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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06812988




Registration number
NCT06812988
Ethics application status
Date submitted
31/01/2025
Date registered
6/02/2025

Titles & IDs
Public title
Treatment of Type 1 Diabetes With Anti-OX40L Bispecific With Anti-TNF Activity In a Single Nanobody® Molecule
Scientific title
A 52-week Randomized, Double-blind, Placebo-controlled, Multi-center Phase 2a Study Assessing Safety and Efficacy of SAR442970, a Dual Anti-TNF-a and Anti-OX40L NANOBODY® Molecule, for Preservation of Pancreatic ß-cell Function in Adults and Adolescents With Recently Diagnosed Type 1 Diabetes
Secondary ID [1] 0 0
U1111-1307-7268
Secondary ID [2] 0 0
ACT18368
Universal Trial Number (UTN)
Trial acronym
T1D OBTAIN
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Type 1 Diabetes Mellitus 0 0
Condition category
Condition code
Metabolic and Endocrine 0 0 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - SAR442970
Treatment: Drugs - Placebo

Experimental: SAR442970 - Participants will receive subcutaneous injection of SAR442970.

Placebo comparator: Placebo - Participants will receive subcutaneous injection of matching placebo.


Treatment: Drugs: SAR442970
Pharmaceutical form: Solution Route of administration: Subcutaneous injection

Treatment: Drugs: Placebo
Pharmaceutical form: Solution Route of administration: Subcutaneous injection
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change from baseline to Week 26 in mean 2-hour mixed meal tolerance test (MMTT) stimulated C-peptide concentration
Timepoint [1] 0 0
From Baseline to Week 26
Secondary outcome [1] 0 0
Change from baseline to Week 52 in mean 2-hour MMTT stimulated Cpeptide concentration
Timepoint [1] 0 0
From Baseline to Week 52
Secondary outcome [2] 0 0
Participant remaining C-peptide positive at Week 26 and Week 52
Timepoint [2] 0 0
Week 26 and Week 52
Secondary outcome [3] 0 0
Time in range (TIR) (70-180 mg/dL) at Week 26 and Week 52
Timepoint [3] 0 0
Week 26 and Week 52
Secondary outcome [4] 0 0
Change from baseline to Week 26 and Week 52 in insulin dose
Timepoint [4] 0 0
From Baseline to Week 26 and Week 52
Secondary outcome [5] 0 0
Change from baseline to Week 26 and Week 52 in glycated hemoglobin A1c (HbA1c) level
Timepoint [5] 0 0
From Baseline to Week 26 and Week 52
Secondary outcome [6] 0 0
Participant having HbA1c =6.5% and =0.25 IU/kg/day of exogenous insulin required at Week 26 and Week 52
Timepoint [6] 0 0
Week 26 and Week 52
Secondary outcome [7] 0 0
Incidence of treatment emergent adverse events (TEAEs), serious adverse events (SAEs), adverse events of special interest (AESIs) and TEAEs leading to treatment discontinuation
Timepoint [7] 0 0
Up to End of Study (approx. 83 Weeks)
Secondary outcome [8] 0 0
Incidence (yes/no) of hypoglycemic events (level 2 or 3 according to American Diabetes Association)
Timepoint [8] 0 0
Up to End of Study (approx. 83 Weeks)
Secondary outcome [9] 0 0
Incidence (yes/no) of hyperglycemic episodes (level 2 according to American Diabetes Association)
Timepoint [9] 0 0
Up to End of Study (approx. 83 Weeks)
Secondary outcome [10] 0 0
Incidence (yes/no) of diabetic ketoacidosis (DKA) events
Timepoint [10] 0 0
Up to End of Study (approx. 83 Weeks)
Secondary outcome [11] 0 0
Incidence (yes/no) of clinically significant changes in vital signs, electrocardiogram (ECG), and/or laboratory evaluation
Timepoint [11] 0 0
Up to End of Study (approx. 83 Weeks)
Secondary outcome [12] 0 0
SAR442970 serum concentrations over time
Timepoint [12] 0 0
Up to End of Study (approx. 83 Weeks)
Secondary outcome [13] 0 0
Incidence of anti-drug antibodies (ADAs) over time
Timepoint [13] 0 0
Up to End of Study (approx. 83 Weeks)
Secondary outcome [14] 0 0
Change from baseline to Week 26 and Week 52 in Problem Areas in Diabetes (PAID) total score (all participants)
Timepoint [14] 0 0
From Baseline to Week 26 and Week 52
Secondary outcome [15] 0 0
Change from baseline to Week 26 and Week 52 in PAID immediate and theoretical domain scores (caregivers of all participants 12 to 17 y.o.)
Timepoint [15] 0 0
From Baseline to Week 26 and Week 52

Eligibility
Key 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.
Minimum age
12 Years
Maximum age
35 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
28/02/2025
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
13/09/2028
Actual
Sample size
Target
84
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD
Recruitment hospital [1] 0 0
Investigational Site Number : 0360003 - Saint Leonards
Recruitment hospital [2] 0 0
Investigational Site Number : 0360002 - Brisbane
Recruitment postcode(s) [1] 0 0
2065 - Saint Leonards
Recruitment postcode(s) [2] 0 0
4029 - Brisbane
Recruitment outside Australia
Country [1] 0 0
Canada
State/province [1] 0 0
British Columbia
Country [2] 0 0
Chile
State/province [2] 0 0
Biobío
Country [3] 0 0
Chile
State/province [3] 0 0
Reg Metropolitana De Santiago

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Sanofi
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Trial Transparency email recommended (Toll free for US & Canada)
Address 0 0
Country 0 0
Phone 0 0
800-633-1610
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

Data sharing statement


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT06812988