Clinical trial NCT04872101: Efficacy and Safety of Delgocitinib Cream in Adults With Moderate to Severe Chronic Hand Eczema (DELTA 2)
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 2)
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: 473
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 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 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 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: Number of Participants With 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: Brussels
country: Belgium
facility: LEO Investigational Site
city: Edegem
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: 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 Brunswick
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: 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: Copenhagen
country: Denmark
facility: LEO Investigational Site
city: Hellerup
country: Denmark
facility: LEO Investigational Site
city: Århus
country: Denmark
facility: LEO Investigational Site
city: Aachen
country: Germany
facility: LEO Investigational Site
city: Bad Bentheim
country: Germany
facility: LEO Investigational Site
city: Frankfurt
country: Germany
facility: LEO Investigational Site
city: Friedrichshafen
country: Germany
facility: LEO Investigational Site
city: Hannover
country: Germany
facility: LEO Invesitgational Site
city: Jena
country: Germany
facility: LEO Investigational Site
city: Lübeck
country: Germany
facility: LEO Investigational Site
city: Mahlow
country: Germany
facility: LEO Investigational Site
city: Münster
country: Germany
facility: LEO Investigational Site
city: Stuttgart
country: Germany
facility: LEO Investigational Site
city: Amsterdam
country: Netherlands
facility: LEO Investigational Site
city: Bergen Op Zoom
country: Netherlands
facility: LEO Investigational Site
city: Breda
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 Investigational Site
city: Lublin
country: Poland
facility: LEO Investigational Site
city: Rzeszow
country: Poland
facility: LEO Investigational Site
city: Warszawa
country: Poland
facility: LEO Investigational Site
city: Warszawa
country: Poland
facility: LEO Investigational Site
city: Wroclaw
country: Poland
facility: LEO Investigational Site
city: Wroclaw
country: Poland
facility: LEO Investigational Site
city: Mieres
country: Spain
facility: LEO Investigational Site
state: Asturias
city: Badalona
country: Spain
facility: LEO Investigational Site
state: Barcelona
city: Bilbao
country: Spain
facility: LEO Investigational Site
state: Vizcaya
city: Alicante
country: Spain
facility: LEO Investigational Site
city: Barcelona
country: Spain
facility: LEO Investigational Site
city: Madrid
country: Spain
facility: LEO Investigational Site
city: Sevilla
country: Spain
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.