An Open-label, Drug-drug Interaction Study to Investigate the Effects of Amlitelimab on the Pharmacokinetics of Selected Cytochrome P450 Substrates in Adult Participants With Moderate-to-severe Atopic Dermatitis

This is an open-label, single group, 2-period, Phase 1, single-sequence study. The study duration will be up to 342 days. The treatment period will be up to Week 29, where Week 29 is defined as End of Treatment (last amlitelimab administration at Week 25).
The number of visits will be 23 or 21 visits for participants who decide to continue amlitelimab therapy in the long-term extension study LTS17367 (RIVER-AD) study.

Start Date13 Nov 2024

Sponsor / Collaborator

Sanofi

CTR20243460 / RecruitingPhase 3

一项 Ⅲ 期、多国家、多中心、随机、双盲、安慰剂对照、平行组、48 周延长研究，旨在评价 12 岁及以上中重度特应性皮炎受试者接受 amlitelimab 两种给药方案皮下注射单药治疗的治疗反应和安全性

[Translation] A phase III, multinational, multicenter, randomized, double-blind, placebo-controlled, parallel-group, 48-week extension study to evaluate the treatment response and safety of two dosing regimens of amlitelimab subcutaneously administered monotherapy in subjects aged 12 years and older with moderate to severe atopic dermatitis

主要目的：评估在中重度 AD 应答者中，与停药相比，amlitelimab Q4W单药治疗以及转为 amlitelimab Q12W单药治疗的治疗反应维持。次要目的：评估在中重度AD应答者中，与停药相比，amlitelimab 单药治疗的治疗反应维持。在中重度 AD 非应答者中表征 amlitelimab 单药治疗的治疗反应。所有受试者：在中重度 AD 受试者中评估 amlitelimab 单药维持治疗的安全性特征；在中重度 AD 受试者中评估 amlitelimab 单药维持治疗的药代动力学（PK）特征；在中重度 AD 受试者中评估 amlitelimab 单药维持治疗的免疫原性。

[Translation]

Primary Objective: To evaluate the maintenance of treatment response to amlitelimab Q4W monotherapy and switching to amlitelimab Q12W monotherapy compared to discontinuation in moderate-to-severe AD responders. Secondary Objectives: To evaluate the maintenance of treatment response to amlitelimab monotherapy compared to discontinuation in moderate-to-severe AD responders. To characterize the treatment response of amlitelimab monotherapy in moderate-to-severe AD non-responders. All Subjects: To evaluate the safety profile of amlitelimab maintenance monotherapy in subjects with moderate-to-severe AD; To evaluate the pharmacokinetic (PK) profile of amlitelimab maintenance monotherapy in subjects with moderate-to-severe AD; To evaluate the immunogenicity of amlitelimab maintenance monotherapy in subjects with moderate-to-severe AD.

Start Date30 Oct 2024

Sponsor / Collaborator

Sanofi-Aventis Recherche et Développement SA

[+2]

CTIS2024-511213-38-00 / Recruiting

A Phase 2a/b, randomized, double blind, placebo controlled, parallel group study to investigate the efficacy and safety of subcutaneous amlitelimab in adult patients with non responsive celiac disease as an adjunct to a gluten free diet - DRI17963

Start Date15 Oct 2024

Sponsor / Collaborator

Sanofi-Aventis Recherche et Développement SA

100 Clinical Results associated with Amlitelimab

100 Translational Medicine associated with Amlitelimab

100 Patents (Medical) associated with Amlitelimab

Literatures (Medical) associated with Amlitelimab

01 Nov 2024·JOURNAL OF ALLERGY AND CLINICAL IMMUNOLOGY

Phase 2b randomized clinical trial of amlitelimab, an anti-OX40 ligand antibody, in patients with moderate-to-severe atopic dermatitis

Article

Author: Blauvelt, Andrew ; Weidinger, Stephan ; Wei, Xiaodan ; Papp, Kim A ; Rynkiewicz, Natalie ; O'Malley, John T ; Hurbin, Fabrice ; Yen, Karl ; Adelman, Samuel ; Weber, Christine ; Worm, Margitta ; Lynde, Charles ; Lee, Chih-Hung ; Wong, Wanling ; Foley, Peter ; Reich, Adam ; Bernigaud, Charlotte ; Papp, Kim A. ; Kataoka, Yoko ; Davey, Sonya ; O’Malley, John T. ; Solente, Anne-Catherine

BACKGROUND:

Amlitelimab, a fully human nondepleting monoclonal antibody targeting OX40 ligand on antigen-presenting cells, could prevent T-cell-driven inflammation seen in atopic dermatitis (AD).

OBJECTIVE:

This trial evaluated the efficacy and safety of amlitelimab in adults with AD.

METHODS:

In this 2-part, phase 2b, randomized, double-blinded placebo-controlled trial (NCT05131477), patients received subcutaneous amlitelimab every 4 weeks at doses of 250 mg with 500-mg loading dose, 250 mg, 125 mg, or 62.5 mg, or placebo for 24 weeks in Part 1 (1:1:1:1:1 randomization). In Part 2, clinical responders were reallocated 3:1 to withdraw amlitelimab or continue the previous dose regimen for 28 weeks. The primary end point was percent change in Eczema Area and Severity Index (EASI) from baseline to Week 16.

RESULTS:

390 and 190 patients enrolled in Part 1 and Part 2, respectively. Significant percent change decreases in EASI were observed with amlitelimab vs. placebo (P<.001). Clinical responses at Week 24 (Investigator Global Assessment 0/1 and/or EASI-75) were maintained at Week 52 in patients continuing or withdrawn from amlitelimab. In patients maintaining clinical response at Week 52 while off-treatment, >80% had serum amlitelimab concentrations below a 4-μg/mL threshold for several weeks prior to Week 52. Reductions in AD-related biomarkers during Part 1 were maintained through Part 2. Amlitelimab was well tolerated over 52 weeks.

CONCLUSIONS:

Amlitelimab treatment significantly reduced clinical and biomarker responses, and was well tolerated in adults with AD through Week 52. Sustained responses were observed in the majority of patients after amlitelimab withdrawal for 28 weeks.

02 Jul 2024·Expert opinion on emerging drugs

Emerging drugs for the treatment of atopic dermatitis: a focus on phase 2 and phase 3 trials

Review

Author: Su, Malcolm ; Ong, Peck Y. ; Obed, Ogechi ; Chong, Albert C.

INTRODUCTION:

Atopic dermatitis (AD) is an inflammatory skin condition that affects millions of pediatric and adult patients with well-studied impact on morbidity and quality of life. Management occurs in a stepwise fashion beginning with preventative measures before immunomodulators are introduced. However, challenges remain in treatment of moderate-to-severe atopic dermatitis that is refractory to first- and second-line treatments and there are only few topical anti-inflammatory options, especially for pediatric patients.

AREAS COVERED:

New medications are required to address these gaps as lesions may persist despite treatment or patients may discontinue treatment due to actual or anticipated adverse effects of mainstay medications. Emerging research into the pathophysiology of AD and the immune system at large has provided opportunities for novel interventions aimed at stopping AD mechanisms at new checkpoints. Clinical trials for 36 agents currently in phase 2 or phase 3 are evaluated with particular focus on the studies for, B244, CBP-201, tapinarof, lebrikizumab, nemolizumab, amlitelimab, and rocatinlimab as they explore novel pathways and have some of the most promising results.

EXPERT OPINION:

These clinical trials contribute to the evolution of AD treatment toward greater precision based on salient pathways with a particular focus on moderate-to-severe AD to enhance efficacy and minimize adverse effects.

25 Oct 2023·The British journal of dermatology

Safety and efficacy of amlitelimab, a fully human nondepleting, noncytotoxic anti-OX40 ligand monoclonal antibody, in atopic dermatitis: results of a phase IIa randomized placebo-controlled trial

Article

Author: Brennan, Nuala ; Weidinger, Stephan ; Gilbert, Sally ; Reich, Adam ; Porter-Brown, Ben ; O’Malley, John T ; Quaratino, Sonia ; Cork, Michael J ; Wilson, Rosamund ; Stebegg, Marisa ; Bieber, Thomas

Abstract:

Background:

Atopic dermatitis (AD) is an inflammatory skin disease with significant unmet need. Blockade of the OX40–OX40 ligand (OX40L) costimulation pathway by targeting OX40L on antigen-presenting cells (APCs) with a fully human noncytotoxic, nondepleting anti-OX40L monoclonal antibody (amlitelimab; SAR445229; KY1005) is a novel way to modulate persistent inflammation.

Objectives:

To assess the safety and efficacy of amlitelimab over 16 weeks in adults with AD in a phase IIa double-blind placebo-controlled study.

Methods:

The study was conducted at 19 hospitals in Germany, Poland, Spain and the UK. Eligible patients with moderate-to-severe AD were randomized (1 : 1 : 1) to low-dose intravenous (IV) amlitelimab (200 mg), high-dose IV amlitelimab (500 mg) or placebo, followed by three maintenance doses (50% of loading dose) at 4, 8 and 12 weeks, with safety follow-up to week 36. The co-primary endpoints were the incidence of treatment-emergent adverse events (all patients who received ≥ 1 dose of the study drug) and mean percentage change in Eczema Area and Severity Index (EASI) to week 16 (full analysis set).

Results:

Between 13 December 2018 and 12 May 2020, 89 patients were randomly assigned to low- (n = 29) or high-dose amlitelimab (n = 30) or placebo (n = 29), of whom 88 proceeded to treatment [37 women (42%), 51 (58%) men; mean (SD) age 33.6 (11.9) years]. Amlitelimab was generally well tolerated with an unremarkable safety profile; no hypersensitivity events were reported. For the primary endpoint, the least square mean percentage change in EASI from baseline to week 16 was –80.12% [95% confidence interval (CI) –95.55 to –64.68; P = 0.009 vs. placebo] and –69.97% (95% CI –85.04 to –54.60; P = 0.07 vs. placebo) for the low- (n = 27) and high-dose (n = 27) amlitelimab groups, respectively, vs. –49.37% (95% CI –66.02 to –32.72) for placebo (n = 24). Numerically greater reductions in EASI were observed for amlitelimab vs. placebo from weeks 2 to 16.

Conclusions:

Novel targeting of OX40L-expressing APCs with amlitelimab was well tolerated and resulted in clinically meaningful improvements in AD.

News (Medical) associated with Amlitelimab

25 Sep 2024

·www.sanofi.com

Media Update: EADV: New data reinforce Sanofi’s innovative approach and leadership across immune-mediated skin diseases

Share EADV: New data reinforce Sanofi’s innovative approach and leadership across immune-mediated skin diseases 24 abstracts for Dupixent, including 4 oral presentations, highlight impact of targeting interleukin-4 (IL4) and interleukin-13 (IL13) across atopic dermatitis (AD), prurigo nodularis (PN) and chronic spontaneous urticaria (CSU) New data show impact of Dupixent on potential for clinical remission in children as young as six years of age with moderate-to-severe AD 15 abstracts for immunology pipeline molecules, including phase 2 presentations in AD for amlitelimab, an OX40-ligand monoclonal antibody Paris, September 25, 2024. Sanofi will present 39 abstracts across approved and pipeline medicines at the 2024 European Academy of Dermatology and Venereology (EADV) medical meeting from September 25-28 in Amsterdam, the Netherlands. Presentations will include 21 abstracts for Dupixent (dupilumab) in partnership with Regeneron, highlighting the impact of targeting IL4 and IL13 across three chronic skin conditions, including disease remission data and long-term data in children with moderate-to-severe atopic dermatitis (AD), and rapid results in adults with prurigo nodularis (PN). In addition, data presentations from Sanofi’s extensive immunology pipeline include oral and poster presentations for amlitelimab, an OX40-ligand monoclonal antibody, demonstrating safety and efficacy results in moderate-to-severe AD, as well as in poster presentations for rilzabrutinib, a novel oral BTK inhibitor, showing its impact on symptoms of AD and moderate-to-severe chronic spontaneous urticaria (CSU). Dietmar Berger, M.D., Ph.D. Chief Medical Officer, Global Head of Development at Sanofi “Our data at EADV highlight the breadth of our diverse and novel approach across inflammatory dermatologic conditions, including AD, PN and CSU. Dupixent data demonstrates the potential benefit of important treatment goals such as clinical remission and the speed and durability of efficacy. We continue to evaluate Dupixent’s real-world safety profile and consistency of patient impact and satisfaction in children, adolescents, and adults with atopic dermatitis across the globe. Additionally, we are excited to share new data from our pipeline, including results for amlitelimab showing the potential to provide durable efficacy that may enable a quarterly dosing interval, with favorable safety profile.” Notable presentations include: Dupixent New results and analyses for Dupixent in children and adults with moderate-to-severe AD and adults with prurigo nodularis. Atopic dermatitis multiple poster presentations will show results in children with moderate-to-severe AD, including those from an open-label extension study on clinical remission in children aged six to 17 years of age, including after stopping treatment with Dupixent, as well as long-term efficacy and safety data for up to two years on children aged six months to five years. Additionally, real-world data in children six months to 11 years of age will show patient-reported disease severity and health-related quality of life outcomes throughout one year. an oral presentation will show real-world safety data from around the world for Dupixent in adults and adolescents with moderate-to-severe AD. Prurigo nodularis PRIME and PRIME2: an oral presentation will show new analyses on disease activity, itch, and skin clearance as early as two weeks from two pivotal clinical studies. The safety results of these studies were generally consistent with the known safety profile of Dupixent in its approved dermatological indications. Dermatology pipeline Data include new results and analyses for amlitelimab, an OX40-ligand monoclonal antibody, in AD, and rilzabrutinib, a novel oral BTK inhibitor, in AD and CSU. Atopic dermatitis amlitelimab: six presentations will share data for amlitelimab in moderate-to-severe AD, including an oral presentation of 68-week safety results. Additional presentations highlight a PK model that support the potential use of a quarterly dosing regimen, a post-hoc analysis showing the impact of amlitelimab on AD of the head and neck, and results from an in vitro analysis demonstrating that the anti-OX40L mechanism of amlitelimab does not deplete T cells. rilzabrutinib: a poster presentation will show the impact of rilzabrutinib on itch in adults with moderate-to-severe AD. Chronic spontaneous urticaria rilzabrutinib: three poster presentations will show the impact of rilzabrutinib on itch, hives and urticaria in adults with moderate-to-severe CSU. Hidradenitis suppurativa three poster presentations will show the impact of disease symptoms on patients with hidradenitis suppurativa and highlight the need for increased disease awareness and effective treatment options. Alopecia areata a poster presentation will show conceptual model and clinical outcome measures in alopecia areata based on the patient experience. Amlitelimab and rilzabrutinib are investigational medicines for which safety and efficacy have not been evaluated by any regulatory authority. Complete list of EADV 2024 presentations: About SanofiWe are an innovative global healthcare company, driven by one purpose: we chase the miracles of science to improve people’s lives. Our team, across the world, is dedicated to transforming the practice of medicine by working to turn the impossible into the possible. We provide potentially life-changing treatment options and life-saving vaccine protection to millions of people globally, while putting sustainability and social responsibility at the center of our ambitions. Sanofi is listed on EURONEXT: SAN and NASDAQ: SNY Sanofi Media RelationsSandrine Guendoul | + 33 6 25 09 14 25 | sandrine.guendoul@sanofi.comEvan Berland | + 1 215 432 0234 | evan.berland@sanofi.comVictor Rouault | + 33 6 70 93 71 40 | victor.rouault@sanofi.comTimothy Gilbert | + 1 516 521 2929 | timothy.gilbert@sanofi.com Sanofi Investor RelationsThomas Kudsk Larsen |+ 44 7545 513 693 | thomas.larsen@sanofi.comAlizé Kaisserian | + 33 6 47 04 12 11 | alize.kaisserian@sanofi.comArnaud Delépine | + 33 6 73 69 36 93 |arnaud.delepine@sanofi.comFelix Lauscher | + 1 908 612 7239 | felix.lauscher@sanofi.comKeita Browne | + 1 781 249 1766 | keita.browne@sanofi.comNathalie Pham | + 33 7 85 93 30 17 | nathalie.pham@sanofi.comTarik Elgoutni | + 1 617 710 3587 | tarik.elgoutni@sanofi.comThibaud Châtelet | + 33 6 80 80 89 90 | thibaud.chatelet@sanofi.com Sanofi Forward-Looking StatementsThis media update contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements are statements that are not historical facts. These statements include projections and estimates regarding the marketing and other potential of the product, or regarding potential future revenues from the product. Forward-looking statements are generally identified by the words “expects”, “anticipates”, “believes”, “intends”, “estimates”, “plans” and similar expressions. Although Sanofi’s management believes that the expectations reflected in such forward-looking statements are reasonable, investors are cautioned that forward-looking information and statements are subject to various risks and uncertainties, many of which are difficult to predict and generally beyond the control of Sanofi, that could cause actual results and developments to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements. 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Clinical ResultPhase 2Immunotherapy

24 Sep 2024

·endpts.com

Amgen reports dual Phase 3 wins in atopic dermatitis and myasthenia gravis

Amgen released data from two pivotal trials on Tuesday that showed its experimental drug rocatinlimab succeeded in a Phase 3 test in atopic dermatitis, while its approved drug Uplizna also yielded positive results in myasthenia gravis. The data are a boost to Amgen’s immunology hopes, and the success with rocatinlimab — an anti-OX40 monoclonal antibody — will solidify its advantage over Sanofi’s asset amlitelimab, which goes after a related target. The rocatinlimab results are the first of eight different Phase 3 trials Amgen is running for the drug. In Tuesday’s trial, called ROCKET-Horizon, rocatinlimab met its primary endpoint and all secondary endpoints by a statistically significant margin, Amgen said. The drug induced at least a 75% reduction in the Eczema Area and Severity Index (EASI-75) in 32.8% of patients, compared with 13.7% on placebo after 24 weeks. Amgen said that the study’s other co-primary endpoints, also measuring skin clearance, were successful as well. Sanofi has positioned amlitelimab, which binds to OX40-Ligand, as one of its key growth drivers in its pivot to immunology. But its first Phase 3 readout won’t take place until the end of 2026. In the meantime, Amgen has at least four other Phase 3 trials for rocatinlimab expected to report data before next July, including studies looking at different doses, the drug’s use as a combination or maintenance therapy, and a trial in adolescents. Amgen will likely have a significant market advantage by filing for rocatinlimab approval much earlier, although on a conference call Tuesday, CSO Jay Bradner didn’t say when it might file with the FDA. Amgen licensed rocatinlimab from Kyowa Kirin in 2021, a few months after it reported Phase 2 results, paying $400 million upfront and promising another $850 million in milestones. Sanofi acquired amlitelimab in its $1.1 billion buyout of Kymab in 2021. Sanofi is still hoping for big things from amlitelimab. Earlier this year, an early look at Phase 2b data prompted the company to amend its Phase 3 trial protocol to allow for increased time off-drug. Amgen also said Tuesday that its rare disease drug Uplizna hit its primary endpoint in a Phase 3 trial for the autoimmune disease myasthenia gravis. In a measurement scale called the Myasthenia Gravis Activities of Daily Living, or MG-ADL, two doses of Uplizna produced an improvement of -4.2 points after 26 weeks, compared with -1.9 points on placebo (p<0.0001). Four of the study’s five secondary endpoints were also statistically significant, Bradner said. The win comes a few months after Uplizna recorded a successful Phase 3 study in IgG4-related disease back in June. Uplizna was first approved in 2020 for an autoimmune disease that affects the eyes called neuromyelitis optica spectrum disorder, or NMOSD.

Clinical ResultPhase 3Drug ApprovalAcquisitionPhase 2

20 Sep 2024

·endpts.com

Sanofi's BTK inhibitor again slows MS progression, but liver enzymes continue to be tricky

Sanofi released new Phase 3 data for its BTK inhibitor tolebrutinib in non-relapsing secondary progressive multiple sclerosis (nrSPMS), showing a 31% improvement in delaying onset of disease progression compared to placebo. But safety issues that have dogged the drug class could complicate the readout. Tolebrutinib is a BTK inhibitor, and it and other related drugs have faced issues with elevated liver enzymes. In the Phase 3 readout, those signals showed up again — 4.1% of patients on tolebrutinib had their liver enzymes jump to three times the normal limit, compared with 1.6% in the placebo group. A smaller group in the trial, called HERCULES, showed even sharper liver enzyme increases: 0.5% of patients saw their liver enzymes spike to 20 times the normal limit, and one of those patients died after needing a liver transplant and suffered post-surgery complications. Every other case resolved without medical intervention, but Sanofi had to implement more rigorous monitoring of patients. Robert Fox, a clinician at the Cleveland Clinic and chair of the HERCULES global steering committee, said that if tolebrutinib is approved, he wouldn’t be surprised if it came with a boxed warning. “Would I be surprised if it’s in a black box? No,” Fox said. “But predicting whether it is or not, that’s not something I can do.” More intensive safety monitoring has lessened the amount of patients whose liver enzymes exceed the 20-fold threshold, but hasn’t eliminated cases entirely, a Sanofi spokesperson told Endpoints News . The spokesperson also said the company is still working through unblinding its safety data and can’t give an exact number of cases after the new protocols were instituted (the patient who died after a liver transplant received the drug beforehand). Sanofi presented the data at the 2024 ECTRIMS conference in Copenhagen. It plans to file with the FDA by the end of 2024. Despite the safety concerns, Fox said the data represented an impressive milestone in MS treatment — the efficacy results were statistically significant, with a p-value of p=0.0026. Fox noted that there isn’t anything on the market to slow secondary progressive MS’ disease progression, and that approved drugs only reduce the frequency of relapse episodes. Tolebrutinib “actually does something where none of the other therapies do anything. So that’s where we are, and so that is the decision that a clinician will have to consider,” Fox said. “If this were to be available for clinical use, how much anti-inflammation does my patient need, and how much slowing [of] that insidious progression does my patient need?” Sanofi acquired tolebrutinib as part of its $3.7 billion acquisition of Principia Biopharma in 2020 and has made it a central part of its new pipeline focus around immunology in addition to amlitelimab (bought from Kymab), lunsekimig (developed from Ablynx’s platform) and rilzabrutinib (also from Principia), among others. But the FDA placed a partial clinical hold on the drug in June 2022 in both MS and myasthenia gravis, an autoimmune disease, after reports of liver injury. While the partial hold remains in effect for other Phase 3 MS studies (it was “modified” to account for the new monitoring protocols, the spokesperson said), Sanofi discontinued development in myasthenia gravis in early 2023. Sanofi released data from two other Phase 3 relapsing MS trials earlier this month comparing tolebrutinib to standard of care, which showed mixed efficacy results. While neither study hit their primary endpoints, a pooled analysis showed they successfully delayed the time to disability. Safety data also presented at ECTRIMS across these two trials were more numerically balanced between the active and standard-of-care arms, but there were still cases of liver enzymes rising 20 times above the normal limit and patient deaths, though the latter were deemed unrelated to treatment. Another Phase 3 in patients with primary progressive MS is expected to read out in 2025. Editor’s note: This story has been updated to correct the p-value from 0.026 to 0.0026, that previously released mixed data came in RMS studies, not nrSPMS, and that patient deaths in these studies were not linked to treatment.

Clinical ResultPhase 3Acquisition

100 Deals associated with Amlitelimab

R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Moderate Atopic Dermatitis	Phase 3	US	Sanofi	08 Nov 2023
Moderate Atopic Dermatitis	Phase 3	CN	Sanofi	08 Nov 2023
Moderate Atopic Dermatitis	Phase 3	AR	Sanofi	08 Nov 2023
Moderate Atopic Dermatitis	Phase 3	AU	Sanofi	08 Nov 2023
Moderate Atopic Dermatitis	Phase 3	BR	Sanofi	08 Nov 2023
Moderate Atopic Dermatitis	Phase 3	CA	Sanofi	08 Nov 2023
Moderate Atopic Dermatitis	Phase 3	CL	Sanofi	08 Nov 2023
Moderate Atopic Dermatitis	Phase 3	FR	Sanofi	08 Nov 2023
Moderate Atopic Dermatitis	Phase 3	DE	Sanofi	08 Nov 2023
Moderate Atopic Dermatitis	Phase 3	GR	Sanofi	08 Nov 2023

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05131477 (STREAM-AD, GlobeNewswire) Manual	Phase 2	Dermatitis, Atopic	390	amlitelimab (patients with continued treatment)	fwnrstojln(diwmlcwqus) = gzuzrexnbv gtbiuforqn (jttyeeoper ) View more	Positive	11 Mar 2024
				amlitelimab (patients withdrawn from treatment)	fwnrstojln(diwmlcwqus) = sqhzileuek gtbiuforqn (jttyeeoper ) View more
STREAM-AD (NEWS) Manual	Phase 2	Dermatitis, Atopic	390	amlitelimab	cadzwouron(zyeosvvjzg) = ffblrmyhvd tsnqpqjyte (gkpsrchlpl ) View more	Positive	15 Oct 2023
				placebo	cadzwouron(zyeosvvjzg) = kfvgpipmqi tsnqpqjyte (gkpsrchlpl ) View more
NCT03754309 (AAD2023)	Phase 2	Dermatitis, Atopic	89	Amlitelimab low-dose	qifrnkzgbz(wjbiueqsdo) = 1 SAE (infected dermal cyst) was reported as possibly related; it resolved and the patient completed the study molqpnyzpr (wsnfzdjqky ) View more	-	17 Mar 2023
				Amlitelimab high-dose
NCT03754309 (Phase 2a, EADV2022)	Phase 2	Dermatitis, Atopic IL-22	89	Amlitelimab low dose (200 mg loading/100 mg maintenance every 4 weeks [Q4W])	ypgquvlfiu(vzeyxwhxte) = svtjwiatgw oxydzjbrst (saviqjlmfw )	Positive	07 Sep 2022
				Amlitelimab high dose (500 mg/250 mg Q4W)	ypgquvlfiu(vzeyxwhxte) = aahupoiwmb oxydzjbrst (saviqjlmfw )
NCT03161288 (Pubmed \| Clin Pharmacol Ther)	Phase 1	-	64	KY1005	xqgflytbxz(gsgonyxllz) = No serious adverse events occurred and all adverse events were temporary and of mild or moderate severity. lwppcpqlly (zfcyrscaqe ) View more	-	29 Jan 2022
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