[Translation] A Phase II, randomized, double-blind, placebo-controlled, parallel-group, 3-arm, multinational, multicenter, proof-of-concept study to evaluate the efficacy and safety of subcutaneous amlitelimab monotherapy in adult subjects with severe alopecia areata

评价与安慰剂相比，amlitelimab 对头发脱落 50% 或以上的斑秃（AA）成人受试者脱发再生的疗效。评价与安慰剂相比，amlitelimab 对头发脱落 50% 或以上的 AA 成人受试者的体征、症状和生活质量改善方面的疗效；评估 amlitelimab 治疗在 AA 受试者中的安全性和耐受性；表征 AA 受试者接受 amlitelimab SC 给药的 PK 特征；表征 AA 受试者接受 amlitelimab SC 给药的免疫原性。

[Translation]

To evaluate the efficacy of amlitelimab in regrowth of hair in adult subjects with alopecia areata (AA) who have lost 50% or more of their hair compared to placebo. To evaluate the efficacy of amlitelimab in improving signs, symptoms, and quality of life in adult subjects with AA who have lost 50% or more of their hair compared to placebo; To assess the safety and tolerability of amlitelimab treatment in AA subjects; To characterize the PK profile of amlitelimab SC-administered in AA subjects; To characterize the immunogenicity of amlitelimab SC-administered in AA subjects.

Start Date11 Oct 2024

Sponsor / Collaborator

Sanofi-Aventis Recherche et Développement SA

[+2]

CTIS2024-511225-64-00 / Recruiting

A Phase 2, randomized, double-blind, placebo-controlled, parallel group, 3-arm, multinational, multicenter, proof-of-concept study to evaluate the efficacy and safety of amlitelimab monotherapy by subcutaneous injection in adult participants with severe alopecia areata - DRI18180

Start Date18 Sep 2024

Sponsor / Collaborator

Sanofi-Aventis Recherche et Développement SA

NCT06557772 / RecruitingPhase 2

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 Nonresponsive Celiac Disease as an Adjunct to a Gluten-free Diet

This is a Phase 2a/b, randomized, double-blind, placebo-controlled, parallel-group, 6-arm study to evaluate the efficacy and safety of amlitelimab in adult participants with non-responsive celiac disease (NRCD) who are on a gluten free diet (GFD) with and without simulated inadvertent gluten exposure (SIGE).
The primary purpose of this study is to demonstrate the efficacy of subcutaneous (SC) amlitelimab in male and female participants (aged 18 to 75 years, inclusive) with NRCD. The study will assess the effect of amlitelimab when compared to placebo to improve or attenuate gluten induced changes in the intestinal mucosa as measured by the villous height to crypt depth (Vh:Cd) ratio. The effect of amlitelimab on participant-reported celiac signs and symptoms along with the safety, tolerability, and pharmacokinetics of amlitelimab will also be studied.
Study details include:
The study duration will be up to 48 weeks for participants not entering the long-term extension study (including a 16-week safety follow-up period).
The study duration will be up to 32 weeks for participants who enter the long-term extension study.
The treatment duration will be up to 28 weeks. The number of visits will be up to 10 visits.

Start Date29 Aug 2024

Sponsor / Collaborator

Sanofi

100 Clinical Results associated with Amlitelimab

100 Translational Medicine associated with Amlitelimab

100 Patents (Medical) associated with Amlitelimab

Literatures (Medical) associated with Amlitelimab

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.

25 Oct 2023·The British journal of dermatology

Safety and effectiveness of amlitelimab, a potential new treatment for atopic dermatitis: results of a clinical trial.

Article

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. These risks and uncertainties include among other things, unexpected regulatory actions or delays, or government regulation generally, that could affect the availability or commercial potential of the product, the fact that product may not be commercially successful, the uncertainties inherent in research and development, including future clinical data and analysis of existing clinical data relating to the product, including post marketing, unexpected safety, quality or manufacturing issues, competition in general, risks associated with intellectual property and any related future litigation and the ultimate outcome of such litigation, and volatile economic and market conditions, and the impact that pandemics or other global crises may have on us, our customers, suppliers, vendors, and other business partners, and the financial condition of any one of them, as well as on our employees and on the global economy as a whole. The risks and uncertainties also include the uncertainties discussed or identified in the public filings with the SEC and the AMF made by Sanofi, including those listed under “Risk Factors” and “Cautionary Statement Regarding Forward-Looking Statements” in Sanofi’s annual report on Form 20-F for the year ended December 31, 2023. Other than as required by applicable law, Sanofi does not undertake any obligation to update or revise any forward-looking information or statements. All trademarks mentioned in this press release are the property of the Sanofi group. Attachment Media Update Share By clicking “Accept All”, you agree to the storing of cookies on your device to enhance site navigation, measure site performance and show you personalized advertising. Please note your consent may be valid for other websites. You can personalize or withdraw your consent at any moment by clicking on the link "Cookies Settings". For more information on how we use cookies, including the total lifespan of cookies and the identity of third-parties intervening on our website, please consult the cookies policy, available in the site footer. When you visit any website, it may store or retrieve information on your browser, mostly in the form of cookies. This information might be about you, your preferences or your device and is mostly used to make the site work as you expect it to, to make your online experience easier by saving browsing information. The information does not usually directly identify you, but it can give you a more personalized web experience. There are two types of cookies, the first-party cookies, created by the website you visit and hosted by Sanofi, and third-party cookies, created by other websites. Because we respect your right to privacy, you can choose not to allow some types of cookies. Click on the different category headings to find out more and change our settings. For more information on the cookies, please consult the “Cookies Policy” available in the footer. These cookies are necessary for the website to function and cannot be switched off in our systems. They are only set to provide you with services you have requested, such as setting your privacy preferences, logging in or filling in forms. You can set your browser to block or alert you about these cookies, but these functions and services will not work for you and in particular, we won’t be able to save your preferences about cookies. These cookies do not store any personally identifiable information. These cookies allow us to count visits and traffic sources so we can measure and improve the performance of our site. They measure how often you visit our website and how you use it. They help us to know which pages are the most and least popular and see how visitors move around the site. All information these cookies collect is aggregated and therefore anonymous. 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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

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

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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)	fbtdrjhkvv(ubfxwrrsqz) = ndhgpvlxoh iqkvcujsms (xyyzxqtddn ) View more	Positive	11 Mar 2024
				amlitelimab (patients withdrawn from treatment)	fbtdrjhkvv(ubfxwrrsqz) = azodcowlev iqkvcujsms (xyyzxqtddn ) View more
STREAM-AD (NEWS) Manual	Phase 2	Dermatitis, Atopic	390	amlitelimab	dcsqylifzt(vedblmhzjl) = emdgyiirmg ayujsfpdfc (kqydthgdiw ) View more	Positive	15 Oct 2023
				placebo	dcsqylifzt(vedblmhzjl) = kmdeellory ayujsfpdfc (kqydthgdiw ) View more
NCT03754309 (AAD2023)	Phase 2	Dermatitis, Atopic	89	Amlitelimab low-dose	luhywvqaha(iornytwplm) = 1 SAE (infected dermal cyst) was reported as possibly related; it resolved and the patient completed the study vsuqmadztd (zzsbolnoip ) 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])	etoqxzahfo(wtilrfgnfk) = gtzdqgefsk mqyjupkztq (mllayckbti )	Positive	07 Sep 2022
				Amlitelimab high dose (500 mg/250 mg Q4W)	etoqxzahfo(wtilrfgnfk) = kisrmawdow mqyjupkztq (mllayckbti )
NCT03161288 (Pubmed \| Clin Pharmacol Ther)	Phase 1	-	64	KY1005	hnpixaltam(cjfxpwjuum) = No serious adverse events occurred and all adverse events were temporary and of mild or moderate severity. cepejofgej (uxmmhcyfso ) View more	-	29 Jan 2022
				Placebo

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