Chronic Hand Eczema
Conditions
Interventions
Product Name: Delgocitinib
Pharmaceutical Form: Cream
INN or Proposed INN: Delgocitinib
CAS Number: 1263774-59-9
Current Sponsor code: LEO 124249
Other descriptive name: LEO 124249A, JTE052
Concentra
Sponsors
LEO Pharma A/S
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Participant must be at least 18 years of age inclusive, at the time of signing the informed consent 2. 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. 3. Disease severity graded as severe at screening and baseline according to IGA-CHE (i.e. an IGA-CHE score of 4). 4. Documented recent history of inadequate response to treatment with TCS (at any time within 1 year before the screening visit) or for whom TCS are documented to be otherwise medically inadvisable 5. Participant is adherent to standard non-medicated skin care including avoidance of known and relevant irritants and allergens. 6. Contraceptive use must be consistent with local regulations (if they are stricter than the protocol requirements) regarding the methods of contraception for those participating in clinical studies. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 459 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 51
Exclusion criteria
Exclusion criteria: 1. Concurrent skin diseases on the hands. 2. Active atopic dermatitis requiring medical treatment in regions other than the hands and feet. 3. Active psoriasis on any part of the body. 4. Hyperkeratotic hand eczema in combination with a history of psoriasis on any part of the body. 5. Clinically significant infection on the hands. 6. Participants who cannot receive alitretinoin 7. 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 the evaluation of the IMP, or reduce the participant’s ability to participate in the trial. 8. History of any known primary immunodeficiency disorder including a positive HIV test at screening, or the participant taking antiretroviral medications as determined by medical history and/or participant’s verbal report. 9. Any disorder that is not stable and could: a) Affect the safety of the participant throughout the trial b) Impede the participant’s ability to complete the trial. 10. Positive HBsAg or HCV antibody serology at screening. 11. Systemic treatment with immunosuppressive drugs, immunomodulating drugs, retinoids, potent CYP3A4 inducers (only for WOCBP who take hormonal contraceptives), or corticosteroids within 28 days prior to baseline. 12. Use of tanning beds, phototherapy, or bleach baths on the hands within 28 days prior to baseline. 13. Previous or current treatment with JAK inhibitors, systemic or topical. 14. Cutaneously applied treatment with immunomodulators or TCS on the hands within 14 days prior to baseline. 15. Use of systemic antibiotics or cutaneously applied antibiotics on the hands within 14 days prior to baseline. 16. Other transdermal and cutaneously applied therapy on the hands (except for the use of participant’s own emollients) within 7 days prior to baseline. 17. 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. 18. Treatment with any marketed biological therapy or investigational biologic agents, except vaccines: a. Any cell-depleting agents including but not limited to rituximab: within 6 months prior to baseline, or until lymphocyte count returns to normal, whichever is longer. b. Other biologics: within 3 months or 5 half-lives, whichever is longer, prior to baseline. 19. Previously used alitretinoin or participated in a clinical trial with alitretinoin or delgocitinib.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To compare the efficacy and health-related quality of life of twice-daily topical application of delgocitinib cream with once-daily oral administration of alitretinoin capsules in the treatment of patients with severe CHE.;Secondary Objective: To compare the safety of twice-daily topical application of delgocitinib cream with once-daily oral administration of alitretinoin capsules in the treatment of patients with severe CHE.;Primary end point(s): Primary endpoint: - Change in Hand Eczema Severity Index (HECSI) score from baseline to Week 12. ;Timepoint(s) of evaluation of this end point: from baseline to Week 12 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Key secondary endpoints: • HECSI-90 (at least 90% improvement in HECSI score from baseline) at Week 12. • Investigator’s Global Assessment for chronic hand eczema© treatment success (IGA-CHE TS) at Week 12. • Change in Hand Eczema Symptom Diary© (HESD) itch score (weekly average) from baseline to Week 12. • Change in HESD pain score (weekly average) from baseline to Week 12. • AUC of HECSI-90 from baseline up to Week 24. • AUC of change from baseline in Dermatology Life Quality Index (DLQI) score up to Week 24. • Change in HECSI score from baseline to Week 24. Secondary endpoints: • Number of treatment-emergent AEs from baseline up to Week 26. • Number of treatment-emergent SAEs from baseline up to Week 26. • Number of AEs leading to IMP discontinuation up to Week 24. ;Timepoint(s) of evaluation of this end point: from baseline up to Week 26 | — |
Countries
Austria, Canada, France, Germany, Italy, Norway, Poland, Slovakia, Spain, United Kingdom
Contacts
Public ContactClinical Project Manager
LEO Pharma A/S
Outcome results
None listed