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

NCT04949841 | Completed Phase 3 Results

• 3 other identifiers: LP0133-14032020-002962-15U1111-1284-2216
• Study Type: interventional
• Target: 801
• Locations: 10 countries
• Sites: 95

Brief 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.

Conditions

Chronic Hand Eczema

Outcome Measures

Primary Outcomes (1)

• Number of Treatment-emergent Adverse Events From Baseline up to Week 38

  An AE will be considered treatment emergent if it started after the baseline visit

  From baseline up to Week 38

Secondary Outcomes (5)

• Number of Participants With IGA-CHE Score at Each Scheduled Visit From Baseline up to Week 36

  From baseline up to Week 38

• Number of Participants With IGA-CHE Score of 0 (Clear) or 1 (Almost Clear) at Each Scheduled Visit From Baseline up to Week 36.

  From baseline up to Week 38

• HECSI Score at Each Scheduled Visit From Baseline up to Week 36

  From baseline up to Week 38

• Number of Participants With HECSI-75 at Each Scheduled Visit From Baseline up to Week 36

  From baseline up to Week 38

• Number of Participants With HECSI-90 at Each Scheduled Visit From Baseline up to Week 36

  From baseline up to Week 38

Study Arms (1)

As-needed treatment with delgocitinib

EXPERIMENTAL

Subjects will be treated with delgocitinib cream 20 mg/g twice daily as needed.

Drug: Delgocitinib

Interventions

Delgocitinib DRUG

Delgocitinib cream 20 mg/g

As-needed treatment with delgocitinib

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• LEO Pharma: lead

Study Sites (95)

LEO Investigational Site

Brussels, 1000, Belgium

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LEO Investigational Site

Ghent, 9000, Belgium

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LEO Investigational Site

Kortrijk, 8500, Belgium

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LEO Investigational Site

Leuven, 3000, Belgium

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LEO Investigational Site

Loverval, 6280, Belgium

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LEO Investigational Site

Maldegem, 9990, Belgium

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LEO Investigational Site

Calgary, Alberta, T2J 7E1, Canada

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LEO Investigational Site

Calgary, Alberta, T3E 0B2, Canada

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LEO Investigational Site

Edmonton, Alberta, T5J 3S9, Canada

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LEO Investigational Site

Edmonton, Alberta, T6G 1C3, Canada

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LEO Investigational Site

Surrey, British Columbia, V3R 6A7, Canada

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LEO Investigational Site

Vancouver, British Columbia, V6 4E1, Canada

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LEO Investigational Site

Fredericton, New Bruswick, E3B 1G9, Canada

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LEO Investigational Site

Ajax, Ontario, L1S 7K8, Canada

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LEO Investigational Site

Cobourg, Ontario, K9A 4J9, Canada

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LEO Investigational Site

Etobicoke, Ontario, M8X 1Y9, Canada

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LEO Investigational Site

Hamilton, Ontario, L8S 1G5, Canada

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LEO Investigational Site

Kingston, Ontario, K7L 2V7, Canada

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LEO Investigational Site

London, Ontario, N6A 3H7, Canada

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LEO Investigational Site

Markham, Ontario, L3P 1X3, Canada

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LEO Investigational Site

Toronto, Ontario, M2M 4J5, Canada

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LEO Investigational Site

Toronto, Ontario, M3H 5Y8, Canada

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LEO Investigational Site

Waterloo, Ontario, N2J 1C4, Canada

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LEO Investigational Site

Windsor, Ontario, N8W 1E6, Canada

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LEO Investigational Site

Montreal, Quebec, H2X 2V1, Canada

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LEO Investigational Site

Aarhus N, 8200, Denmark

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LEO investigational Site

Copenhagen, 2400, Denmark

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LEO Pharma Investigational Site

Hellerup, 2900, Denmark

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LEO Investigational Site

Bordeaux, 33000, France

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LEO Investigational Site

Dijon, 21000, France

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LEO Investigational Site

Le Mans, 72037, France

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LEO Investigational Site

Lille, 5900, France

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LEO Investigational Site

Martigues, 13500, France

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LEO Pharma Investigational Site

Nantes, 44093, France

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LEO Investigational Site

Nice, 06000, France

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LEO Investigational Site

Nice, 06202, France

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LEO Investigational Site

Paris, 75014, France

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LEO Investigational Site

Reims, 51100, France

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LEO Investigational Site

Toulouse, 31000, France

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LEO Investigational Site

Aachen, 52074, Germany

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LEO Investigational Site

Bad Bentheim, 48455, Germany

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LEO Investigational Site

Berlin, 10115, Germany

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LEO Investigational Site

Bretzenheim, 55128, Germany

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LEO Investigational Site

Dresden, 01307, Germany

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LEO Investigational Site

Frankfurt am Main, 60590, Germany

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LEO Investigational Site

Friedrichshafen, 88045, Germany

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LEO Investigational Site

Gera, 07548, Germany

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LEO Investigational Site

Göttingen, 37073, Germany

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LEO Investigational Site

Hamburg, 22391, Germany

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LEO Investigational Site

Hanover, 30159, Germany

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LEO Investigational Site

Haßfurt, 97437, Germany

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LEO Investigational Site

Jena, 07743, Germany

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LEO Investigational Site

Lübeck, 23538, Germany

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LEO Investigational Site

Mahlow, 15831, Germany

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LEO Pharma Investigational Site

Memmingen, 87700, Germany

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LEO Investigational Site

München, 80802, Germany

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Leo Investigational Site

Münster, 48149, Germany

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LEO Investigational Site

Osnabrück, 49074, Germany

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LEO Investigational Site

Stuttgart, 70178, Germany

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LEO Investigational Site

Brescia, 25123, Italy

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LEO Investigational Site

L’Aquila, 67100, Italy

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LEO Investigational Site

Rome, 00168, Italy

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LEO Investigational Site

Vicenza, 36100, Italy

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LEO Investigational Site

Amsterdam, 1105 AZ, Netherlands

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LEO Investigational Site

Bergen op Zoom, 4614 VT, Netherlands

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LEO Investigational Site

Groningen, 9713 GZ, Netherlands

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LEO Investigational Site

Hoofddorp, 2134 TM, Netherlands

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LEO Investigational Site

Utrecht, 3584 CX, Netherlands

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LEO Investigitional Site

Bialystok, 15-375, Poland

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LEO Investigational Site

Bialystok, 15-794, Poland

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LEO Investigational Site

Gdansk, 80-546, Poland

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LEO Investigational Site

Krakow, 30-033, Poland

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LEO Investigational Site

Krakow, 31-011, Poland

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LEO Investigational Site

Lodz, 90-436, Poland

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LEO Investigational Site

Lublin, 20-081, Poland

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LEO Investigational Site

Lublin, 20-406, Poland

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LEO Investigational Site

Osielsko, 86-031, Poland

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LEO Pharma Investigational Site

Rzeszów, 35-055, Poland

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LEO Investigational Site

Warsaw, 02-507, Poland

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LEO Investigational Site

Warsaw, 02-625, Poland

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LEO Investigational Site

Warsaw, 02-953, Poland

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LEO Investigational Site

Warsaw, 02-962, Poland

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LEO Investigational Site

Wroclaw, 50-566, Poland

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LEO Investigational Site

Wroclaw, 51-318, Poland

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LEO Investigational Site

Alicante, 03010, Spain

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LEO Investigational Site

Badalona, 08915, Spain

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LEO Investigitional Site

Barcelona, 08041, Spain

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LEO Investigational Site

Bilbao, 48013, Spain

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LEO Investigational Site

Madrid, 28031, Spain

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LEO Investigational Site

Mieres, 33611, Spain

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LEO Investigational Site

Seville, 41009, Spain

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LEO Investigational Sites

Redhill, Surrey, RH1 5RH, United Kingdom

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LEO Investigational Site

London, SE1 7EH, United Kingdom

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LEO Investigational Site

Middlesbrough, TS4 3BW, United Kingdom

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LEO Investigational Site

Salford, M6 8HD, United Kingdom

Location

MeSH Terms

Interventions

delgocitinib

Results Point of Contact

• Title: Clinical Disclosure
• Organization: LEO Pharma

disclosure@leo-pharma.com

+4544945888

Study Officials

• Medical Expert

  LEO Pharma

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 29, 2021
• First Posted: July 2, 2021
• Study Start: August 23, 2021
• Primary Completion: September 18, 2023
• Study Completion: September 18, 2023
• Last Updated: April 8, 2025
• Results First Posted: January 20, 2025

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

GB (4); ES (7); DK (3); IT (4); BE (6); CA (19); FR (11); DE (20); NL (5); PL (16)