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

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 on 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 (including a 16-week safety follow-up period) with 10 visits for participants who opt not to enter the optional long-term extension.
The study duration will be up to 172 weeks (including an 8-week safety follow-up period) with 22 visits for participants who enter the optional long-term extension.
The double-blind placebo-controlled treatment duration will be up to 28 weeks.

Start Date29 Aug 2024

Sponsor / Collaborator

Sanofi

CTR20241770

/ RecruitingPhase 3

一项 Ⅲ 期、随机、双盲、安慰剂对照、平行组、3 组、多国家、多中心研究，旨在评价以外用糖皮质激素为背景治疗且对既往生物治疗或口服 Janus 激酶（JAK）抑制剂治疗反应不充分的 12 岁及以上中重度特应性皮炎（AD）受试者皮下接受 amlitelimab 治疗的疗效和安全性

[Translation] A phase III, randomized, double-blind, placebo-controlled, parallel-group, 3-arm, multinational, multicenter study to evaluate the efficacy and safety of subcutaneous amlitelimab in subjects aged 12 years and older with moderate to severe atopic dermatitis (AD) who were on background topical corticosteroids and had an inadequate response to previous biologic therapy or oral Janus kinase (JAK) inhibitor therapy

主要目的: 证明与安慰剂相比，以外用药为背景治疗且对既往生物治疗或口服 JAK 抑制剂（JAKi）治疗反应不充分的 12 岁及以上中重度特应性皮炎（AD）受试者接受 amlitelimab 给药的疗效。次要目的：评估与安慰剂相比，以外用药为背景治疗且对既往生物治疗或口服 JAKi 治疗反应不充分的 12 岁及以上中重度 AD 受试者接受 amlitelimab 给药对其体征、症状、生活质量和精神健康的影响。评估以外用药为背景治疗且对既往生物治疗或口服 JAKi 治疗反应不充分的 12 岁及以上中重度 AD 受试者接受 amlitelimab 给药的安全性特征。表征以外用药为背景治疗且对既往生物治疗或口服 JAKi 治疗反应不充分的 12 岁及以上中重度 AD 受试者接受 amlitelimab 给药的药代动力学特征。表征以外用药为背景治疗且对既往生物治疗或口服 JAKi 治疗反应不充分的 12 岁及以上中重度 AD 受试者接受 amlitelimab 给药的免疫原性。

[Translation]

Primary Objectives: To demonstrate the efficacy of amlitelimab compared to placebo in subjects 12 years and older with moderate to severe atopic dermatitis (AD) who have an inadequate response to prior biologic therapy or oral JAKi therapy and who are taking background therapy with topical medications. Secondary Objectives: To assess the effects of amlitelimab compared to placebo on signs, symptoms, quality of life, and mental well-being in subjects 12 years and older with moderate to severe AD who have an inadequate response to prior biologic therapy or oral JAKi therapy and who are taking background therapy with topical medications. To assess the safety profile of amlitelimab in subjects 12 years and older with moderate to severe AD who have an inadequate response to prior biologic therapy or oral JAKi therapy and who are taking background therapy with topical medications. To characterize the pharmacokinetic profile of amlitelimab in subjects 12 years and older with moderate to severe AD who have an inadequate response to prior biologic therapy or oral JAKi therapy and who are taking background therapy with topical medications. To characterize the immunogenicity of amlitelimab in subjects 12 years and older with moderate to severe AD who are on background therapy with exogenous medications and have an inadequate response to prior biologic or oral JAKi therapy.

Start Date13 Aug 2024

Sponsor / Collaborator

Sanofi-Aventis Recherche & Développement SA

[+2]

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 2025·Journal of Scleroderma and Related Disorders

Design of CONQUEST, a novel, randomized, placebo-controlled, Phase 2b platform clinical trial to investigate new treatments for patients with early active systemic sclerosis with interstitial lung disease

Article

Author: Assassi, Shervin ; Steffgen, Juergen ; Benton, Wade W ; Maher, Toby M ; Gordon, Gregory ; Maslova, Karina ; Khanna, Dinesh ; Evnin, Luke B

Objective::

Safe, effective therapies are urgently needed for patients with systemic sclerosis. However, clinical trial recruitment is challenging given the limited number of people with systemic sclerosis and further restrictions imposed by eligibility criteria. Innovative approaches are needed to accelerate development of new therapies. This article describes the rationale and trial design for CONQUEST (NCT06195072), a novel platform clinical trial sponsored by the Scleroderma Research Foundation, a not-for-profit organization.

Methods::

CONQUEST is a multicentre, double-blind, randomized, placebo-controlled, Phase 2b platform trial evaluating the efficacy, safety and pharmacodynamics of multiple investigational products to treat early active systemic sclerosis with interstitial lung disease versus placebo. The primary objective is to evaluate change from baseline to Week 52 in forced vital capacity (mL). Secondary objectives include evaluating changes from baseline to Week 52 in high-resolution computed-tomography-assessed lung involvement and dyspnoea, and overall treatment response (measured using the revised composite response index in diffuse systemic sclerosis score in participants with diffuse cutaneous systemic sclerosis).

Results::

Patients will be enrolled across more than 150 centres in over 25 countries. Recruitment started on 15 April 2024.

Conclusion::

As the first platform clinical trial in the rheumatology field, CONQUEST aims to meaningfully accelerate the development of new therapies for early active systemic sclerosis. Depending on regimen-specific results, trial data could be used to plan and design a Phase 3 trial or may be used alone or together with another registrational trial to establish substantial evidence of effectiveness and safety. The first molecules to be studied, amlitelimab and nerandomilast, both have a strong scientific rationale to modify underlying disease processes in systemic sclerosis.

ClinicalTrials.gov::

Platform Clinical Study for Conquering Scleroderma (CONQUEST); NCT06195072; https://www.clinicaltrials.gov/study/NCT06195072

01 Apr 2025·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 ; Worm, Margitta ; Weber, Christine ; 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 mAb 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 (ClinicalTrials.gov identifier NCT05131477), patients received subcutaneous amlitelimab every 4 weeks at doses of 250 mg plus a 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 stop taking amlitelimab or continue the previous dose regimen for 28 weeks. The primary end point was percentage of change in Eczema Area and Severity Index (EASI) from baseline to week 16.

RESULTS:

In all, 390 and 190 patients enrolled in Part 1 and Part 2, respectively. A significant percentage of change decrease in EASI was observed with amlitelimab doses versus with placebo (P < .001). Clinical responses at week 24 (Investigator Global Assessment 0/1 and/or a 75% reduction in EASI) were maintained at week 52 in patients continuing or stopping amlitelimab. Of the patients maintaining clinical response at week 52 after no longer receiving treatment, more than 80% had serum amlitelimab concentrations less than the 4-μg/mL threshold for several weeks before 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 for 28 weeks after they had stopped taking amlitelimab.

01 Feb 2025·The Journal of clinical and aesthetic dermatology

Investigating Efficacy of Atopic Dermatitis Systemic Therapeutics After Discontinuation Part I: Biologics.

Review

Author: Al-Tariq, Kabir ; Kaiser, Michael ; Del Rosso, James ; Issa, Naiem T ; Abdin, Rama ; Kwatra, Shawn ; Jaalouk, Dana

Objective:

The authors sought to review published literature on the efficacy of biologics as monotherapy for atopic dermatitis (AD) following discontinuation.

Methods:

A comprehensive search of PubMed/MEDLINE was conducted examining drug withdrawal in AD clinical trials where participants were treated with biologics. Trials were included if they exclusively involved participants with AD that reported the maintenance or achievement of Eczema Area and Severity Index (EASI)-75 and Investigator Global Assessment (IGA) scores of 0 or 1 after withdrawal of biologic therapy. Clinical trials involving multidrug regimens, including those investigating concomitant topical therapeutics, were excluded from our analysis.

Results:

Five clinical trial programs met our inclusion criteria, each investigating a different biologic: dupilumab, tralokinumab, lebrikizumab, amlitelimab, and rocatinlimab.

Limitations:

Limitations to this review include a small number of trials that met the inclusion criteria, variations in study design that hinder direct comparisons, and the absence of long-term follow up data.

Conclusion:

The variability in eligibility criteria, treatment durations, and withdrawal periods across trials presents a major challenge in assessing biologics for AD, complicating the comparison of their sustained responses in the absence of head-to-head studies. This heterogeneity, combined with factors such as disease duration and prior use of systemic medications before trial enrollment, hampers the identification of key pathways in AD pathogenesis and impedes efforts to better understand and characterize the disease.

News (Medical) associated with Amlitelimab

02 Jun 2025

·www.biospace.com

Sanofi Inks $9.5B Blueprint Buyout to Expand Rare Disease Portfolio

Taylor Tieden for BioSpace Blueprint has a next-generation systemic mastocytosis treatment, called elenestinib, that Sanofi CEO Paul Hudson told analysts provides an “opportunity to grow through the ‘30s.” Sanofi has struck a $9.5 billion deal to buy Blueprint Medicines for an approved rare disease drug and an early-stage immunology pipeline. The deal, $9.1 billion of which is upfront, will give Sanofi ownership of the systemic mastocytosis therapy Ayvakit. Blueprint posted net product revenues of $479 million in 2024 and, after achieving 61% growth in the first quarter, recently raised its guidance for this year to between $700 million and $720 million. Brian Foard, Sanofi’s head of specialty care, discussed the product’s longer-term prospects on a call with analysts Monday. The launch is “just getting started,” he said. Sanofi’s valuation of Blueprint reflects “extremely low advanced therapy penetration” so far, the executive said, and the company’s belief in the potential of Ayvakit over a long period of time. Leerink analyst Andy Berens expects that Blueprint’s revenue will hit $1.7 billion in 2030. Other observers have higher hopes, putting the consensus estimate at $2.1 billion. Leerink analyst David Risinger said in a note to investors that Sanofi “will need to deliver on its plans to find and treat more patients.” The ability of Blueprint’s pipeline to deliver blockbuster sales over the long term will be critical, too, Risinger said. There are unanswered questions about Ayvakit’s growth trajectory. Analysts asked Foard whether he expects the product to lose exclusivity in 2034 or 2040, two years in which different patents on the drug expire. Foard declined to comment beyond saying the company is “extremely comfortable with the IP.” Blueprint has a next-generation systemic mastocytosis treatment, called elenestinib, that Sanofi CEO Paul Hudson told analysts provides an “opportunity to grow through the ‘30s.” Hudson said elenestinib’s potential is “a big deal.” Elenestinib is one of two Blueprint pipeline programs that Sanofi named as drivers of the deal. The other candidate is BLU-808, a KIT inhibitor that has applications in a range of inflammatory diseases. The deal features contingent value rights tied to development and regulatory milestones for BLU-808. Hitting the milestones will bring the total value of the deal up to $9.5 billion. Hudson said Blueprint’s “established presence among key specialist physicians” was another driver of the deal. Under Hudson, Sanofi has invested in a range of immunology candidates. Blueprint’s commercial infrastructure maps on to the capabilities Sanofi expects to need to launch its immunology drugs. “If you think about where they are today, their call points, uniquely, fit us perfectly,” Foard said. “Think about our pipeline that is being built right now with amlitelimab, with lunsekimig, with TL1A. The call points for those assets are going to be dermatologists, allergists, GIs, which is exactly where Blueprint is today. So, it is going to be a natural build around these individuals.” Sanofi, which is selling a controlling stake in its consumer-healthcare arm, has struck three takeovers this year. The Blueprint deal joins agreements to buy Dren Bio and Vigil Neuroscience for $600 million and $470 million upfront, respectively. The buyouts have added to a pipeline that Hudson said has endured “a bumpy year in terms of some of the readouts.” The Blueprint takeover is at the upper end of the valuation range that Hudson has told investors Sanofi will look at. Yet, the buyout, which Sanofi will finance through cash and new debt, has not sated the company’s appetite. Sanofi CFO François-Xavier Roger told analysts the company retains “significant capacity for further business development, particularly in early-stage medicines and vaccines.”

AcquisitionImmunotherapy

30 May 2025

·www.fiercebiotech.com

Sanofi, Regeneron\'s IL-33 drug fails one of 2 COPD studies as FDA timeline thrown in doubt

Sanofi said it will take itepekimab data to regulators to \"evaluate our path forward.\"\n Sanofi’s plans to submit itepekimab to regulators for approval this year have been thrown into doubt after the Regeneron-partnered drug failed one of a pair of phase 3 chronic obstructive pulmonary disease (COPD) trials.Both of the studies, dubbed Aerify-1 and Aerify-2, evaluated administering the IL-33 drug itepekimab subcutaneously every two weeks or four weeks across a combined total of more than 2,000 former smokers with moderate to severe COPD. Both trials were designed to demonstrate a statistically significant reduction in moderate or severe exacerbations of COPD compared to placebo after 52 weeks.Aerify-1 hit this endpoint by demonstrating a 27% relative reduction in exacerbations among patients who received itepekimab every two weeks and a 21% reduction among those who received the drug every four weeks.But Aerify-2 was less successful, producing just a 2% reduction at two-week dosing and a 12% reduction at four-week dosing.Sanofi partly blamed the results on the lower total number of exacerbations “than prospectively anticipated,” which the company said had “decreas[ed] the power of both trials.”“Enrollment largely occurred during the time of the global COVID pandemic, which could have contributed to the overall lower exacerbation rates,” the pharma explained.Adverse events were “generally comparable” between the itepekimab and placebo cohorts, Sanofi said in its May 30 release. In the failed Aerify-2 trial, adverse events that led to death were 3% for each of the itepekimab cohorts compared to 2% for the placebo group.The failure of that trial is a significant setback for a drug that was listed in Sanofi’s most recent earnings presentation in April as being lined up for a regulatory filing in the second half of this year. At the time, Houman Ashrafian, Ph.D., Sanofi’s head of R&D, described the COPD readouts as “significant” and told analysts they could potentially lead to itepekimab’s market launch in 2026.In a statement attached to this morning’s data, Ashrafian sounded more muted on the drug’s near-term plans.“While we are encouraged by the results of AERIFY-1, the results of both studies merit further exploration to have a full understanding of the data and the role that IL-33 plays in this complex disease,” Ashrafian said. “Certain people with COPD are in desperate need of new treatment options, especially those who continue to experience exacerbations despite being on maximal therapy, and we remain committed to discussing these data with regulatory agencies to evaluate our path forward.”Sanofi declined to confirm to Fierce Biotech that its previous FDA timeline remains on track. The French Big Pharma had been developing itepekimab in collaboration with Regeneron. The two companies have seen blockbuster success with their immunology drug Dupixent and had previously evaluated the two therapies in combination as an asthma treatment in a phase 2 trial before halting that work in 2021. Separate phase 2 and 3 trials of itepekimab in COPD remain ongoing. Even if today’s unimpressive results mark the end of the road for itepekimab in that respiratory indication, the drug is still being evaluated in trials for rhinosinusitis with nasal polyps and bronchiectasis.“We are encouraged by the initial results from AERIFY-1 and are carefully reviewing the results from both itepekimab trials to inform next steps,” Regeneron Chief Scientific Officer George Yancopoulos, M.D., Ph.D., said in today’s release.“We remain committed to our broader itepekimab development program,” Yancopoulos added. “The learnings will be invaluable as we continue to advance itepekimab in respiratory diseases with unmet need.”The Aerify-2 fail continues a run of bad luck for Sanofi this year. The Paris-based pharma has also seen its psoriasis drug balinatunfib, its asthma hopeful amlitelimab and its Johnson & Johnson-sourced E. coli vaccine all underwhelm in the clinic in 2025.

$Sanofi, Regeneron\'s IL-33 drug fails one of 2 COPD studies as FDA timeline thrown in doubt$

Phase 2Phase 3VaccineClinical Result

24 Apr 2025

·www.fiercebiotech.com

Sanofi\'s oral TNF inhibitor misses mark in phase 2 psoriasis trial, prompting focus on combos

Sanofi expects to publish phase 2 data on balinatunfib in rheumatoid arthritis in the second half of 2025. \n Sanofi’s development of an oral spin on Humira’s mechanism has hit a setback. The candidate fell short in a phase 2 psoriasis trial, prompting the French drugmaker to pull back from plans to develop the molecule as a monotherapy.Led by AbbVie’s Humira, biologic TNF inhibitors transformed the treatment of autoimmune diseases over the past 20 years. However, the biologic modality can cause adverse effects and loss of efficacy in some patients. Sanofi identified the small molecule balinatunfib as a candidate that could bypass those issues and, by inhibiting TNFR1 but not TNFR2, offer a differentiated side effect profile compared to biologics.The Big Pharma put the idea to the test in a phase 2 trial that enrolled 221 people with psoriasis to take balinatunfib as a monotherapy. After 12 weeks, Sanofi found its small molecule was statistically no better than placebo on a measure of the proportion of patients whose symptoms improved by at least 75%, the French company revealed in its first-quarter 2025 earnings results.Sanofi blamed the primary endpoint miss on “the nature of this limited phase 2 study.” Efficacy levels were “comparable to other oral medicines in psoriasis,” according to the company, and the data support the potential for differentiated safety. Based on the results, Sanofi believes balinatunfib could pair well with other drugs and is looking into opportunities including fixed-dose combinations in various diseases. On an earnings call in January, Houman Ashrafian, Ph.D., head of R&D at Sanofi, said the company would look to establish balinatunfib as pre-biologic monotherapy if phase 2 data supported single-agent use. While the phase 2 efficacy data have closed that avenue off, Sanofi continues to believe in the combination opportunities that Ashrafian sketched out in January.“There\'s a logic for it to be used in combination treatment strategies, particularly in the modern era where we have seen the combination cytokine blockade can both increase the efficacy ceiling or surpass efficacy ceiling and also provide durability,” the Sanofi executive said on the same January call. Sanofi CEO Paul Hudson added at the time that “if safety is right, the combination opportunity is significant.”Sanofi expects to publish phase 2 data on balinatunfib in rheumatoid arthritis in the second half of 2025. The readout could confirm the small molecule has a profile that is suitable for further development in combinations. Sanofi noted in this morning\'s earnings presentation that rheumatoid arthritis is “already a combination market.” Sanofi recently began phase 2 trials in Crohn’s disease and ulcerative colitis. The company disclosed the balinatunfib update alongside news about a phase 2 trial of brivekimig. The study, which tested the TNFxOX4OL nanobody in hidradenitis suppurativa, met a primary endpoint that looked at the effect on total abscess and inflammatory nodule count. Sanofi is prioritizing brivekimig in the indication because it looks more efficacious than the anti-OX40L antibody amlitelimab.

$Sanofi\'s oral TNF inhibitor misses mark in phase 2 psoriasis trial, prompting focus on combos$

Phase 2Clinical Result

100 Deals associated with Amlitelimab

R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Dermatitis, Atopic	Phase 3	United States	Sanofi-Aventis Recherche & Développement SA	08 May 2024
Dermatitis, Atopic	Phase 3	United States	Genzyme Ireland Ltd.	08 May 2024
Dermatitis, Atopic	Phase 3	Japan	Sanofi-Aventis Recherche & Développement SA	08 May 2024
Dermatitis, Atopic	Phase 3	Japan	Genzyme Ireland Ltd.	08 May 2024
Dermatitis, Atopic	Phase 3	Canada	Genzyme Ireland Ltd.	08 May 2024
Dermatitis, Atopic	Phase 3	Canada	Sanofi-Aventis Recherche & Développement SA	08 May 2024
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

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05421598 (TIDE-Asthma, Company_Website) Manual	Phase 2	Asthma Adjuvant	437	Amlitelimab	rmkowlttci(jrdrovuyhv) = the primary endpoint of annualized exacerbation rate at week 48 was not met at the highest dose level. znclrdsbyu (plsdgwhunq ) Not Met	Negative	15 Apr 2025
				Placebo
NCT05131477 (STREAM-AD, Pubmed) Manual	Phase 2	Dermatitis, Atopic	580	Amlitelimab (Part 1)	eekgmxqtyy(lgxoqkjazn): P-Value = < 0.001	Positive	08 Nov 2024
				Amlitelimab (Part 2)
NCT05131477 (STREAM-AD, GlobeNewswire) Manual	Phase 2	Dermatitis, Atopic	390	amlitelimab (patients with continued treatment)	emnbfmddro(qjnotpimyu) = flmrtrjqyi jdlgxnaaou (wohpzenllm ) View more	Positive	11 Mar 2024
				amlitelimab (patients withdrawn from treatment)	emnbfmddro(qjnotpimyu) = hpzylczvnh jdlgxnaaou (wohpzenllm ) View more
NCT05131477 (STREAM-AD, NEWS) Manual	Phase 2	Dermatitis, Atopic	390	amlitelimab	tyuzuyxvyd(oqsvphmnyd) = khpvbjxryz kzonmvanui (iqwegmdato ) View more	Positive	15 Oct 2023
				placebo	tyuzuyxvyd(oqsvphmnyd) = uzfbslqnko kzonmvanui (iqwegmdato ) View more
NCT03754309 (AAD2023)	Phase 2	Dermatitis, Atopic	89	Amlitelimab low-dose	waqsmemsem(ergmtimyao) = 1 SAE (infected dermal cyst) was reported as possibly related; it resolved and the patient completed the study ksfvrvsknv (fvdrxienps ) 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])	tzlbarvxxi(efmyjrshds) = mhxzzszvth opuuycqwqh (jbndocwapl )	Positive	07 Sep 2022
				Amlitelimab high dose (500 mg/250 mg Q4W)	tzlbarvxxi(efmyjrshds) = wyuwtwyofu opuuycqwqh (jbndocwapl )

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