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Clinical Trial
. 2025 Jul;93(1):95-103.
doi: 10.1016/j.jaad.2025.03.008. Epub 2025 Mar 11.

Long-term safety and efficacy of delgocitinib cream for up to 52 weeks in adults with Chronic Hand Eczema: Results of the phase 3 open-label extension DELTA 3 trial following the DELTA 1 and 2 trials

Melinda Gooderham  1 , Sonja Molin  2 , Robert Bissonnette  3 , Margitta Worm  4 , Marie-Noëlle Crépy  5 , Luca Stingeni  6 , Richard B Warren  7 , Sibylle Schliemann  8 , Marie-Louise Schuttelaar  9 , Silvia Ferrucci  10 , Esther Serra-Baldrich  11 , Jonathan I Silverberg  12 , Cherry Lou Balita-Crisostomo  13 , Marie Louise Østerdal  13 , Ursula Plohberger  13 , Tove Agner  14
Affiliations
Free article
Clinical Trial

Long-term safety and efficacy of delgocitinib cream for up to 52 weeks in adults with Chronic Hand Eczema: Results of the phase 3 open-label extension DELTA 3 trial following the DELTA 1 and 2 trials

Melinda Gooderham et al. J Am Acad Dermatol. 2025 Jul.
Free article

Abstract

Background: Delgocitinib cream is the only topical treatment that has been specifically developed and approved for moderate to severe Chronic Hand Eczema (CHE).

Objective: The objective of this trial was to evaluate the long-term safety and efficacy of delgocitinib cream 20 mg/g as needed for 36 weeks in adults with CHE.

Methods: In phase 3 open-label DELTA 3 (NCT04949841), patients who completed the 16-week treatment period in the DELTA 1 and 2 trials were treated on an as-needed basis with twice-daily delgocitinib cream for 36 weeks (n= 801). Patients with Investigator's Global Assessment for CHE (IGA-CHE) ≥2 received treatment until IGA-CHE ≤1 was achieved. The primary endpoint was the number of treatment-emergent adverse events. Key secondary endpoints were IGA-CHE 0/1 and ≥75%/≥90% improvement in Hand Eczema Severity Index (HECSI-75/90) scores.

Results: Delgocitinib was well-tolerated (n= 801; R = 231.1; patient years of observation = 535.7), with most frequent adverse events being COVID-19 and nasopharyngitis. DELTA 3 baseline IGA-CHE 0/1 (24.6%) and HECSI-75/HECSI-90 (51.8%/31.8%) were maintained to week 36 (30.0% and 58.6%/36.6%, respectively) among delgocitinib-treated patients in the parent trials. Among those previously treated with cream vehicle, corresponding response rates improved from DELTA 3 baseline (9.1% and 23.7%/12.0%, respectively) to week 36 (29.5% and 51.5%/35.7%).

Limitations: Open-label trial.

Conclusion: Delgocitinib cream treatment was well-tolerated and efficacious in maintaining disease control in patients with CHE for up to 52 weeks.

Keywords: CHE; Chronic Hand Eczema; DELTA 3; clinical trial; contact dermatitis; delgocitinib cream; hand eczema; inflammation; long-term; moderate to severe; open-label; phase 3; safety.

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Conflict of interest statement

Conflicts of interest Dr Gooderham has been an investigator, speaker and/or advisor for: Abbvie, Acelyrin, Amgen, Akros, AnaptysBio, Arcutis Biotherapeutics, Aristea Therapeutics, ASLAN Pharmaceuticals, Apogee, Bausch Health, BMS, Boehringer Ingelheim, Cara Therapeutics, Celgene, Dermira, Dermavant, Eli Lilly, Galderma, Incyte, Inmagene Biopharmaceuticals, Janssen, LEO Pharma A/S, L’Oreal, MedImmune, Meiji Seika Pharma, Moonlake, Nektar, Nimbus, Novartis, Pfizer, Regeneron, Reistone Biopharma, Roche, Sanofi Genzyme, Sun Pharma, Tarsus, Takeda Pharmaceuticals, UCB, Union, and Ventyx. Dr Molin has been an investigator and/or has received honoraria as consultant/advisor or speaker and/or grants from Abbvie, Almirall, Aralez, Arcutis, Basilea, Bausch and Lomb, Bristol Myer Squibb, Boehringer Ingelheim, Evidera, Galderma, GSK, Incyte, Jamp Biopharma, LEO Pharma A/S, Lilly, Novartis, Pfizer, Sanofi, Sun Pharma, and UCB. Dr Bissonnette is an advisory board member, consultant, speaker and/or investigator for and receives honoraria and/or grants from Abbvie, Amgen, Apogee, Arcutis, Asana BioSciences, Bellus Health, BioMimetix, Bluefin Biomedicine, Boehringer Ingelheim, Boston, CARA Therapeutic, Clexio, Dermavant, Eli Lilly, Escient, Evidera, Fresh Tracks (Brickell), Galderma, GlaxoSmithKline, Incyte, Inmagene Bio, Janssen, LEO Pharma A/S, Merck, Novartis, Opsidio, Pfizer, RAPT Therapeutic, Regeneron, Sanofi, Target RWE, Vyne Therapeutics, and Zencor. Dr Worm reports grants and personal fees from Abbvie Deutschland, Allergopharma, Aimmune, ALK-Abello, Almirall S. A., Amgen GmbH, Biotest, Bristol-Myers Squibb GmbH & Co, DBV Technologies, KGaA, Mylan Germany, LEO Pharma A/S, Lilly Deutschland, Regeneron Pharmaceuticals, Sanofi Aventis, Novartis, and Pfizer Deutschland GmbH, outside the submitted work and is past WAO cochair of the anaphylaxis committee. Dr Crépy is a consultant, advisory board member, investigator, and/or speaker for Abbvie, Eli Lilly, LEO Pharma A/S, Novartis, Pfizer, and Sanofi Genzyme. Dr Stingeni has been principal investigator in clinical trials sponsored by and/or has received personal fees for participation in advisory board from Abbvie, Almirall, Amgen, LEO Pharma A/S, Eli Lilly, Novartis, and Sanofi, outside the submitted work. Dr Warren has received research grants or consulting fees from Abbvie, Almirall, Amgen, Arena, Astellas, Avillion, Biogen, Boehringer Ingelheim, Bristol-Myers Squibb, Celgene, DiCE, GSK, Janssen, Lilly, LEO Pharma A/S, Novartis, Pfizer, Sanofi, Sun Pharma, UCB, and UNION. Dr Schliemann is or has been a consultant, advisory board member, investigator, and/or speaker for LEO Pharma A/S, Sanofi Aventis, Novartis Pharma, Lilly Pharma, and Abbvie. Dr Schuttelaar has been a consultant, advisory board member, investigator, and/or speaker for Abbvie, Amgen, Eli Lilly, Galderma, LEO Pharma A/S, Novartis, Pfizer, Regeneron Pharmaceuticals, Inc, and Sanofi Genzyme. Dr Ferrucci has been principal investigator and/or speaker for Abbvie, Almirall, Amgen, Sanofi Genzyme, Lilly, Novartis, and LEO Pharma A/S and has participated in the advisory boards of Abbvie, Almirall, and Sanofi Genzyme. Dr Serra-Baldrich has served as an investigator and/or speaker and/or advisor for Abbvie, Almirall-Hermal, Lilly, LEO Pharma A/S, Pfizer, Sanofi, Novartis, and Galderma. Dr Silverberg reports personal fees from Abbvie, Afyx, AnaptysBio, Aobiome, Arena, Asana, Aslan, BioMX, Bluefin, Bodewell, Boehringer Ingelheim, Celgene, Connect Biopharma, Dermavant, Dermira, DS Biopharma, Eli Lilly, Galderma, GlaxoSmithKline, Incyte, Kiniksa, Kymab, LEO Pharma A/S, Luna, Menlo, Novartis, Pfizer, RAPT, Realm, Regeneron, and Sanofi Genzyme, grants and/or personal fees from Galderma, GlaxoSmithKline and Pfizer, and stock/stock options from Abbvie, Arcutis, and Eli Lilly outside the submitted work. Dr Balita-Crisostomo, Ms Østerdal, and Ms Plohberger are employees of LEO Pharma A/S. Dr Agner has been a speaker/consultant/advisor for Abbvie, Almirall, Eli Lilly, LEO Pharma A/S, Pfizer, and Sanofi Genzyme.

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