Clinical trial NCT04949841: Open-label Multi-site Extension Trial in Subjects Who Completed the DELTA 1 or DELTA 2 Trials
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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Chronic Hand Eczema
Lead sponsor: LEO Pharma
Sponsor class: INDUSTRY
First posted: 2021-07-02
Enrollment: 801
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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).

Eligibility criteria: 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.

Primary outcomes:
measure: Number of Treatment-emergent Adverse Events From Baseline up to Week 38
timeFrame: From baseline up to Week 38
Secondary outcomes:
measure: Number of Participants With IGA-CHE Score at Each Scheduled Visit From Baseline up to Week 36
timeFrame: From baseline up to Week 38
measure: Number of Participants With IGA-CHE Score of 0 (Clear) or 1 (Almost Clear) at Each Scheduled Visit From Baseline up to Week 36.
timeFrame: From baseline up to Week 38
measure: HECSI Score at Each Scheduled Visit From Baseline up to Week 36
timeFrame: From baseline up to Week 38
measure: Number of Participants With HECSI-75 at Each Scheduled Visit From Baseline up to Week 36
timeFrame: From baseline up to Week 38
measure: Number of Participants With HECSI-90 at Each Scheduled Visit From Baseline up to Week 36
timeFrame: From baseline up to Week 38
Other outcomes:
Locations:
city: Brussel
country: Belgium
facility: LEO Investigational Site
city: Gent
country: Belgium
facility: LEO Investigational Site
city: Kortrijk
country: Belgium
facility: LEO Investigational Site
city: Leuven
country: Belgium
facility: LEO Investigational Site
city: Loverval
country: Belgium
facility: LEO Investigational Site
city: Maldegem
country: Belgium
facility: LEO Investigational Site
city: Calgary
country: Canada
facility: LEO Investigational Site
state: Alberta
city: Calgary
country: Canada
facility: LEO Investigational Site
state: Alberta
city: Edmonton
country: Canada
facility: LEO Investigational Site
state: Alberta
city: Edmonton
country: Canada
facility: LEO Investigational Site
state: Alberta
city: Surrey
country: Canada
facility: LEO Investigational Site
state: British Columbia
city: Vancouver
country: Canada
facility: LEO Investigational Site
state: British Columbia
city: Fredericton
country: Canada
facility: LEO Investigational Site
state: New Bruswick
city: Ajax
country: Canada
facility: LEO Investigational Site
state: Ontario
city: Cobourg
country: Canada
facility: LEO Investigational Site
state: Ontario
city: Etobicoke
country: Canada
facility: LEO Investigational Site
state: Ontario
city: Hamilton
country: Canada
facility: LEO Investigational Site
state: Ontario
city: Kingston
country: Canada
facility: LEO Investigational Site
state: Ontario
city: London
country: Canada
facility: LEO Investigational Site
state: Ontario
city: Markham
country: Canada
facility: LEO Investigational Site
state: Ontario
city: Toronto
country: Canada
facility: LEO Investigational Site
state: Ontario
city: Toronto
country: Canada
facility: LEO Investigational Site
state: Ontario
city: Waterloo
country: Canada
facility: LEO Investigational Site
state: Ontario
city: Windsor
country: Canada
facility: LEO Investigational Site
state: Ontario
city: Montreal
country: Canada
facility: LEO Investigational Site
state: Quebec
city: Aarhus N
country: Denmark
facility: LEO Investigational Site
city: Copenhagen
country: Denmark
facility: LEO investigational Site
city: Hellerup
country: Denmark
facility: LEO Pharma Investigational Site
city: Bordeaux
country: France
facility: LEO Investigational Site
city: Dijon
country: France
facility: LEO Investigational Site
city: Le Mans
country: France
facility: LEO Investigational Site
city: Lille
country: France
facility: LEO Investigational Site
city: Martigues
country: France
facility: LEO Investigational Site
city: Nantes
country: France
facility: LEO Pharma Investigational Site
city: Nice
country: France
facility: LEO Investigational Site
city: Nice
country: France
facility: LEO Investigational Site
city: Paris
country: France
facility: LEO Investigational Site
city: Reims
country: France
facility: LEO Investigational Site
city: Toulouse
country: France
facility: LEO Investigational Site
city: Aachen
country: Germany
facility: LEO Investigational Site
city: Bad Bentheim
country: Germany
facility: LEO Investigational Site
city: Berlin
country: Germany
facility: LEO Investigational Site
city: Dresden
country: Germany
facility: LEO Investigational Site
city: Frankfurt am Main
country: Germany
facility: LEO Investigational Site
city: Friedrichshafen
country: Germany
facility: LEO Investigational Site
city: Gera
country: Germany
facility: LEO Investigational Site
city: Göttingen
country: Germany
facility: LEO Investigational Site
city: Hamburg
country: Germany
facility: LEO Investigational Site
city: Hannover
country: Germany
facility: LEO Investigational Site
city: Hassfurt
country: Germany
facility: LEO Investigational Site
city: Jena
country: Germany
facility: LEO Investigational Site
city: Luebeck
country: Germany
facility: LEO Investigational Site
city: Mahlow
country: Germany
facility: LEO Investigational Site
city: Mainz-Bretzenheim
country: Germany
facility: LEO Investigational Site
city: Memmingen
country: Germany
facility: LEO Pharma Investigational Site
city: München
country: Germany
facility: LEO Investigational Site
city: Münster
country: Germany
facility: Leo Investigational Site
city: Osnabrück
country: Germany
facility: LEO Investigational Site
city: Stuttgart
country: Germany
facility: LEO Investigational Site
city: Brescia
country: Italy
facility: LEO Investigational Site
city: L'Aquila
country: Italy
facility: LEO Investigational Site
city: Rome
country: Italy
facility: LEO Investigational Site
city: Vicenza
country: Italy
facility: LEO Investigational Site
city: Amsterdam
country: Netherlands
facility: LEO Investigational Site
city: Bergen Op Zoom
country: Netherlands
facility: LEO Investigational Site
city: Groningen
country: Netherlands
facility: LEO Investigational Site
city: Hoofddorp
country: Netherlands
facility: LEO Investigational Site
city: Utrecht
country: Netherlands
facility: LEO Investigational Site
city: Białystok
country: Poland
facility: LEO Investigitional Site
city: Białystok
country: Poland
facility: LEO Investigational Site
city: Gdansk
country: Poland
facility: LEO Investigational Site
city: Kraków
country: Poland
facility: LEO Investigational Site
city: Kraków
country: Poland
facility: LEO Investigational Site
city: Lublin
country: Poland
facility: LEO Investigational Site
city: Lublin
country: Poland
facility: LEO Investigational Site
city: Osielsko
country: Poland
facility: LEO Investigational Site
city: Rzeszów
country: Poland
facility: LEO Pharma Investigational Site
city: Warsaw
country: Poland
facility: LEO Investigational Site
city: Warsaw
country: Poland
facility: LEO Investigational Site
city: Warszawa
country: Poland
facility: LEO Investigational Site
city: Warszawa
country: Poland
facility: LEO Investigational Site
city: Wrocław
country: Poland
facility: LEO Investigational Site
city: Wrocław
country: Poland
facility: LEO Investigational Site
city: Łódź
country: Poland
facility: LEO Investigational Site
city: Alicante
country: Spain
facility: LEO Investigational Site
city: Badalona
country: Spain
facility: LEO Investigational Site
city: Barcelona
country: Spain
facility: LEO Investigitional Site
city: Bilbao
country: Spain
facility: LEO Investigational Site
city: Madrid
country: Spain
facility: LEO Investigational Site
city: Mieres
country: Spain
facility: LEO Investigational Site
city: Sevilla
country: Spain
facility: LEO Investigational Site
city: Redhill
country: United Kingdom
facility: LEO Investigational Sites
state: Surrey
city: London
country: United Kingdom
facility: LEO Investigational Site
city: Middlesborough
country: United Kingdom
facility: LEO Investigational Site
city: Salford
country: United Kingdom
facility: LEO Investigational Site
Study officials:
affiliation: LEO Pharma
name: Medical Expert
role: STUDY_DIRECTOR
References: