Clinical trial NCT04871711: Efficacy and Safety of Delgocitinib Cream in Adults With Moderate to Severe Chronic Hand Eczema
Official title: A Phase 3 Clinical Trial to Confirm Efficacy and Evaluate Safety of Twice-daily Delgocitinib Cream 20 mg/g Compared With Cream Vehicle for a 16-week Treatment Period in Adult Subjects With Moderate to Severe Chronic Hand Eczema (DELTA 1)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Chronic Hand Eczema
Lead sponsor: LEO Pharma
Sponsor class: INDUSTRY
First posted: 2021-05-04
Enrollment: 487
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This was a 16-week study in adult participants with chronic hand eczema (CHE). \> The participants visited the clinic regularly to have the study doctor assess their CHE and to answer questions about itch, pain, CHE symptoms, and quality of life.

\> The purpose was to assess how delgocitinib cream works to treat CHE when compared to a placebo cream with no active substance.


Eligibility criteria: Main inclusion criteria:

* Diagnosis of CHE, defined as hand eczema that has persisted for more than 3 months or returned twice or more within the last 12 months.
* Disease severity graded as moderate to severe at screening and baseline according to Investigator's Global Assessment for chronic hand eczema (IGA-CHE) (i.e. an IGA-CHE score of 3 or 4).
* Hand Eczema Symptom Diary (HESD) itch score (weekly average) of ≥4 points at baseline.
* Participants who have a documented recent history of inadequate response to treatment with topical corticosteroids (TCS) or for whom TCS are documented to be otherwise medically inadvisable (e.g. due to important side effects or safety risks).
* Participants adherent to standard non-medicated skin care including avoidance of known and relevant irritants and allergens.

Main exclusion criteria:

* Concurrent skin diseases on the hands, e.g. tinea manuum.
* Active atopic dermatitis requiring medical treatment in regions other than the hands and feet.
* Active psoriasis on any part of the body.
* Hyperkeratotic hand eczema in combination with a history of psoriasis on any part of the body.
* Clinically significant infection on the hands.
* Systemic treatment with immunosuppressive drugs, immunomodulating drugs, retinoids, or corticosteroids within 28 days prior to baseline.
* Use of tanning beds, phototherapy, or bleach baths on the hands within 28 days prior to baseline.
* Previous or current treatment with Janus kinase (JAK) inhibitors (including delgocitinib/LEO 124249), systemic or topical.
* Cutaneously applied treatment with immunomodulators or TCS on the hands within 14 days prior to baseline.
* Use of systemic antibiotics or cutaneously applied antibiotics on the hands within 14 days prior to baseline.
* Other transdermal or cutaneously applied therapy on the hands (except for the use of subject's own emollients) within 7 days prior to baseline.
* Cutaneously applied treatments in regions other than the hands, which could interfere with clinical trial evaluations or pose a safety concern within 7 days prior to baseline.
* Treatment with any marketed biological therapy or investigational biologic agents:

  * Any cell-depleting agents: within 6 months prior to baseline, or until lymphocyte count returns to normal, whichever is longer.
  * Other biologics: within 3 months or 5 half-lives, whichever is longer, prior to baseline.
* Clinically significant infection within 28 days prior to baseline which, in the opinion of the investigator, may compromise the safety of the participant in the trial, interfere with evaluation of the IMP, or reduce the participant's ability to participate in the trial.
* History of any known primary immunodeficiency disorder including a positive human immunodeficiency virus (HIV) test at screening, or the participant taking antiretroviral medications as determined by medical history and/or participant's verbal report.
* Any disorder which is not stable and could:

  * Affect the safety of the participant throughout the trial.
  * Impede the participant's ability to complete the trial.
* Positive hepatitis B surface antigen or hepatitis C virus antibody serology at screening.

Primary outcomes:
measure: Number of Participants With IGA-CHE TS at Week 16
timeFrame: 16 weeks
Secondary outcomes:
measure: Number of Participants With Reduction of HESD Itch Score (Weekly Average) of ≥4 Points From Baseline at Week 16
timeFrame: 16 weeks
measure: Number of Participants With Reduction of HESD Score (Weekly Average) of ≥4 Points From Baseline at Week 16
timeFrame: 16 weeks
measure: Number of Participants With IGA-CHE TS at Week 8
timeFrame: 8 weeks
measure: Number of Participants With IGA-CHE TS at Week 4
timeFrame: 4 weeks
measure: Number of Participants With Reduction of HESD Itch Score (Weekly Average) of ≥4 Points From Baseline at Week 8
timeFrame: 8 weeks
measure: Number of Participants With Reduction of HESD Itch Score (Weekly Average) of ≥4 Points From Baseline at Week 4
timeFrame: 4 weeks
measure: Number of Participants With Reduction of HESD Itch Score (Weekly Average) of ≥4 Points From Baseline at Week 2
timeFrame: 2 weeks
measure: Number of Participants With Reduction of HESD Score (Weekly Average) of ≥4 Points From Baseline at Week 8
timeFrame: 8 weeks
measure: Number of Participants With Reduction of HESD Score (Weekly Average) of ≥4 Points From Baseline at Week 4
timeFrame: 4 weeks
measure: Number of Participants With Reduction of HESD Pain Score (Weekly Average) of ≥4 Points From Baseline at Week 16
timeFrame: 16 weeks
measure: Number of Participants With Reduction of HESD Pain Score (Weekly Average) of ≥4 Points From Baseline at Week 8
timeFrame: 8 weeks
measure: Number of Participants With Reduction of HESD Pain Score (Weekly Average) of ≥4 Points From Baseline at Week 4
timeFrame: 4 weeks
measure: Number of Participants With HECSI-90 at Week 16
timeFrame: 16 weeks
measure: Number of Participants With HECSI-75 at Week 16
timeFrame: 16 weeks
measure: Number of Participants With HECSI-75 at Week 8
timeFrame: 8 weeks
measure: Percentage Change in HECSI Score From Baseline to Week 16
timeFrame: 16 weeks
measure: Change in DLQI Score From Baseline to Week 16
timeFrame: 16 weeks
measure: Change in HESD Score (Weekly Average) From Baseline to Week 16
timeFrame: 16 weeks
measure: Change in HESD Itch Score (Weekly Average) From Baseline to Week 16
timeFrame: 16 weeks
measure: Change in HESD Pain Score (Weekly Average) From Baseline to Week 16
timeFrame: 16 weeks
measure: Change in HEIS Score From Baseline to Week 16
timeFrame: 16 weeks
measure: Change in HEIS PDAL Score From Baseline to Week 16
timeFrame: 16 weeks
measure: Reduction of DLQI Score of ≥4 Points From Baseline at Week 16
timeFrame: 16 weeks
measure: Number of Treatment-emergent AEs From Baseline up to End of Trial
timeFrame: 16 weeks (18 weeks for participants not participating in the long-term extension trial [LP0133-1403])
Other outcomes:
Locations:
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: Red Deer
country: Canada
facility: LEO Investigational Site
state: Alberta
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: Montreal
country: Canada
facility: LEO Investigational Site
state: Quebec
city: Nice
country: France
facility: LEO Investigational Site
state: Alpes-Maritimes
city: Reims
country: France
facility: LEO Investigational Site
state: Ardennes
city: Nantes
country: France
facility: LEO Investigational Site
state: Loire-Atlantique 6
city: Vandoeuvre-les-Nancy
country: France
facility: LEO Investigational Site
state: Meurthe-et-Moselle
city: Lille
country: France
facility: LEO Investigational Site
state: Nord
city: Le Mans
country: France
facility: LEO Investigational Site
state: Sarthe
city: Bordeaux
country: France
facility: LEO Investigational Site
city: Dijon
country: France
facility: LEO Investigational Site
city: Lorient
country: France
facility: LEO Investigational Site
city: Martigues
country: France
facility: LEO Investigational Site
city: Nice
country: France
facility: LEO Investigational Site
city: Paris
country: France
facility: LEO Investigational Site
city: Toulouse
country: France
facility: LEO Investigational Site
city: Berlin
country: Germany
facility: LEO Investigational Site
city: Dresden
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: Haßfurt
country: Germany
facility: LEO Investigational Site
city: Mainz
country: Germany
facility: LEO Investigational Site
city: Memmingen
country: Germany
facility: LEO Investigational Site
city: München
country: Germany
facility: LEO Investigational Site
city: Osnabrück
country: Germany
facility: LEO Investigational Site
city: Brescia
country: Italy
facility: LEO Investigational Site
city: L'Aquila
country: Italy
facility: LEO Investigational Site
city: Milano
country: Italy
facility: LEO Investigational Site
city: Perugia
country: Italy
facility: LEO Investigational Site
city: Roma
country: Italy
facility: LEO Investigational Site
city: Vicenza
country: Italy
facility: LEO Investigational Site
city: Białystok
country: Poland
facility: LEO Investigational Site
city: Gdansk
country: Poland
facility: LEO Investigational Site
city: Krakow
country: Poland
facility: LEO Investigational Site
city: Kraków
country: Poland
facility: LEO Investigational Site
city: Lodz
country: Poland
facility: LEO Investigational Site
city: Lublin
country: Poland
facility: LEO Investigational Site
city: Osielsko
country: Poland
facility: LEO Investigational Site
city: Warszawa
country: Poland
facility: LEO Investigational Site
city: Warszawa
country: Poland
facility: LEO Investigational Site
city: Salford
country: United Kingdom
facility: LEO Investigational Site
state: Greater Manchester
city: Leicester
country: United Kingdom
facility: LEO Investigational Site
state: Leicestershire
city: London
country: United Kingdom
facility: LEO Investigational Site
state: Leytonstone
city: Middlesborough
country: United Kingdom
facility: LEO Investigational Site
state: North Yorkshire
city: Redhill
country: United Kingdom
facility: LEO Investigational Site
state: Surrey
city: London
country: United Kingdom
facility: LEO Investigational Site
Study officials:
affiliation: LEO Pharma
name: Medical Expert
role: STUDY_DIRECTOR
References:
citation: Bissonnette R, Warren RB, Pinter A, Agner T, Gooderham M, Schuttelaar MLA, Crepy MN, Stingeni L, Serra-Baldrich E, Baranowski K, Korn S, Kurvits M, Plohberger U, Strange Vest N, Schliemann S; trial investigators. Efficacy and safety of delgocitinib cream in adults with moderate to severe chronic hand eczema (DELTA 1 and DELTA 2): results from multicentre, randomised, controlled, double-blind, phase 3 trials. Lancet. 2024 Aug 3;404(10451):461-473. doi: 10.1016/S0140-6736(24)01027-4. Epub 2024 Jul 18.