LEO Pharma Shares Phase 3 Delgocitinib Data for Hand Eczema

In a second late-breaking presentation, pooled data from five phase 2b and phase 3 trials of delgocitinib cream confirmed a consistent safety profile for the treatment of moderate to severe CHE in adults

LEO Pharma A/S, a global leader in medical dermatology, presented two late-breaking delgocitinib cream presentations for Chronic Hand Eczema (CHE), showcasing the findings for the DELTA TEEN phase 3 trial and the pooled safety data from five phase 2b and phase 3 trials. Fifteen additional abstracts were also presented as part of LEO Pharma’s extensive scientific program at the 34^th European Academy of Dermatology and Venereology (EADV) Congress in Paris.

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The 16-week DELTA TEEN phase 3 clinical trial (N=98) assessed the efficacy and safety of delgocitinib cream in adolescents, aged 12-17, with moderate to severe CHE for whom topical corticosteroids are inadequate or inappropriate. The study met the primary endpoint as assessed by the Investigator’s Global Assessment for CHE Treatment Success (IGA CHE TS) at Week 16, defined as an IGA-CHE score of 0/1 (clear/almost clear) with a ≥2 step improvement from baseline. Delgocitinib cream was shown to be superior in comparison to cream vehicle, with 63.5% of patients responding in the delgocitinib cream arm vs. 29.2% in the cream vehicle arm.

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The delgocitinib cream treatment also showed superiority to cream vehicle across key secondary outcome measures. This included a ≥90% improvement in the Hand Eczema Severity Index (HECSI-90) score from baseline to Week 16 (71.6%) compared to cream vehicle (37.5%) and a ≥4-point reduction in Hand Eczema Symptom Diary (HESD) itch (64.8% vs. 36.8%), pain (63.3% vs. 33.3%), and total (55.6% vs. 31.3%) scores from baseline to Week 16.¹

No serious adverse events (AEs) were reported, and all AEs reported with delgocitinib cream were mild or moderate in severity. The overall proportion of patients reporting AEs was slightly higher for delgocitinib cream than for cream vehicle. Few AEs assessed as probably or possibly related to the trial drug and AEs leading to withdrawal from the trial or permanent discontinuation were reported, with numerically lower rates for delgocitinib cream than cream vehicle.¹

Delgocitinib is not approved for use in patients aged 12-17 years, and the efficacy and safety in this population has not been evaluated by any health authority.

“The findings from the phase 3 DELTA TEEN trial may offer hope for young people whose CHE can impact their wellbeing and leisure activities,” said Professor Sonja Molin, Academic Dermatologist at Charite Universitätsmedizin Berlin and Adjunct Associate Professor of Dermatology at Queen’s University and coordinating investigator. “These results are encouraging and bring us one step closer to advancing the standard of care for this underserved patient group, helping to fulfill their unmet dermatological needs.”

In addition, results from a pooled analysis of five phase 2b and phase 3 trials were unveiled as the company’s second late-breaking presentation for CHE at EADV 2025.² The analysis assessed the short- and long-term safety profiles of delgocitinib cream for the treatment of CHE for up to 52 weeks.²

The data integrated five trials and analyzed the safety profile of delgocitinib cream compared to cream vehicle and oral alitretinoin.² The findings demonstrated that during the initial treatment period (ITP), the event rates (R) of AEs with delgocitinib cream (R=302.1) were similar to cream vehicle (R=337.5) and notably lower than oral alitretinoin (R=830.2).² It was also found that the safety profile of delgocitinib cream during the as-needed treatment period remained consistent with the ITP, with AE rates decreasing in frequency over time.² The pooled safety data support the wider safety profile of delgocitinib cream for up to 52 weeks of treatment in adults with CHE.²

“The results from the pooled safety analysis are incredibly valuable as they further strengthen our understanding of this treatment option,” said Dr. Robert Bissonnette, Lead Author and MD from Innovaderm Research, Montreal. “It is reassuring to see that the safety data pooled from five clinical trials remains consistent with previously established findings.”

“We remain deeply committed to further raising awareness of CHE and expanding our extensive scientific research, not only to advance medical dermatology, but, most importantly, to support those living with this debilitating condition,” said Professor Jacob Pontoppidan Thyssen, Chief Scientific Officer & Executive Vice President, Science, Search & Innovation at LEO Pharma. “Nearly half of CHE patients feel they are a burden to their families, and around 63% avoid holding hands with their partners, highlighting the profound everyday impact this disease can have on patients’ lives. These figures are more than just statistics; they reflect the real and often unseen challenges faced by those living with CHE. At LEO Pharma, we are dedicated to reducing the burden of this skin condition, which we acknowledge affects far more than just the skin.”

About the DELTA TEEN Trial

DELTA TEEN was a 16-week, phase 3, randomized, double-blind, vehicle-controlled, parallel group, multi-site trial to evaluate the efficacy and safety of twice-daily applications of delgocitinib cream compared with cream vehicle in adolescents 12-17 years of age with moderate to severe CHE.

The primary endpoint of DELTA TEEN was the Investigator’s Global Assessment for chronic hand eczema Treatment Success (IGA-CHE TS) at Week 16. Treatment Success was defined as an IGA-CHE score of 0 (clear) or 1 (almost clear) with at least a two-step improvement from baseline.

About the Phase 2b Dose-ranging Trial

The phase 2b Dose-ranging Trial was a 16-week, phase 2b, double-blind, randomized, 5-arm, vehicle-controlled, dose-ranging trial to evaluate the efficacy and safety of twice-daily application of delgocitinib cream 1, 3, 8, and 20 mg/g for 16 weeks in adult subjects with mild to severe CHE.¹⁹

The primary endpoint of the trial was the Investigator’s Global Assessment for chronic hand eczema Treatment Success (IGA-CHE TS) at Week 16. Treatment Success was defined as an IGA-CHE score of 0 (clear) or 1 (almost clear) with at least a two-step improvement from baseline.¹⁹

About the DELTA 1, 2 and 3 Trials

The primary objective for the randomized, double-blind, vehicle-controlled, multi-center phase 3 clinical trials (DELTA 1 and DELTA 2) was to evaluate the efficacy of twice-daily applications of delgocitinib cream compared with cream vehicle in the treatment of adults with moderate to severe CHE.^20-22

The primary endpoint of the trials was the Investigator’s Global Assessment for chronic hand eczema Treatment Success (IGA-CHE TS) at Week 16. Treatment Success was defined as an IGA-CHE score of 0 (clear) or 1 (almost clear) with at least a two-step improvement from baseline. Additional IGA-CHE scores included 2 (mild), 3 (moderate), and 4 (severe).^20-22

Key secondary endpoints at Week 16 included reduction of itch and pain scores of ≥4 points measured by the Hand Eczema Symptom Diary (HESD) from baseline to Week 16, as well as at least 75% improvement from baseline and at least 90% improvement from baseline on the Hand Eczema Severity Index (HECSI) at Week 16. The number of treatment-emergent adverse events from baseline to Week 16 defined the key safety endpoint of the trials.^20-22

Subjects who completed 16 weeks of treatment with delgocitinib cream or cream vehicle twice daily in trials DELTA 1 or DELTA 2 were offered to roll-over to the 36-week DELTA 3 Open-label, Multi-site Extension trial. The purpose of this extension trial was to evaluate the long-term safety of delgocitinib.²³

About the DELTA FORCE Trial

DELTA FORCE was a 24-week, randomized, assessor-blinded, active-controlled, parallel-group, phase 3, two-arm trial to compare the efficacy and safety of delgocitinib cream twice-daily with oral alitretinoin capsules once-daily in adult participants with severe chronic hand eczema.²⁴

The primary endpoint of the trial was the change in Hand Eczema Severity Index (HECSI) score from baseline to Week 12. Participants assigned to receive delgocitinib cream applied the drug to the skin twice a day for 16 weeks. Participants assigned to receive alitretinoin capsules took the drug orally once a day for 12 weeks. All participants were permitted to continue for up to 24 weeks if the doctor considered that they were benefiting from the treatment.²⁴

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.^25,26 CHE is one of the most common skin diseases of the hands with a global prevalence rate of approximately 4.7%.^27,28 In a substantial number of patients, HE can develop into a chronic disease.²⁷ CHE is a fluctuating disease characterized by itch and pain, and patients may experience signs such as erythema, scaling, lichenification, hyperkeratosis, vesicles, edema, and fissures on hands and wrists.²⁹

CHE has been shown to cause psychological and functional burdens that impact patient quality of life,^30,31 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.³² Furthermore, careers and earning potential have also been shown to be impacted by the burden of living with CHE.³³

About ANZUPGO^® (delgocitinib) Cream

ANZUPGO cream is a topical pan-Janus kinase (JAK) inhibitor for the treatment of moderate to severe CHE in adults. It inhibits the activation of JAK-STAT signaling, which plays a key role in the pathogenesis of CHE.³⁴

ANZUPGO is approved in the European Union, United Kingdom, Switzerland, Canada, Australia, South Korea, and the United Arab Emirates for the treatment of moderate to severe Chronic Hand Eczema (CHE) in adults for whom topical corticosteroids are inadequate or inappropriate. ANZUPGO cream is also under investigation in other markets.

ANZUPGO^® (delgocitinib) cream is also FDA approved in the U.S. for moderate to severe chronic hand eczema (CHE) in adults who have had an inadequate response to, or for whom topical corticosteroids are not advisable. Use of ANZUPGO in combination with other JAK inhibitors or potent immunosuppressants is not recommended by the U.S. FDA.³⁵

Please click here for full U.S. Prescribing Information, including Patient Information and Instructions for Use.

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.

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Source- businesswire