Treatment for Type 1 Diabetes using a new medication

A 52-week Randomized, Double-blind, Placebo-controlled, Multi-center Phase 2a Study Assessing Safety and Efficacy of SAR442970, a Dual Anti-TNF-α and Anti-OX40L NANOBODY® Molecule, for Preservation of Pancreatic β-cell Function in Adults and Adolescents With Recently Diagnosed Type 1 Diabetes

This study is testing a new medication to see if it can help people with newly diagnosed type 1 diabetes keep their insulin-producing cells working better.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 84 (estimated)
• Ages: 12 Years to 35 Years
• Sex: All
• Sponsor: Sanofi (Industry-sponsored)
• Drugs / interventions: teplizumab
• Locations: 12 sites (Buenos Aires and 11 other locations)
• Trial ID: NCT06812988 on ClinicalTrials.gov

What this trial studies

This Phase 2a clinical trial evaluates the safety and efficacy of SAR442970, a bispecific molecule with anti-TNF activity, in preserving β-cell function in individuals with recently diagnosed type 1 diabetes. The study is randomized, placebo-controlled, and includes two parts: one for adults aged 18 to 35 and another for adolescents and young adults aged 12 to 21. Participants will be monitored over a total duration of up to 83 weeks, including a 52-week treatment period and a 26-week safety follow-up. Approximately 84 participants will be enrolled, with a randomization ratio of 3:1 for active treatment versus placebo.

Who should consider this trial

Good fit: Ideal candidates are individuals aged 12 to 35 who have been diagnosed with type 1 diabetes and have started insulin therapy within the last 90 days.

Not a fit: Patients who are older than 35 or have been on insulin therapy for more than 90 days may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could help preserve insulin-producing β-cells in patients with type 1 diabetes, potentially improving their long-term health outcomes.

How similar studies have performed: Other studies have explored similar approaches in type 1 diabetes treatment, but the specific bispecific molecule used in this trial is novel.

Eligibility criteria

Inclusion Criteria:

1. Participant must be 18 to 35 y.o. inclusive, at the time of signing the informed consent in order to be enrolled in Part A. Participant must be 12 to 21 y.o. inclusive, at the time of signing the informed consent in order to be enrolled in Part B.
2. Participants who meet the criteria of T1D according to American Diabetes Association (ADA 2024).
3. Initiated exogenous insulin replacement therapy not longer than 90 days prior to Screening visit at which random C-peptide will be assessed.
4. Receiving insulin hormone replacement therapy:
5. 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)
6. Have random C-peptide levels ≥0.2 nmol/L determined at Screening.

Exclusion Criteria:

Participants are excluded from the study if any of the following criteria apply:

1. Serious systemic viral, bacterial or fungal infection (eg, pneumonia, pyelonephritis), infection requiring hospitalization or intravenous (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.
2. History of invasive opportunistic infections, such as, but not limited to histoplasmosis, listeriosis, coccidioidomycosis, candidiasis, pneumocystis jirovecii, and aspergillosis, regardless of resolution.
3. 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.
4. 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, 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).
5. 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).
6. History of moderate to severe congestive heart failure (New York Health Association \[NYHA\] Class III or IV), or recent cerebrovascular accident, or any other condition which, in the opinion of the Investigator, would put the participant at risk by participation in the protocol.
7. History of demyelinating disease (including myelitis) or neurologic symptoms suggestive of demyelinating disease.
8. Has other autoimmune or inflammatory conditions
9. Diabetes of forms other than autoimmune T1D that include but are 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 judgment of the investigator.
10. History of malignancy or lymphoproliferative disease other than adequately treated localized carcinoma in situ of the cervix or nonmetastatic squamous cell carcinoma, or nonmetastatic basal cell carcinoma of the skin that was excised and completely cured or any family history in two or more relatives (immediate family) of same cancer (ie, rare cancers, those manifesting at a young age in a parent or sibling, certain genetic-based inheritable cancers).
11. Systemic corticosteroids (duration \>7 days), adrenocorticotropic hormone 1 month prior to Screening.
12. Any IV, intramuscular (IM) or SC administered biologic treatments (mono- or polyclonal antibodies affecting function of immune system), \<3 months or \<5 half-lives (whichever is longer), prior to randomization.
13. 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 or is scheduled in expected period of study (78 weeks after randomization) if this vaccination cannot be safely postponed.
14. Any non-live (inactivated, mRNA, recombinant, conjugate, toxoid) vaccine administered less than 14 days prior to randomization.
15. Any immunosuppressive therapy within 12 weeks prior to randomization and through 78 weeks after randomization
16. Course of Thymoglobulin®, teplizumab or other immunomodulatory treatments at any time
17. 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, sodium-glucose co-transporter-2 and 1 (SGLT2/1) inhibitor, and verapamil within 2 weeks prior to Screening.
18. Abnormal laboratory test(s) at Screening
19. Participants who have impaired renal function with estimated glomerular filtration rate (eGFR) (using the Modification of Diet in Renal Disease \[MDRD\] formula) \<60 mL/min/1.73 m2, or using the bedside Schwartz equation in the participants under the age of 18 y.o.

Where this trial is running

Buenos Aires and 11 other locations

• Investigational Site Number : 0320001 — Buenos Aires, Argentina (Recruiting)
• Investigational Site Number : 0360003 — Saint Leonards, New South Wales, Australia (Recruiting)
• Investigational Site Number : 0360002 — Brisbane, Queensland, Australia (Recruiting)
• Investigational Site Number : 0360001 — Parkville, Victoria, Australia (Recruiting)
• Investigational Site Number : 1240006 — Surrey, British Columbia, Canada (Recruiting)
• Investigational Site Number : 1240001 — Vancouver, British Columbia, Canada (Recruiting)
• Investigational Site Number : 1520004 — Concepción, Biobío, Chile (Recruiting)
• Investigational Site Number : 1520001 — Santiago, Reg Metropolitana De Santiago, Chile (Recruiting)
• Investigational Site Number : 1520003 — Santiago, Reg Metropolitana De Santiago, Chile (Recruiting)
• Investigational Site Number : 3760001 — Jerusalem, Israel (Recruiting)
• Investigational Site Number : 3760003 — Kefar Sava, Israel (Recruiting)
• Investigational Site Number : 3760002 — Ramat Gan, Israel (Recruiting)

Study contacts

• Study coordinator: Trial Transparency email recommended (Toll free for US & Canada)

Conditions Type 1 Diabetes Mellitus