An Open-label, Phase 1, Randomized, Parallel Design Study to Determine the Bioequivalence and Investigate the Safety and Tolerability of Subcutaneous Amlitelimab Delivered by 2 Different Devices in Healthy Adult Participants

This is a single-center, open-label, randomized, single-dose, parallel, Phase 1, 4-arm study designed to determine the bioequivalence and investigate the safety and tolerability profiles of subcutaneous amlitelimab delivered by 2 different devices at 2 different total doses in healthy adult participants.

Start Date25 Aug 2025

Sponsor / Collaborator

Sanofi

CTR20242734

/ RecruitingPhase 2

CONQUEST 治疗硬化症平台临床研究：一项评价试验药物在系统性硬化症相关间质性肺疾病受试者中的安全性和有效性的多中心、双盲、随机、安慰剂对照、IIb 期平台临床研究

[Translation] CONQUEST: A multicenter, double-blind, randomized, placebo-controlled, phase IIb platform study to evaluate the safety and efficacy of an investigational drug in subjects with systemic sclerosis-related interstitial lung disease

本研究的主要目的是根据第 52 周治疗期结束时 FVC（mL；在 SSc-ILD 研究受试者中测量）较基线的变化来评价 IP 相比安慰剂的有效性。本研究的次要目的是评价如下内容：？根据第 52 周如下指标较基线的变化来评价 IP 相比安慰剂的有效性： o 通过高分辨率计算机断层扫描（HRCT）定量 ILD（QILD）-全肺（WL）[QILD-WL]测量的肺部受累；以及 o 通过慢性疾病治疗功能评估（FACIT）-呼吸困难评分测量的呼吸困难（严重程度和功能限制）。？第 52 周时在弥漫性皮肤型 SSc 研究受试者中通过修订版弥漫性 SSc 综合反应指数（CRISS）评分测量的总体治疗反应；以及？ IP 的安全性和耐受性。

[Translation]

The primary objective of this study was to evaluate the effectiveness of IP compared with placebo based on the change from baseline in FVC (mL; measured in SSc-ILD study subjects) at the end of the treatment period at Week 52. The secondary objectives of this study were to evaluate the following: ? To evaluate the effectiveness of IP compared with placebo based on the change from baseline at Week 52 in: o Lung involvement as measured by Quantitative ILD (QILD)-Whole Lung (WL) [QILD-WL] on high-resolution computed tomography (HRCT); and o Dyspnea (severity and functional limitation) as measured by the Functional Assessment of Chronic Illness Therapy (FACIT)-Dyspnea score. ? Overall treatment response as measured by the Composite Response Index for Diffuse SSc-Revised (CRISS) score at Week 52 in diffuse cutaneous SSc study subjects; and ? The safety and tolerability of IP.

Start Date27 Jun 2025

Sponsor / Collaborator

Beijing MEDPACE Medicine Technology Co.,Ltd.

[+2]

NCT06686628

/ CompletedPhase 1

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 Date20 Nov 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

01 Jun 2026·JOURNAL OF THE EUROPEAN ACADEMY OF DERMATOLOGY AND VENEREOLOGY

Disproportionate quality of life decline and unaddressed limitations in amlitelimab atopic dermatitis trial

Letter

Author: Chen, Shiuan‐Chih ; Ting, Tsai Ling

Data sharing is not applicable to this article as no datasets were generated or analysed during the current study.

23 Mar 2026·Cureus Journal of Medical Science

Biologic Monotherapies for Moderate-to-Severe Atopic Dermatitis: A Systematic Review and Bayesian Network Meta-Analysis of Established and Investigational Agents

Review

Author: Babul, Najib ; Soliman, Yssra ; Babul, Arya ; Mehta, Devina ; Hussain, Momina

Biologic therapies targeting maladaptive type 2 inflammation have transformed the management of moderate‑to‑severe atopic dermatitis (AD); however, comparative evidence integrating both approved and next‑generation investigational agents remains limited. This Bayesian network meta‑analysis (BNMA) provides the first unified evaluation of all biologic monoclonal antibodies approved as monotherapy for AD (dupilumab, lebrikizumab, tralokinumab) together with emerging immunotherapies, including amlitelimab, rademikibart, rezpegaldesleukin, rocatinlimab, telazorlimab, temtokibart, and zumilokibart, across key efficacy measures. A PRISMA‑2020-compliant systematic review and PROSPERO‑registered protocol (CRD420251162704) identified phase 2-3 randomized, double‑blind, placebo‑controlled trials reporting week‑16 outcomes (week‑24 for rocatinlimab). A Bayesian random‑effects NMA estimated relative risks (RRs) for EASI‑75, EASI‑90, IGA‑AD 0/1, and ≥4‑point improvement in itch Numeric Rating Scale (NRS). Treatment hierarchy was evaluated using both Bayesian (SUCRA) and frequentist (P‑score) approaches. Seventeen randomized controlled trials (RCTs) involving more than 6,000 patients were included in the analysis. Dupilumab demonstrated the most consistent and reliable efficacy across all evaluated endpoints, including improvements in EASI-75, EASI-90, IGA-AD 0/1, and itch NRS. Among investigational therapies, rocatinlimab showed a notable signal for deep clinical responses, although the available evidence remains limited and less precise. Other emerging agents, including rademikibart, temtokibart, and zumilokibart, demonstrated encouraging efficacy profiles, whereas telazorlimab showed comparatively modest clinical benefit. Ranking analyses consistently positioned dupilumab as the most reliable and highest-performing therapy overall, followed by rocatinlimab. Overall, biologic therapies were generally well tolerated in the short term; however, dupilumab remains the only agent supported by extensive long-term safety data extending up to a decade. This analysis relied on indirect comparisons anchored to short‑term placebo‑controlled induction periods, limiting assessment of long‑term safety and durability, particularly for mechanistically distinct agents such as rezpegaldesleukin, a regulatory T cell (Treg) pathway agonist, and rocatinlimab, an OXO pathway inhibitor. Evidence for several emerging therapies was restricted to small phase 2 trials, resulting in wide credible intervals (Crls) and lower certainty in comparative rankings. Trial heterogeneity in baseline severity, ethnic composition, and geographic setting may have introduced residual confounding despite sensitivity and meta‑regression analyses. These factors should be considered when interpreting relative efficacy estimates This NMA demonstrates that dupilumab remains the most reliable and effective biologic monotherapy for moderate‑to‑severe AD, supported by the greatest precision, reproducibility, and long‑term safety. Rocatinlimab shows promising investigational efficacy but requires efficacy and long-term safety validation. Zumilokibart, rademikibart, and temtokibart emerge as additional candidates with encouraging activity, whereas telazorlimab showed limited clinical benefit. Collectively, these findings provide a comprehensive comparative framework to inform biologic selection and therapeutic sequencing.

05 Mar 2026·RHEUMATOLOGY

Advancing drug development for systemic sclerosis by prioritizing findings from human genetic association studies

Review

Author: Providencia, Rui ; Denton, Christopher P ; McMahan, Zsuzsanna H ; Assassai, Shervin ; Hughes, Michael

Abstract:

Objectives:

SSc is a rare rheumatological disease associated with significant morbidity and mortality. Despite significant recent international clinical trial activity, the yield of approved compounds has been disappointingly low. Our aim was to identify and prioritize potential ‘druggable’ targets with insights from human genetics, by integrating the available evidence with publicly available bioinformatics sources relevant for SSc drug development.

Methods:

Genetic variants for SSc were identified through a search of the GWAS Catalog, and the associated-mapped genes were cross-referenced with the OpenTargets platform for drug interactions. Confirmation/validation was demonstrated through structured literature searches and review of the evidence on MEDLINE and ClinialTrials.gov for each individual drug and its association with SSc.

Results:

We identified 89 unique drugs, none of which is included in existing SSc guidelines/recommendations. Amlitelimab (anti-OX40L mAb) is currently being explored in CONQUEST (Platform Clinical Study for Conquering Scleroderma), a multicentre randomized controlled platform trial for SSc interstitial lung disease. Key groupings of drug therapies were (i) female sex hormones and function, (ii) neurotransmitter-targeting therapies, and (iii) inflammatory–fibrotic pathways. The Janus kinase (JAK)/STAT pathway is an attractive therapeutic target in SSc, targeting known pathobiology.

Conclusion:

Our systematic approach, combining evidence from different bioinformatics platforms, has identified drug opportunities for repurposing/druggable targets for SSc. A novel and unexpected finding was the identification of multiple neurotransmitter-targeting drug therapies, particularly relevant to SSc-related RP and gastrointestinal involvement. Future studies of these candidates for SSc drug repurposing, many of which are widely available and often inexpensive, are indicated.

122

News (Medical) associated with Amlitelimab

31 Jul 2026

·www.biospace.com

Press Release: Sanofi announces decision not to submit amlitelimab in atopic dermatitis for global regulatory reviews

Sanofi announces decision not to submit amlitelimab in atopic dermatitis for global regulatory reviews Paris, July 24, 2026. Sanofi today announced the discontinuation of clinical development of amlitelimab, an OX40-ligand monoclonal antibody, in moderate-to-severe atopic dermatitis (AD). This decision not to submit for global regulatory reviews was made as part of an ongoing strategic assessment of the pipeline. Sanofi has determined that the totality of efficacy and safety evidence generated to date does not support further development of amlitelimab in AD. While the ESTUARY phase 3 long-term extension study (clinical study identifier: NCT06407934 ) showed long-term maintenance of clinical response without relapse in patients aged 12 years and older with moderate-to-severe AD and an emerging safety pro builds on previous data, amlitelimab would not represent a meaningful improvement to the standard of care for patients with AD. Additional results from the amlitelimab development program in AD, including from the ESTUARY study, will be presented at a forthcoming medical meeting. Patients and their physicians need additional effective treatments due to the heterogeneity of underlying immune mechanisms that contribute to AD, and Sanofi remains committed to pursuing advances in inflammatory skin conditions. ezstandalone.cmd.push(function () { ezstandalone.showAds(131); }); Sanofi is deeply grateful to the patients, caregivers, and investigators who supported the development of amlitelimab in AD, including in the ESTUARY study. Sanofi will work closely with investigators, site teams, and regulatory authorities to ensure a wind-down of ongoing amlitelimab AD studies, with appropriate transition of care for all enrolled patients. Financial considerations Sanofi is not amending its full-year 2026 guidance as a result of this announcement. About amlitelimab Amlitelimab (SAR445229, KY1005) is a fully human, non-T cell depleting monoclonal antibody that blocks the OX40L, a key immune regulator. With its novel mechanism of action, amlitelimab selectively blocks OX40L signaling during the inflammatory prequel, the initiating phase of an overactive immune system, to potentially normalize T-cell-mediated inflammation without T-cell depletion. The phase 2 study of amlitelimab in celiac disease is ongoing and expected to readout in the second half of 2026. About Sanofi Sanofi is an R&D driven, AI-powered biopharma company committed to improving people’s lives and delivering compelling growth. We apply our deep understanding of the immune system to invent medicines and vaccines that treat and protect millions of people around the world, with an innovative pipeline that could benefit millions more. Our team is guided by one purpose: we chase the miracles of science to improve people’s lives; this inspires us to drive progress and deliver positive impact for our people and the communities we serve, by addressing the most urgent healthcare, environmental, and societal challenges of our time. Sanofi is listed on EURONEXT: SAN and NASDAQ: SNY. Sanofi Media Relations Sandrine Guendoul | +33 6 25 09 14 25 | sandrine.guendoul@sanofi.com Evan Berland | +1 215 432 0234 | evan.berland@sanofi.com Léo Le Bourhis | +33 6 75 06 43 81 | leo.lebourhis@sanofi.com Victor Rouault | +33 6 70 93 71 40 | victor.rouault@sanofi.com Timothy Gilbert | +1 516 521 2929 | timothy.gilbert@sanofi.com Léa Ubaldi | +33 6 30 19 66 46 | lea.ubaldi@sanofi.com Ekaterina Pesheva | +1 410 926 6780 | ekaterina.pesheva@sanofi.com Sanofi Investor Relations Thomas Kudsk Larsen |+44 7545 513 693 | thomas.larsen@sanofi.com Alizé Kaisserian | +33 6 47 04 12 11 | alize.kaisserian@sanofi.com Keita Browne | +1 781 249 1766 | keita.browne@sanofi.com Nathalie Pham | +33 7 85 93 30 17 | nathalie.pham@sanofi.com Nina Goworek | +1 908 569 7086 | nina.goworek@sanofi.com Thibaud Châtelet | +33 6 80 80 89 90 | thibaud.chatelet@sanofi.com Yun Li | +33 6 84 00 90 72 | yun.li3@sanofi.com Sanofi Forward-Looking Statements This press release contains forward-looking statements within the meaning of applicable securities laws, including 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 and their underlying assumptions, statements regarding plans, objectives, intentions, and expectations with respect to future financial results, events, operations, services, product development and potential, and statements regarding future events and economic performance. Words such as “expect,” “anticipate,” “believe,” “intend,” “estimate,” “plan,” “can,” “contemplate,” “could,” “is designed to,” “may,” “might,” “potential,” “objective,” "attempt," “target,” “project,” "strategy," "strive," "desire," “predict,” “forecast,” “ambition,” “guideline,” "seek," “should,” “will,” "goal," or the negative of these, and similar expressions are intended to identify forward-looking statements. 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, the uncertainties inherent in research and development, future clinical data and analysis, including post marketing, decisions by regulatory authorities, such as the U.S Food and Drug Administration or the European Medicines Agency, regarding whether and when to approve any drug, device or biological application that may be filed for any such product candidates as well as their decisions regarding labelling and other matters that could affect the availability or commercial potential of such product candidates; the fact that product candidates if approved may not be commercially successful; unexpected regulatory actions or delays, or government regulation generally; authorities’ decisions regarding whether and when to approve a product candidate; political pressure in the United States to mandate lower drug prices including “most favored nation” pricing for State Medicaid programs; the future approval and commercial success of therapeutic alternatives; Sanofi’s ability to benefit from external growth opportunities, to complete related transactions and/or obtain regulatory clearances, 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 pending or future litigation and the ultimate outcome of such litigation; trends in exchange rates and prevailing interest rates, volatile economic and market conditions, cost containment initiatives and subsequent changes thereto, and the impact that 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 French Markets Authority (AMF) made by Sanofi, including those listed under “Risk Factors” and “Cautionary Statement Regarding ForwardLooking Statements” in Sanofi’s annual report on Form 20-F for the year ended December 31, 2025 or contained in our periodic reports on Form 6-K. Other than as required by applicable law, Sanofi does not undertake any obligation to update or revise any forward-looking information or statements. In light of these risks, uncertainties and assumptions, you should not place undue reliance on any forward-looking statements contained herein. Attachment Amlitelimab Press Release-EN

30 Jul 2026

·www.fiercebiotech.com

Sanofi’s new CEO ‘looking deeply’ at late-stage pipeline as clinical clearout continues

When Belén Garijo, M.D., Ph.D., left the top job at Germany’s Merck KGaA to head over to Sanofi, she was inheriting a company in need of course correction. Paul Hudson, the previous CEO at the French pharma, had been pushed out after a string of high-profile setbacks in Sanofi’s clinical-stage pipeline. They included the anti-OX40L-ligand antibody amlitelimab flunking a phase 2 asthma trial, the oral TNF inhibitor balinatunfib missing the goal of a midstage psoriasis study and the Regeneron-partnered IL-33 candidate itepekimab failing one of a pair of phase 3 studies in chronic obstructive pulmonary disease. Every setback increased the pressure on Sanofi to find a replacement for the revenue lost when Dupixent comes off patent around 2031. Sanofi’s decision only last week to finally call time on amlitelimab in atopic dermatitis—once touted as a $5 billion opportunity—was a reminder of how far the company’s pipeline had drifted off course. When Sanofi’s board appointed Garijo in February, they were clear about her mission: to “bring an increased rigor to the implementation of Sanofi's strategy,” as well as “strengthen the productivity, governance and innovation capacity of R&D.” It seems like Garijo got the memo. While the incoming CEO has kept a low profile for her first few months in the post, she used a second-quarter earnings call with journalists on Thursday to open herself up to detailed questions on her approach to the business, clinical strategy and acquisitions. Garijo explained that she has spent the first 12 weeks on the job getting to grips with the company, as well as “translating those convictions into decisions.” Backed by former Roche executive Paulo Fontoura, M.D., Ph.D., who Garijo has appointed to join as Sanofi’s head of R&D in September, the CEO is looking to “simplify the way we make decisions.” “Our principle is quite straightforward,” she explained on the July 30 call. “We will continue to invest where science is strongest, where unmet medical need is greatest, and where we can create sustainable long-term value.” This ruthless approach to the pipeline was demonstrated by some updates in this morning’s earnings announcement. They revealed that amlitelimab has now been joined on the scrapheap by two other culprits behind last year’s poor clinical track record—balinatunfib and itepekimab. Garijo acknowledged these changes, while pointing out that the “portfolio strategic assessment is still ongoing.” So could other high-profile programs also soon find themselves joining amlitelimab and balinatunfib in the clinical trashcan? Garijo told Fierce on the call that the company doesn’t “have a target number of products to discontinue.” “We are going to look very deeply at our current late-stage portfolio, and we will decide on scientific needs, potential to create long-term value, and obviously ensuring the right risk profile of our pipeline moving forward,” she added. Despite more changes on the horizon, Sanofi’s commitment to its key focus areas of immunology, rare diseases and vaccines remain unchanged, Garijo said on the call. Fierce also asked Sanofi’s leadership whether these pipeline changes are likely to entail a wider restructuring across the company and related job losses. “We don’t have restructuring plans per se that we are working on—we have many initiatives of cost efficiencies across the organization,” Sanofi’s Chief Financial Officer François Roger responded. “At the end of the day, what matters is what will be the impact on our bottom line.” Acquisitions remain on the table as a way to restock the pipeline, with Garijo explaining that Sanofi is looking for “potentially additional growth opportunities [that] will continue to complement our internal innovation.” In his own response to a question on the topic, Roger hinted that Sanofi would consider joining the recent Big Pharma trend for megadeals. “Historically, we had said that we were rather targeting smaller assets in the range of $2-5 billion, because we were essentially focusing at that time more on early-stage assets—phase 1, phase 2,” he told journalists on the call. “We have a little bit of a larger view today.” Still, the CFO was careful to stress that the company is “not focusing on size” when it comes to dealmaking. “We are more focusing on the relevance from a scientific point of view, from—as Belén just said—in terms of unmet medical need, in terms of commercial potential,” he added. “So it’s not about size; it's more about relevance against our portfolio, against our skills and knowledge.” Apart from clearing out some underwhelming late-stage candidates and a willingness to slightly dial up the M&A spend when needed, how else will Garijo’s reign differ from the past few years? It sounded like the rhetoric is going to become more realistic, with the new CEO seeking to avoid getting swept up in blockbuster predictions. Instead, the benchmark for keeping a drug in the clinic is going to be raised. “Whenever we have a transition between phase 2 and phase 3, I want to make sure that the data that we have coming from phase 2 studies or phase 1b—depending on the therapeutic area—justif[ies] a significant commitment of capital and, of course, that we have a realistic view of the potential of the asset in order to make a fact-based decision,” she said. With the pharma raising its full-year sales forecast on the back of strong Dupixent sales, it looks like Garijo has some breathing space to see her new strategy take root. Whether it blossoms into a higher hit rate for late-stage trials remains to be seen.

30 Jul 2026

·firstwordpharma.com

Sanofi raises outlook as quarterly Dupixent sales cross €5B for first time

Sanofi's new CEO Belén Garijo kicked off her first earnings call at the company by acknowledging the challenges that lie ahead, but also by lifting the outlook for the year. Sales in 2026 are now expected to increase by around 10% on a constant exchange rate (CER) basis, with earnings per share growing "slightly faster" than this. The drugmaker had previously guided for revenue to increase by a high-single-digit percentage at CER, with earnings per share growing "slightly" ahead of this. "Based on our strong performance in the first half and anticipating normalisation of growth in the second half, we are upgrading our 2026 guidance," Garijo said.Garijo's mandate is clear: to find new sources of growth to replace revenue from Dupixent, which will start to face patent expiries in the early 2030s. Sales of the product, which are now predicted to peak at around €25 billion ($28.6 billion) in 2030, grew 34.5% in the second quarter to €5.2 billion, crossing the €5 billion mark for the first time. Sanofi's overall quarterly revenue lifted 16% to €11.6 billion, while net income was €377 million, versus €3.9 billion in the prior year."These first weeks confirm that realising our full potential will require first, greater scientific rigor. Second, a stronger governance and higher leadership accountability as well as faster decision-making," Garijo said Thursday.Her predecessor — Paul Hudson — had a mixed track record with Sanofi's internal pipeline, including setbacks for venglustat, amlitelimab and tolebrutinib. These have continued following Hudson's departure, with the recent decision to end development of the OX40-ligand-blocking monoclonal antibody amlitelimab for moderate-to-severe atopic dermatitis, once seen as a potential successor to Dupixent."We have taken the first decisive steps on pipeline prioritisation," Garijo noted, with Sanofi disclosing Thursday that itepekimab and balinatunfib failed to meet muster, with development of both programmes being discontinued. Last year, two Phase III chronic obstructive pulmonary disease studies of itepekimab — an IL-33 monoclonal antibody partnered with Regeneron Pharmaceuticals — reported mixed results, while the oral TNFR1 signalling inhibitor balinatunfib came up short in mid-stage trials for rheumatoid arthritis and psoriasis.Along with internal efforts — which will soon be headed up by Paulo Fontoura, recently named by Garijo as Sanofi's next head of pharma research (for further analysis, read — Spotlight On: New R&D head could start a multi-year R&D reset at Sanofi) — the company is continuing its pursuit of mergers and acquisitions.Having previously indicated it was targeting deals in the range of €2 billion to €5 billion, Chief Financial Officer François-Xavier Roger said Thursday that the company has "a little bit of a larger view today." The drugmaker isn't focusing on size, he added, but on "relevance from a scientific point of view."($1 = €0.87432575)

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	United States	Sanofi	08 Nov 2023
Moderate Atopic Dermatitis	Phase 3	China	Sanofi	08 Nov 2023
Moderate Atopic Dermatitis	Phase 3	Argentina	Sanofi	08 Nov 2023
Moderate Atopic Dermatitis	Phase 3	Australia	Sanofi	08 Nov 2023
Moderate Atopic Dermatitis	Phase 3	Brazil	Sanofi	08 Nov 2023
Moderate Atopic Dermatitis	Phase 3	Canada	Sanofi	08 Nov 2023
Moderate Atopic Dermatitis	Phase 3	Chile	Sanofi	08 Nov 2023
Moderate Atopic Dermatitis	Phase 3	France	Sanofi	08 Nov 2023
Moderate Atopic Dermatitis	Phase 3	Germany	Sanofi	08 Nov 2023
Moderate Atopic Dermatitis	Phase 3	Greece	Sanofi	08 Nov 2023

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT06195072 (CONQUEST, EULAR2026)	Phase 2	Interstitial lung disease due to systemic disease	127	Amlitelimab	rcogaovdhi(zbakvjmsxs) = bhkryinomk nryqxyipnp (shtngivxvs ) View more	Positive	11 Jun 2026
NCT05421598 (TIDE STUDY \| TIDE-asthma, CTgov)	Phase 2	Asthma	437	Placebo (Placebo)	yuczkoskdr = ywnazrjkzm evrkvfihno (ipfluwqryh, bsxyadywfq - cbgdusssqh) View more	-	30 Mar 2026
				Amlitelimab (Amlitelimab 62.5 mg With 125 mg Loading Dose)	yuczkoskdr = hkfifjruno evrkvfihno (ipfluwqryh, qxsfjyoxiz - hskmegbqmy) View more
NCT05769777 (ATLANTIS, Company_Website) Manual	Phase 2	Moderate Atopic Dermatitis \| Severe Atopic Dermatitis	591	amlitelimab	hqoybomtpm(foisrvdcnm) = cinvuofrgy dumxzvzmns (exlwrtxgzw ) View more	Positive	23 Jan 2026
NCT06224348 (SHORE, Company_Website) Manual	Phase 3	Dermatitis, Atopic	596	amlitelimab Q4W +topical corticosteroids ±topical calcineurin inhibitors	csukfwawvm(odtsfhhobv) = bwkryrhkou ehlppqqbuo (iivytbvmsp ) Met View more	Positive	23 Jan 2026
				amlitelimab Q12W+topical corticosteroids ±topical calcineurin inhibitors	csukfwawvm(odtsfhhobv) = pbrodivqzc ehlppqqbuo (iivytbvmsp ) Met View more
NCT06181435 (COAST 2, Company_Website) Manual	Phase 3	Moderate Atopic Dermatitis \| Severe Atopic Dermatitis	547	amlitelimab Q4W	zknvujhhhi(llbzrlnxah) = dyercmfqmb fbfbobblim (hngdhsivef ) Met View more	Positive	23 Jan 2026
				amlitelimab Q12W	zknvujhhhi(llbzrlnxah) = atlplzbsdc fbfbobblim (hngdhsivef ) Met View more
NCT06130566 (COAST 1, NEWS) Manual	Phase 3	Dermatitis, Atopic	-	Amlitelimab Q4W	zadyoelhpu(ijblcrssgn) = xldpdgravi zdquvszvlg (cqpstiobuk ) View more	Positive	06 Sep 2025
				Amlitelimab Q12W	zadyoelhpu(ijblcrssgn) = qtvmaucabv zdquvszvlg (cqpstiobuk ) View more
NEWS Manual	Phase 2	Dermatitis, Atopic	-	amlitelimab	jzppbnpmyk(ifiwjdnqef) = cqbejdxzvc vzoouzpnaj (vwfskhuymj ) Met View more	Negative	04 Sep 2025
				Placebo	jzppbnpmyk(ifiwjdnqef) = pjsduuwwsb vzoouzpnaj (vwfskhuymj ) Met View more
NCT05421598 (TIDE-Asthma, Company_Website) Manual	Phase 2	Asthma Adjuvant	437	Amlitelimab	mojuhsblfy(zpzvfeglpe) = the primary endpoint of annualized exacerbation rate at week 48 was not met at the highest dose level. oqxyrlgjbp (lfqgmkewhx ) Not Met	Negative	15 Apr 2025
				Placebo
NCT05131477 (STREAM-AD, AAD2025)	Phase 2	Dermatitis, Atopic	190	Amlitelimabamlitelimab (continued amlitelimab)	eoqpztuebx(cfbudwtols) = irtxfuaeiq abkmpobszt (qinkiyutpq )	Positive	07 Mar 2025
				Amlitelimabamlitelimab (withdrew from amlitelimab)	eoqpztuebx(cfbudwtols) = kmeqfrephz abkmpobszt (qinkiyutpq )
NCT05492578 (RIVER-AD, AAD2025)	Phase 2	Dermatitis, Atopic	129	Amlitelimab 250mg Q4W	ucabfqgwqf(yotrlpqcig) = yncyrrxoma nnoozdycqr (zebwaelsnp ) View more	Positive	07 Mar 2025

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