Efficacy and Safety of Teplizumab in the Treatment of Japanese Pediatric and Adult Participants Aged 8 to 34 Years With Stage 2 Type 1 Diabetes: A Multicenter, Randomized, Open-label, Controlled Study.

This is a parallel, Phase 2, two-arm study to assess the efficacy and safety of 14-days intravenous (IV) infusion of teplizumab treatment.
Teplizumab has been approved by FDA to delay the onset of Stage 3 Type 1 Diabetes (T1D) in adults and pediatric patients aged 8 years and older with Stage 2 T1D. The dose regimen of teplizumab in this study is consistent with the regimen approved by US FDA.
Given prior clinical studies conducted in Western countries, this design is appropriate to assess the efficacy, safety and tolerability, pharmacokinetic, pharmacodynamic, and immunogenicity of a 14-day IV infusion regimen of teplizumab in Japanese Stage 2 T1D participants aged 8 to 34 years.

Start Date30 Apr 2025

Sponsor / Collaborator

Sanofi

NCT06892002

/ RecruitingNot Applicable

A Real-World Observational Study Characterizing Patients With Type 1 Diabetes Treated With Teplizumab

Type 1 diabetes mellitus (T1D) is a chronic autoimmune disease caused by the destruction of pancreatic β cells. T1D pathogenesis progresses through several stages: Stage 1 T1D includes the presence of β cell autoimmunity and thus presence of islet autoantibodies, without the presence of dysglycemia and symptoms. Stage 2 T1D includes the presence of islet autoantibodies and dysglycemia, also with no symptoms. Stage 3 T1D includes presence of islet autoantibodies, overt hyperglycemia, and symptoms; most patients with Stage 3 T1D meet standard diagnostic criteria for diabetes and require insulin treatment.
Teplizumab has been shown to delay progression to Stage 3 in participants at Stage 2 in a Phase 2 clinical trial, leading to subsequent approval in the United States of America (USA). Patients outside of the USA are able to receive the treatment through Pre-Registration Import Licenses and Managed Access Programs. The current study will collect data on the use of teplizumab in routine care, to better understand which patients received teplizumab and how these patients were managed after they received the treatment.

Start Date11 Feb 2025

Sponsor / Collaborator

Sanofi

NCT06481904

/ RecruitingNot Applicable

An Observational, Long-term Safety Study of TZIELD® (Teplizumab-mzwv) in Patients With Stage 2 Type 1 Diabetes

Stage 2 Type 1 Diabates (T1D) is an early stage of T1D characterized by dysglycemia but not yet leading to clinical symptoms. Progression of the disease to Stage 3 (clinical T1D), leads to overt hyperglycemia requiring eventually exogenous insulin.
TZIELD® (teplizumab-mzwv) has been approved to delay onset of stage 3 T1D, by the United States (US) Food and Drug Administration (FDA) for adults and children aged 8 years and older with Stage 2 T1D.
The purpose of this study is to collect general information on patients with stage 2 T1D and further information on the long-term effects of TZIELD® in patients with Stage 2 T1D, treated as per standard of care.

Start Date27 Sep 2024

Sponsor / Collaborator

Sanofi

100 Clinical Results associated with Teplizumab

100 Translational Medicine associated with Teplizumab

100 Patents (Medical) associated with Teplizumab

598

Literatures (Medical) associated with Teplizumab

01 Jun 2025·CURRENT OPINION IN IMMUNOLOGY

Pharmacotherapeutic strategies to promote regulatory T cell function in autoimmunity

Review

Author: Campbell, Daniel J ; Wright, Robert C ; Levings, Megan K

Autoimmune diseases arise when self-antigen-specific T and B cells escape central and peripheral mechanisms of tolerance. One such mechanism is control of autoreactivity by regulatory T cells (Tregs), which have an essential role in suppressing autoimmunity. Consequently, there is significant interest in developing ways to boost or restore the function of Tregs in order to prevent or treat autoimmunity, induce tolerance, and thus reduce the reliance on broadly immunosuppressive agents. Strategies include enhancing the numbers and/or function of Tregs directly in vivo or via adoptive cell therapy. Here, we review recent advances in our understanding of how pharmacologic approaches can be applied to enhance Treg function in vivo through repurposing of established drug therapies or application of new therapies. Specifically, we discuss the potential of Treg-promoting drugs, including interleukin-2 and its derivatives, and tumor necrosis factor receptor 2 agonists, as well as Treg-preserving tyrosine kinase 2 inhibitors. We discuss how co-stimulatory blockade with CTLA-4 immunoglobulin affects tolerogenic environments and consider whether lymphodepleting therapies, such as antithymocyte globulin and teplizumab, might be needed to condition the environment for better Treg-promoting effects. We focus on the potential application of Treg-promoting drugs in type 1 diabetes and draw on evidence from transplantation. With multiple pharmacotherapeutic strategies to optimize Tregs in vivo, there is significant promise for new approaches to effectively and durably induce autoimmune disease remission.

01 May 2025·DIABETES OBESITY & METABOLISM

Real‐world experiences of adult individuals or caregivers of children who received teplizumab treatment in stage 2 type 1 diabetes

Article

Author: D'Souza, Jennifer ; Dex, Terry ; Gitelman, Stephen E. ; O'Donnell, Holly K. ; Ginchereau Sowell, France ; Simmons, Kimber M. ; Wieloch, Mattias ; Hill, Robert ; Turnbull, James ; Hood, Korey K. ; Zaccai, Julia

Abstract:

Aims:

This study surveyed individuals and caregivers of children who received teplizumab at stage 2 type 1 diabetes (T1D) to garner real‐world experiences and their health outlook for the future following treatment with the first approved disease‐modifying immune therapy for delaying the onset of Stage 3 T1D.

Materials and Methods:

This was a cross‐sectional, observational, online survey (conducted September–October 2024) of adults (≥18 years) and caregivers of children (8–17 years) who received teplizumab while participating in the US COMPASS patient support program. Questions pertained to demographics, health history, T1D screening, the decision to take teplizumab, treatment, post‐treatment experience, outlook on prognosis and self‐reported health status. All data were summarized using descriptive statistics.

Results:

A total of 47/116 invited individuals responded (30 adults, 17 caregivers of children). Almost half of respondents had a family history of T1D, and 36% reported autoimmune comorbidities. The top reason for both screening for T1D and receiving teplizumab was for a chance at delaying Stage 3 T1D. Although respondents expressed continued concern over diabetes progression, 87% felt grateful to receive teplizumab, 72% felt it would help slow down the disease, 60% felt it would make T1D easier to manage and most (>80%) would recommend treatment/make the same decision for another family member.

Conclusions:

Individuals living with or caring for someone who received teplizumab felt grateful for the opportunity to delay disease or make it easier to manage following teplizumab, with most agreeing they would recommend teplizumab and make the same decision for family in their situation.

Plain Language Summary:

Type 1 diabetes (T1D) happens when the body destroys cells in the pancreas that make insulin. This ultimately causes high blood sugar. People with T1D often worry about the long‐term effects of the disease. Teplizumab is the first FDA‐approved treatment that delays the onset of high blood sugar in people in the early stages of T1D—when there are signs of cell damage and mild increases in blood sugar. We surveyed adults (N = 30) and caregivers (N = 17) of children treated with teplizumab about their journey before and after treatment. More than half of adults were initially told they might have a different type of diabetes, usually type 2, before being accurately diagnosed with early‐stage T1D. Doctors specializing in diabetes were most often the ones who recommended screening for T1D. The most common reason to screen was a chance for more time before the onset of high blood sugar. Greater than 80% of people were grateful they or their child had the opportunity to receive teplizumab, and most would recommend it to others in a similar situation. After receiving teplizumab, most people still worried about their blood sugar and measured it frequently. Most thought that teplizumab would delay the disease progression to symptoms, and more than half thought teplizumab would make T1D easier to manage. These findings are the first to describe the journey of adults and caregivers of children treated with teplizumab, their reasons for screening, and their beliefs about the future.

01 Apr 2025·DRUGS

Emerging Immunotherapies for Disease Modification of Type 1 Diabetes

Review

Author: Bruggeman, Brittany S ; Foster, Timothy P ; Haller, Michael J

Type 1 diabetes mellitus (T1DM) is characterized by the progressive, autoimmune-mediated destruction of β cells. As such, restoring immunoregulation early in the disease course is sought to retain endogenous insulin production. Nevertheless, in the more than 100 years since the discovery of insulin, treatment of T1DM has focused primarily on hormone replacement and glucose monitoring. That said, immunotherapies are widely used to interdict autoimmune and autoinflammatory diseases and are emerging as potential therapeutics seeking the preservation of β-cell function among those with T1DM. In the past 4 decades of diabetes research, several immunomodulatory therapies have been explored, culminating with the US Food and Drug Administration approval of teplizumab to delay stage 3 (clinical) onset of T1DM. Clinical trials seeking to prevent or reverse T1DM by repurposing immunotherapies approved for other autoimmune conditions and by exploring new therapeutics are ongoing. Collectively, these efforts have the potential to transform the future of diabetes care. We encapsulate the past 40 years of immunotherapy trials, take stock of our successes and failures, and chart paths forward in this new age of clinically available immune therapies for T1DM.

168

News (Medical) associated with Teplizumab

14 Mar 2025

·www.globenewswire.com

Tiziana Life Sciences Regains Compliance with Nasdaq Listing Minimum Bid Price Rule

NEW YORK, March 14, 2025 (GLOBE NEWSWIRE) -- Tiziana Life Sciences, Ltd. (Nasdaq: TLSA) (“Tiziana” or the “Company”), a biotechnology company developing breakthrough immunomodulation therapies with its lead development candidate, intranasal foralumab, a fully human, anti-CD3 monoclonal antibody, today announced that it has received a notification from the Nasdaq Stock Market LLC (“Nasdaq”) Listing Qualifications Department informing the Company that it has regained compliance with the Nasdaq listing minimum bid price requirement for continued listing on the Nasdaq Capital Market exchange. Tiziana was previously notified by Nasdaq on January 29, 2025 that it was not in compliance with the minimum bid-price listing rule (under Rule 5550(a)(2)) because its common stock failed to meet the closing bid price of $1.00 or more for 30 consecutive business days. To regain compliance, the Company was required to maintain a minimum closing bid price of $1.00 or more for at least ten consecutive trading days which was met on March 12, 2025. Accordingly, the Company has regained compliance with Listing Rule 5550(a)(2), and this matter is now closed. The Company’s securities will continue to be listed and traded on The Nasdaq Stock Market. About Foralumab Foralumab, a fully human anti-CD3 monoclonal antibody, is a biological drug candidate that has been shown to stimulate T regulatory cells when dosed intranasally. At present, 10 patients with Non-Active Secondary Progressive Multiple Sclerosis (na-SPMS) have been dosed in an open-label intermediate sized Expanded Access (EA) Program (NCT06802328) with either an improvement or stability of disease seen within 6 months in all patients. The FDA has recently allowed an additional 20 patients to be enrolled in this EA program. In addition, intranasal foralumab is currently being studied in a Phase 2a, randomized, double-blind, placebo-controlled, multicenter, dose-ranging trial in patients with non-active secondary progressive multiple sclerosis (NCT06292923). Activated T cells play an important role in the inflammatory process. Foralumab, the only fully human anti-CD3 monoclonal antibody (mAb) currently in clinical development, binds to the T cell receptor and dampens inflammation by modulating T cell function, thereby suppressing effector features in multiple immune cell subsets. This effect has been observed in patients with COVID and with multiple sclerosis, as well as in healthy normal subjects. The non-active SPMS intranasal foralumab Phase 2 trial (NCT06292923) began screening patients in November of 2023. Immunomodulation by nasal anti-CD3 mAb represents a novel avenue for treatment of neuroinflammatory and neurodegenerative human diseases.[1],[2] About Tiziana Life Sciences Tiziana Life Sciences is a clinical-stage biopharmaceutical company developing breakthrough therapies using transformational drug delivery technologies to enable alternative routes of immunotherapy. Tiziana’s innovative nasal approach has the potential to provide an improvement in efficacy as well as safety and tolerability compared to intravenous (IV) delivery. Tiziana’s lead candidate, intranasal foralumab, which is the only fully human anti-CD3 mAb currently in clinical development, has demonstrated a favorable safety profile and clinical response in patients in studies to date. Tiziana’s technology for alternative routes of immunotherapy has been patented with several applications pending and is expected to allow for broad pipeline applications. For more information about Tiziana Life Sciences and its innovative pipeline of therapies, please visit www.tizianalifesciences.com. For further inquiries: Tiziana Life Sciences LtdPaul Spencer, Business Development, and Investor Relations+44 (0) 207 495 2379email: info@tizianalifesciences.com [1] https://www-pnas-org.libproxy1.nus.edu.sg/doi/10.1073/pnas.2220272120[2] https://www-pnas-org.libproxy1.nus.edu.sg/doi/10.1073/pnas.2309221120

ImmunotherapyPhase 2

31 Dec 2024

·www.echemi.com

7 New Drugs Expected to Be Approved in 2025

In 2024, China approved several new drugs, and more blockbuster drugs are expected to be launched in 2025, covering oncology, autoimmune diseases, rare diseases, and other therapeutic areas. Drug Name Mechanism of Action Indications Development Institutions Evantuzumab c-Met/EGFR bispecific antibody Non-small cell lung cancer Johnson & Johnson; Genmab Taqetuzumab CD3/GPRC5D bispecific antibody Multiple myeloma Johnson & Johnson; Genmab Zenidatuzumab Anti-HER2 bispecific antibody Biliary tract cancer Zymeworks; Jazz Pharmaceuticals; BeiGene Inalises PI3Kα inhibitor HR-positive breast cancer Roche; Chugai Pharmaceutical Asunitinib STAMP allosteric inhibitor Speculated use for chronic myeloid leukemia treatment Novartis Tazemetostat EZH2 inhibitor Follicular lymphoma Epizyme; Huadong Medicine; Eisai Relatuzumab-alpha PDL1/TGF-β bispecific antibody Stomach cancer; gastroesophageal junction cancer Hengrui Medicine; Dong-A Pharma Vabysmo EGFR antibody-drug conjugate Nasopharyngeal cancer Lepu Biopharma Tenapanor NHE3 inhibitor Chronic kidney disease hyperphosphatemia Ardelyx; Kyowa Kirin; Fosun Pharma; AstraZeneca Mersutide OXM analog; GLP-1R/GCGR agonist Obesity Eli Lilly; Innovent Biologics Vusirumab IL-1β monoclonal antibody Gouty arthritis Junshi Biosciences Romosozumab SOST monoclonal antibody Osteoporosis Astellas; Amgen; UCB Teplizumab CD3 monoclonal antibody Type 1 diabetes Ligand Pharmaceuticals; Johnson & Johnson; Sanofi Solrepinib Syk inhibitor Immune thrombocytopenic purpura Huadong Medicine BBM-H901 Factor IX gene therapy Hemophilia B Gene Therapy Fitusiran RNAi therapy Hemophilia A; Hemophilia B Sanofi; Alnylam Andexanet alfa Recombinant factor Xa Factor Xa inhibitor antidote Portola Pharmaceuticals Lisocabtagene maraleucel IL-23p19 monoclonal antibody Crohn's disease Boehringer Ingelheim; AbbVie Lemborexant & Daridorexant OX1R antagonist; OX2R antagonist Insomnia Eisai & Idorsia; Sihuan Pharmaceutical; Nxera Pharma Highlights of new drug approvals in 2024 include: 1. Oncology: The world’s first antibody-drug conjugate (ADC) targeting folate receptor alpha (FRα) for ovarian cancer: Mirvetuximab soravtansine. PD-1/VEGF bispecific antibody envafolimab and Nectin-4 ADC enfortumab vedotin. 2. Autoimmune diseases: IL-17A/F monoclonal antibody bimekizumab for ankylosing spondylitis. 3. Rare diseases: Novartis’ complement factor B inhibitor for paroxysmal nocturnal hemoglobinuria (PNH). Blockbuster drugs expected to be approved in 2025 include: Oncology: Amivantamab (Q1) The world’s first c-Met/EGFR bispecific antibody. Highlight: Phase III study showed significant extension of median progression-free survival (mPFS). Talquetamab (Q2) A CD3/GPRC5D bispecific antibody and the world’s first drug targeting GPRC5D. Clinical results: Objective response rate (ORR) in Chinese patients was 69.0%-73.6%. Zanidatamab (Q2) A HER2-targeting bispecific antibody based on Azymetric™ technology. Indication: HER2-positive biliary tract cancer (BTC) with an ORR of up to 52%. Inavolisib (Q3) Roche’s highly selective PI3Kα inhibitor for PIK3CA-mutated breast cancer. Asciminib (Q3) Novartis’ Bcr-Abl allosteric inhibitor for Philadelphia chromosome-positive chronic myeloid leukemia (CML). SHR-1701 (Q4) A PD-L1/TGF-βRII bifunctional fusion protein for first-line treatment of gastric cancer. Phase III study demonstrated significant extension in median overall survival. MRG003 (Q4) China’s first EGFR-targeting ADC with remarkable efficacy in nasopharyngeal carcinoma. Endocrinology and Metabolism: Tenapanor (Q1) The world’s only approved NHE3 inhibitor for controlling hyperphosphatemia in chronic kidney disease patients. Trend Analysis: Continued Innovation in Oncology: The emergence of multiple bispecific antibodies and ADC drugs is making targets and treatment options more precise and diverse. Breakthroughs in Autoimmune and Rare Diseases: New biologics are gradually addressing drug resistance and limited treatment options in previous therapies. Emergence of Domestic Innovative Drugs: Examples include SHR-1701 and MRG003, highlighting the growing research and development capabilities of Chinese pharmaceutical companies. The sequential launch of these drugs will provide new therapeutic options for Chinese patients and enhance China’s position in the global pharmaceutical market.

Drug ApprovalPhase 3Clinical ResultADCImmunotherapy

17 Dec 2024

·pipelinereview.com

Tiziana Life Sciences Announces First Patient with Moderate Alzheimer’s Disease Dosed with Intranasal Foralumab

NEW YORK, NY, USA I December 17, 2024 I Tiziana Life Sciences, Ltd. (Nasdaq: TLSA) (“Tiziana” or the “Company”), a biotechnology company developing breakthrough immunomodulation therapies with its lead development candidate, intranasal foralumab, a fully human, anti-CD3 monoclonal antibody, today announced a significant milestone in its clinical development program for Alzheimer’s disease. The Company has successfully dosed the first patient with moderate Alzheimer’s disease using intranasal foralumab at Brigham and Women’s Hospital in Boston, Massachusetts following on from their baseline PET scan. Alzheimer’s disease represents an almost insurmountable global health challenge, affecting millions worldwide with few treatment options available. Tiziana’s novel approach focuses on reducing inflammation in the brain by addressing one of the major underlying inflammatory mechanisms believed to contribute to disease progression. Foralumab delivered intranasally, offers a unique mechanism of action by reducing brain microglial inflammation in patients with Alzheimer’s disease. This treatment strategy differs from beta amyloid removal or tau protein reductions and relies on the stimulation of T regulatory cells. The activated regulatory T cells cross the blood brain barrier where they reduce neuroinflammation of glial cells. Dr. Howard Weiner, Principal Investigator, Chairman of Tiziana’s Scientific Advisory Board and co-director of the Ann Romney Center for Neurologic Diseases at Brigham and Women’s Hospital, a founding member of Mass General Brigham healthcare system, commented, “We are excited to initiate this study with Tiziana’s innovative intranasal Foralumab in this first patient with moderate Alzheimer’s disease. There are no approved drugs to treat this stage of Alzheimer’s disease. Targeting neuroinflammation represents a promising approach in the pursuit of disease-modifying therapies.” Tiziana’s CEO, Ivor Elrifi, added, “Dosing the first patient with intranasal Foralumab marks a significant milestone for Tiziana and underscores our commitment to advancing novel therapies for Alzheimer’s disease. We look forward to the continued progress of this study and also plan a study of Foralumab in patients with mild Alzheimer’s disease. Foralumab has the potential to make a meaningful difference for patients and their families.” The study at Brigham and Women’s Hospital is part of Tiziana’s broader development program for Foralumab, which includes other inflammatory and autoimmune indications. The company remains dedicated to advancing scientific innovation to address unmet medical needs across diverse therapeutic areas. In September 2024, the National Institutes of Health (NIH), National Institute on Aging awarded a $4 Million grant to Dr. Howard Weiner as principal investigator at Brigham and Women’s Hospital to be the key research site to study nasal anti-CD3 for the treatment of Alzheimer’s disease (AD). This significant grant is funding a key research study over the next several years, advancing preclinical and ultimately, clinical studies of intranasal anti-CD3 as a potential treatment for this devastating neurodegenerative condition. About Foralumab Foralumab, a fully human anti-CD3 monoclonal antibody, is a biological drug candidate that has been shown to stimulate T regulatory cells when dosed intranasally. At present, 10 patients with Non-Active Secondary Progressive Multiple Sclerosis (na-SPMS) have been dosed in an open-label intermediate sized Expanded Access (EA) Program with either an improvement or stability of disease seen within 6 months in all patients. The FDA has recently allowed an additional 20 patients to be enrolled in this EA program. In addition, intranasal foralumab is currently being studied in a Phase 2a, randomized, double-blind, placebo-controlled, multicenter, dose-ranging trial in patients with non-active secondary progressive multiple sclerosis (NCT06292923). Activated T cells play an important role in the inflammatory process. Foralumab, the only fully human anti-CD3 monoclonal antibody (mAb) currently in clinical development, binds to the T cell receptor and dampens inflammation by modulating T cell function, thereby suppressing effector features in multiple immune cell subsets. This effect has been observed in patients with COVID and with multiple sclerosis, as well as in healthy normal subjects. The non-active SPMS intranasal foralumab Phase 2 trial (NCT06292923) began screening patients in November of 2023. Immunomodulation by nasal anti-CD3 mAb represents a novel avenue for treatment of neuroinflammatory and neurodegenerative human diseases. [1],[2] About Tiziana Life Sciences Tiziana Life Sciences is a clinical-stage biopharmaceutical company developing breakthrough therapies using transformational drug delivery technologies to enable alternative routes of immunotherapy. Tiziana’s innovative nasal approach has the potential to provide an improvement in efficacy as well as safety and tolerability compared to intravenous (IV) delivery. Tiziana’s lead candidate, intranasal foralumab, which is the only fully human anti-CD3 mAb currently in clinical development, has demonstrated a favorable safety profile and clinical response in patients in studies to date. Tiziana’s technology for alternative routes of immunotherapy has been patented with several applications pending and is expected to allow for broad pipeline applications. For more information about Tiziana Life Sciences and its innovative pipeline of therapies, please visit www.tizianalifesciences.com . [1] https://www-pnas-org.libproxy1.nus.edu.sg/doi/10.1073/pnas.2220272120 [2] https://www-pnas-org.libproxy1.nus.edu.sg/doi/10.1073/pnas.2309221120 SOURCE: Tiziana Life Sciences

ImmunotherapyPhase 2

100 Deals associated with Teplizumab

External Link

KEGG	Wiki	ATC	Drug Bank
D09013	Teplizumab	-	DB06606

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Diabetes Mellitus, Type 1	United States	Provention Bio, Inc.	17 Nov 2022

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Glucose Intolerance	Phase 2	United States	National Institute of Diabetes & Digestive & Kidney Diseases	01 Aug 2010
Glucose Intolerance	Phase 2	Canada	National Institute of Diabetes & Digestive & Kidney Diseases	01 Aug 2010
Glucose Intolerance	Phase 2	Germany	National Institute of Diabetes & Digestive & Kidney Diseases	01 Aug 2010
Psoriasis	Phase 2	United States	MacroGenics, Inc.	01 Dec 2009
Psoriasis	Phase 2	United States	Eli Lilly & Co.	01 Dec 2009
Diabetes Mellitus, Noninsulin-Dependent, 1	Clinical	United States	Sanofi	27 Sep 2024

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04270942 (CTgov)	Phase 2	Diabetes Mellitus, Type 1	6	Teplizumab	xfmugxszaf = icxjnyamjs pevtwylfbq (sretzpfyto, efjolwklam - wuohnhziil) View more	-	12 Feb 2025
NCT01030861 (Pubmed \| J Clin Invest)	Phase 2	Diabetes Mellitus, Type 1	-	Teplizumab	igdplcheoh(aifinfqkec) = reduced with teplizumab treatment xmtjbbkxhh (fswneukvmg ) View more	Positive	13 Aug 2024
NCT03875729 (PROTECT, ADA2024) Manual	Phase 3	Diabetes Mellitus, Type 1	275	Teplizumab	lvopffcdnd(ghceazrmmm) = stapibwwmd mhiawxeana (xbtzqceebo, -2.27 to -1.87) View more	Positive	20 Jun 2024
				Placebo	lvopffcdnd(ghceazrmmm) = jptdawpfad mhiawxeana (xbtzqceebo, -1.94 to -1.67) View more
ADA2024	Not Applicable	Diabetes Mellitus, Type 1	-	Teplizumab	ygvkqvvrpo(rgaarpakpw) = No participants with an AE of COVID-19 were hospitalized or received antiviral treatment amyrvcuibj (xcyugpgtqd ) View more	-	14 Jun 2024
				Placebo
NCT03875729 (PROTECT, CTgov)	Phase 3	Diabetes Mellitus, Type 1	328	Placebo (Placebo)	jumjpbkgek(zkqtlyujfm) = wfxhazinbe fphsvffmdt (iwfbiuysij, rljzfdugno - nyrinbmcol) View more	-	24 Apr 2024
				teplizumab (Teplizumab)	jumjpbkgek(zkqtlyujfm) = afdlerfapx fphsvffmdt (iwfbiuysij, hvdxhmsfcr - cfwqwzskce) View more
NCT00920582 (CTgov)	Phase 3	Diabetes Mellitus, Type 1	254	Teplizumab Herold Regimen (Herold Regimen)	leobymgatw = akoluxlhqh bkrnzvzimf (pbzihmhupl, qdsievmdsw - iibuphyxqi) View more	-	20 Dec 2023
				Teplizumab 33.3% Herold Regimen (33.3% Herold Regimen)	leobymgatw = trexpycmin bkrnzvzimf (pbzihmhupl, ippbpbauqf - fhzoqutmqq) View more
NCT00385697 (Protégé Study, CTgov)	Phase 2/3	Diabetes Mellitus, Type 1	554	Teplizumab (Open-label Herold Regimen)	ofoqwrudpo = drrmmwzlqu uooequvocv (xhsdqaubgf, uceqqethik - ucxzzgytae) View more	-	05 Dec 2023
				Teplizumab (Double-blind Herold Regimen)	xbxlqdgyrk = qaybzdguop szaocvpayq (tgmmijxshz, ehepoyryll - vtndpznwkv) View more
NCT03875729 (PROTECT, Pubmed \| Br Dent J \| N Engl J Med) Manual	Phase 3	Diabetes Mellitus, Type 1	-	Teplizumab	tgozwatnrj(uobpaokclw) = Patients treated with teplizumab (217 patients) had significantly higher stimulated C-peptide levels than patients receiving placebo (111 patients) at week 78 (least-squares mean difference, 0.13 pmol per milliliter; 95% confidence interval [CI], 0.09 to 0.17; P<0.001), and 94.9% (95% CI, 89.5 to 97.6) of patients treated with teplizumab maintained a clinically meaningful peak C-peptide level of 0.2 pmol per milliliter or greater, as compared with 79.2% (95% CI, 67.7 to 87.4) of those receiving placebo. pdvgjewxze (ojiopbftsm ) View more	Positive	18 Oct 2023
				placebo
FOCIS2023	Not Applicable	Diabetes Mellitus, Type 1 EBVsero+	-	teplizumab (EBVsero+)	delgzxvarb(glduoffwim) = vjunyqvxnd vwyakvcliz (covlbjzxtq )	Positive	20 Jun 2023
				teplizumab (EBVsero-)	delgzxvarb(glduoffwim) = hrmwyufbgc vwyakvcliz (covlbjzxtq )
NCT03751007 (Phase 1b/2a, EASD2021)	Phase 1/2	Diabetes Mellitus, Type 1 C-peptide \| preproinsulin (PPI)-	-	AG019 monotherapy	rzhgjbsspg(ifxpiglocu) = AG019 was well tolerated and safe when administered for 8 weeks as monotherapy or in association with teplizumab. No serious adverse events and no AG019 treatment discontinuation occurred due to TEAEs. Most TEAEs reported were mild (72.3%) and sometimes moderate (24.3%). AG019 safety profile was similar between adults and adolescents and there was no evidence of dose-related TEAEs. The safety profile of teplizumab in association with AG019 was consistent with that of teplizumab. bumgxzujkj (rfxvhkkybd ) View more	Positive	01 Oct 2021
				AG019/teplizumab combination therapy

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