FrexalimAB in Preservation of Endogenous insULIN Secretion Compared to Placebo in adUlts and Adolescents on Top of inSulin Therapy (FABULINUS)
NCT ID: NCT06111586
Last Updated: 2025-12-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
192 participants
INTERVENTIONAL
2023-12-11
2030-10-29
Brief Summary
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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.
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Frexalimab Dose 1
Frexalimab
Intravenous (IV) Infusion at Day 1 and subcutaneous (SC) Injection from W2 to W102
Insulin
SC injection, dose and frequency will be established and/or adjusted by investigator
Frexalimab Dose 2
Frexalimab
Intravenous (IV) Infusion at Day 1 and subcutaneous (SC) Injection from W2 to W102
Insulin
SC injection, dose and frequency will be established and/or adjusted by investigator
Frexalimab Dose 3
Frexalimab
Intravenous (IV) Infusion at Day 1 and subcutaneous (SC) Injection from W2 to W102
Insulin
SC injection, dose and frequency will be established and/or adjusted by investigator
Placebo
Matching Placebo
Placebo
IV Infusion at Day 1 and SC Injection from W2 to W102
Insulin
SC injection, dose and frequency will be established and/or adjusted by investigator
Interventions
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Frexalimab
Intravenous (IV) Infusion at Day 1 and subcutaneous (SC) Injection from W2 to W102
Placebo
IV Infusion at Day 1 and SC Injection from W2 to W102
Insulin
SC injection, dose and frequency will be established and/or adjusted by investigator
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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.
12 Years
35 Years
ALL
No
Sponsors
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Sanofi
INDUSTRY
Responsible Party
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Locations
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University of California San Francisco - Mission Bay- Site Number : 8400012
San Francisco, California, United States
University of Colorado - Anschutz Medical Campus- Site Number : 8400003
Aurora, Colorado, United States
University of Florida College of Medicine- Site Number : 8400010
Gainesville, Florida, United States
University of Miami Hospital- Site Number : 8400013
Miami, Florida, United States
AdventHealth Orlando- Site Number : 8400002
Orlando, Florida, United States
Rocky Mountain Diabetes and Osteoporosis Center- Site Number : 8400009
Idaho Falls, Idaho, United States
NorthShore University Health System - Endeavor Health Medical Group - Skokie - Woods Drive- Site Number : 8400007
Skokie, Illinois, United States
Joslin Diabetes Center - Boston- Site Number : 8400015
Boston, Massachusetts, United States
University at Buffalo - Downtown Campus- Site Number : 8400004
Buffalo, New York, United States
University of North Carolina at Chapel Hill- Site Number : 8400001
Chapel Hill, North Carolina, United States
Cincinnati Children's Hospital Medical Center- Site Number : 8400019
Cincinnati, Ohio, United States
The Children's Hospital of Philadelphia Site Number : 8400005
Philadelphia, Pennsylvania, United States
University of Texas - Southwestern Medical Center- Site Number : 8400011
Dallas, Texas, United States
Benaroya Research Institute at Virginia Mason- Site Number : 8400016
Seattle, Washington, United States
Investigational Site Number : 0400004
Linz, , Austria
Investigational Site Number : 0400001
Vienna, , Austria
Investigational Site Number : 0560002
Brussels, , Belgium
Investigational Site Number : 0560001
Leuven, , Belgium
Investigational Site Number : 1240001
Vancouver, British Columbia, Canada
Investigational Site Number : 1240007
London, Ontario, Canada
Investigational Site Number : 1240005
Montreal, Quebec, Canada
Investigational Site Number : 1240004
Montreal, Quebec, Canada
Investigational Site Number : 1240003
Montreal, Quebec, Canada
Investigational Site Number : 2030003
Ostrava, , Czechia
Investigational Site Number : 2030002
Prague, , Czechia
Investigational Site Number : 2030001
Prague, , Czechia
Investigational Site Number : 2080005
Herlev, , Denmark
Investigational Site Number : 2460001
Helsinki, , Finland
Investigational Site Number : 2460004
Oulu, , Finland
Investigational Site Number : 2460003
Tampere, , Finland
Investigational Site Number : 2460002
Turku, , Finland
Investigational Site Number : 2500004
Corbeil-Essonnes, , France
Investigational Site Number : 2500005
Mont-de-Marsan, , France
Investigational Site Number : 2500006
Paris, , France
Investigational Site Number : 2500007
Pontoise, , France
Investigational Site Number : 2500003
Saint-Herblain, , France
Investigational Site Number : 2760003
Dresden, , Germany
Investigational Site Number : 2760001
Hanover, , Germany
Investigational Site Number : 2760002
Oldenburg in Holstein, , Germany
Investigational Site Number : 2760004
Ulm, , Germany
Investigational Site Number : 3480001
Balatonfüred, , Hungary
Investigational Site Number : 3480004
Budapest, , Hungary
Investigational Site Number : 3480002
Nyíregyháza, , Hungary
Investigational Site Number : 3480003
Nyíregyháza, , Hungary
Investigational Site Number : 3480006
Székesfehérvár, , Hungary
Investigational Site Number : 3800008
Torrette, Ancona, Italy
Azienda Ospedaliera Universitaria Meyer IRCCS-Site Number : 3800003
Florence, Firenze, Italy
IRCCS Ospedale San Raffaele-Site Number : 3800006
Milan, Milano, Italy
Azienda Ospedaliera Universitaria 'Federico II'-Site Number : 3800009
Naples, Napoli, Italy
Investigational Site Number : 3800007
Rome, Roma, Italy
Azienda Ospedaliero-Universitaria Maggiore Della Carità-Site Number : 3800001
Novara, , Italy
Azienda Socio Sanitaria Territoriale Dei Sette Laghi - Ospedale Filippo del Ponte-Site Number : 3800002
Varese, , Italy
Azienda Ospedaliera Universitaria Integrata Verona - Centro regionale di Diabetologia Pediatrica-Site Number : 3800004
Verona, , Italy
Investigational Site Number : 6160006
Warsaw, Masovian Voivodeship, Poland
Investigational Site Number : 6160004
Warsaw, Masovian Voivodeship, Poland
Investigational Site Number : 6160001
Warsaw, Masovian Voivodeship, Poland
Investigational Site Number : 6160007
Warsaw, Masovian Voivodeship, Poland
Investigational Site Number : 6160008
Bialystok, Podlaskie Voivodeship, Poland
Investigational Site Number : 6160002
Katowice, Silesian Voivodeship, Poland
Investigational Site Number : 6160009
Szczecin, West Pomeranian Voivodeship, Poland
Investigational Site Number : 6160005
Lodz, , Poland
Investigational Site Number : 7050001
Ljubljana, , Slovenia
Investigational Site Number : 7240001
Barcelona, Barcelona [Barcelona], Spain
Investigational Site Number : 7240002
Esplugues de Llobregat, Barcelona [Barcelona], Spain
Investigational Site Number : 7240005
Oviedo, Principality of Asturias, Spain
Investigational Site Number : 7240003
Seville, Sevilla, Spain
Investigational Site Number : 7240004
Málaga, , Spain
Investigational Site Number : 7240006
Valencia, , Spain
Investigational Site Number : 7240007
Vitoria-Gasteiz, Álava, Spain
Investigational Site Number : 7520002
Solna, , Sweden
Investigational Site Number : 7520001
Stockholm, , Sweden
Investigational Site Number : 7520003
Stockholm, , Sweden
Investigational Site Number : 8260001
Cambridge, Cambridgeshire, United Kingdom
Investigational Site Number : 8260009
Dundee, Dundee City, United Kingdom
Investigational Site Number : 8260003
Birmingham, England, United Kingdom
Investigational Site Number : 8260007
Birmingham, England, United Kingdom
Investigational Site Number : 8260010
Glasgow, Glasgow City, United Kingdom
Investigational Site Number : 8260004
Leicester, Leicestershire, United Kingdom
Investigational Site Number : 8260006
Harrow, London, City of, United Kingdom
Countries
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Central Contacts
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Trial Transparency email recommended (Toll free number for US & Canada)
Role: CONTACT
Phone: 800-633-1610
Email: [email protected]
Facility Contacts
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Lorenzo Lenzi
Role: primary
Pauline Grogan
Role: primary
Enza Mozzillo
Role: primary
Elisa Simonini
Role: primary
Adolfo Andrea Trettene
Role: primary
Claudia Piona
Role: primary
Related Links
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DRI17476 Plain Language Results Summary
Other Identifiers
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U1111-1275-9618
Identifier Type: REGISTRY
Identifier Source: secondary_id
2022-500531-36
Identifier Type: REGISTRY
Identifier Source: secondary_id
DRI17476
Identifier Type: -
Identifier Source: org_study_id