A Phase 3 Multi-center Trial to Evaluate the Efficacy and Safety of Tralokinumab in Combination With Topical Corticosteroids in Children (Age 2 to <12 Years) and Infants (Age 6 Months to <2 Years) With Moderate-to-severe Atopic Dermatitis. The Trial is Randomized, Double-blind, Placebo-controlled, and Parallel-group for Children (Age 2 to <12 Years) and Open-label and Single-group for Infants (Age 6 Months to <2 Years)

The purpose of this trial is to test whether treatment with tralokinumab (administered subcutaneous injections [SC]) in combination with topical corticosteroids (TCS) is safe and effective to treat moderate-to-severe atopic dermatitis (AD) in children and infants. This will be judged by a range of assessments that rate the severity and extent of atopic dermatitis and its symptoms, as well as general health status and quality of life. The trial will last for up to 4 years. There will be visits every 2 weeks for the first year and every 6 weeks thereafter. Some of the visits will be conducted by phone.
The study involves two different age groups: children aged 2 to under 12 years and infants aged 6 months to under 2 years. This trial compares tralokinumab +TCS to placebo + TCS for children with moderate-to-severe AD and evaluates tralokinumab + TCS for infants with moderate-to-severe AD. Infants will not receive placebo. All subjects will go through a screening process, which is the first part of the trial and will last up to 4 weeks. During this period, it will be checked if the child or infant meets the criteria to participate in the trial.
The children will be randomly assigned to receive tralokinumab + TCS or placebo + TCS for the initial 16 weeks, with the treatment being double-blinded. During the first 16 weeks, children will have a 2 out of 3 chance of getting tralokinumab and a 1 out of 3 chance of getting placebo. Thereafter, all subjects will receive tralokinumab + TCS. The infants will receive tralokinumab + TCS as open-label treatment for the entire treatment period, meaning that the participants will know they are receiving tralokinumab. After stopping treatment, all participants will enter a 4-week safety follow-up period.

Start Date10 Jun 2024

Sponsor / Collaborator

Leo Pharma, Inc.

CTIS2022-502653-34-01

/ RecruitingPhase 3

A phase 3b, interventional, adaptive, clinical trial to evaluate the efficacy and safety of tralokinumab 300 mg every second week monotherapy compared with placebo in subjects with moderate-to-severe atopic hand eczema who are candidates for systemic therapy (ADHAND) - LP0162-2328

Start Date10 Jun 2024

Sponsor / Collaborator

LEO Pharma A/S

NCT06366932

/ RecruitingPhase 4IIT

Optimization of Atopic Dermatitis Treatment That Requires Second-line Systemic Therapy Through Multiomic Predictive Models of Treatment Response (DermAtOmics-II)

This is a low-intervention phase IV trial. The main objective is to optimize the treatment of patients with moderate-severe atopic dermatitis that require systemic treatment after failure, intolerance or contraindication to cyclosporine.

Start Date25 Sep 2023

Sponsor / Collaborator

Instituto de Investigación Hospital Universitario La Paz

100 Clinical Results associated with Tralokinumab

100 Translational Medicine associated with Tralokinumab

100 Patents (Medical) associated with Tralokinumab

285

Literatures (Medical) associated with Tralokinumab

01 Mar 2025·International Journal of Dermatology

Tralokinumab‐induced psoriasis relapse in a patient with atopic dermatitis

Letter

Author: Tavoletti, Gianluca ; Chiei Gallo, Alessandra ; Termini, Davide ; Marzano, Angelo V. ; Ferrucci, Silvia M.

Atopic dermatitis (AD) and psoriasis are distinct inflammatory skin disorders mediated by T helper (Th) 2 and Th1/Th17 cell pathways, resp.Tralokinumab, a monoclonal antibody targeting interleukin-13, has shown efficacy in treating moderate-to-severe AD by modulating the Th2-mediated inflammatory response.We present a case of a 48-yr-old man with a quiescent history of childhood psoriasis and a familial predisposition. The patient was diagnosed with late-onset AD, initially managed with cyclosporine, and later switched to dupilumab because of an inadequate response.Despite this, his AD symptoms persisted, leading to the initiation of tralokinumab therapy.Tralokinumab significantly improved his AD symptoms, reducing his Eczema Area and Severity Index (EASI) from 24 to 4 within 4 mo. However, within 3 mo of starting tralokinumab, he exhibited a severe exacerbation of psoriasis.The increased expression of IL-23 and IL-17A in these instances further corroborates the notion of an immune shift from Th2 to Th1/Th17 dominance when Th2 pathways are selectively targeted.

01 Mar 2025·American Journal of Clinical Dermatology

Biomarkers in Atopic Dermatitis: A Review of the Role of IL-13 and the Impact of Tralokinumab Treatment

Review

Author: Madsen, Daniel E ; Schneider, Shannon K R ; Martel, Britta C ; Nguyen, Andrea ; Armstrong, April W ; Gorelick, Joe

Atopic dermatitis (AD) is a chronic, inflammatory skin disease that can significantly affect quality of life. Presence, severity, and therapeutic response of AD are traditionally reported through clinical assessments including the Eczema Area and Severity Index or Investigator's Global Assessment. These clinical rating scales are visual assessments used in clinical trials to denotate AD severity. Alternatively, biomarkers open the potential to further enhance diagnosis of AD, assess disease status and severity, and potentially enable tailored treatment options for patients. Biomarkers can be classified according to their clinical use, clinical presentation, and underlying/endogenous molecular mechanisms. Specifically, interleukin (IL)-13, which has been shown to be a key biomarker in AD pathogenesis, can be used for prediction of AD development and to monitor clinical severity/response to treatment. Treatment with tralokinumab, a human monoclonal antibody that binds directly to-and subsequently blocks signaling of-IL-13, has been shown to reduce inflammation, re-balance the skin microbiome, and improve the skin barrier in patients with AD. In this review, key AD-related biomarkers, the role of IL-13 in driving AD pathogenesis, and the impact of IL-13 inhibition by tralokinumab on other AD-related biomarkers are discussed.

18 Feb 2025·British Journal of Dermatology

Predicting success with reduced dosing frequency of tralokinumab in patients with moderate-to-severe atopic dermatitis

Article

Author: Peris, Ketty ; Bewley, Anthony ; Steffensen, Louise Abildgaard ; Ivens, Ulla ; Tindberg, Ann-Marie ; Simpson, Eric L ; Wollenberg, Andreas ; Weidinger, Stephan ; Silvestre, Juan Francisco ; Soehoel, Anders ; Hong, H Chih-ho

AbstractBackgroundApproved tralokinumab maintenance dosing regimens for treatment of moderate-to-severe atopic dermatitis (AD) include 300 mg every 2 weeks (Q2W) and every 4 weeks (Q4W). Clinicians may consider tralokinumab Q4W for patients whose skin has become clear or almost clear at week 16 with initial Q2W dosing.ObjectivesTo identify predictive factors associated with maintained response after switching to tralokinumab Q4W, evaluate recapture of treatment response after relapse on Q4W, and assess treatment-emergent immunogenicity with tralokinumab Q4W.MethodsThese post hoc analyses utilized machine learning to identify predictive factors for maintained treatment response at week 52 using data from the week 16 responder population of the phase III ECZTRA 1 and 2 trials, i.e. patients who met Investigator’s Global Assessment of clear/almost clear skin (IGA 0/1) and/or ≥ 75% improvement in Eczema Area and Severity Index (EASI 75) at week 16 with tralokinumab Q2W monotherapy. Top-ranked factors were then assessed individually and together to identify factors associated with a similar maintained efficacy at week 52 between patients rerandomized to tralokinumab Q2W or Q4W monotherapy at week 16. Additionally, the probability of recapturing IGA 0/1 and/or EASI 75 response after relapse was assessed in patients on tralokinumab Q4W transferred to the open-label arm.ResultsThe two top-ranked predictive factors for maintained response at week 52 were IGA score at week 16 (76.1%) and worst daily pruritus numeric rating scale (NRS) < 3 at week 16 (56.5%). Patients whose AD reached stable clinical response scores of both IGA 0/1 and worst daily pruritus NRS < 3 from weeks 12–16 with tralokinumab Q2W similarly maintained IGA 0/1 response at week 52 regardless of dosing regimen beyond week 16 (72.0% of patients on Q2W and 72.2% of those on Q4W). Of patients who relapsed on Q4W, 94.6% recaptured treatment response after returning to Q2W dosing. The immunogenicity potential of tralokinumab was low, and patients with positive antidrug antibodies did not show loss of efficacy or higher incidences of adverse events.ConclusionsThese data suggest that Q4W is an effective dosing regimen for most patients who achieved stable disease control as shown by clear/almost clear skin and no itch to mild itch over 4 consecutive weeks on the initial regimen of tralokinumab Q2W.

News (Medical) associated with Tralokinumab

26 Feb 2025

·endpts.com

Leo Pharma says its yearslong makeover is about to pay off

For the first time since 2018, dermatology-focused Leo Pharma projects that it could turn a profit this year. Its Wednesday guidance comes on the heels of a broad multiyear restructuring — a plan that focused on strengthening Leo’s balance sheet ahead of a potential IPO. And the pharma company should be on track to go public in 2026 if it becomes net profit positive and free cash flow positive this year, CEO Christophe Bourdon told Endpoints News in an interview. Leo also plans to ink dermatology deals this year, with a focus on in-licensing assets that have the potential to address a significant unmet need, Bourdon said. In January, it made a pact with Gilead to advance the Danish company’s early-stage pipeline of STAT6 inhibitors. The biotech’s troubles started in April 2021, when it was slapped with a CRL for its atopic dermatitis candidate, which was meant to compete with Sanofi and Regeneron’s Dupixent. The drug went on to secure approval in December that same year with the brand name Adbry. But when Bourdon joined the company in 2022, it was dealing with high launch costs for Adbry, on top of high R&D costs. It was also operating at an EBITDA in the minus double-digits. It has since been through a series of changes over several years: significant staff cuts , a two-way split in R&D operations that involved an executive reshuffle, and a $14 million acquisition of the rare skin disease company Timber Pharmaceuticals. And on Wednesday, Leo said it delivered a 7% in EBITDA last year. In 2024, sales of the company’s dermatology portfolio hit 10 billion Danish krone ($1.4 billion), which is a 12% rise from 2023, mainly driven by growth in the US. Its total revenues climbed 10% to DKK 12.5 billion ($1.76 billion), bolstered by cash from partnerships. “When I kicked off 2024, I committed to three things — grow the top line, advance innovation and improve the profitability of the organization,” Bourdon said. “We’ve nailed those three objectives.” The company secured EU approval for its chronic hand eczema drug Anzupgo in September. Launch activities for Anzupgo are underway in Germany and Denmark. The pan-JAK inhibitor is also under FDA review with a decision expected in the third quarter. There are no approved treatments for chronic hand eczema in the US. There are five million patients eligible for treatment with Anzupgo across the US and Europe, Bourdon said. Leo’s medical market access and commercial teams are ready for a US launch in the middle of the year, he added. Last month, Gilead licensed Leo’s preclinical oral STAT6 inhibitors and protein degraders for inflammatory diseases, including certain skin conditions. Leo received $250 million upfront, but the pact could be worth up to $1.7 billion when factoring in milestones, with Leo also eligible for tiered royalties on sales. Targeting STAT6 involves entering the nucleus of the cell and degrading complement to correct inflammatory pathways of disease, Bourdon said, adding the approach exemplifies the latest “wave of innovation” in dermatology. It also has potential applications in oncology, he said.

Drug ApprovalAcquisitionLicense out/in

12 Jan 2025

·medcitynews.com

Gilead’s New $250M Drug R&D Pact Adds Contenders in the Hunt for Hot Inflammation Target - MedCity News

Gilead Sciences’ inflammation drug prospects have come via deals, and the latest one brings drug candidates for an elusive target that’s in pursuit by a growing number of companies. The drugmaker is paying $250 million up front to acquire preclinical small molecules from LEO Pharma. Gilead will continue development of oral formulations of these potential drugs, while privately held LEO will develop topical versions, according to deal terms announced Saturday. Denmark-based LEO could receive up to $1.7 billion in additional payments, depending on the progress of the partnered research. LEO aims to block inhibit the activity of IL-4 and IL-13, two signaling proteins that are validated targets associated with inflammation. Both proteins are already addressed by currently available injectable drugs, including Adbry, an FDA-approved IL-13-blocking antibody marketed by LEO for treating atopic dermatitis. But immunology drug research has been pursuing ways to block these targets with oral small molecules. Some of that research has focused on alternative ways of inhibiting inflammation driven by IL-4 and IL-13. Health IT Reducing Clinical and Staff Burnout with AI Automation As technology advances, AI-powered tools will increasingly reduce the administrative burdens on healthcare providers. By Dr. Michael Blackman, Chief Medical Officer at Greenway Health Signal transducer and activator of transcription factor 6, or STAT6, is a protein that’s required for IL-4 and IL-13 signaling. LEO says preclinical research indicates that targeting STAT6 offers the potential to treat a broad population of patients with an oral alternative to injectable biologic drugs. The LEO drugs are small molecule inhibitors and targeted protein degraders. Gilead’s deal with LEO brings it into a burgeoning field of companies developing STAT6-targeting drugs. While Sanofi’s blockbuster Dupixent, an antibody inhibitor of IL-4 and IL-13, is a cornerstone of the pharma giant’s immunology strategy, the company also has designs on developing that product’s successor. In 2023, Sanofi paid $125 million up front to begin a partnership with privately held Recludix Pharma, a preclinical developer of small molecule inhibitors of STAT6. Recludix is scheduled to present on Wednesday during the annual J.P. Morgan Healthcare Conference in San Francisco. Sanofi has spread its STAT6 bets via a partnership with Nurix Therapeutics, developer of targeted protein degraders. Nurix is also partnered with Gilead in an alliance that spans oncology and immunology.Yet another protein degrader biotech, Kymera Therapeutics, in October began a Phase 1 test of its STAT6 degrader, KT-621. Just before the end of 2024, Johnson & Johnson announced it had licensed global rights, excluding Japan, to Kaken Pharmaceutical’s preclinical STAT6 inhibitor for autoimmune and allergic diseases. To industry observers, the flurry of STAT6 dealmaking is encouraging for the field. Leerink Partners analyst Faisal Khurshid wrote in a note sent to investors on Sunday that as the fourth major licensing deal for STAT6, Gilead’s collaboration with LEO underscores the growing strategic importance of this mechanism. An oral STAT6 degrader has the potential to be a category-defining medicine for T helper type 2 (Th2) inflammatory disorders, and could become an “oral Dupixent,” Khurshid said. Sponsored Post The Funding Model for Cancer Innovation is Broken — We Can Fix It Closing cancer health equity gaps require medical breakthroughs made possible by new funding approaches. By Eve McDavid - CEO of Mission-Driven Tech “We see STAT6 as strategically important for companies aiming to develop small molecules for I&I (immunology & inflammation) indications and/or hold a position in Th2 inflammatory disorders (i.e., atopic dermatitis, asthma),” Khurshid said.

PROTACsPhase 1License out/in

08 Jan 2025

·www.prnewswire.com

Clarivate Identifies Eleven Potential Blockbuster and Transformative Drugs in Annual Drugs to Watch Report

Anticipated advancements in obesity, oncology, gene therapy and other areas poised to revolutionize patient care LONDON, Jan. 8, 2025 /PRNewswire/ -- Clarivate Plc (NYSE:CLVT) a leading global provider of transformative intelligence, today announced the release of the twelfth annual Drugs to Watch™ report, a trusted guide to the therapies poised to redefine the future of healthcare. This year, the highly anticipated resource highlights 11 drugs projected to achieve blockbuster status or revolutionize treatment paradigms within five years. Since its inception, Drugs to Watch has identified over 98 transformative therapies, cementing its role as an essential resource for navigating the ever-evolving pharmaceutical landscape. This year's report, powered by insights from the Clarivate Cortellis intelligence suite of products, highlights 11 therapies that have recently launched or are set to debut in 2025. These innovations, addressing critical challenges in areas such as obesity, oncology, and gene therapy, are forecast to achieve blockbuster sales by 2030 or dramatically improve patient outcomes on a global scale. The report also explores pivotal trends shaping the industry, including the surging demand for obesity treatments, the transformative potential of gene editing, and the growing impact of regulatory innovation. The report offers an in-depth analysis of the chronic disease market in Mainland China, spotlighting five therapies expected to exceed $1 billion in annual sales over the next five years or deliver transformative outcomes for patients. It also explores critical topics shaping global healthcare, including regulatory advancements, the role of radiopharmaceutical theranostics in oncology, and the growing use of real-world data (RWD) and patient-reported outcomes (PROs) to drive health equity and enhance regulatory submissions. Henry Levy, President, Life Sciences & Healthcare, Clarivate, remarked: "Innovation in the life sciences is reaching unprecedented heights, and this year's Drugs to Watch™ report once again demonstrates the industry's ability to deliver therapies that address unmet medical needs and challenge existing paradigms of care. At Clarivate, we take pride in the precision and reliability of our predictions—last year, we identified 13 molecules as Drugs to Watch, with 12 already approved and launched and one poised for launch. This track record reflects the strength of our comprehensive data and deep expertise. By continuing to provide actionable insights, we empower the sector to navigate opportunities, overcome challenges and drive progress in advancing global health." Mike Ward, Global Head of Thought Leadership, Life Sciences & Healthcare, Clarivate, stated: "2025 represents a turning point for the life sciences sector as it embraces cutting-edge technologies such as AI and machine learning to enhance drug discovery and development. This year's report captures the dynamic forces at play, including groundbreaking progress in precision oncology, the rise of radiopharmaceuticals, and the growing focus on addressing global health disparities." The 2025 Drugs to Watch™ report highlights key trends reshaping the life sciences landscape, emphasizing the transformative impact of emerging technologies and therapeutic breakthroughs. Advances in AI and machine learning are streamlining drug discovery, clinical trials, and real-world data integration, enabling precision medicine approaches. The obesity market is undergoing a revolution driven by next-generation GLP-1 therapies, while radiopharmaceutical theranostics are redefining cancer treatment with a "see it and treat it" paradigm. Gene editing technologies are unlocking new opportunities in personalized medicine, and evolving regulatory frameworks are fostering greater emphasis on patient-reported outcomes and health equity. Together, these trends showcase the sector's resilience and its ability to navigate challenges while driving innovation to improve patient care worldwide. This year's drugs to watch exemplify the fusion of innovation and dedication to advancing patient care in an increasingly complex healthcare ecosystem. The Drugs to Watch™ 2025 list include: AWIQLI® (LAI 287; insulin icodec) developed by Novo Nordisk | Type 1 and type 2 diabetes mellitus AWIQLI®, the first once-weekly, subcutaneous insulin, has launched in Australia, Canada, the EU, Mainland China, and Japan. Its weekly dosing offers a significant advantage over daily basal insulin, potentially reducing the treatment burden for patients with type 1 or type 2 diabetes (T1DM and T2DM). CagriSema (cagrilintide + semaglutide) developed by Novo Nordisk | Obesity and type 2 diabetes mellitus CagriSema, combining cagrilintide, a long-acting amylin analog, with semaglutide, promises superior efficacy over semaglutide (OZEMPIC/WEGOVY®) and tirzepatide (MOUNJARO/ZEPBOUND®) in treating obesity and type 2 diabetes. This next-generation GLP-1 therapy leverages the benefits of GLP-1s, such as enhanced insulin secretion and appetite reduction, while incorporating amylin's effects, including slowed glucose absorption and release. If approved, CagriSema will be the first fixed-dose combination of amylin and GLP-1 receptor agonists in the obesity and T2DM markets. COBENFY™ (KarXT; xanomeline-trospium) developed by Bristol Myers Squibb | Schizophrenia and psychosis related to Alzheimer's disease Amid setbacks for emerging schizophrenia treatments, the approval of COBENFY marks a transformative milestone as the first drug in over 30 years with a novel mechanism of action for treating schizophrenia. Combining xanomeline and trospium, COBENFY selectively targets M1 and M4 receptors, rather than traditional dopamine pathways, while minimizing cholinergic side effects. While further data is needed to assess its effectiveness in Alzheimer's disease-related psychosis, COBENFY shows strong commercial potential if proven effective in treating AD-related hallucinations and delusions. EBGLYSS™ (lebrikizumab) developed by Eli Lilly and Co and Almirall | Atopic dermatitis EBGLYSS™, the third biologic targeting IL-13 for atopic dermatitis, follows DUPIXENT® (dupilumab) and ADBRY®/ADTRALZA® (tralokinumab) to market. Its less frequent dosing, more selective IL-13 inhibition, and strong efficacy and safety data position it as a likely first-line treatment for moderate-to-severe atopic dermatitis when topical corticosteroids are inadequate. Fitusiran developed by Alnylam® Pharmaceuticals Inc and Sanofi | Hemophilia A and B Fitusiran, shown to be effective in phase 3 trials for both hemophilia A and B, regardless of inhibitor status, has the potential to offer a new approach to hemophilia treatment. This small interfering RNA (siRNA) therapy works by inhibiting SerpinPC1 mRNA, reducing antithrombin levels, promoting thrombin generation, and helping to rebalance hemostasis to prevent bleeds. Leveraging Alnylam® Pharmaceuticals' ESC-GalNAc conjugate technology, fitusiran could become the first antithrombin-lowering therapy based on a double-stranded RNA molecule, pending approval. GSK-3536819 (MenABCWY) developed by GSK plc | Meningococcus GSK plc's GSK-3536819 vaccine candidate, a 5-in-1, first-generation formulation, targets the five groups of Neisseria meningitidis (A, B, C, W, and Y) responsible for most invasive meningococcal disease (IMD) cases worldwide. It combines the antigenic components of GSK's licensed meningococcal vaccines, BEXSERO (MenB) and MENVEO (MenACWY), both of which have established efficacy and safety profiles. IMDELLTRA™ (tarlatamab-dlle) developed by Amgen | Small-cell lung cancer (SCLC) IMDELLTRA™ is a first-in-class immunotherapy for extensive-stage small cell lung cancer (ES-SCLC). Using Amgen's bispecific T cell engager (BiTE®) molecules, it targets CD3 on T cells and DLL3 on tumor cells, enabling T cells to attack and lyse the tumor. DLL3 is expressed on the surface of SCLC cells in more than 85% of patients but is minimally expressed on healthy cells making it an attractive target. This mechanism positions IMDELLTRA as a potential standard of care for previously treated ES-SCLC. mRESVIA (mRNA-1345) developed by Moderna Inc | RSV With its U.S. FDA approval in May 2024, mRESVIA® joined AREXVY and ABRYSVO, both featured in Drugs to Watch 2024, as respiratory syncytial virus (RSV) vaccines currently available for adults ages 60 years and older, helping further support the public health initiative to reduce the RSV-related disease burden. Even with available vaccines, RSV infections continue to be a public health concern, particularly for infants and older adults (65 years and older). SEL-212 developed by Sobi® and Cartesian Therapeutics Inc/Selecta Biosciences Inc | Gout SEL-212 is a novel, once-monthly treatment combining pegylated uricase (pegadricase; SEL-037) with ImmTOR™, an immune tolerance technology designed to inhibit the formation of anti-drug antibodies (ADAs). For this application, ImmTOR consists of SEL-110.36, an inhibitor of uricase-specific ADA. This approach may help overcome the limitations of reduced efficacy and tolerability seen with other biologic treatments, such as KRYSTEXXA® (pegloticase), in patients with chronic gout. Vepdegestrant (ARV-471) developed by Arvinas Inc and Pfizer Inc | Breast cancer A global collaboration between Arvinas Inc and Pfizer Inc, vepdegestrant may become the first PROteolysis Targeting Chimera (PROTAC®) protein degrader on the market. Designed to target and degrade the estrogen receptor (ER) protein, early studies suggest PROTAC-induced degradation is more complete than with oral selective estrogen receptor degraders (SERDs). This offers potential for overcoming endocrine resistance in breast cancer. Label expansions, including combination with IBRANCE® (palbociclib), are being explored. Zanzalintinib (XL092) developed by Exelixis Inc | Colorectal cancer, renal cell carcinoma and squamous cell carcinoma of head and neck Zanzalintinib is a third-generation oral tyrosine kinase inhibitor targeting VEGF receptors, MET, and TAM kinases involved in tumor growth and immunosuppression. Currently in phase 3 trials for non-clear-cell renal cell carcinoma (nccRCC), colorectal cancer (CRC) and squamous cell carcinoma of the head and neck (SCCHN), the company anticipates one potential zanzalintinib launch per year starting as early as 2026. Compared to CABOMETYX® (cabozantinib), zanzalintinib may offer benefits, including approval for nccRCC histology and a broader patient population. Access the Drugs to Watch 2025 report from Clarivate, here. For more Drugs to Watch updates and analyses throughout the year, visit the Drugs to Watch web page and follow Clarivate for Life Sciences & Healthcare on LinkedIn and X. Join the conversation, using #DrugstoWatch. To learn more about how Clarivate can help healthcare companies inform and shape the drug discovery, development and delivery process, visit here. Methodology for the Clarivate Drugs to Watch 2025 Report To identify this year's Drugs to Watch, Clarivate drew from the expertise of over 160 analysts covering hundreds of diseases, drugs and markets, along with 11 integrated data sets that span the R&D and commercialization lifecycle, including: Cortellis Competitive Intelligence™, Disease Landscape & Forecast, Epidemiology Intelligence, BioWorld™, Cortellis Regulatory Intelligence™, Drug Timeline & Success Rates, Cortellis Clinical Trials Intelligence™, Cortellis Deals Intelligence™, Access & Reimbursement payer studies, Clarivate Real-World Data and Analytics, Web of Science™, Derwent Innovation™, and other industry sources including biopharma company press releases, filings and peer-reviewed publications. Candidate drugs in phase 2 or phase 3 trials, at pre-registration or registration stage, or already launched in 2024 were selected for analysis, including both novel treatments and already-marketed drugs pursuing new indications that could be particularly impactful. Drugs launched prior to 2024 were excluded. The dataset was filtered for drugs that had total forecast sales of $1 billion or more by 2030. Clarivate experts and analysts evaluated each drug in its individual context, based on factors such as expected approval or launch dates, competitive landscape, regulatory status, trial results, market dynamics and other key factors, and added novel drugs that, while likely to fall short of blockbuster status, are poised to be therapeutic game-changers. Please note that Clarivate analysts generated the data shown in this report prior to December 31, 2024. The Drugs to Watch 2025 Report and the treatments referenced in this release are based on Clarivate's current expectations per existing data, but actual results derived from the drugs named in the report and here may differ significantly. Clarivate is committed to comprehensively supporting customers across the entire drug, device and medical technology lifecycles to advance human health. By combining patient journey data, therapeutic area expertise, artificial intelligence and analytics in ways that unlock hidden insights, data-driven decisions and accelerating innovation, Clarivate's end-to-end research intelligence is designed to enable customers to make informed evidence-based decisions. About Clarivate Clarivate™ is a leading global provider of transformative intelligence. We offer enriched data, insights & analytics, workflow solutions and expert services in the areas of Academia & Government, Intellectual Property and Life Sciences & Healthcare. For more information, please visit . Media Contact: Catherine Daniel Director, External Communications, Life Sciences & Healthcare [email protected] SOURCE Clarivate Plc WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

VaccinePhase 3Immunotherapy

100 Deals associated with Tralokinumab

External Link

KEGG	Wiki	ATC	Drug Bank
-	Tralokinumab	D11AH	DB12169

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Dermatitis	South Korea	Leo Pharma, Inc.	31 Aug 2023
Dermatitis, Atopic	Iceland	LEO Pharma A/S	17 Jun 2021
Dermatitis, Atopic	European Union	LEO Pharma A/S	17 Jun 2021
Dermatitis, Atopic	Norway	LEO Pharma A/S	17 Jun 2021
Dermatitis, Atopic	Liechtenstein	LEO Pharma A/S	17 Jun 2021

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Asthma	Phase 1	Poland	AstraZeneca PLC	13 Jun 2014
Asthma	Phase 1	United States	AstraZeneca PLC	13 Jun 2014
Asthma	Phase 1	Belgium	AstraZeneca PLC	13 Jun 2014
Asthma	Phase 1	Colombia	AstraZeneca PLC	13 Jun 2014
Asthma	Phase 1	Spain	AstraZeneca PLC	13 Jun 2014
Asthma	Preclinical	United States	AstraZeneca PLC	13 Jun 2014
Asthma	Preclinical	Spain	AstraZeneca PLC	13 Jun 2014
Asthma	Preclinical	Belgium	AstraZeneca PLC	13 Jun 2014
Asthma	Preclinical	Colombia	AstraZeneca PLC	13 Jun 2014
Asthma	Preclinical	Poland	AstraZeneca PLC	13 Jun 2014

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03587805 (ECZTEND, CTgov)	Phase 3	Dermatitis, Atopic	1,672	Tralokinumab	keeauudmwk(toiydsbtpd) = cxlgawaydl bjhyywjmgi (qcrwezkfyg, fbbysvdlhc - kfpggcduto) View more	-	16 Jan 2025
NCT03587805 (ECZTEND, Biospace) Manual	Phase 3	Dermatitis, Atopic	1,672	ADBRY® (tralokinumab-ldrm)	(cxwjggdedd) = no new safety signals. Adverse events (AEs) were reported at relatively lower rates in ECZTEND, with the majority being mild/moderate. jccbntaezv (kzotvdnfwi ) View more	Positive	25 Oct 2024
NCT03160885 \| NCT03131648 (ECZTRA 1 and 2, Pubmed \| Am J Clin Dermatol)	Phase 3	Severe Atopic Dermatitis	1,328	Tralokinumab	fshzxxnnyq(fizxuajpeg) = gkksiisesr pmimpkrwfq (iulkeeptnz ) View more	Positive	01 Jan 2024
	Phase 3	Severe Atopic Dermatitis	1,328	Placebo	fshzxxnnyq(fizxuajpeg) = swssnzyijn pmimpkrwfq (iulkeeptnz ) View more	Positive	01 Jan 2024
EADV2023	Not Applicable	Dermatitis, Atopic IL-13 \| MDC \| CCL17 ... View more	16	Tralokinumab 300 mg	hfrcejqufm(jpoqpzwsii) = zkxnsviwdy tlsterobtc (jpgnvhbndl ) View more	Positive	11 Oct 2023
NCT03587805 (ECZTEND, EADV2023)	Phase 3	Moderate Atopic Dermatitis	347	Tralokinumab ± optional topical corticosteroids (TCS)	dvbrjzrftv(buwxqzzsmw) = The safety profile was favorable and consistent with earlier analyses, with no new safety signals arising with continued tralokinumab use btejhivvwe (oafdhwgaen )	-	11 Oct 2023
EADV2023	Not Applicable	Dermatitis, Atopic	-	Lebrikizumab	clzwdrewkr(gditigwubi) = fsjmwrupag diiphnzerw (syyojxyqty, 27 - 49) View more	-	11 Oct 2023
EADV2023	Not Applicable	Dermatitis, Atopic	-	Dupilumab	clzwdrewkr(gditigwubi) = lkavqaxnsl diiphnzerw (syyojxyqty, 14 - 66) View more	-	11 Oct 2023
WCD2023	Not Applicable	Dermatitis, Atopic	24	Tralokinumab	alqjcaveyy(jyssfmrdql) = qhpqdsfrne chfnknaokd (odzgdsfafr )	Positive	03 Jul 2023
NCT03526861 (ECZTRA 6, Pubmed)	Phase 3	Severe Atopic Dermatitis	301	Tralokinumab 150 mg	onpzccxyli(ipcwmerjzx) = Tralokinumab was well tolerated, without frequency of conjunctivitis increasing through week 52. whsivvytno (uicftntwve )	Positive	19 Apr 2023
NCT03526861 (ECZTRA 6, Pubmed)	Phase 3	Severe Atopic Dermatitis	301	Tralokinumab 300 mg		Positive	19 Apr 2023
NCT03587805 (ECZTEND, AAD2023)	Phase 3	Dermatitis, Atopic	289	Tralokinumab 300mg	znvgoxlecs(itqdbminhb) = cqieqyjtxj gcoggzrhpo (xnfamgrlkb ) View more	-	17 Mar 2023
NCT03587805 (ECZTEND, AAD2023)	Phase 3	Dermatitis, Atopic	289	Placebo	znvgoxlecs(itqdbminhb) = pbklikrita gcoggzrhpo (xnfamgrlkb ) View more	-	17 Mar 2023
NCT03587805 (ECZTEND, Pubmed \| J Am Acad Dermatol)	Phase 3	Dermatitis, Atopic	1,174	Tralokinumab plus optional topical corticosteroids	(aitjuuvmnl) = yiielfvwiz btcvqrrbbl (wgomyvozxd ) View more	Positive	01 Oct 2022

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