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

Last updated: April 3, 2025
Sponsor: LEO Pharma
Overall Status: Completed

Phase

3

Condition

Allergy

Atopic Dermatitis

Hives (Urticaria)

Treatment

Delgocitinib

Clinical Study ID

NCT04949841
LP0133-1403
2020-002962-15
U1111-1284-2216
  • Ages > 18
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Participants must have met eligibility criteria at screening and baseline in theparent trial (DELTA 1 or DELTA 2).

  • Participants must have completed the treatment period in the parent trial (to beassessed at baseline visit in this extension trial).

  • Participants must have complied with the clinical trial protocol in the parent trialto the satisfaction of the investigator.

  • A woman of childbearing potential must use an acceptable method of birth controlthroughout the trial up until the end-of-treatment/early termination visit.

Exclusion

Exclusion Criteria:

  • Participants who prematurely discontinued treatment with IMP or initiated rescuemedication in the parent trial.

  • Participants who experienced any adverse event (AE) during participation in theparent trial, which precludes further treatment with delgocitinib cream 20 mg/g inthe judgement of the investigator.

  • Any medical or psychiatric condition that could put the participant at undue risk byparticipating in the trial, or which, by the investigator's judgment, makes theparticipant inappropriate for the trial.

Study Design

Total Participants: 801
Treatment Group(s): 1
Primary Treatment: Delgocitinib
Phase: 3
Study Start date:
August 23, 2021
Estimated Completion Date:
September 18, 2023

Study 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).

Connect with a study center

  • LEO Investigational Site

    Brussel, 1000
    Belgium

    Site Not Available

  • LEO Investigational Site

    Gent, 9000
    Belgium

    Site Not Available

  • LEO Investigational Site

    Kortrijk, 8500
    Belgium

    Site Not Available

  • LEO Investigational Site

    Leuven, 3000
    Belgium

    Site Not Available

  • LEO Investigational Site

    Loverval, 6280
    Belgium

    Site Not Available

  • LEO Investigational Site

    Maldegem, 9990
    Belgium

    Site Not Available

  • LEO Investigational Site

    Calgary, Alberta T3E 0B2
    Canada

    Site Not Available

  • LEO Investigational Site

    Edmonton, Alberta T6G 1C3
    Canada

    Site Not Available

  • LEO Investigational Site

    Red Deer, Alberta T4P 1K4
    Canada

    Site Not Available

  • LEO Investigational Site

    Surrey, British Columbia V3R 6A7
    Canada

    Site Not Available

  • LEO Investigational Site

    Vancouver, British Columbia V6 4E1
    Canada

    Site Not Available

  • LEO Investigational Site

    Fredericton, New Bruswick E3B 1G9
    Canada

    Site Not Available

  • LEO Investigational Site

    Ajax, Ontario L1S 7K8
    Canada

    Site Not Available

  • LEO Investigational Site

    Cobourg, Ontario K9A 4J9
    Canada

    Site Not Available

  • LEO Investigational Site

    Etobicoke, Ontario M8X 1Y9
    Canada

    Site Not Available

  • LEO Investigational Site

    Hamilton, Ontario L8S 1G5
    Canada

    Site Not Available

  • LEO Investigational Site

    Kingston, Ontario K7L 2V7
    Canada

    Site Not Available

  • LEO Investigational Site

    London, Ontario N6A 3H7
    Canada

    Site Not Available

  • LEO Investigational Site

    Markham, Ontario L3P 1X3
    Canada

    Site Not Available

  • LEO Investigational Site

    Toronto, Ontario M3H 5Y8
    Canada

    Site Not Available

  • LEO Investigational Site

    Waterloo, Ontario N2J 1C4
    Canada

    Site Not Available

  • LEO Investigational Site

    Windsor, Ontario N8W 1E6
    Canada

    Site Not Available

  • LEO Investigational Site

    Montreal, Quebec H2X 2V1
    Canada

    Site Not Available

  • LEO Investigational Site

    Aarhus N, 8200
    Denmark

    Site Not Available

  • LEO investigational Site

    Copenhagen, 2400
    Denmark

    Site Not Available

  • LEO Pharma Investigational Site

    Hellerup, 2900
    Denmark

    Site Not Available

  • LEO Investigational Site

    Bordeaux, 33000
    France

    Site Not Available

  • LEO Investigational Site

    Dijon, 21000
    France

    Site Not Available

  • LEO Investigational Site

    Le Mans, 72037
    France

    Site Not Available

  • LEO Investigational Site

    Lille, 5900
    France

    Site Not Available

  • LEO Investigational Site

    Martigues, 13500
    France

    Site Not Available

  • LEO Pharma Investigational Site

    Nantes, 44093
    France

    Site Not Available

  • LEO Investigational Site

    Nice, 06202
    France

    Site Not Available

  • LEO Investigational Site

    Paris, 75014
    France

    Site Not Available

  • LEO Investigational Sites

    Paris, 75014
    France

    Site Not Available

  • LEO Investigational Site

    Reims, 51100
    France

    Site Not Available

  • LEO Investigational Site

    Toulouse, 31000
    France

    Site Not Available

  • LEO Investigational Site

    Aachen, 52074
    Germany

    Site Not Available

  • LEO Investigational Site

    Bad Bentheim, 48455
    Germany

    Site Not Available

  • LEO Investigational Site

    Berlin, 10115
    Germany

    Site Not Available

  • LEO Investigational Site

    Dresden, 01307
    Germany

    Site Not Available

  • LEO Investigational Site

    Frankfurt am Main, 60590
    Germany

    Site Not Available

  • LEO Investigational Site

    Friedrichshafen, 88045
    Germany

    Site Not Available

  • LEO Investigational Site

    Gera, 07548
    Germany

    Site Not Available

  • LEO Investigational Site

    Göttingen, 37073
    Germany

    Site Not Available

  • LEO Investigational Site

    Hamburg, 22391
    Germany

    Site Not Available

  • LEO Investigational Site

    Hannover, 30159
    Germany

    Site Not Available

  • LEO Investigational Site

    Hassfurt, 97437
    Germany

    Site Not Available

  • LEO Investigational Site

    Jena, 07743
    Germany

    Site Not Available

  • LEO Investigational Site

    Luebeck, 23538
    Germany

    Site Not Available

  • LEO Investigational Site

    Mahlow, 15831
    Germany

    Site Not Available

  • LEO Investigational Site

    Mainz-Bretzenheim, 55128
    Germany

    Site Not Available

  • LEO Pharma Investigational Site

    Memmingen, 87700
    Germany

    Site Not Available

  • LEO Investigational Site

    München, 80802
    Germany

    Site Not Available

  • Leo Investigational Site

    Münster, 48149
    Germany

    Site Not Available

  • LEO Investigational Site

    Osnabrück, 49074
    Germany

    Site Not Available

  • LEO Investigational Site

    Stuttgart, 70178
    Germany

    Site Not Available

  • LEO Investigational Site

    Brescia, 25123
    Italy

    Site Not Available

  • LEO Investigational Site

    L'Aquila, 67100
    Italy

    Site Not Available

  • LEO Investigational Site

    Rome, 00168
    Italy

    Site Not Available

  • LEO Investigational Site

    Vicenza, 36100
    Italy

    Site Not Available

  • LEO Investigational Site

    Amsterdam, 1105 AZ
    Netherlands

    Site Not Available

  • LEO Investigational Site

    Bergen Op Zoom, 4614 VT
    Netherlands

    Site Not Available

  • LEO Investigational Site

    Groningen, 9713 GZ
    Netherlands

    Site Not Available

  • LEO Investigational Site

    Hoofddorp, 2134 TM
    Netherlands

    Site Not Available

  • LEO Investigational Site

    Utrecht, 3584 CX
    Netherlands

    Site Not Available

  • LEO Investigational Site

    Białystok, 15-794
    Poland

    Site Not Available

  • LEO Investigitional Site

    Białystok, 15-375
    Poland

    Site Not Available

  • LEO Investigational Site

    Gdansk, 80-546
    Poland

    Site Not Available

  • LEO Investigational Site

    Kraków, 31-011
    Poland

    Site Not Available

  • LEO Investigational Site

    Lublin, 20-406
    Poland

    Site Not Available

  • LEO Investigational Site

    Osielsko, 86-031
    Poland

    Site Not Available

  • LEO Pharma Investigational Site

    Rzeszów, 35-055
    Poland

    Site Not Available

  • LEO Investigational Site

    Warsaw, 02-953
    Poland

    Site Not Available

  • LEO Investigational Site

    Warszawa, 02-507
    Poland

    Site Not Available

  • LEO Investigational Site

    Wrocław, 50-566
    Poland

    Site Not Available

  • LEO Investigational Site

    Łódź, 90-436
    Poland

    Site Not Available

  • LEO Investigational Site

    Alicante, 03010
    Spain

    Site Not Available

  • LEO Investigational Site

    Badalona, 08915
    Spain

    Site Not Available

  • LEO Investigitional Site

    Barcelona, 08041
    Spain

    Site Not Available

  • LEO Investigational Site

    Bilbao, 48013
    Spain

    Site Not Available

  • LEO Investigational Site

    Madrid, 28031
    Spain

    Site Not Available

  • LEO Investigational Site

    Mieres, 33611
    Spain

    Site Not Available

  • LEO Investigational Site

    Sevilla, 41009
    Spain

    Site Not Available

  • LEO Investigational Sites

    Redhill, Surrey RH1 5RH
    United Kingdom

    Site Not Available

  • LEO Investigational Site

    London, SE1 7EH
    United Kingdom

    Site Not Available

  • LEO Investigational Site

    Middlesborough, TS4 3BW
    United Kingdom

    Site Not Available

  • LEO Investigational Site

    Salford, M6 8HD
    United Kingdom

    Site Not Available

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