concentration, calculated from AUC from baseline to W52 for Part B (12-21 y.o.)	mixed meal tolerance test (MMTT) stimulated C-peptide concentration is to be calculated from AUC	Baseline to Week 52
Change in mean 2h mixed meal tolerance test (MMTT) stimulated C-peptide concentration, calculated from AUC from baseline to W26 for Part C (6-11 y.o.)	mixed meal tolerance test (MMTT) stimulated C-peptide concentration is to be calculated from AUC	Baseline to Week 26

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of treatment emergent adverse events (TEAEs), serious adverse events (SAEs), adverse events of special interest (AESIs) and TEAEs leading to treatment discontinuation		Until Week 130
Number of participants with at least one hypoglycemic event		Until Week 130
Number of participants with at least one hyperglycemic episode		Until Week 130
Number of participants with at least one diabetic ketoacidosis (DKA) event		Until Week 130
Number of participants with clinically significant changes in vital signs, electrocardiogram (ECG), and/or laboratory evaluation		Until Week 130
Frexalimab plasma concentrations over time		Until Week 104
Incidence of anti-drug antibodies (ADAs) over time		Until Week 130
Height and growth rate over time (for participants <18 y.o. at screening)		Until Week 130
Time in range (70-180 mg/dL), assessed by CGM at W52 and W104(part B)		At Week 52 and Week 104
Proportion of participants who remain C-peptide positive (mean 2h MMTT stimulated C-peptide concentration ≥0.2 nmol/L) at W52 and W104(part B)	mixed meal tolerance test (MMTT) stimulated C-peptide concentration is to be calculated from AUC	At Week 52 and Week 104
Proportion of participants with reduction from baseline to W52 and W104 of less than 10% in mean 2h MMTT stimulated C-peptide concentration(part B)	mixed meal tolerance test (MMTT) stimulated C-peptide concentration is to be calculated from AUC	From baseline to Week 52 and Week 104
Proportion of participants with partial remission at W52 and W104 (defined as IDAA1c score ≤9.0, where it is calculated as HbA1c [%] + 4x insulin dose [IU/kg/day])(part B)		At Week 52 and Week 104
Change from baseline to W52 and W104 in insulin dose [IU/kg/day](part B)		From baseline to Week 52 and Week 104
HbA1c level at Week 52 and Week 104(part B)		at Week 52 and Week 104
Proportion of participants with HbA1c ≤6.5% and requiring no injections of exogenous insulin at W52 and W104(part B)		At Week 52 and Week 104
Proportion of participants with HbA1c ≤6.5% and requiring ≤0.25 IU of insulin at W52 and W104(part B)		At Week 52 and Week 104
Proportion of participants with HbA1c <7% at W52 and W104(part B)		At Week 52 and Week 104
Change from baseline to W52 and W104 in PedsQL Diabetes Symptoms domain score (all participants≥8 y.o.) (part B)		From baseline to Week 52 and Week 104
Change from baseline to W52 and W104 in Pediatric Quality of Life (PedsQL) Diabetes Management domain score (all participants≥8 y.o.) (part B)		From baseline to Week 52 and Week 104
Change from baseline to W52 and W104 in Problem Areas In Diabetes (PAID) total score (all participants)(part B)		From baseline to Week 52 and Week 104
Change from baseline to W52 and W104 in Diabetes Treatment Satisfaction Questionnaires (DTSQs) total and item scores (all participants)(part B)		From baseline to Week 52 and Week 104
Change from baseline to W52 and W104 in PAID immediate and theoretical domain scores (caregivers of all participants 12-17 y.o.)(part B)		From baseline to Week 52 and Week 104
Change from baseline to W52 and W104 in DTSQs Total and item scores (caregivers of all participants 12-17 y.o.)(part B)		From baseline to Week 52 and Week 104
Time in tight range (TITR, 70 - 140 mg/dL), assessed by CGM at W52 and W104(part B)		Time in tight range (TITR, 70 - 140 mg/dL), assessed by CGM at W52 and W104
Change from baseline to W104 in mean 2h mixed meal tolerance test (MMTT) stimulated C-peptide concentration, calculated from AUC(part B)		From baseline to Week 104
Change from baseline to W52 and W104 in IDAA1c score(part B)		From baseline to Week 52
Time in range (70-180 mg/dL), assessed by study CGM at W26 and W52(part C)		At week 26 and week 52
Time in tight range (TITR, 70 - 140 mg/dL), assessed by study CGM at W26 and W52(part C)		At Week 26 and Week 52
Change from baseline to W52 in mean 2h mixed meal tolerance test (MMTT) stimulated C-peptide concentration, calculated from AUC(Part C)		From baseline to week 52
Proportion of participants who remain C-peptide positive (mean 2h MMTT stimulated C-peptide concentration ≥0.2 nmol/L) at W26 and W52(part C)		At Week 26 and Week 52
Proportion of participants with reduction from baseline to W26 and W52 of less than 10% in mean 2h MMTT stimulated C-peptide concentration(Part C)		From baseline to week 26 and week 52
Proportion of participants with partial remission at W26 and W52 (defined as IDAA1c score ≤9.0, where it is calculated as HbA1c [%] + 4x insulin dose [IU/kg/day]) (part C)		At week 26 and week 52
Change from baseline to W26 and W52 in IDAA1c score(part C)		From baseline to Week 26 and Week 52
Change from baseline to W26 and W52 in insulin dose [IU/kg/day] (part C)		From baseline to Week 26 and Week 52
HbA1c level change from baseline to Week 52 and Week 104(part B)		From baseline to Week 52 and Week 104
Proportion of participants with HbA1c ≤6.5% and requiring no injections of exogenous insulin at W26 and W52(part C)		At week 26 and week 52
Proportion of participants with HbA1c ≤6.5% and requiring ≤0.25 IU of insulin at W26 and W52(part C)		At week 26 and week 52
Proportion of participants with HbA1c <7% at W26 and W52(part C)		At week 26 and week 52
Change from baseline to W26 and W52 in PedsQL Diabetes Symptoms domain score (all participants≥8 y.o.) (part C)		From baseline to Week 26 and Week 52
Change from baseline to W26 and W52 in [BB7.1][LS7.2]PedsQL Diabetes Management domain score (all participants≥8 y.o.) (part C)		From baseline to Week 26 and Week 52
Change from baseline to W26 and W52 in Problem Areas In Diabetes (PAID) total score (all participants)(part C)		From baseline to Week 26 and Week 52
Change in PedsQL Diabetes Symptoms and Management domains scores (caregivers of participants 6 -7 y.o.) from baseline to W26 and W52 (Part C)		From baseline to Week 26 and Week 52
Change from baseline to W26 and W52 in PAID immediate and theoretical domain scores (caregivers of all participants 6-17 y.o.)(part C)		From baseline to Week 26 and Week 52
Change from baseline to W26 and W52 [BB8.1]in DTSQs Total and item scores (caregivers of all participants 6-17 y.o.)(part C)		From baseline to Week 26 and Week 52
HbA1c level at W26 and W52(part C)		at Week 26 and Week 52
HbA1c level change from baseline to W26 and W52(part C)		From baseline to Week 26 and Week 52

Collaborators and Investigators

• Sponsor: Sanofi

Publications and helpful links

General Publications

• Cherkas A, Rotthaeuser B, Porksen N, Labard P, Nguyen-Pascal ML, Coudert M, Berthou B, Baccara-Dinet M, Boka G, Peakman M, Reschke F, Haller MJ. A Phase 2 Trial of Frexalimab, a CD40L Antagonist, in Adolescents and Adults With Recent-Onset Type 1 Diabetes (FABULINUS): Rationale and Study Design. Diabetes Obes Metab. 2026 May 27. doi: 10.1111/dom.70785. Online ahead of print.

Helpful Links

• DRI17476 Plain Language Results Summary

Study record dates

Study Major Dates

• Study Start (Actual): December 11, 2023
• Primary Completion (Estimated): April 28, 2027
• Study Completion (Estimated): October 29, 2030

Study Registration Dates

• First Submitted: October 27, 2023
• First Submitted That Met QC Criteria: October 31, 2023
• First Posted (Actual): November 1, 2023

Study Record Updates

• Last Update Posted (Actual): June 29, 2026
• Last Update Submitted That Met QC Criteria: June 23, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Endocrine System Diseases; Metabolic Diseases; Autoimmune Diseases; Immune System Diseases; Glucose Metabolism Disorders; Diabetes Mellitus; Nutritional and Metabolic Diseases; Diabetes Mellitus, Type 1; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptide Hormones; Peptides; Amino Acids, Peptides, and Proteins; Insulins; Pancreatic Hormones; Proinsulin; Insulin
• Other Study ID Numbers: DRI17476; U1111-1275-9618 (Registry Identifier: ICTRP); 2022-500531-36 (Registry Identifier: CTIS)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No