FABULINUS Study: Frexalimab for Newly Diagnosed Type 1 Diabetes
This study is testing a drug called frexalimab against a placebo (an inactive substance) in people with newly diagnosed Type 1 Diabetes (T1D). All participants will also be on insulin therapy. The main goal is to see if frexalimab can help preserve your body's own insulin production, measured by a substance called C-peptide, over 26 or 52 weeks. You may be able to join if you are between 6 and 35 years old, have T1D, and started insulin therapy within the last 90 days. The study aims to enroll 197 participants.
- Study design
- This is a Phase 2, randomized, double-blind study. This means participants are randomly assigned to receive either frexalimab or placebo, and neither you nor your doctors will know which you are receiving.
- What's involved
- The study involves a screening period of 3 to 5 weeks. The main treatment period lasts 26 or 52 weeks, followed by a blinded extension period of 26 or 52 weeks, and an optional open-label extension period of 104 weeks. There is also a 26-week safety follow-up.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be followed for safety for 26 weeks after the treatment period ends.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
NCT06111586
Frexalimab in Preservation of Endogenous Insulin Secretion Compared to Placebo in Adults, Adolescents and Children on Top of Insulin Therapy (FABULINUS)
Active, Not Recruiting
PHASE2Ages 6–35InterventionalTreatmentSanofi
~197 participants
Updated 2026-06-29 on ClinicalTrials.gov
What's tested:FrexalimabPlaceboInsulin
At a glance
Recruiting sites
0 of 79 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
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.)
Measured over Baseline to Week 52
+1 more outcome measured
Conditions
Where it's being run
79 sites across 47 statesFrance5
Hungary5
Finland4
Germany4
Florida3
Austria3
Quebec3
Czechia3
Who to contact
This trial hasn't published a contact. View it on ClinicalTrials.gov
Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
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
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.
What this trial measures
- 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.)Baseline to Week 52
mixed meal tolerance test (MMTT) stimulated C-peptide concentration is to be calculated from AUC
- 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.)Baseline to Week 26
mixed meal tolerance test (MMTT) stimulated C-peptide concentration is to be calculated from AUC