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

Chronic Hand Eczema Clinical Trial

— DELTA3  

Official title:

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04949841
• Other study ID #: LP0133-1403
• Secondary ID: 2020-002962-15
• Status: Completed
• Phase: Phase 3
• Start date: August 23, 2021
• Est. completion date: September 18, 2023

Study information

• Verified date: December 2023
• Source: LEO Pharma
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 801
• Est. completion date: September 18, 2023
• Est. primary completion date: September 18, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Hand Eczema
• Eczema

Intervention

Drug:
• Delgocitinib
Delgocitinib cream 20 mg/g

Locations

Country	Name	City	State
Belgium	LEO Investigational Site	Brussel
Belgium	LEO Investigational Site	Gent
Belgium	Leo Investigational Site	Kortrijk
Belgium	LEO Investigational Site	Leuven
Belgium	Leo Investigational Site	Loverval
Belgium	LEO Investigational Site	Maldegem
Canada	LEO Investigational Site	Ajax	Ontario
Canada	LEO Investigational Site	Calgary	Alberta
Canada	LEO Investigational Site	Calgary	Alberta
Canada	LEO Investigational Site	Cobourg	Ontario
Canada	LEO Investigational Site	Edmonton	Alberta
Canada	LEO Investigational Site	Edmonton	Alberta
Canada	LEO Investigational Site	Etobicoke	Ontario
Canada	LEO Investigational Site	Fredericton	New Bruswick
Canada	LEO Investigational Site	Hamilton	Ontario
Canada	LEO Investigational Site	Kingston	Ontario
Canada	LEO Investigational Site	London	Ontario
Canada	LEO Investigational Site	Markham	Ontario
Canada	LEO Investigational Site	Montreal	Quebec
Canada	LEO Investigational Site	Red Deer	Alberta
Canada	LEO Investigational Site	Surrey	British Columbia
Canada	LEO Investigational Site	Toronto	Ontario
Canada	LEO Investigational Site	Toronto	Ontario
Canada	LEO Investigational Site	Vancouver	British Columbia
Canada	LEO Investigational Site	Waterloo	Ontario
Canada	LEO Investigational Site	Windsor	Ontario
Denmark	LEO Investigational Site	Aarhus N
Denmark	LEO investigational site	Copenhagen
Denmark	LEO Pharma Investigational Site	Hellerup
France	LEO Investigational Site	Bordeaux
France	LEO Investigational Site	Dijon
France	LEO Investigational Site	Le Mans
France	LEO Investigational Site	Lille
France	LEO Investigational Site	Martigues
France	LEO Pharma Investigational Site	Nantes
France	LEO Investigational Site	Nice
France	LEO Investigational Site	Nice
France	LEO Investigational Site	Paris
France	LEO Investigational Sites	Paris
France	LEO Investigational Site	Reims
France	LEO Investigational Site	Toulouse
Germany	LEO Investigational Site	Aachen
Germany	Leo Investigational Site	Bad Bentheim
Germany	Leo Investigational Site	Berlin
Germany	LEO Investigational Site	Dresden
Germany	Leo Investigational Site	Frankfurt am Main
Germany	LEO Investigational Site	Friedrichshafen
Germany	LEO Investigational Site	Gera
Germany	Leo Investigational Site	Göttingen
Germany	Leo Investigational Site	Hamburg
Germany	LEO Investigational Site	Hannover
Germany	LEO Investigational Site	Hassfurt
Germany	LEO Investigational Site	Jena
Germany	LEO Investigational Site	Luebeck
Germany	LEO Investigational Site	Mahlow
Germany	LEO Investigational Site	Mainz-Bretzenheim
Germany	LEO Pharma Investigational Site	Memmingen
Germany	Leo Investigational Site	München
Germany	Leo Investigational Site	Münster
Germany	LEO Investigational Site	Osnabrück
Germany	LEO Investigational Site	Stuttgart
Italy	LEO Investigational Site	Brescia
Italy	LEO Investigational Site	L'Aquila
Italy	LEO Investigational Site	Rome
Italy	LEO Investigational Site	Vicenza
Netherlands	LEO Investigational Site	Amsterdam
Netherlands	Leo Investigational Site	Bergen Op Zoom
Netherlands	LEO Investigational Site	Groningen
Netherlands	LEO Investigational Site	Hoofddorp
Netherlands	LEO Investigational Site	Utrecht
Poland	LEO Investigational Site	Bialystok
Poland	LEO Investigitional Site	Bialystok
Poland	Leo Investigational Site	Gdansk
Poland	LEO Investigational Site	Kraków
Poland	LEO Investigational Site	Kraków
Poland	LEO Investigational Site	Lódz
Poland	LEO Investigational Site	Lublin
Poland	Leo Investigational Site	Lublin
Poland	LEO Investigational Site	Osielsko
Poland	LEO Pharma Investigational Site	Rzeszów
Poland	LEO Investigational Site	Warsaw
Poland	LEO Investigational Site	Warsaw
Poland	LEO Investigational Site	Warszawa
Poland	LEO Investigational Site	Warszawa
Poland	LEO Investigational Site	Wroclaw
Poland	LEO Investigational Site	Wroclaw
Spain	LEO Investigational Site	Alicante
Spain	LEO Investigational Site	Badalona
Spain	LEO Investigitional Site	Barcelona
Spain	LEO Investigational Site	Bilbao
Spain	LEO Investigational Site	Madrid
Spain	LEO Investigational Site	Mieres
Spain	LEO Investigational Site	Sevilla
United Kingdom	Leo Investigational Site	London
United Kingdom	LEO Investigational Site	Middlesborough
United Kingdom	LEO Investigational Sites	Redhill	Surrey
United Kingdom	LEO Investigational Site	Salford

Sponsors (1)

Lead Sponsor	Collaborator
LEO Pharma

Countries where clinical trial is conducted

Belgium,  Canada,  Denmark,  France,  Germany,  Italy,  Netherlands,  Poland,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of treatment-emergent adverse events from baseline up to Week 38		From baseline to Week 38
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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