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 Date26 Mar 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

NCT06470217

/ RecruitingPhase 2IIT

A Prospective, Randomised Controlled, Phase II Clinical Study of Tirilizumab in Combination with Albumin-bound Paclitaxel with Cisplatin for Neoadjuvant and Adjuvant Treatment of Locally Advanced Resectable Oral Squamous Cell Carcinoma

The dosing regimen in the trial group was: tirilizumab with albumin-bound paclitaxel and cisplatin for 3 preoperative Cycles. After neoadjuvant therapy, patients underwent surgery and were stratified according to pathological conditions after surgery; if significant pathological remission (MPR) was achieved, 6 cycles of adjuvant therapy with tirilizumab monotherapy (concurrent radiochemotherapy was available for those with high-risk factors) were performed; if MPR was not achieved, concurrent radiochemotherapy was performed.
Control regimen: patients underwent direct surgical treatment, with postoperative radiotherapy or radiochemotherapy depending on the presence or absence of histological or pathological high-risk factors.

Start Date19 Jun 2024

Sponsor / Collaborator

Shanghai Ninth People's Hospital, Shanghai JiaoTong University School of Medicine

100 Clinical Results associated with Teplizumab

100 Translational Medicine associated with Teplizumab

100 Patents (Medical) associated with Teplizumab

592

Literatures (Medical) associated with Teplizumab

01 Mar 2025·Diabetologia

Trajectory of beta cell function and insulin clearance in stage 2 type 1 diabetes: natural history and response to teplizumab

Article

Author: Sims, Emily K ; Galderisi, Alfonso ; Moran, Antoinette ; Evans-Molina, Carmella ; Cuthbertson, David ; Nathan, Brandon M ; Ismail, Heba M ; Herold, Kevan C ; Petrelli, Alessandra

AbstractAims/hypothesisWe aimed to analyse TrialNet Anti-CD3 Prevention (TN10) data using oral minimal model (OMM)-derived indices to characterise the natural history of stage 2 type 1 diabetes in placebo-treated individuals, to describe early metabolic responses to teplizumab and to explore the predictive capacity of OMM measures for disease-free survival rate.MethodsOMM-estimated insulin secretion, sensitivity and clearance and the disposition index were evaluated at baseline and at 3, 6 and 12 months post randomisation in placebo- and teplizumab-treated groups, and, within each group, in slow- and rapid-progressors (time to stage 3 disease >2 or

$$\le$$

≤ 2 years). OMM metrics were also compared with the standard AUC C-peptide. Percentage changes in CD8+ T memory cell and programmed death-1 (PD-1) expression were evaluated in each group.ResultsBaseline metabolic characteristics were similar between 28 placebo- and 39 teplizumab-treated participants. Over 12 months, insulin secretion declined in placebo-treated and rose in teplizumab-treated participants. Within groups, placebo slow-progressors (n=14) maintained insulin secretion and sensitivity, while both declined in placebo rapid-progressors (n=14). Teplizumab slow-progressors (n=28) maintained elevated insulin secretion, while teplizumab rapid-progressors (n=11) experienced mild metabolic decline. Compared with rapid-progressor groups, insulin clearance significantly decreased between baseline and 3, 6 and 12 months in the slow-progressor groups in both treatment arms. In aggregate, both higher baseline insulin secretion (p=0.027) and reduced 12 month insulin clearance (p=0.045) predicted slower progression. A >25% loss of insulin secretion at 3 months had specificity of 0.95 (95% CI 0.86, 1.00) to identify rapid-progressors and correctly classified the 2 year risk for progression in 92% of participants, with a sensitivity of 0.19 (95% CI 0.08, 0.30). OMM-estimated insulin secretion outperformed AUC C-peptide to differentiate groups by treatment or to predict progression. Metabolic changes were paralleled by relative frequency of change in PD-1+ CD8+ T effector memory cells.Conclusions/interpretationOMM measures characterise the metabolic heterogeneity in stage 2 diabetes, identifying differences between rapid- and slow-progressors, and heterogeneous impacts of immunotherapy, suggesting the need to account for these differences when designing and interpreting clinical trials.Graphical Abstract

01 Mar 2025·Minerva Endocrinology

Teplizumab's breakthrough: a beacon of hope in the battle against type 1 diabetes mellitus

Article

Author: Ahmad, Shayan

01 Jan 2025·Current Diabetes Reviews

Journey of Teplizumab: A Promising Drug in the Treatment of Type 1 Diabetes Mellitus

Review

Author: Das, Debashree Debasish ; Sharma, Nikita ; Chawla, Pooja A.

:Type 1 diabetes (T1D) is a chronic autoimmune disease caused by CD4+ and CD8+ that are activated via CD3+ cells and finally lead to the macrophages destroying the beta cells in the pancreas thereby causing diabetes. The anti-CD3 humanized monoclonal antibody was approved on 17th November 2022 by the United States Food Drug Administration (USFDA) with the name teplizumab and the brand name TZIELD. This is the only approved drug that treats type 1 diabetes (T1D) by delaying the onset of stage 3 in type 1 diabetes (T1D). This review outlines essential features of teplizumab including its brief introduction to its mechanism and other therapies for the treatment and various risks as well as the pharmacokinetics and pharmacodynamics of this disease and the clinical trial reports for the completed and ongoing therapies.

147

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/doi/10.1073/pnas.2220272120[2] https://www.pnas.org/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/doi/10.1073/pnas.2220272120 [2] https://www.pnas.org/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.

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Indication	Highest Phase	Country/Location	Organization	Date
Diabetes Mellitus, Type 1	NDA/BLA	China	Ajinomoto Althea, Inc.	28 Aug 2024
Diabetes Mellitus, Type 1	NDA/BLA	China	Sanofi (China) Investment Co. Ltd.	28 Aug 2024
Diabetes Mellitus, Type 1	NDA/BLA	China	Provention Bio, Inc.	28 Aug 2024
Psoriasis	IND Application	United States	MacroGenics, Inc.	01 Dec 2009
Psoriasis	IND Application	United States	Eli Lilly & Co.	01 Dec 2009
Glucose Intolerance	Preclinical	Germany	National Institute of Diabetes & Digestive & Kidney Diseases	01 Aug 2010
Glucose Intolerance	Preclinical	United States	National Institute of Diabetes & Digestive & Kidney Diseases	01 Aug 2010
Glucose Intolerance	Preclinical	Canada	National Institute of Diabetes & Digestive & Kidney Diseases	01 Aug 2010

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04270942 (CTgov)	Phase 2	Diabetes Mellitus, Type 1	6	Teplizumab	vcdwojnbet(mgfvryqogt) = bnfeupjcwy gmumjgzive (rgjwfcwqbt, hihepzkazo - vbilpxkfac) View more	-	12 Feb 2025
NCT03875729 (PROTECT, ADA2024) Manual	Phase 3	Diabetes Mellitus, Type 1	275	Teplizumab	(osxwgtxfol) = wmfegfvmjx yyljiszaur (qykdrdqzuh, -2.27 to -1.87) View more	Positive	20 Jun 2024
				Placebo	(osxwgtxfol) = ywrffhxjvc yyljiszaur (qykdrdqzuh, -1.94 to -1.67) View more
ADA2024	Not Applicable	Diabetes Mellitus, Type 1	-	Teplizumab	zrjwqxubna(tlbcpwhhdm) = No participants with an AE of COVID-19 were hospitalized or received antiviral treatment uhgsoaqlmf (ikhswainoa ) View more	-	14 Jun 2024
				Placebo
NCT03875729 (PROTECT, CTgov)	Phase 3	Diabetes Mellitus, Type 1	328	Placebo (Placebo)	brinslpawc(pkvvodcjkb) = ictmvhvgrl bqisgwtoaj (nxxsjsscpc, wbocdyxcio - xkqyulqcyt) View more	-	24 Apr 2024
				teplizumab (Teplizumab)	brinslpawc(pkvvodcjkb) = nzygqomgwo bqisgwtoaj (nxxsjsscpc, yuaryemygy - kjpkatejor) View more
NCT00920582 (CTgov)	Phase 3	Diabetes Mellitus, Type 1	254	Teplizumab Herold Regimen (Herold Regimen)	dzgskftmzr(yawdgtllmi) = myillvwuab pnnijhedbn (yqgmlsbmbi, xwxubdwrnm - axqmjfrlpp) View more	-	20 Dec 2023
				Teplizumab 33.3% Herold Regimen (33.3% Herold Regimen)	dzgskftmzr(yawdgtllmi) = mafjopogpu pnnijhedbn (yqgmlsbmbi, tysieqgayn - xkwivlpwmx) View more
NCT00385697 (Protégé Study, CTgov)	Phase 2/3	Diabetes Mellitus, Type 1	554	Teplizumab (Open-label Herold Regimen)	zfqoslpysm(ivpibljhwd) = xnshjnmteb sqdyypxzud (dfehuyddcf, tnuakoetul - mhnlaznmic) View more	-	05 Dec 2023
				Teplizumab (Double-blind Herold Regimen)	zjrrocdkhn(nbztkimmvl) = wolfhzrlnl ztrkwzlsjo (osgmmqlqoj, dprgobngsw - lykzetzleb) View more
NCT03875729 (PROTECT, Pubmed \| Br Dent J \| N Engl J Med) Manual	Phase 3	Diabetes Mellitus, Type 1	-	Teplizumab	zeligtmqrv(sgaaldzhgc) = 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. siqppklbrc (mmortrsplb ) View more	Positive	18 Oct 2023
				placebo
FOCIS2023	Not Applicable	Diabetes Mellitus, Type 1 EBVsero+	-	teplizumab (EBVsero+)	rkkebujnxl(izgjojdrlh) = rxruyennld phrdwxgrkp (rfdfdpajbv )	Positive	20 Jun 2023
				teplizumab (EBVsero-)	rkkebujnxl(izgjojdrlh) = wybfwyivry phrdwxgrkp (rfdfdpajbv )
FOCIS2020	Not Applicable	Diabetes Mellitus, Type 1	-	Teplizumab	paarbpluac(cduybkjtlt) = qpojliexbw mxhkmxbhoi (shbnishocr )	-	28 Oct 2020
NCT01030861 (CTgov)	Phase 2	Diabetes Mellitus, Type 1 \| Glucose Intolerance	76	Teplizumab (Teplizumab)	pgbtizzsxs(bpmtveimke) = wrysqoitfa oeanvoldtq (onrwcivxdr, nnyictrxqm - yyxxodwwei) View more	-	05 Aug 2020
				Placebo infusion (Placebo Infusion)	pgbtizzsxs(bpmtveimke) = npxgmtutaq oeanvoldtq (onrwcivxdr, hjhdmsorlk - dhrwgiecuo) View more

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