Informations générales (source: ClinicalTrials.gov)
A 52-week Randomized, Double-blind, Placebo-controlled, Multi-center Phase 2b Study With a 52-week Blinded Extension Assessing Safety and Efficacy of Frexalimab, a CD40L-antagonist Monoclonal Antibody, for Preservation of Pancreatic β-cell Function in Adults and Adolescents With Newly Diagnosed Type 1 Diabetes on Insulin Therapy
Interventional
Phase 2
Sanofi (Voir sur ClinicalTrials)
décembre 2023
octobre 2028
11 septembre 2025
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.
Etablissements
| Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| HOPITAL NOVO | CAMPINOS Catherine | 18/09/2025 17:50:07 | Contacter | ||
Critères
Tous
- 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
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), except autoimmune thyroiditis with controlled function of thyroid gland
and celiac disease (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.