Last updated 9 days ago

Treatment of Type 1 Diabetes With Anti-OX40L Bispecific With Anti-TNF Activity In a Single Nanobody® Molecule

84 patients around the world

Available in Chile

The total study duration will be up to 83 weeks including Screening and Safety follow-up period.

Sanofi

84Patients around the world

This study is for people with

Diabetes

Diabetes mellitus type 1

Requirements for the patient

To 35 Years

All Gender

Medical requirements

: 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.
Participants who meet the criteria of T1D according to American Diabetes Association (ADA 2024).
Initiated exogenous insulin replacement therapy not longer than 90 days prior to Screening visit at which random C-peptide will be assessed.
Receiving insulin hormone replacement therapy.
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).
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.

: Serious systemic viral, bacterial or fungal infection, infection requiring hospitalization or intravenous antibiotics or significant chronic viral, bacterial, or fungal infection 30 days before and during Screening.
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 as documented by medical history and examination, chest X-rays, and/or TB testing.
Evidence of any clinically significant, severe or unstable, acute or chronically progressive, uncontrolled infection, medical or surgical condition, or any condition that may affect participant safety in the judgment of the Investigator.
History of a systemic hypersensitivity reaction or significant allergies, other than localized injection site reaction, to any humanized mAb.
History of moderate to severe congestive heart failure, 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.
History of demyelinating disease or neurologic symptoms suggestive of demyelinating disease.
Has other autoimmune or inflammatory conditions.
Diabetes of forms other than autoimmune T1D that include but are not limited to genetic forms of diabetes, maturity-onset diabetes of the young, latent autoimmune diabetes of the adult, secondary to medications or surgery, type 2 diabetes by judgment of the investigator.
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.
Systemic corticosteroids duration greater than 7 days, adrenocorticotropic hormone 1 month prior to Screening.
Any IV, intramuscular or SC administered biologic treatments within 3 months or 5 half-lives prior to randomization.
Any live vaccine within 3 months prior to randomization or is scheduled in expected period of study if this vaccination cannot be safely postponed.
Any non-live vaccine administered less than 14 days prior to randomization.
Any immunosuppressive therapy within 12 weeks prior to randomization and through 78 weeks after 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 within 2 weeks prior to Screening.
Abnormal laboratory test(s) at Screening.
Participants who have impaired renal function with estimated glomerular filtration rate less than 60 mL/min/1.73 m2.

StudyT1D OBTAIN

SponsorSanofi

Study typeInterventional

Conditions

Diabetes mellitus type 1

Requirements

To 35 YearsAll Gender

Unique study IDclinicaltrials.gov

NCT06812988