Open-label Multi-site Extension Trial in Subjects Who Completed the DELTA 1 or DELTA 2 Trials (DELTA3)

A Phase 3 Extension Trial of DELTA 1 and DELTA 2 to Evaluate the Long-term Safety of a Twice-daily Treatment With Delgocitinib Cream 20 mg/g as Needed for up to 36 Weeks in Adult Subjects With Chronic Hand Eczema (DELTA 3)

The purpose of this extension trial is to evaluate the long-term safety of delgocitinib.

Subjects will visit the clinic every 4 week to assess the safety and efficacy of the treatment, until Week 36. A final follow-up phone call is planned on Week 38.

Study Overview

• Status: Completed
• Conditions: Chronic Hand Eczema
• Intervention / Treatment: Drug: Delgocitinib

Detailed Description

Subject who completed 16 weeks of treatment with delgocitinib cream 20 mg/g or vehicle cream twice daily in trials DELTA 1 or DELTA 2 will be offered to roll-over to this extension trial.

Subjects will be treated with delgocitinib cream 20 mg/g twice daily only if they need it to control their chronic hand eczema. In the periods when the disease is controlled, no treatment will be administered.

Clinic visits every 4 weeks are planned (with the possibility of unscheduled visits) to investigate safety and efficacy of treatment, as well as its effect on patient-reported outcomes (PROs).

• Study Type: Interventional
• Enrollment (Actual): 801
• Phase: Phase 3

Contacts and Locations

Study Locations

• Belgium
  • Brussel, Belgium, 1000
    • Leo Investigational Site
  • Gent, Belgium, 9000
    • Leo Investigational Site
  • Kortrijk, Belgium, 8500
    • Leo Investigational Site
  • Leuven, Belgium, 3000
    • Leo Investigational Site
  • Loverval, Belgium, 6280
    • Leo Investigational Site
  • Maldegem, Belgium, 9990
    • Leo Investigational Site
• Canada
  • Alberta
    • Calgary, Alberta, Canada, T2J 7E1
      • Leo Investigational Site
    • Calgary, Alberta, Canada, T3E 0B2
      • Leo Investigational Site
    • Edmonton, Alberta, Canada, T5J 3S9
      • Leo Investigational Site
    • Edmonton, Alberta, Canada, T6G 1C3
      • Leo Investigational Site
    • Red Deer, Alberta, Canada, T4P 1K4
      • Leo Investigational Site
  • British Columbia
    • Surrey, British Columbia, Canada, V3R 6A7
      • Leo Investigational Site
    • Vancouver, British Columbia, Canada, V6 4E1
      • Leo Investigational Site
  • New Bruswick
    • Fredericton, New Bruswick, Canada, E3B 1G9
      • Leo Investigational Site
  • Ontario
    • Ajax, Ontario, Canada, L1S 7K8
      • Leo Investigational Site
    • Cobourg, Ontario, Canada, K9A 4J9
      • Leo Investigational Site
    • Etobicoke, Ontario, Canada, M8X 1Y9
      • Leo Investigational Site
    • Hamilton, Ontario, Canada, L8S 1G5
      • Leo Investigational Site
    • Kingston, Ontario, Canada, K7L 2V7
      • Leo Investigational Site
    • London, Ontario, Canada, N6A 3H7
      • Leo Investigational Site
    • Markham, Ontario, Canada, L3P 1X3
      • Leo Investigational Site
    • Toronto, Ontario, Canada, M2M 4J5
      • Leo Investigational Site
    • Toronto, Ontario, Canada, M3H 5Y8
      • Leo Investigational Site
    • Waterloo, Ontario, Canada, N2J 1C4
      • Leo Investigational Site
    • Windsor, Ontario, Canada, N8W 1E6
      • Leo Investigational Site
  • Quebec
    • Montreal, Quebec, Canada, H2X 2V1
      • Leo Investigational Site
• Denmark
  • Aarhus N, Denmark, 8200
    • Leo Investigational Site
  • Copenhagen, Denmark, 2400
    • Leo Investigational Site
  • Hellerup, Denmark, 2900
    • LEO Pharma Investigational Site
• France
  • Bordeaux, France, 33000
    • Leo Investigational Site
  • Dijon, France, 21000
    • Leo Investigational Site
  • Le Mans, France, 72037
    • Leo Investigational Site
  • Lille, France, 5900
    • Leo Investigational Site
  • Martigues, France, 13500
    • Leo Investigational Site
  • Nantes, France, 44093
    • LEO Pharma Investigational Site
  • Nice, France, 06000
    • Leo Investigational Site
  • Nice, France, 06202
    • Leo Investigational Site
  • Paris, France, 75014
    • LEO Investigational Sites
  • Paris, France, 75014
    • Leo Investigational Site
  • Reims, France, 51100
    • Leo Investigational Site
  • Toulouse, France, 31000
    • Leo Investigational Site
• Germany
  • Aachen, Germany, 52074
    • Leo Investigational Site
  • Bad Bentheim, Germany, 48455
    • Leo Investigational Site
  • Berlin, Germany, 10115
    • Leo Investigational Site
  • Dresden, Germany, 01307
    • Leo Investigational Site
  • Frankfurt am Main, Germany, 60590
    • Leo Investigational Site
  • Friedrichshafen, Germany, 88045
    • Leo Investigational Site
  • Gera, Germany, 07548
    • Leo Investigational Site
  • Göttingen, Germany, 37073
    • Leo Investigational Site
  • Hamburg, Germany, 22391
    • Leo Investigational Site
  • Hannover, Germany, 30159
    • Leo Investigational Site
  • Hassfurt, Germany, 97437
    • Leo Investigational Site
  • Jena, Germany, 07743
    • Leo Investigational Site
  • Luebeck, Germany, 23538
    • Leo Investigational Site
  • Mahlow, Germany, 15831
    • Leo Investigational Site
  • Mainz-Bretzenheim, Germany, 55128
    • Leo Investigational Site
  • Memmingen, Germany, 87700
    • LEO Pharma Investigational Site
  • München, Germany, 80802
    • Leo Investigational Site
  • Münster, Germany, 48149
    • Leo Investigational Site
  • Osnabrück, Germany, 49074
    • Leo Investigational Site
  • Stuttgart, Germany, 70178
    • Leo Investigational Site
• Italy
  • Brescia, Italy, 25123
    • Leo Investigational Site
  • L'Aquila, Italy, 67100
    • Leo Investigational Site
  • Rome, Italy, 00168
    • Leo Investigational Site
  • Vicenza, Italy, 36100
    • Leo Investigational Site
• Netherlands
  • Amsterdam, Netherlands, 1105 AZ
    • Leo Investigational Site
  • Bergen Op Zoom, Netherlands, 4614 VT
    • Leo Investigational Site
  • Groningen, Netherlands, 9713 GZ
    • Leo Investigational Site
  • Hoofddorp, Netherlands, 2134 TM
    • Leo Investigational Site
  • Utrecht, Netherlands, 3584 CX
    • Leo Investigational Site
• Poland
  • Białystok, Poland, 15-375
    • LEO Investigitional Site
  • Białystok, Poland, 15-794
    • Leo Investigational Site
  • Gdansk, Poland, 80-546
    • Leo Investigational Site
  • Kraków, Poland, 30-033
    • Leo Investigational Site
  • Kraków, Poland, 31-011
    • Leo Investigational Site
  • Lublin, Poland, 20-406
    • Leo Investigational Site
  • Lublin, Poland, 20-081
    • Leo Investigational Site
  • Osielsko, Poland, 86-031
    • Leo Investigational Site
  • Rzeszów, Poland, 35-055
    • LEO Pharma Investigational Site
  • Warsaw, Poland, 02-953
    • Leo Investigational Site
  • Warsaw, Poland, 02-962
    • Leo Investigational Site
  • Warszawa, Poland, 02-625
    • Leo Investigational Site
  • Warszawa, Poland, 02-507
    • Leo Investigational Site
  • Wrocław, Poland, 50-566
    • Leo Investigational Site
  • Wrocław, Poland, 51-318
    • Leo Investigational Site
  • Łódź, Poland, 90-436
    • Leo Investigational Site
• Spain
  • Alicante, Spain, 03010
    • Leo Investigational Site
  • Badalona, Spain, 08915
    • Leo Investigational Site
  • Barcelona, Spain, 08041
    • LEO Investigitional Site
  • Bilbao, Spain, 48013
    • Leo Investigational Site
  • Madrid, Spain, 28031
    • Leo Investigational Site
  • Mieres, Spain, 33611
    • Leo Investigational Site
  • Sevilla, Spain, 41009
    • Leo Investigational Site
• United Kingdom
  • London, United Kingdom, SE1 7EH
    • Leo Investigational Site
  • Middlesborough, United Kingdom, TS4 3BW
    • Leo Investigational Site
  • Salford, United Kingdom, M6 8HD
    • Leo Investigational Site
  • Surrey
    • Redhill, Surrey, United Kingdom, RH1 5RH
      • LEO Investigational Sites

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Participants must have met eligibility criteria at screening and baseline in the parent trial (DELTA 1 or DELTA 2).
• Participants must have completed the treatment period in the parent trial (to be assessed at baseline visit in this extension trial).
• Participants must have complied with the clinical trial protocol in the parent trial to the satisfaction of the investigator.
• A woman of childbearing potential must use an acceptable method of birth control throughout the trial up until the end-of-treatment/early termination visit.

Exclusion Criteria:

• Participants who prematurely discontinued treatment with IMP or initiated rescue medication in the parent trial.
• Participants who experienced any adverse event (AE) during participation in the parent trial, which precludes further treatment with delgocitinib cream 20 mg/g in the judgement of the investigator.
• Any medical or psychiatric condition that could put the participant at undue risk by participating in the trial, or which, by the investigator's judgment, makes the participant inappropriate for the trial.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: As-needed treatment with delgocitinib; Subjects will be treated with delgocitinib cream 20 mg/g twice daily as needed.	Drug: Delgocitinib; Delgocitinib cream 20 mg/g

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Number of treatment-emergent adverse events from baseline up to Week 38	From baseline to Week 38

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
IGA-CHE score at each scheduled visit from baseline up to Week 36	The Investigator's Global Assessment for chronic hand eczema (IGA-CHE) is an instrument used in clinical trials to rate the severity of the participant's chronic hand eczema (CHE) and is based on a 5-point scale ranging from 0 (clear) to 4 (severe).	From baseline to Week 36
IGA-CHE score of 0 (clear) or 1 (almost clear) at each scheduled visit from baseline up to Week 36.	The Investigator's Global Assessment for chronic hand eczema (IGA-CHE) is an instrument used in clinical trials to rate the severity of the participant's chronic hand eczema (CHE) and is based on a 5-point scale ranging from 0 (clear) to 4 (severe).	From baseline to Week 36
HECSI score at each scheduled visit from baseline up to Week 36	The Hand Eczema Severity Index (HECSI) is an instrument used in clinical trials to rate the severity of 6 clinical signs (erythema, infiltration/papulation, vesicles, fissures, scaling, and oedema) and the extent of the lesions in each of the 5 hand regions (fingertips, fingers [except fingertips], palm of hands, back of hands, and wrists) by use of standard scales. The HECSI score will range from 0 (lowest possible score) to 360 (highest possible score).	From baseline to Week 36
HECSI-75 at each scheduled visit from baseline up to Week 36	The Hand Eczema Severity Index (HECSI) is an instrument used in clinical trials to rate the severity of 6 clinical signs (erythema, infiltration/papulation, vesicles, fissures, scaling, and oedema) and the extent of the lesions in each of the 5 hand regions (fingertips, fingers [except fingertips], palm of hands, back of hands, and wrists) by use of standard scales. The HECSI score will range from 0 (lowest possible score) to 360 (highest possible score). HECSI-75 is defined as at least 75% improvement in HECSI score from parent trial baseline.	From baseline to Week 36
HECSI-90 at each scheduled visit from baseline up to Week 36	The Hand Eczema Severity Index (HECSI) is an instrument used in clinical trials to rate the severity of 6 clinical signs (erythema, infiltration/papulation, vesicles, fissures, scaling, and oedema) and the extent of the lesions in each of the 5 hand regions (fingertips, fingers [except fingertips], palm of hands, back of hands, and wrists) by use of standard scales. The HECSI score will range from 0 (lowest possible score) to 360 (highest possible score). HECSI-90 is defined as at least 90% improvement in HECSI score from parent trial baseline.	From baseline to Week 36

Collaborators and Investigators

• Sponsor: LEO Pharma
• Investigators: Study Director: Medical Expert, LEO Pharma

Study record dates

Study Major Dates

• Study Start (Actual): August 23, 2021
• Primary Completion (Actual): September 18, 2023
• Study Completion (Actual): September 18, 2023

Study Registration Dates

• First Submitted: June 29, 2021
• First Submitted That Met QC Criteria: June 29, 2021
• First Posted (Actual): July 2, 2021

Study Record Updates

• Last Update Posted (Actual): December 7, 2023
• Last Update Submitted That Met QC Criteria: December 6, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Dermatitis; Skin Diseases, Eczematous; Eczema
• Other Study ID Numbers: LP0133-1403; 2020-002962-15 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: De-identified IPD can be made available to researchers in a closed environment for a specified period of time.
• IPD Sharing Time Frame: Data is available to request after results of the trial are available on leopharmatrials.com
• IPD Sharing Access Criteria: Data-sharing is subject to approved scientifically sound research proposal and signed data-sharing agreement.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No