临床试验/2022-500531-36-00

2022-500531-36-00招募中2 期

A 52-week randomized, double-blind, placebo-controlled, multi-center Phase 2b study with a 52-week blinded extension and an optional open-label extension—assessing the safety and efficacy of frexalimab, a CD40L-antagonist monoclonal antibody, for the preservation of pancreatic β-cell function in adults and adolescents with newly diagnosed type 1 diabetes on insulin therapy

Sanofi-Aventis Recherche & Developpement59 个研究点分布在 12 个国家目标入组 192 人开始时间: 2023年12月18日最近更新: 2025年6月18日

适应症

干预措施

试验速览

阶段: 2 期
状态: 招募中
发起方
入组人数: 192
试验地点: 59
主要终点: Change from baseline to W52 in mean 2h mixed meal tolerance test (MMTT) stimulated C-peptide concentration

研究概览入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

To demonstrate the efficacy of different doses of frexalimab in comparison with placebo and in addition to standard of care (SOC) on endogenous insulin secretion in participants (12-21 y.o.) with newly diagnosed T1D over a 52-week period.

入排标准

年龄范围: 0 years 至 64 years（18-64 Years, 0-17 Years）
接受健康志愿者: 是

入选标准

•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 o one or multiple daily injections (MDI) of basal insulin, prandial insulin and/or premixed insulin, or o 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: o Glutamic acid decarboxylase (GAD-65) o Insulinoma Antigen-2 (IA-2) o Zinc-transporter 8 (ZnT8) or o 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

排除标准

•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.
•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.
•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, 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.

研究组 & 干预措施

-

Auxiliary

Participants receiving -

干预措施: - (Drug)

结局指标

主要结局

Change from baseline to W52 in mean 2h mixed meal tolerance test (MMTT) stimulated C-peptide concentration

次要结局

Time in range (70-180 mg/dL), assessed by CGM at W52 and W104
Time in tight range (TITR, 70 – 140 mg/dL), assessed by CGM at W52 and W104
Change from baseline to W104 in mean 2h mixed meal tolerance test (MMTT) stimulated C-peptide concentration, calculated from AUC
Proportion of participants who remain C-peptide positive (mean 2h MMTT stimulated C-peptide concentration ≥0.2 nmol/L) at W52 and W104
Proportion of participants with reduction from baseline to W52 and W104 of less than 10% in mean 2h MMTT stimulated C-peptide concentration
Proportion of participants with partial remission at W52 and W104 (defined as IDAA1c score ≤9.0, where it is calculated as HbA1c [%] + 4x insulin dose [IU/kg/day])
Change from baseline to W52 in IDAA1c score
Change from baseline to W52 and W104 in insulin dose [IU/kg/day]
HbA1c level and its change from baseline at W52 and W104
Proportion of participants with HbA1c ≤6.5% and requiring no injections of exogenous insulin at W52 and W104
Proportion of participants with HbA1c ≤6.5% and requiring ≤0.25 IU of insulin at W52 and W104
Proportion of participants with HbA1c <7% at W52 and W104
Incidence of treatment emergent adverse events (TEAEs), serious adverse events (SAEs), adverse events of special interest (AESIs) and TEAEs leading to treatment discontinuation
Number of participants with at least one hypoglycemic event
Number of participants with at least one hyperglycemic episode
Number of participants with at least one diabetic ketoacidosis (DKA) event
Number of participants with clinically significant changes in vital signs, electrocardiogram (ECG), and/or laboratory evaluation
Height and growth rate over time (for participants <18 y.o. at screening)
Frexalimab plasma concentrations over time and PK parameters
Incidence of anti-drug antibodies (ADAs) over time
Change from baseline to W52 and W104 in PedsQL Diabetes Symptoms domain score (all participants)
Change from baseline to W52 and W104 in Pediatric Quality of Life (PedsQL) Diabetes Management domain score (all participants)
Change from baseline to W52 and W104 in Problem Areas In Diabetes (PAID) total score (all participants)
Change from baseline to W52 and W104 in Diabetes Treatment Satisfaction Questionnaires (DTSQs) total and item scores (all participants)
Change from baseline to W52 and W104 in PAID immediate and theoretical domain scores (caregivers of all participants 12-17 y.o.)
Change from baseline to W52 and W104 in DTSQs Total and item scores (caregivers of all participants 12-17 y.o.)

研究者

发起方

Sanofi-Aventis Recherche & Developpement

申办方类型

Pharmaceutical company

责任方

Principal Investigator

主要研究者

Clinical Sciences and Operations

Scientific

Sanofi-Aventis Research & Development

研究点 (59)

Loading locations...

相似试验

招募中

3 期

A Study to Learn About the Effects of Felzartamab Infusions on Adults With Immunoglobulin A Nephropathy (IgAN) ( PREVAIL )

2024-519345-30-00Biogen Idec Research Limited201

已完成

2 期

Dose ranging study of amlitelimab in adult participants with moderate-to-severe asthmaAsthma

2024-510641-33-00Sanofi-Aventis Recherche & Developpement104

进行中（未招募）

3 期

在非复发性继发进展型多发性硬化成人中进行的 frexalimab(SAR441344)的疗效和安全性研究

CTR2024168020

招募中

4 期

Aflibercept 8mg for high-frequent Faricimab and prior Aflibercept 2mg treated Neovascular age-related macular degeneration: a monocenter, single-arm, open-label extension study (A-FAN)

2024-515497-26-00Medical University Of Graz33

招募中

3 期

C2321003: A Study to Learn About the Investigational Medicine Called PF-06821497 (Mevrometostat) in Men with Metastatic Castration-Resistant Prostate Cancer Who Have Not Tried Novel Hormonal Therapy or Chemotherapy for Metastatic Prostate Cancer (MEVPRO-2)

2024-511652-40-00Pfizer Inc.328