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

/ 主动终止Phase 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

/ Active, not recruitingPhase 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 Dec 2025·JOURNAL OF THE EUROPEAN ACADEMY OF DERMATOLOGY AND VENEREOLOGY

Improvement and maintenance of clinical outcome assessments in atopic dermatitis with amlitelimab

Article

Author: Gray, Cori ; Weber, Christine ; Brookes, Ella ; Merola, Joseph F. ; Weidinger, Stephan ; Blauvelt, Andrew ; Igawa, Ken ; Wang, Jennifer ; Chovatiya, Raj

Abstract:

Background:

Amlitelimab, a fully human, nondepleting, anti‐OX40 ligand monoclonal antibody, demonstrated reductions in lesional and pruritic endpoints in adults with moderate‐to‐severe atopic dermatitis (AD) in phase 2a and 2b trials.

Objectives:

Here, we examined the effect and durability of amlitelimab on clinical outcome assessments (COAs) in the randomized STREAM‐AD phase 2b trial.

Methods:

Adults with moderate‐to‐severe AD with prior inadequate response to or inadvisability of topical medications received subcutaneous amlitelimab (250 mg with 500‐mg loading dose, 250 mg, 125 mg or 62.5 mg) or placebo every 4 weeks in Part 1 (Weeks 0–24; 1:1:1:1:1 randomization). In Part 2, Week 24 clinical responders (defined as patients achieving Investigator Global Assessment [IGA] 0/1 and/or ≥ 75% reduction in the Eczema Area and Severity Index [EASI‐75]) were rerandomized 3:1 to withdraw or continue amlitelimab pre–Week 24 dose through Week 52. COAs, including SCORing Atopic Dermatitis, affected body surface area, Patient‐Oriented Eczema Measure, Dermatology Life Quality Index and Atopic Dermatitis Control Tool, were evaluated.

Results:

Of the 390 randomized patients in Part 1, 190 were rerandomized in Part 2. Significant improvements in COAs were observed with all amlitelimab doses versus placebo at Week 24 ( p < 0.05 for all COAs). At Week 24, the majority of clinical responders achieved meaningful changes in COAs. At Week 52, these improvements were maintained in the majority of patients who achieved COA improvements at Week 24, regardless of treatment continuation or withdrawal during the 28‐week Part 2 period.

Conclusions:

Amlitelimab treatment led to clinically meaningful improvements in COAs by Week 24 versus placebo. COA improvements were maintained at Week 52 in patients continuing amlitelimab, as well as in patients who withdrew from amlitelimab, supporting the durable response of amlitelimab and the viability of extended drug dosing, which may ease treatment burden.

Clinical Trial Registration:

ClinicalTrials.gov Identifier: NCT05131477.

01 Dec 2025·PHARMACOEPIDEMIOLOGY AND DRUG SAFETY

Efficacy and Safety of All Monoclonal Antibodies in Moderate‐to‐Severe Atopic Dermatitis: A Systematic Review and Network Meta‐Analysis

Review

Author: Fu, Linlin ; Yao, Yao ; Zhang, Jinping ; Cai, Wenting ; Wu, Yan

ABSTRACT:

Objective:

The aim of this study was to compare the efficacy and safety of monoclonal antibodies (mAb) for moderate‐to‐severe atopic dermatitis (AD).

Methods:

The randomized controlled trials (RCTs) of monoclonal antibodies in the treatment of moderate‐to‐severe AD were searched in the database of PubMed, Embase, Web of Science and Cochrane Library, up to November 2024. The control group included placebo. The efficacy indicators were the percentage of patients achieving 50%, 75%, 90% improvement in Eczema Area and Severity Index score (EASI‐50, EASI‐75, EASI‐90) and the percentage of patients with an Investigator Global Assessment (IGA) Score of 0 or 1 from baseline until the time of efficacy observation, and the percent change in Pruritus Numerical Rating Scale (NRS), EASI score, SCORing Atopic Dermatitis (SCORAD), and change in Percent Body Surface Area (BSA), Dermatology Life Quality Index (DLQI). The statistical analysis was performed by Stata14 and RevMan5.4. Data processing, network evidence plots, surface under the cumulative ranking curve (SUCRA) ranking, league plots and funnel plots were generated. Risk ratio (RR) and 95% confidence interval (95% CI) were used as effect sizes to analyze binary categorical variables.

Results:

This study included 32 RCTs with 7588 patients. Spesolimab, Rademikibart, Dupilumab, Amlitelimab were more effective than placebo in EASI‐50 (RRs ranging between 1.31 and 22.65), EASI‐75(RRs ranging between 1.51 and 36.58), EASI‐90(RRs ranging between 3.72 and 5.49), and the percentage of patients in IGA score of 0 or 1 (RRs ranging between 1.78 and 13.36). Dupilumab showed relatively good efficacy according to SUCRA ranking on percent change in NRS, EASI, SCORAD. Dupilumab exhibited a lower incidence of serious adverse events than placebo, and the difference was statistically significant (RR = 0.43, 95% CI 0.30–0.63). Other safety analysis results showed no statistical difference.

Conclusions:

Through the analysis of the primary efficacy indicators, this network meta‐analysis (NMA) study indicated that all monoclonal antibodies performed better than placebo. Based on the results of this study, Spesolimab, Rademikibart, Dupilumab, Amlitelimab were recommended treatment options with relatively good efficacy and safety.

01 Dec 2025·CPT-Pharmacometrics & Systems Pharmacology

Population Pharmacokinetic and Pharmacodynamic Modeling for the Prediction of the Extended Amlitelimab Phase 3 Dosing Regimen in Atopic Dermatitis

Article

Author: O'Malley, John T. ; Papp, Kim ; Fabre, David ; Weidinger, Stephan ; Yen, Karl ; Tiraboschi, Gilles ; Lee, Chih‐Hung ; Bernigaud, Charlotte ; Beck, Lisa ; Hurbin, Fabrice ; Bieber, Thomas

ABSTRACT:

Amlitelimab is a fully human, nondepleting, anti‐OX40 ligand monoclonal antibody being investigated for the treatment of moderate‐to‐severe atopic dermatitis (AD) in adults and adolescents. Population pharmacokinetic (PopPK) and pharmacokinetic/pharmacodynamic‐Eczema Area and Severity Index (PopPK/PD‐EASI) models were used to inform dosing regimen selection for amlitelimab phase 3 trials. The PopPK model was developed using phase 1 (healthy volunteers) and phase 2 (participants with AD) trial data, including individual exposure variables from the STREAM‐AD phase 2b trial following subcutaneous amlitelimab doses ranging from 62.5 to 250 mg given every 4 weeks (Q4W). The PopPK model was used to compute exposures for an extended dosing regimen of 250 mg Q12W (with 500 mg loading dose [+LD]). The PopPK/PD‐EASI model was developed from phase 2 trials to predict treatment responses (EASI values) with selected dosing scenarios. Finally, the dose for individuals with lower body weight (i.e., < 40 kg) was determined. Utilizing the PopPK model, the amlitelimab 250 mg Q12W + LD computed exposures were between the exposures of 62.5 mg Q4W and 250 mg Q4W + LD efficacious doses in the STREAM‐AD trial. Using the PopPK/PD‐EASI model, the simulated efficacy for dosing scenarios of 250 mg Q12W + LD regimen from initiation or 250 mg Q4W + LD for 24 weeks followed by Q12W to Week 60 was similar to continuous 250 mg Q4W. Simulations identified that a twofold dose reduction would allow participants < 40 kg to achieve amlitelimab exposures within the range observed in participants ≥ 40 kg on 250 mg Q4W or Q12W. These results support evaluation of a Q12W dosing regimen for adults and adolescents in phase 3 trials.

News (Medical) associated with Amlitelimab

02 Feb 2026

·www.fiercebiotech.com

Sanofi\'s troubled GCS inhibitor fails phase 3 Fabry trial but scores in Gaucher disease

Venglustat was once considered as a potential \"pipeline in a pill.\"\n Sanofi’s pipeline features a number of once-hyped candidates that are struggling to deliver in the clinic, and the latest mixed phase 3 data from venglustat continue this trend.The French Big Pharma was studying venglustat, an oral, brain-penetrant glucosylceramide synthase (GCS) inhibitor, in a pair of late-stage studies of rare lysosomal storage disorders. One of these trials, called Peridot, assessed the pill in 122 patients with Fabry disease, while the Leap2Mono trial focused on 43 patients with type 3 Gaucher disease (GD3).The Peridot study missed its primary endpoint of demonstrating superiority in patient-reported improvement of symptoms—namely neuropathic pain in upper and lower extremities, as well as abdominal pain—compared to a placebo cohort. Sanofi explained this failure by pointing to a “reduction in neuropathic and abdominal pain … observed in both study arms.”It was better news in the Leap2Mono study, where the 21 patients who received venglustat saw statistically significant improvements in neurological symptoms at Week 52 as measured by scales for ataxia and for neuropsychological status. The improvement between the venglustat cohort and the 22 patients who received enzyme replacement therapy (ERT) worked out as a p-value of 0.007, Sanofi explained in its Feb. 2 release.When it came to non-neurological secondary endpoints like changes in spleen volume, liver volume and hemoglobin level, venglustat “performed as well as ERT,” according to the pharma.Venglustat was well tolerated, Sanofi said. The most common adverse events were headache, nausea, spleen enlargement and diarrhea—although reports of headache were higher in the ERT cohort.Based on the Leap2Mono data, Sanofi said it will seek regulatory approval for venglustat in GD3. The company already markets the ERT Cerezyme and the oral glucosylceramide synthase inhibitor Cerdelga for the disease.The failure of the Peridot study doesn’t mark the end of Sanofi’s Fabry ambitions, either. As well as its approved Fabry ERT Fabrazyme, Sanofi is still running a phase 3 study of venglustat on left cardiac ventricular mass index in patients with the disease.“These findings underscore Sanofi\'s commitment to rare disease research and the promise we aim to deliver for people living with these conditions,” Sanofi’s head of R&D Houman Ashrafian, Ph.D., said in this morning’s release.“What excites us most is the potential to address critical unmet medical needs,” Ashrafian added. “A daily pill could make a serious difference for Gaucher patients facing neurological challenges.”This morning’s phase 3 readouts continued a run of mixed data for venglustat, which had at one point been hailed as one of Sanofi\'s top prospects and a potential “pipeline in a pill” contender. Those ambitions were blunted as far back as 2021, when venglustat failed midstage studies in both Parkinson’s disease and autosomal dominant polycystic kidney disease. By 2024, venglustat’s options were narrowed down to just Fabry disease and GD3 after Sanofi gave up on GM2 gangliosidosis as an indication “based on the absence of positive trends on clinical endpoints.”While Sanofi remains hopeful of getting venglustat approved for GD3, the Fabry failure this morning also continues a longer-term trend of the drugmaker’s pipeline struggling to achieve its potential. The company’s R&D chief admitted to Fierce last year that clinical setbacks for its anti-OX40L-ligand antibody amlitelimab, its oral TNF inhibitor balinatunfib and its Regeneron-partnered IL-33 candidate itepekimab had resulted in a “mixed” 2025.On an earnings call with journalists last week, Sanofi CEO Paul Hudson directly acknowledged that it had been a “bumpy ride” for R&D.“I\'m well aware of the headlines—we had some challenges,” the CEO said at the time.

$Sanofi\'s troubled GCS inhibitor fails phase 3 Fabry trial but scores in Gaucher disease$

Phase 3Clinical ResultDrug Approval

02 Feb 2026

·endpoints.news

Kyowa Kirin reveals side effect in trial; GSK was lone bidder for RAPT

Plus, news on AstraZeneca, Johnson & Johnson, Averin Capital and Chugai: 🧪 Kyowa Kirin discloses side effect for recently regained drug: A patient participating in a Phase 3 trial to treat eczema developed a case of Kaposi’s sarcoma, a cancer of the blood vessels, Kyowa Kirin CEO Masashi Miyamoto told analysts Monday in Tokyo. The patient had “risk factors” and had received an experimental anti-OX40 drug known as rocatinlimab in the ROCKET program. “The treatment was discontinued, but we hear that the patient is recovering,” Miyamoto said, according to a transcript of the call. Amgen on Friday terminated its partnership on rocatinlimab with Kyowa Kirin, with both companies describing the move as “portfolio prioritization” on Amgen’s part and neither disclosing the side effect at the time. A similar program from Sanofi (amlitelimab, which targets the OX40 ligand) also saw a case of cutaneous Kaposi’s sarcoma emerge in a high-risk patient during a Phase 3 trial. — Max Gelman 💰 GSK was sole bidder for RAPT Therapeutics: The UK drug giant was the only company to make an offer for the food allergy biotech that it’s acquiring for $2.2 billion . Eight other companies contacted by RAPT either didn’t respond, weren’t interested in a deal or didn’t submit an offer, according to a regulatory document revealed Monday. GSK hiked its offer multiple times, starting at $50 a share on Dec. 22 before landing on the $58 price that was disclosed on Jan. 20. — Kyle LaHucik 📈 AstraZeneca starts trading on New York Stock Exchange: The company is now trading across the NYSE, London Stock Exchange and Nasdaq Stockholm. The decision comes just a few days after AstraZeneca announced a $15 billion investment in China, as well as a $1.2 billion upfront collaboration with Hong Kong-based CSPC Pharmaceuticals on eight different drugs, including a once-monthly injection for obesity. — Max Gelman 📊 J&J touts real-world data of its prostate cancer med : The pharma found that patients who received Erleada had a statistically significant 51% reduction in the risk of death compared to patients who took Bayer’s Nubeqa without docetaxel, a kind of chemotherapy. The retrospective analysis included patients with metastatic castration-sensitive prostate cancer who initiated treatment between August 2022 and June 2025 through 24 months of follow-up, totaling almost 1,500 people who took Erleada and 287 people who initiated with Nubeqa. — Max Bayer 💰 David Berry launches $250M SPAC: Berry and his healthcare investment firm Averin have launched a special purpose acquisition company called Averin Capital Acquisition. They plan to raise $250 million in a Nasdaq IPO so the blank-check company can combine with a business at the “intersection of technology and health,” according to a Friday SEC filing . Berry was CEO of Flagship-founded Valo Health when the biotech tried going public via a SPAC combination. Those plans were culled, and Valo remains private. In 2024, Berry left Valo and Flagship, where he had spent about 18 years helping build healthcare companies. Averin invests in startups like liquid biopsy company Freenome. — Kyle LaHucik 🛑 Chugai trims chronic disease program from pipeline: The antibody known as BRY10 was in a Phase 1 healthy volunteer study, but Chugai opted not to advance it, according to a company presentation . — Max Gelman

Phase 3Clinical ResultAcquisitionPhase 1

02 Feb 2026

·firstwordpharma.com

Sanofi posts a win for venglustat in Gaucher study, but a miss in Fabry disease

Sanofi announced Monday mixed results from a pair of pivotal studies of venglustat in two rare lysosomal storage disorders, with the oral glucosylceramide synthase inhibitor (GCSi) recording a hit in type 3 Gaucher disease (GD3) and a miss in Fabry disease. The contrasting outcomes are the latest to emerge from the company's late-stage pipeline, following differing results earlier this year from the investigational OX40-ligand-blocking monoclonal antibody amlitelimab in two atopic dermatitis trials.The Phase III LEAP2MONO study randomised 43 adult and paediatric patients with neurological manifestations of GD3 to receive venglustat once-daily or enzyme replacement therapy (ERT). The trial's primary endpoints were change in Scale for Assessment and Rating of Ataxia (SARA) modified total score and change in Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) total scale index score, with key secondary goals including percent change in spleen volume, liver volume and platelet count, as well as change in haemoglobin levels.Results showed that venglustat demonstrated statistically significant improvements in neurological symptoms as measured by both SARA and RBANS at week 52 compared to ERT. Sanofi added that the therapy also achieved three out of the four key secondary endpoints, performing as well as ERT on non-neurological outcomes, including changes in spleen volume, liver volume and haemoglobin levels.Regulatory filings in GD3"What excites us most is the potential to address critical unmet medical needs. A daily pill could make a serious difference for Gaucher patients facing neurological challenges," said Houman Ashrafian, head of R&D at Sanofi. The company indicated that based on the results, it will pursue global regulatory filings for venglustat in GD3.Sanofi currently markets the injectable therapy Cerezyme (imiglucerase) for Gaucher disease, as well as the oral drug Cerdelga (eliglustat) for those with type 1 disease. The drugmaker's portfolio also includes the injectable therapy Fabrazyme (agalsidase beta) for Fabry disease. However, the latest results dent its hopes of adding an oral Fabry disease therapy to its arsenal.Fabry setbackThe Phase III PERIDOT study randomised 122 patients aged 16 years and older with Fabry disease to receive venglustat or placebo. Sanofi noted that the trial failed to hit its primary endpoint of percent change from baseline on patient-defined most bothersome symptoms, as assessed by the Fabry Disease Patient-Reported Outcome (FD-PRO) instrument.According to the company, reductions in neuropathic and abdominal pain were observed in both study arms. Additional analyses of the data are ongoing, while the late-stage CARAT trial evaluating the effect of venglustat on left cardiac ventricular mass index in men and women with Fabry disease is ongoing.Findings from both LEAP2MONO and PERIDOT are scheduled to be presented this week at the annual WORLDSymposium.Aside from the positive results in GD3, Venglustat, which works by reducing the abnormal accumulation of sugar-and-fat molecules in cells and organs, has racked up a number of study failures. In 2024, Sanofi disclosed that the Phase III AMETHIST trial for GM2 gangliosidosis was discontinued based on “the absence of positive trends” for clinical endpoints, adding to a pivotal Phase II/III study setback in autosomal dominant polycystic kidney disease and another in Parkinson's disease with GBA mutations.

Phase 3Clinical Result

100 Deals associated with Amlitelimab

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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

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT06130566 (COAST 1, NEWS) Manual	Phase 3	Dermatitis, Atopic	-	Amlitelimab Q4W	pcjmweguqo(fsakiefkca) = jvtrzlgngr crrreddwfm (xitrpggvgp ) View more	Positive	06 Sep 2025
				Amlitelimab Q12W	pcjmweguqo(fsakiefkca) = izfatwqngh crrreddwfm (xitrpggvgp ) View more
NEWS Manual	Phase 2	Dermatitis, Atopic	-	amlitelimab	gunkppkojg(egnownfltj) = ipwvkkybwg nsaojsxems (bpzqhfpdfb ) Met View more	Negative	04 Sep 2025
				Placebo	gunkppkojg(egnownfltj) = nhtrxfcfiz nsaojsxems (bpzqhfpdfb ) Met View more
NCT05421598 (TIDE-Asthma, Company_Website) Manual	Phase 2	Asthma Adjuvant	437	Amlitelimab	axdvpwwari(eldwjtujsv) = the primary endpoint of annualized exacerbation rate at week 48 was not met at the highest dose level. gckbdgiapf (chfcyzgvpj ) Not Met	Negative	15 Apr 2025
				Placebo
NCT05131477 (STREAM-AD, Pubmed) Manual	Phase 2	Dermatitis, Atopic	580	Amlitelimab (Part 1)	lhrwbxeqtv(qlooavpfyk): 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)	jizdtzzgit(gzewtcwfbi) = xqmlzgumww ibyfrepswz (etwwuixfyv ) View more	Positive	11 Mar 2024
				amlitelimab (patients withdrawn from treatment)	jizdtzzgit(gzewtcwfbi) = nydfwhfqam ibyfrepswz (etwwuixfyv ) View more
NCT05131477 (STREAM-AD, NEWS) Manual	Phase 2	Dermatitis, Atopic	390	amlitelimab	ahpmfxfawo(xilrfxzipr) = filyypoiap sggbsshvji (opwzvqdygt ) View more	Positive	15 Oct 2023
				placebo	ahpmfxfawo(xilrfxzipr) = cqwsulvobp sggbsshvji (opwzvqdygt ) View more
NCT03754309 (AAD2023)	Phase 2	Dermatitis, Atopic	89	Amlitelimab low-dose	kopfvhisoo(ddwvfqjmpq) = 1 SAE (infected dermal cyst) was reported as possibly related; it resolved and the patient completed the study esdpipwspp (kqsnnxozyd ) 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])	kuxzasgofk(nuffavqzdy) = mirnitnuuo gfjgfoortv (nwczhizjcj )	Positive	07 Sep 2022
				Amlitelimab high dose (500 mg/250 mg Q4W)	kuxzasgofk(nuffavqzdy) = hmywhogzur gfjgfoortv (nwczhizjcj )
NCT03161288 (Pubmed \| Clin Pharmacol Ther)	Phase 1	-	64	KY1005	fytcokhgkk(ljseinkdab) = No serious adverse events occurred and all adverse events were temporary and of mild or moderate severity. bfifsuctij (mioopeyvim ) View more	-	29 Jan 2022
				Placebo

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