Phase III Clinical Study of JTE-052 new drug product - Bioequivalence study between new drug product and JTE-052 ointment in patients with atopic dermatitis -

Start Date22 Apr 2024

Sponsor / Collaborator-

JPRN-jRCT2031230570 / CompletedPhase 1IIT

Phase I Clinical Study of JTE-052 new drug product - Dermal Safety Study -

Start Date19 Feb 2024

Sponsor / Collaborator-

100 Clinical Results associated with Delgocitinib

100 Translational Medicine associated with Delgocitinib

100 Patents (Medical) associated with Delgocitinib

Literatures (Medical) associated with Delgocitinib

01 Dec 2024·CLINICAL AND EXPERIMENTAL ALLERGY

Topical Anti‐Inflammatory Treatments for Eczema: A Cochrane Systematic Review and Network Meta‐Analysis

Review

Author: Doyle, Megan ; Williams, Hywel C. ; Stuart, Beth ; Futamura, Masaki ; Roberts, Amanda ; Axon, Emma ; Parker, Roses ; Santer, Miriam ; Steele, Lloyd ; Boyle, Robert J. ; Cro, Suzie ; Chu, Derek K. ; Lax, Stephanie J. ; Van Vogt, Eleanor ; Reynolds, Clare ; Candy, Bridget ; Drucker, Aaron M.

ABSTRACT:

Objective:

Eczema is the most burdensome skin condition worldwide and topical anti‐inflammatory treatments are commonly used to control symptoms. The relative effectiveness and safety of different topical anti‐inflammatory treatments is uncertain.

Design:

Network meta‐analysis performed within a Cochrane systematic review to compare and statistically rank efficacy and safety of topical anti‐inflammatory eczema treatments.

Data Sources:

Cochrane Skin Specialised Register, CENTRAL, MEDLINE, Embase and trial registries to June 2023.

Eligibility Criteria for Selected Trials:

Included trials were within‐participant or between‐participant randomised controlled trials. Participants had eczema that was not clinically infected and was not contact dermatitis, seborrheic eczema or hand eczema. Interventions were topical anti‐inflammatory treatments but not complementary treatments, antibiotics alone, wet wraps, phototherapy or systemic treatments. Comparators were no treatment/vehicle or another topical anti‐inflammatory.

Results:

We identified 291 trials (45,846 participants), mainly in high‐income countries. Most were industry‐funded with median 3 weeks treatment duration. Risk of bias assessed using the Cochrane Risk of Bias 2.0 tool was high in 89% of trials, mainly due to risk of selective reporting. Network meta‐analysis of binary outcomes ranked potent and/or very potent topical steroids, tacrolimus 0.1% and ruxolitinib 1.5% among the most effective treatments for improving patient‐reported symptoms (40 trials, all low confidence) and clinician‐reported signs (32 trials, all moderate confidence). For investigator global assessment, the Janus kinas inhibitors ruxolitinib 1.5%, delgocitinib 0.5% or 0.25%, very potent/potent topical steroids and tacrolimus 0.1% were ranked as most effective (140 trials, all moderate confidence). Continuous outcome data were mixed. Local application site reactions were most common with tacrolimus 0.1% (moderate confidence) and crisaborole 2% (high confidence) and least common with topical steroids (moderate confidence). Skin thinning was not increased with short‐term use of any topical steroid potency (low confidence) but skin thinning was reported in 6/2044 (0.3%) participants treated with longer‐term (6–60 months) topical steroids.

Conclusion:

Potent topical steroids, Janus kinase inhibitors and tacrolimus 0.1% were consistently ranked as among the most effective topical anti‐inflammatory treatments for eczema.

01 Nov 2024·INTERNATIONAL JOURNAL OF DERMATOLOGY

Cutaneous T‐cell pseudolymphoma successfully treated with topical delgocitinib

Letter

Author: Hoshina, Daichi ; Kimura, Ayame

Cutaneous pseudolymphoma is a benign reactive eruption characterized by nodular lymphocytic infiltration that mimics malignant lymphoma.Several causative or triggering factors are known: drugs, foreign bodies, tattoos, vaccines, and infections.The various clin. manifestations include erythema, papules, and nodules, and cases with multiple lesions can occur.The histopathol. findings are rather important for diagnosis, although the diagnosis should be made only after other disease entities have been excluded.Here, we report a refractory case of cutaneous T-cell pseudolymphoma (CTPL) successfully treated with the topical pan Janus kinase (JAK) inhibitor delgocitinib.

01 Nov 2024·Dermatology and Therapy

Cost-Effectiveness Study of Difamilast 1% for the Treatment of Atopic Dermatitis in Adult Japanese Patients

Article

Author: Kondo, Tomohiro ; Zhang, Yilong ; Noto, Shinichi ; Matsukawa, Miyuki ; Nakahara, Takeshi ; Takeda, Hiroe

INTRODUCTION:

Difamilast has proven to be an effective treatment for the treatment of atopic dermatitis (AD) in Japan, but its cost-effectiveness remains unknown. Therefore, the objective of the current study was to determine the cost-effectiveness of difamilast 1% compared with delgocitinib 0.5% in Japanese adult patients with moderate-to-severe AD and compared with placebo in Japanese adult patients with all-severity AD from a Japanese public health-care perspective.

METHODS:

The analysis was conducted using a cost-effectiveness model from the Japanese public health-care perspective. This model had four health states ("clear," "mild," "moderate," and "severe") defined according to the Eczema Area and Severity Index score. The time horizon of the analysis was 1 year. Because the analysis period was short, no discount rate was applied. The proportions of patients previously estimated by the anchored matching-adjusted indirect comparison were implemented in the model. The model was further populated with data from the literature. The main model outcomes were quality-adjusted life-years (QALY), costs, and outcomes, including the incremental cost-effectiveness ratio. All prices were stated in JPY at the price level from 2018 April to 2019 March. One-way sensitivity analysis and probabilistic sensitivity analysis (PSA) were performed to assess the robustness of the results.

RESULTS:

In the base case, the cost-effectiveness of difamilast 1% compared with delgocitinib 0.5% and placebo was JPY 827,054/QALY and JPY 1,518,657/QALY, respectively. The PSA showed that the cost-effectiveness of difamilast 1% compared with delgocitinib 0.5% and placebo had a 66.6% and 99.6% probability of being below the JPY 5 million/QALY threshold, respectively.

CONCLUSION:

The results suggest that difamilast 1% is a more cost-effective treatment option compared with delgocitinib 0.5% in Japanese adult patients with moderate-to-severe AD and compared with placebo in adult patients with all-severity AD from a Japanese public health-care perspective.

News (Medical) associated with Delgocitinib

05 Dec 2024

·pmlive.com

LEO Pharma’s Anzupgo cream granted MHRA approval to treat chronic hand eczema

LEO Pharma has announced that its Anzupgo (delgocitinib) cream has been approved by the Medicines and Healthcare Products Regulatory Agency (MHRA) to treat chronic hand eczema (CHE). The treatment has been specifically authorised for use in adults with moderate-to-severe cases of the inflammatory skin disease for whom topical corticosteroids are inadequate or inappropriate. CHE is defined as hand eczema that lasts for more than three months or relapses at least twice within a year. Alongside physical symptoms such as itch and pain, the condition has been shown to cause psychological and functional burdens that impact quality of life, with approximately 70% of patients with severe cases reporting problems performing everyday activities. LEO’s Anzupgo is designed to inhibit the activation of the JAK-STAT signalling pathway, which plays a key role in CHE, and is now the first topical pan-JAK inhibitor treatment approved by the MHRA specifically for adults with moderate-to-severe CHE. The UK regulator’s decision, which comes less than three months after the European Commission approved Anzupgo for the same indication, was supported by positive results from the phase 3 DELTA 1 and DELTA 2 trials, which compared the safety and efficacy of the therapy to vehicle cream. The primary endpoint, Investigator’s Global Assessment for CHE treatment success at week 16, was met in both studies and all secondary endpoints were achieved, including a reduction in itch and pain scores of at least four points, as measured by the Hand Eczema Symptom Diary from baseline to week 16. Data from the 36-week DELTA 3 open-label extension trial also informed the approval. Leanne Walsh, vice president and general manager, LEO Pharma UK and Ireland, said the approval “marks a significant milestone for adults in Great Britain living with moderate-to-severe CHE”. Also commenting on the authorisation, Richard Warren, consultant dermatologist at Northern Care Alliance NHS Foundation Trust and The University Of Manchester, said: “The physical symptoms of CHE can be debilitating, substantially disrupting patients’ lives… [The] approval of a first, topical JAK inhibitor treatment option for moderate-to-severe CHE adult patients adds to the treatment options available for healthcare professionals and patients.” LEO said it is now “collaborating closely” with the National Institute for Health and Care Excellence to make Anzupgo cream available on the NHS.

Phase 3Drug ApprovalClinical Result

05 Dec 2024

·www.pharmaceutical-technology.com

LEO Pharma’s eczema cream gains MHRA marketing authorisation

Anzupgo (delgocitinib) 20mg/g cream is intended to treat moderate to severe chronic hand eczema in adults. Credit: Kmpzzz/Shutterstock. Leo Pharma has gained marketing authorisation from the UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) for its topical pan-Janus kinase (JAK) inhibitor, Anzupgo (delgocitinib) 20mg/g cream, to treat chronic hand eczema (CHE) in Britain. The approval enables the treatment of adults with moderate to severe CHE when topical corticosteroids are inadequate or inappropriate. The decision was based on the positive outcomes of the Phase III programme, which encompassed the DELTA 1 and DELTA 2 trials. The trials assessed the cream’s efficacy and safety against a cream vehicle, meeting their primary and secondary goals. Subjects from the DELTA 1 and DELTA 2 trials were given the opportunity to join the DELTA 3 trial, a 36-week open-label extension study. LEO Pharma UK and Ireland vice-president and general manager Leanne Walsh stated: “Today’s MHRA approval of delgocitinib cream marks a significant milestone for adults in Great Britain living with moderate to severe chronic hand eczema. “This approval offers a new treatment paradigm and demonstrates our commitment to addressing the unmet needs of people living with skin conditions.” The cream targets the JAK-STAT signalling pathway involved in CHE pathogenesis. The condition is marked by skin barrier dysfunction, inflammation and changes in the skin microbiome. The current approval of delgocitinib cream adds to its existing authorisations in the European Union and Switzerland for the same indication. LEO Pharma obtained exclusive development and commercialisation rights to the cream for dermatological uses globally, excluding Japan, through a license agreement with Japan Tobacco (JT) in 2014. JT holds the rights in Japan. In September 2024, the European Commission (EC) granted marketing authorisation for delgocitinib cream to treat adults with moderate to severe CHE. LEO Pharma UK and Ireland is working with the National Institute for Health and Care Excellence ( Nice ) to ensure the cream’s availability on the National Health Service (NHS). Chronic hand eczema is a complex and variable inflammatory skin condition, with primary symptoms such as itching and pain affecting the hands and wrists.

Phase 3Drug ApprovalLicense out/inClinical Result

03 Dec 2024

·www.businesswire.com

MHRA Grants Marketing Authorisation for LEO Pharma’s Anzupgo® ▼(delgocitinib) cream in Great Britain

MAIDENHEAD, England--( BUSINESS WIRE )--NOT FOR UK USE - NOT INTENDED FOR UK MEDIA LEO Pharma, a global leader in medical dermatology, today announced that the Medicines and Healthcare Products Regulatory Agency (MHRA) has granted marketing authorisation for delgocitinib cream for the treatment of adult patients with moderate to severe Chronic Hand Eczema (CHE), for whom topical corticosteroids are inadequate or inappropriate. 1 CHE is a heterogeneous, fluctuating, inflammatory skin disease with key symptoms of itch and pain across the hands and wrists. 2,3 Its pathophysiology is characterised by skin barrier dysfunction, skin inflammation, and skin microbiome alterations. 2 Hand Eczema is categorised as CHE when it lasts for more than three months, or relapses twice or more often per year. 3,4 The condition can have a high psychological, social, and occupational burden. 5,6 “ The physical symptoms of Chronic Hand Eczema can be debilitating, substantially disrupting patients' lives. Additionally, patients report that the disease can profoundly affect their mental well-being, relationships, and daily activities,” shared Prof. Richard Warren, Consultant Dermatologist at Northern Care Alliance NHS Foundation Trust and The University Of Manchester . “ Today’s approval of a first, topical JAK inhibitor treatment option for moderate to severe CHE adult patients adds to the treatment options available for healthcare professionals and patients.” “ Today’s MHRA approval of delgocitinib cream marks a significant milestone for adults in Great Britain living with moderate to severe Chronic Hand Eczema,” said Leanne Walsh, Vice President and General Manager, LEO Pharma UK and Ireland . “ This approval offers a new treatment paradigm and demonstrates our commitment to addressing the unmet needs of people living with skin conditions.” The MHRA decision was based on results from the delgocitinib cream phase 3 program, which included the DELTA 1 and DELTA 2 clinical trials that evaluated the safety and efficacy of delgocitinib cream compared to the cream vehicle. 7-9 Both trials met their primary and all secondary endpoints. 9-11 Subjects who completed the 16-week DELTA 1 or DELTA 2 trials were immediately offered to enrol in the 36-week DELTA 3 open-label extension trial. 12 “ CHE is a truly debilitating condition as patients may live with itchy, sore, scaly, weepy, fissured hands. This can really affect patients' ability to work but also to interact with family and loved ones,” noted Prof. Anthony Bewley, Consultant Dermatologist at Barts Health NHS Trust. “ CHE is so much more than a difficult skin disease, as research has shown that living with CHE can have an impact on patients' psychological well-being, and can lead to anxiety, depression, or both. The development of a new topical treatment for adult patients with moderate to severe CHE is very welcome.” LEO Pharma UK and Ireland is collaborating closely with NICE to make delgocitinib cream available on the NHS. *Ends* Notes to editors About Chronic Hand Eczema Chronic Hand Eczema (CHE) is defined as Hand Eczema (HE) that lasts for more than three months or relapses twice or more within a year. 3,4 CHE is one of the most common skin disorders of the hands 13 with a prevalence rate of approximately 4.7%. 14 In a substantial number of patients, HE can develop into a chronic condition. 13 CHE is a fluctuating disorder characterized by itch and pain, and patients may experience signs such as erythema, scaling, lichenification, hyperkeratosis, vesicles, edema, and fissures on hands and wrists. 5 CHE has been shown to cause psychological and functional burdens that impact patient quality of life, 6 with approximately 70% of individuals who live with severe CHE admitting to problems in performing everyday activities, and suffering disruption in their daily life due to the condition. 15 Furthermore, careers and earning potential have also been shown to be impacted by the burden of living with CHE. 16 About delgocitinib Cream Delgocitinib cream is a topical pan-Janus kinase (JAK) inhibitor for the treatment of moderate to severe CHE. It inhibits the activation of JAK-STAT signalling, which plays a key role in the pathogenesis of CHE. 17 The pathophysiology is characterized by skin barrier dysfunction, inflammation of the skin, and alterations of the skin microbiome. 2 Delgocitinib cream is currently approved in the European Union and Switzerland for the treatment of moderate to severe CHE in adults for whom topical corticosteroids are inadequate or inappropriate. In 2014, LEO Pharma A/S and Japan Tobacco Inc. (JT) entered into a license agreement in which LEO Pharma gained exclusive rights to develop and commercialize delgocitinib for topical use in dermatological indications worldwide, excluding Japan, where JT retains rights. 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 4,000 people, serving millions of patients across the world. In 2023, the company generated net sales of DKK 11.4 billion. References Anzupgo ® (delgocitinib) cream SmPC. LEO Pharma; December 2024 . Lee GR, et al. Dermatol Ther . 2019;e12840:1–12. Lynde C, et al. J Cutan Med Surg. 2010;14:267–284. Erratum in: J Cutan Med Surg. 2011;15:360. Diepgen TL, et al. J Dtsch Dermatol Ges . 2015;13(1):e1–22. Thyssen J, et al. Contact Dermatitis . 2022;86:357–78. Grant L, et al. Adv Ther . 2020;37(2):692-706. Clinicaltrials.gov. 2024. Available from: https://clinicaltrials.gov/study/NCT04871711 . Clinicaltrials.gov. 2024. Available from: https://clinicaltrials.gov/ct2/show/NCT04872101 . Bissonnette R, et al. Lancet . 2024;404(10451):461-473. Schliemann S, et al. European Academy of Dermatology and Venereology (EADV) Congress . 2023. Bissonnette R, et al. European Academy of Dermatology and Venereology (EADV) Congress . 2023. Clinicaltrials.gov. 2024. Available from: https://clinicaltrials.gov/ct2/show/NCT04949841 . Bissonnette R, et al. JEADV . 2010;24;1–20 Apfelbacher C, et al. European Society of Contact Dermatitis (ESCD) congress . 2024. Cortesi PA, et al. Contact Dermatitis . 2014;70(3):158-168. Voorberg AN, et al. Acta Derm Venereol . 2022;102:adv00626. Dubin C, et al. Ther Clin Risk Manag . 2020;16:1319-1332. Erratum in: Ther Clin Risk Manag . 2021:17:233. MAT-78329 December 2024

Phase 3Clinical ResultLicense out/inDrug Approval

100 Deals associated with Delgocitinib

External Link

KEGG	Wiki	ATC	Drug Bank
D11046	-	D11AH	DB16133

R&D Status

Approved

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
Chronic eczema	EU	LEO Pharma A/S	19 Sep 2024
Chronic eczema	IS	LEO Pharma A/S	19 Sep 2024
Chronic eczema	LI	LEO Pharma A/S	19 Sep 2024
Chronic eczema	NO	LEO Pharma A/S	19 Sep 2024
Dermatitis, Atopic	JP	Japan Tobacco, Inc.	23 Jan 2020

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Mandibulofacial Dysostosis	Phase 3	CN	LEO Laboratories Ltd.	05 Sep 2023
Mandibulofacial Dysostosis	Phase 3	CN	Shanghai Leo Pharmaceutical Consulting Co., Ltd.	05 Sep 2023
Mandibulofacial Dysostosis	Phase 3	CN	LEO Pharma A/S	05 Sep 2023
Eczema, Dyshidrotic	Phase 3	DK	Japan Tobacco, Inc.	30 Jan 2022
Eczema, Dyshidrotic	Phase 3	DK	LEO Pharma A/S	30 Jan 2022
Frontal Fibrosing Alopecia	Phase 2	DK	Japan Tobacco, Inc.	30 Jan 2022
Lupus Erythematosus, Discoid	Phase 2	US	Leo Pharma, Inc.	09 Jul 2019
Lupus Erythematosus, Discoid	Phase 2	DK	Leo Pharma, Inc.	09 Jul 2019
Lupus Erythematosus, Discoid	Phase 2	FR	Leo Pharma, Inc.	09 Jul 2019
Lupus Erythematosus, Discoid	Phase 2	DE	Leo Pharma, Inc.	09 Jul 2019

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05259722 (BusinessWire) Manual	Phase 3	Chronic eczema	513	Delgocitinib cream	cijjnipkin(zotqdfgpld) = uuxujqefbl uolwnxldcc (pchmnylqer ) Met View more	Positive	25 Sep 2024
				Alitretinoin capsules	cijjnipkin(zotqdfgpld) = scjxeqzjha uolwnxldcc (pchmnylqer ) Met View more
NCT04872101 \| NCT04871711 (DELTA 2, Pubmed) Manual	Phase 3	Eczema	-	Delgocitinib cream 20 mg/g	hwenjvzmkc(zzelbuaazv) = eypwthybxw ypehlexziy (etefaoexqb ) View more	Positive	01 Jul 2024
				Cream vehicle	hwenjvzmkc(zzelbuaazv) = gtxzszonhy ypehlexziy (etefaoexqb ) View more
NCT04949841 (DELTA 3, BusinessWire) Manual	Phase 3	Chronic eczema	801	Delgocitinib cream	oplqkwlvnq(gejjuzwkbf) = COVID-19 and nasopharyngitis atkrzqvfge (mepppaqhmj )	Positive	10 Mar 2024
DELTA 3 (NEWS) Manual	Phase 3	Eczema, Dyshidrotic	-	delgocitinib	jovabruvtc(joasmlbilp) = safety profile of twice-daily treatment with delgocitinib cream for up to 36 weeks was consistent with previous results from DELTA 1 and 2. hkmhwuxrwt (mnpzmwzcoh ) View more	Positive	31 Oct 2023
DELTA 2 (NEWS) Manual	Phase 3	Eczema, Dyshidrotic	473	Delgocitinib	jujjenixzr(qduexqfrzp) = qklbzenjio dneooarwdw (xxzaewvioj ) View more	Positive	13 Oct 2023
				cream vehicle	jujjenixzr(qduexqfrzp) = aqhloyuzmh dneooarwdw (xxzaewvioj ) View more
NCT04872101 (DELTA 2, EADV2023)	Phase 3	Eczema, Dyshidrotic	-	Delgocitinib cream 20 mg/g	xkhaueyfss(lrefztvzdb) = uhpwaqnhsr vpwsyzmbrf (dljtyaakdk )	-	11 Oct 2023
NCT04871711 (DELTA 1, EADV2023)	Phase 3	Eczema, Dyshidrotic	487	Delgocitinib cream 20 mg/g	qqgesecfkp(rrpsuxtfmc) = vdrkpvsmsz wbgjxojior (rozrypcwrn ) View more	Positive	11 Oct 2023
				Cream vehicle	qqgesecfkp(rrpsuxtfmc) = lnlowdxwpd wbgjxojior (rozrypcwrn ) View more
NCT04872101 \| NCT04871711 (DELTA 1 and DELTA 2, EADV2023)	Phase 3	Chronic eczema	639	Delgocitinib cream 20 mg/g	jzigcwfsnr(zteiypwena): difference = 0.11 (95% CI, 0.08 - 0.13)	Positive	11 Oct 2023
				Cream vehicle
NCT04872101 (DELTA 2, EADV2023)	Phase 3	Eczema, Dyshidrotic	-	Delgocitinib cream 20 mg/g	oegdagepfb(jwxlbqassa) = gkdfsnaejg emvluieuhu (wolqhnixod ) View more	Positive	11 Oct 2023
				Cream vehicle	oegdagepfb(jwxlbqassa) = iwckmtbkoa emvluieuhu (wolqhnixod ) View more
NCT04871711 (DELTA 1, BusinessWire) Manual	Phase 3	Chronic eczema	487	delgocitinib	kaqvizmiai(oebxxasktb) = at least a two-step improvement from baseline fygofpzlpi (jwwaxzqfsz )	Positive	06 Dec 2022
				Vehicle

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