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.

NCT06366932 / RecruitingPhase 4

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

Hospital Universitario La Paz

NCT05958407 / 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

The purpose of this study is to test if treatment with tralokinumab is safe and effectful to treat moderate-to-severe atopic hand eczema. This will be judged by a range of assessments that rate the severity and extent of atopic hand eczema and its symptoms, as well as general health status and quality of life.
The trial will last for up to 40 weeks. There will be up to 15 visits, 3 of which will be conducted by phone. The first part of the trial is called a screening period and will last up to 4 weeks. For the first 16 weeks after screening, trial participants will receive either tralokinumab or dummy injections every two weeks. After the first 16 weeks, all trial participants will receive tralokinumab injections every two weeks for 16 weeks. The last part of the trial is a period of 4 weeks after the end of treatment period, where trial participants are off the drug for safety follow-up.

Start Date28 Aug 2023

Sponsor / Collaborator

Leo Pharma, Inc.

100 Clinical Results associated with Tralokinumab

100 Translational Medicine associated with Tralokinumab

100 Patents (Medical) associated with Tralokinumab

194

Literatures (Medical) associated with Tralokinumab

31 Dec 2024·The Journal of dermatological treatment

Injection site reactions after dupilumab or tralokinumab for atopic dermatitis

Article

Author: Martora, Fabrizio ; D'Ascenzo, Silvia ; Napolitano, Maddalena ; Patruno, Cataldo

Background: Injection site reaction (ISR) is a local phenomenon defined as a constellation of symptoms, including swelling, erythema, pruritus, and pain around the site of injection.Objective: ISR is reported as a frequent adverse event after subcutaneous injection (SCI) of several biologics.Methods: We performed an observational real-life study to compare dupilumab and tralokinumab as regards ISR, analysing frequency, duration and intensity of symptoms related to SCI. From January 2023 to June 2023, we enrolled adult patients affected by moderate to severe AD and being on dupilumab or tralokinumab treatment. A 12 items questionnaire was administered to all enrolled patients.Results and conclusions: Three hundred and ninety-two patients were included. ISR was a frequent occurrence in both the treatment groups, with tralokinumab causing ISR more frequently than dupilumab. However, the reactions were generally mild and no patient stopped therapy.

01 Feb 2024·Journal of the American Academy of Dermatology

Executive summary: Guidelines of care for the management of atopic dermatitis in adults with phototherapy and systemic therapies

Review

Author: Davis, Dawn M R ; Darr, Jennifer M ; Alikhan, Ali ; Schwarzenberger, Kathryn ; Cohen, David E ; Frazer-Green, Lindsy ; Silverberg, Jonathan I ; Eichenfield, Lawrence F ; Paller, Amy S ; Singh, Anne Marie ; Drucker, Aaron M ; Sidbury, Robert ; Bercovitch, Lionel ; Wu, Peggy A

BACKGROUND:

The summarized guidelines update the 2014 recommendations for the management of AD with phototherapy and systemic therapies.

METHODS:

A multidisciplinary workgroup conducted a systematic review and applied the GRADE approach for assessing the certainty of the evidence and formulating and grading recommendations.

RESULTS:

The workgroup developed 11 recommendations on the management of AD in adults with phototherapy and systemic therapies, including biologics, oral Janus Kinase inhibitors, and other immunomodulatory medications.

CONCLUSIONS:

The evidence supported strong recommendations for the use of dupilumab, tralokinumab, abrocitinib, baricitinib, and upadacitinib and conditional recommendations in favor of using phototherapy, azathioprine, cyclosporine, methotrexate, and mycophenolate, and against the use of systemic corticosteroids.

01 Feb 2024·Journal of the American Academy of Dermatology

Guidelines of care for the management of atopic dermatitis in adults with phototherapy and systemic therapies

Review

Author: Davis, Dawn M R ; Darr, Jennifer M ; Alikhan, Ali ; Schwarzenberger, Kathryn ; Cohen, David E ; Frazer-Green, Lindsy ; Silverberg, Jonathan I ; Eichenfield, Lawrence F ; Singh, Anne Marie ; Paller, Amy S ; Drucker, Aaron M ; Bercovitch, Lionel ; Sidbury, Robert ; Wu, Peggy A

BACKGROUND:

For people with atopic dermatitis (AD) refractory to topical therapies, treatment with phototherapy and systemic therapies can be considered. Multiple biologic therapies and Janus kinase (JAK)inhibitors have been approved since 2014 to treat AD. These guidelines update the 2014 recommendations for management of AD with phototherapy and systemic therapies.

OBJECTIVE:

To provide evidence-based recommendations on the use of phototherapy and systemic therapies for AD in adults.

METHODS:

A multidisciplinary workgroup conducted a systematic review and applied the GRADE approach for assessing the certainty of evidence and formulating and grading recommendations.

RESULTS:

The workgroup developed 11 recommendations on the management of AD in adults with phototherapy and systemic agents, including biologics, oral JAK inhibitors, and other immunomodulatory medications.

LIMITATIONS:

Most randomized controlled trials of phototherapy and systemic therapies for AD are of short duration with subsequent extension studies, limiting comparative long-term efficacy and safety conclusions.

CONCLUSIONS:

We make strong recommendations for the use of dupilumab, tralokinumab, abrocitinib, baricitinib, and upadacitinib. We make conditional recommendations in favor of using phototherapy, azathioprine, cyclosporine, methotrexate, and mycophenolate, and against the use of systemic corticosteroids.

News (Medical) associated with Tralokinumab

13 Jun 2024

·www.pharmaceutical-technology.com

Leo’s single-dose autoinjector secures FDA approval for atopic dermatitis

Adbry targets the cytokine IL-13, which drives inflammatory processes of symptoms commonly seen in atopic dermatitis. Credit: Pormezz / Shutterstock. Leo Pharma has announced that its injection treatment for atopic dermatitis, Adbry (tralokinumab-ldrm), will gain an alternative mode of administration following a US Food and Drug Administration (FDA) approval for its single-dose autoinjector. Recommended Buyer's Guides Buyer's Guide Leading Guide to Packaging Materials, Containers and Containment Services for the Pharmaceutical Industry Buyer's Guide Top Guide for Drug Delivery Systems Adbry targets interleukin-13 (IL-13), a cytokine that drives inflammatory processes associated with the symptoms of atopic dermatitis. Adbry is indicated for the treatment of moderate-to-severe atopic dermatitis in patients aged 12 years and older whose disease is not adequately controlled with topical prescription therapies, following a December 2021 approval. According to GlobalData’s consensus forecasts, Adbry is expected to generate global sales of $1.3bn in 2030. The treatment produced net global sales of $106m in 2023. GlobalData is the parent company of Pharmaceutical Technology . As per the 13 June press announcement, the treatment will now be available for adult patients as a 300 mg/2 mL single dose autoinjector treatment as another option to the existing 150 mg/1 mL pre-filled injectable, which will continue to be available in the US. Leo Pharma is taking steps to make the newly approved device available to US patients in the coming months, EVP and President, Region North America at Leo Pharma, Brian Hilberdink said in the press release. “We understand that no patient is the same, and through this extended approval we have taken a positive step forward to equip those living with atopic dermatitis with more choices,” said Shannon Schneider, Senior Medical Affairs Director at LEO Pharma. See Also: NPX-267 by NextPoint Therapeutics for Triple-Negative Breast Cancer (TNBC): Likelihood of Approval PF-07960613 by Pfizer for Respiratory Syncytial Virus (RSV) Infections: Likelihood of Approval Ballerup, Denmark-based LEO is not the only pharma making strides in the atopic dermatitis space. As per a GlobalData report , the atopic dermatitis market is predicted to be worth $24.4bn across the 61 geographical markets in 2030, with 71.8% of that coming from the seven major markets of US, France, Germany, Italy, Spain, UK, and Japan.” Earlier in the week, Denmark-based Union Therapeutics shared positive data from its Phase IIb ADESOS study (NCT05469464) which evaluated orismilast as an oral treatment for moderate- to-severe atopic dermatitis. Union is looking to initiate a Phase III programme and has reached out to the FDA with initial plans. Also in the picture is Dermavant’s nonsteroidal topical nonsteroidal, VTAMA (tapinarof), which received FDA acceptance for its supplemental New Drug Application (sNDA). According to GlobalData’s analysts, atopic dermatitis presents a mine of opportunities , particularly for drugs that target AhR due to the low rate of adverse effects seen in previous clinical trials.

Clinical ResultDrug ApprovalPhase 2Phase 3

12 Jun 2024

·www.biospace.com

Adtralza® (tralokinumab injection) Pre-Filled Pen Now Available in Canada

The single-use 2 mL pre-filled pen is an additional injection choice for administering Adtralza for the treatment of moderate-to-severe atopic dermatitis (AD).1 The new Adtralza (tralokinumab injection) pre-filled pen means patients can administer their prescribed dose with half the number of injections, and also simplifies the process, with a hidden needle and press-down auto-injection.1 Adtralza is currently indicated in patients 12 years and older with moderate-to-severe atopic dermatitis (AD) whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable.1 TORONTO--(BUSINESS WIRE)-- LEO Pharma Inc. today announced the availability of the Adtralza® (tralokinumab 300 mg/2 mL) pre-filled pen in Canada. Adtralza is currently indicated in patients 12 years and older with moderate-to-severe atopic dermatitis (AD) whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable.1 Prior to the introduction of the pre-filled pen, Adtralza was only available in a 1 mL pre-filled syringe. With the new 2 mL pre-filled pen, patients now have another convenient option with half the number of required injections compared to the 1 mL pre-filled syringe.1 “The pre-filled pen simplifies the injection process and can be helpful for those who are uncomfortable with the sight of needles,” said Dr. Chih-ho Hong, M.D., board certified dermatologist working in Greater Vancouver, BC, and national coordinating investigator for ECZTRA 6 trial in Canada. “It also means half the number of required injections. This option can help reduce patient treatment burden significantly.” “Atopic dermatitis can be difficult to manage, and can feel overwhelming,” said Amanda Cresswell-Melville, Executive Director, Eczema Society of Canada. “More treatment options mean more hope to those impacted by this burdensome condition.” “We are pleased to offer Canadians with moderate-to-severe AD an additional option with the single-use pre-filled pen,” said Jill Archibald, President and CEO, LEO Pharma Inc., Canada. “LEO Pharma is committed to supporting patients and providing them with options that offer convenience and help meet their treatment goals.” For patients who prefer the pre-filled syringe, this option will continue to be available in Canada. About Adtralza® (tralokinumab injection) Adtralza is a human, monoclonal antibody developed to specifically target the IL-13 cytokine, which plays a key role in the immune process underlying atopic dermatitis signs and symptoms. Adtralza specifically binds to the IL-13 cytokine with high affinity, thereby inhibiting interaction with the IL-13 receptor α1 and α2 subunits (IL-13Rα1 and IL-13Rα2).1 In Canada, Adtralza is available in a single-use pre-filled syringe (150 mg/1 mL) as well as a single-use pre-filled pen (300 mg/2 mL). Adtralza received approval from Health Canada in October 2021, for the treatment of moderate to severe atopic dermatitis in adults. Subsequently, in February 2023, the indication was expanded to include adolescents aged 12 – 17 years. The pre-filled pen received approval in August 2023.1 For more information, please refer to the Canadian product monograph for Adtralza located here. About Atopic Dermatitis/Eczema Eczema is a chronic inflammatory skin condition, characterized by dry skin, with patches that are red and intensely itchy. These patches of eczema may ooze, become scaly, crusted, or hardened. The condition can impact the patient’s quality of life negatively, as symptoms can range mild to severe. While eczema can appear anywhere on the skin, it is commonly found on the flexor areas, such as the bends of the arms and back of the knees.2 Out of the several types of eczema, atopic dermatitis is the most common. Atopy refers to the genetic susceptibility towards eczema, asthma and allergic rhinitis (hay fever). People with AD can also suffer from one of the other atopic diseases. 2 About LEO Pharma LEO Pharma is a global company dedicated to advancing the standard of care for the benefit of people with skin conditions, their families and society. Founded in 1908 and majority owned by the LEO Foundation, LEO Pharma has devoted decades of research and development to advance the science of dermatology, and today, the company offers a wide range of therapies for all disease severities. LEO Pharma is headquartered in Denmark with a global team of 4,200 people, serving millions of patients across the world. For more information, please visit . Adtralza® and the LEO Lion logo are registered trademarks of LEO Pharma A/S used under license and distributed by LEO Pharma Inc. Canada. ___________________________ LEO Pharma. Product Monograph: Adtralza®. Toronto, ON. 2023. Eczema Society of Canada. What is eczema? Eczema Overview. Accessed June 6, 2024 MAT-74087 June 2024 View source version on businesswire.com: Contacts Melissa Borland LEO Pharma, Senior Manager Communications, North America 647.241.1475 MQBCA@leo-pharma.com Jes Broe Frederiksen LEO Pharma, Global Communications Manager, Corporate Affairs Tel: +45 53 60 59 48 Email: jebfe@leo-pharma.com Source: LEO Pharma Inc. View this news release online at:

Drug Approval

27 Mar 2024

·firstwordpharma.com

AstraZeneca's tralokinumab trial in IPF gets helping hand from Brainomix's AI tool

Brainomix's AI-powered automated CT processing software successfully helped identify idiopathic pulmonary fibrosis (IPF) patients at risk of decline in a clinical trial of AstraZeneca's IL-13 monoclonal antibody tralokinumab. The drug is already sold as Adtralza/Adbry for atopic dermatitis.According to the findings recently published in the American Journal of Respiratory and Critical Care Medicine, Brainomix's e-Lung software outperforms standard methods in stratifying patients at risk of IPF progression. The University of Oxford spinout believes the results underscore the tool's potential to improve the efficiency of future clinical trials. Patient data from AstraZeneca's Phase II trial of tralokinumab was processed with Brainomix's software. The tool has been trained using thousands of CT scans and is powered by the weighted reticulovascular score (WRVS). This novel biomarker incorporates reticular opacities and vascular structures of the lung.Optimising clinical trials Brainomix's senior medical director Peter George, who led the study, said his team has shown that "from a single baseline CT scan, WRVS is able to identify patients at risk of decline in Forced Vital Capacity (FCV) over the next 52 weeks." He noted that the data suggest that the tool may "allow for enrichment of clinical trials with progressive patients, could identify patients at low risk of IPF progression, might facilitate well-matched treatment arms and could reduce the size of future clinical trials."Results presented at last year's American Thoracic Society meeting showed that WRVS was more strongly associated with transplant free survival of IPF patients than FVC alone. WRVS was also able to predict both short- and long-term outcomes of the patients, including lung function decline and survival.Brainomix has collaborated with several notable partners, including Boehringer Ingelheim, Bridge Biotherapeutics, Stryker, Argenica and Lumosa.

Phase 2

100 Deals associated with Tralokinumab

External Link

KEGG	Wiki	ATC	Drug Bank
-	Tralokinumab	D11AH	DB12169

R&D Status

Approved

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
Dermatitis	KR	Leo Pharma, Inc.	31 Aug 2023
Dermatitis, Atopic	EU	LEO Pharma A/S	17 Jun 2021
Dermatitis, Atopic	IS	LEO Pharma A/S	17 Jun 2021
Dermatitis, Atopic	LI	LEO Pharma A/S	17 Jun 2021
Dermatitis, Atopic	NO	LEO Pharma A/S	17 Jun 2021

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Eczema	Phase 3	US	Leo Pharma, Inc.	19 Jun 2018
Eczema	Phase 3	JP	Leo Pharma, Inc.	19 Jun 2018
Eczema	Phase 3	AU	Leo Pharma, Inc.	19 Jun 2018
Eczema	Phase 3	BE	Leo Pharma, Inc.	19 Jun 2018
Eczema	Phase 3	CA	Leo Pharma, Inc.	19 Jun 2018
Eczema	Phase 3	FR	Leo Pharma, Inc.	19 Jun 2018
Eczema	Phase 3	DE	Leo Pharma, Inc.	19 Jun 2018
Eczema	Phase 3	NL	Leo Pharma, Inc.	19 Jun 2018
Eczema	Phase 3	PL	Leo Pharma, Inc.	19 Jun 2018
Eczema	Phase 3	GB	Leo Pharma, Inc.	19 Jun 2018

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03587805 (ECZTEND, EADV2023)	Phase 3	Dermatitis, Atopic	347	Tralokinumab ± optional topical corticosteroids (TCS)	idporfommu(dmumcidfsa) = The safety profile was favorable and consistent with earlier analyses, with no new safety signals arising with continued tralokinumab use ktcufcysur (wqecrrdtya )	-	11 Oct 2023
EADV2023	Not Applicable	Dermatitis, Atopic IL-13 \| MDC \| CCL17 ... View more	16	Tralokinumab 300 mg	azgincwwoi(dpjbnkbfch) = wnfemcyhmc jzqkeyuknn (mndzbkjqyk ) View more	Positive	11 Oct 2023
WCD2023	Not Applicable	Dermatitis, Atopic	24	Tralokinumab	zlyvqogbys(gkoekevhhz) = ykziggcqiy kelcqcyozq (zegrxvltpf )	Positive	03 Jul 2023
NCT03526861 (ECZTRA 6, Pubmed)	Phase 3	Dermatitis, Atopic	301	Tralokinumab 150 mg	fhcsqcsqjk(fnjphgisyo) = Tralokinumab was well tolerated, without frequency of conjunctivitis increasing through week 52. wvxtgeiekz (roznrkttic )	Positive	19 Apr 2023
				Tralokinumab 300 mg
NCT03587805 (ECZTEND, AAD2023)	Phase 3	Dermatitis, Atopic	289	Tralokinumab 300mg	mqxaytbmrx(nbdtpjgddr) = suwfndwnpi xgatqicqfj (styhikghdo ) View more	-	17 Mar 2023
				Placebo	mqxaytbmrx(nbdtpjgddr) = snejckfyef xgatqicqfj (styhikghdo ) View more
NCT03363854 \| NCT03160885 \| NCT03131648 (ECZTRA 1, 2, and 3, Pubmed)	Phase 3	Dermatitis, Atopic	1,596	Tralokinumab	mpeitqigzk(ydkhcsgepj) = oahfcujxoc mbkeejyqlx (dukjkfatxt, 12.6, 28.7) View more	Positive	24 Sep 2022
				Placebo	mpeitqigzk(ydkhcsgepj) = gbmtgghoes mbkeejyqlx (dukjkfatxt ) View more
NCT04587453 (CTgov)	Phase 3	Dermatitis, Atopic	106	Topical corticosteroids (TCS)+Tralokinumab (Tralokinumab+TCS)	vbbvrwxosn(jbrdgclcef) = byeyndbakx ercdsvwfxj (iqfpklnbqa, ehgjgapmqy - vmgzucvkki) View more	-	22 Sep 2022
				Placebo (Placebo+TCS)	vbbvrwxosn(jbrdgclcef) = tiaryhlvru ercdsvwfxj (iqfpklnbqa, yeernrnkxl - vhzdfnajja) View more
Pubmed	Phase 2/3	Dermatitis, Atopic	2,285	Tralokinumab	uggrrolxcw(tcudbxncqp) = lpofmugrxg erbmvxygmj (drlirbquhs ) View more	Positive	09 Sep 2022
				Placebo	uggrrolxcw(tcudbxncqp) = ndnfesfqle erbmvxygmj (drlirbquhs ) View more
NCT03587805 (ECZTEND, EADV2022)	Phase 2/3	Dermatitis, Atopic	347	Tralokinumab 300 mg every 2 weeks	xciwbqjrmp(nqsuvuzkcx) = uusfymbdzg ujwlyoojjv (jhnhoxikmw ) View more	Positive	07 Sep 2022
NCT03363854 (ECZTRA 3, Pubmed) Manual	Phase 3	Dermatitis, Atopic	233	Tralokinumab	crmxbxncem(taaekktnzc) = sygzzdrbaf yeuyijzwwb (yqblxmlvvz ) View more	Positive	20 Jul 2022
				Placebo	ufxhcfjnua(pxndaixcuk) = dvhjccqqxb obsbquxlfr (tpggkgqrgn )

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