DELTA 1: Efficacy and Safety of Delgocitinib Cream in Adults With Moderate to Severe Chronic Hand Eczema

• Sponsor: LEO Pharma (Industry)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT04871711
• Collaborator: (none)
• Enrollment: 487
• Locations: 54
• Arms: 2
• Anticipated Duration (Months): 17.5
• Patients Per Site: 9
• Patients Per Site Per Month: 0.5

Study Details

Study Description

Brief Summary

This is a 16-week study in adult participants with chronic hand eczema (CHE). The participants will visit 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 is to assess how delgocitinib cream works to treat CHE when compared to a placebo cream with no active substance.

Condition or Disease	Intervention/Treatment	Phase
Chronic Hand Eczema	Drug: Delgocitinib cream; Drug: Cream vehicle	Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 487 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• 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)
• Actual Study Start Date: May 10, 2021
• Anticipated Primary Completion Date: Oct 26, 2022
• Anticipated Study Completion Date: Oct 26, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Delgocitinib cream 20 mg/g Twice-daily topical application for 16 weeks	Drug: Delgocitinib cream; Cream for topical application; Other Names: LEO 124249 cream
Placebo Comparator: Cream vehicle Twice-daily topical application for 16 weeks	Drug: Cream vehicle; The cream vehicle is similar to the delgocitinib cream except that it does not contain any active ingredient.

Outcome Measures

Primary Outcome Measures

1. IGA-CHE TS at Week 16 [16 weeks]

   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 global chronic hand eczema (CHE) and is based on a 5-point scale ranging from 0 (clear) to 4 (severe). IGA-CHE treatment success (IGA-CHE TS) is defined as an IGA-CHE score of 0 (clear) or 1 (almost clear) with a ≥2-step improvement from baseline.

Secondary Outcome Measures

1. Reduction of HESD itch score (weekly average) of ≥4 points from baseline at Week 16 [16 weeks]

   The Hand Eczema Symptom Diary (HESD) is an eDiary in which participants will assess the worst severity of 6 individual signs and symptoms of CHE over the past 24 hours using an 11-point numeric rating scale throughout the trial on a daily basis. This endpoint will only assess the 'itch' component and will be evaluated among participants with a baseline HESD itch score (weekly average) ≥4 points.

2. Reduction of HESD score (weekly average) of ≥4 points from baseline at Week 16 [16 weeks]

   The Hand Eczema Symptom Diary (HESD) is an eDiary in which participants will assess the worst severity of 6 individual signs and symptoms of CHE over the past 24 hours using an 11-point numeric rating scale throughout the trial on a daily basis. The HESD score is derived as the average of the 6 signs and symptoms. This endpoint will be evaluated among participants with a baseline HESD score (weekly average) ≥4 points.

3. IGA-CHE TS at Week 8 [8 weeks]

   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 global CHE and is based on a 5-point scale ranging from 0 (clear) to 4 (severe). IGA-CHE treatment success (IGA-CHE TS) is defined as an IGA-CHE score of 0 (clear) or 1 (almost clear) with a ≥2-step improvement from baseline.

4. IGA-CHE TS at Week 4 [4 weeks]

   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 global CHE and is based on a 5-point scale ranging from 0 (clear) to 4 (severe). IGA-CHE treatment success (IGA-CHE TS) is defined as an IGA-CHE score of 0 (clear) or 1 (almost clear) with a ≥2-step improvement from baseline.

5. Reduction of HESD itch score (weekly average) of ≥4 points from baseline at Week 8 [8 weeks]

   The Hand Eczema Symptom Diary (HESD) is an eDiary in which participants will assess the worst severity of 6 individual signs and symptoms of CHE over the past 24 hours using an 11-point numeric rating scale throughout the trial on a daily basis. This endpoint will only assess the 'itch' component and will be evaluated among participants with a baseline HESD itch score (weekly average) ≥4 points.

6. Reduction of HESD itch score (weekly average) of ≥4 points from baseline at Week 4 [4 weeks]

   The Hand Eczema Symptom Diary (HESD) is an eDiary in which participants will assess the worst severity of 6 individual signs and symptoms of CHE over the past 24 hours using an 11-point numeric rating scale throughout the trial on a daily basis. This endpoint will only assess the 'itch' component and will be evaluated among participants with a baseline HESD itch score (weekly average) ≥4 points.

7. Reduction of HESD itch score (weekly average) of ≥4 points from baseline at Week 2 [2 weeks]

   The Hand Eczema Symptom Diary (HESD) is an eDiary in which participants will assess the worst severity of 6 individual signs and symptoms of CHE over the past 24 hours using an 11-point numeric rating scale throughout the trial on a daily basis. This endpoint will only assess the 'itch' component and will be evaluated among participants with a baseline HESD itch score (weekly average) ≥4 points.

8. Reduction of HESD score (weekly average) of ≥4 points from baseline at Week 8 [8 weeks]

   The Hand Eczema Symptom Diary (HESD) is an eDiary in which participants will assess the worst severity of 6 individual signs and symptoms of CHE over the past 24 hours using an 11-point numeric rating scale throughout the trial on a daily basis. The HESD score is derived as the average of the 6 signs and symptoms. This endpoint will be evaluated among participants with a baseline HESD score (weekly average) ≥4 points.

9. Reduction of HESD score (weekly average) of ≥4 points from baseline at Week 4 [4 weeks]

   The Hand Eczema Symptom Diary (HESD) is an eDiary in which participants will assess the worst severity of 6 individual signs and symptoms of CHE over the past 24 hours using an 11-point numeric rating scale throughout the trial on a daily basis. The HESD score is derived as the average of the 6 signs and symptoms. This endpoint will be evaluated among participants with a baseline HESD score (weekly average) ≥4 points.

10. Reduction of HESD pain score (weekly average) of ≥4 points from baseline at Week 16 [16 weeks]

    The Hand Eczema Symptom Diary (HESD) is an eDiary in which participants will assess the worst severity of 6 individual signs and symptoms of CHE over the past 24 hours using an 11-point numeric rating scale throughout the trial on a daily basis. This endpoint will only assess the 'pain' component and will be evaluated among participants with a baseline HESD pain score (weekly average) ≥4 points.

11. Reduction of HESD pain score (weekly average) of ≥4 points from baseline at Week 8 [8 weeks]

    The Hand Eczema Symptom Diary (HESD) is an eDiary in which participants will assess the worst severity of 6 individual signs and symptoms of CHE over the past 24 hours using an 11-point numeric rating scale throughout the trial on a daily basis. This endpoint will only assess the 'pain' component and will be evaluated among participants with a baseline HESD pain score (weekly average) ≥4 points.

12. Reduction of HESD pain score (weekly average) of ≥4 points from baseline at Week 4 [4 weeks]

    The Hand Eczema Symptom Diary (HESD) is an eDiary in which participants will assess the worst severity of 6 individual signs and symptoms of CHE over the past 24 hours using an 11-point numeric rating scale throughout the trial on a daily basis. This endpoint will only assess the 'pain' component and will be evaluated among participants with a baseline HESD pain score (weekly average) ≥4 points.

13. HECSI-90 at Week 16 [16 weeks]

    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 baseline.

14. HECSI-75 at Week 16 [16 weeks]

    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 baseline.

15. HECSI-75 at Week 8 [8 weeks]

    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 baseline.

16. Percentage change in HECSI score from baseline to Week 16 [16 weeks]

    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).

17. Change in DLQI score from baseline to Week 16 [16 weeks]

    The Dermatology Life Quality Index (DLQI) is a validated questionnaire consisting of 10 items addressing the participant's perception of the impact of their skin disease on different aspects of their quality of life over the last week. The DLQI score is the sum of the 10 items (score ranging from 0 to 30).

18. Change in HESD score (weekly average) from baseline to Week 16 [16 weeks]

    The Hand Eczema Symptom Diary (HESD) is an eDiary in which participants will assess the worst severity of 6 individual signs and symptoms of CHE over the past 24 hours using an 11-point numeric rating scale throughout the trial on a daily basis. The HESD score is derived as the average of the 6 signs and symptoms.

19. Change in HESD itch score (weekly average) from baseline to Week 16 [16 weeks]

    The Hand Eczema Symptom Diary (HESD) is an eDiary in which participants will assess the worst severity of 6 individual signs and symptoms of CHE over the past 24 hours using an 11-point numeric rating scale throughout the trial on a daily basis. This endpoint will only assess the 'itch' component.

20. Change in HESD pain score (weekly average) from baseline to Week 16 [16 weeks]

    The Hand Eczema Symptom Diary (HESD) is an eDiary in which participants will assess the worst severity of 6 individual signs and symptoms of CHE over the past 24 hours using an 11-point numeric rating scale throughout the trial on a daily basis. This endpoint will only assess the 'pain' component.

21. Change in HEIS score from baseline to Week 16 [16 weeks]

    The Hand Eczema Impact Scale (HEIS) addresses 9 items within the following domains: Proximal Daily Activity Limitations (PDAL), embarrassment with the appearance of the hands, frustration with CHE, sleep, work, and physical functioning. Each item is scored on a 5-point scale ranging from 0 (not at all) to 4 (extremely). The HEIS score is the average of the 9 items.

22. Change in HEIS PDAL score from baseline to Week 16 [16 weeks]

    Proximal Daily Activity Limitations (PDAL) is one of the items addressed in the Hand Eczema Impact Scale (HEIS) and is scored on a 5-point scale ranging from 0 (not at all) to 4 (extremely).

23. Reduction of DLQI score of ≥4 points from baseline at Week 16 [16 weeks]

    The Dermatology Life Quality Index (DLQI) is a validated questionnaire consisting of 10 items addressing the participant's perception of the impact of their skin disease on different aspects of their quality of life over the last week. The DLQI score is the sum of the 10 items (score ranging from 0 to 30). This endpoint will be evaluated among participants with a baseline DLQI score ≥4 points.

24. Number of treatment-emergent AEs from baseline up to end of trial per participant [16 weeks (18 weeks for participants not participating in the long-term extension trial [LP0133-1403])]

    An adverse event (AE) will be considered treatment emergent if started after the first application of investigational medicinal product (IMP), or if started before the first application of IMP and worsened in severity after first dose of IMP. End of trial is defined as Week 16 for participants who roll over to the long-term extension trial and as Week 18 for participants who do not roll over.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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 IGA-CHE (i.e. an IGA-CHE score of 3 or 4).

• 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	LEO Investigational Site	Calgary	Alberta	Canada	T2J 7E1
2	LEO Investigational Site	Calgary	Alberta	Canada	T3E 0B2
3	LEO Investigational Site	Edmonton	Alberta	Canada	T5J 3S9
4	LEO Investigational Site	Edmonton	Alberta	Canada	T6G 1C3
5	LEO Investigational Site	Red Deer	Alberta	Canada	T4P-1K4
6	LEO Investigational Site	Kingston	Ontario	Canada	K7L 2V7
7	LEO Investigational Site	London	Ontario	Canada	N6A 3H7
8	LEO Investigational Site	Markham	Ontario	Canada	L3P 1X3
9	LEO Investigational Site	Toronto	Ontario	Canada	M3H 5Y8
10	LEO Investigational Site	Montreal	Quebec	Canada	H2X 2V1
11	LEO Investigational Site	Nice	Alpes-Maritimes	France	06202
12	LEO Investigational Site	Reims	Ardennes	France	51100
13	LEO Investigational Site	Nantes	Loire-Atlantique 6	France	44093
14	LEO Investigational Site	Vandoeuvre-les-Nancy	Meurthe-et-Moselle	France	54511
15	LEO Investigational Site	Lille	Nord	France	59000
16	LEO Investigational Site	Le Mans	Sarthe	France	72037
17	LEO Investigational Site	Bordeaux		France	33000
18	LEO Investigational Site	Dijon		France	21000
19	LEO Investigational Site	Lorient		France	56322
20	LEO Investigational Site	Martigues		France	13500
21	LEO Investigational Site	Nice		France	06000
22	LEO Investigational Site	Paris		France	75014
23	LEO Investigational Site	Toulouse		France	31000
24	LEO Investigational Site	Berlin		Germany	10117
25	LEO Investigational Site	Dresden		Germany	01307
26	LEO Investigational Site	Gera		Germany	07548
27	LEO Investigational Site	Göttingen		Germany	37073
28	LEO Investigational Site	Hamburg		Germany	22391
29	LEO Investigational Site	Haßfurt		Germany	97437
30	LEO Investigational Site	Mainz		Germany	55128
31	LEO Investigational Site	Memmingen		Germany	87700
32	LEO Investigational Site	München		Germany	80802
33	LEO Investigational Site	Osnabrück		Germany	49074
34	LEO Investigational Site	Brescia		Italy	25123
35	LEO Investigational Site	L'Aquila		Italy	67100
36	LEO Investigational Site	Milano		Italy	20122
37	LEO Investigational Site	Perugia		Italy	06134
38	LEO Investigational Site	Roma		Italy	00168
39	LEO Investigational Site	Vicenza		Italy	36100
40	LEO Investigational Site	Białystok		Poland	15-794
41	LEO Investigational Site	Gdansk		Poland	80-546
42	LEO Investigational Site	Krakow		Poland	30-033
43	LEO Investigational Site	Kraków		Poland	31-011
44	LEO Investigational Site	Lodz		Poland	90-436
45	LEO Investigational Site	Lublin		Poland	20-081
46	LEO Investigational Site	Osielsko		Poland	86-031
47	LEO Investigational Site	Warszawa		Poland	02-507
48	LEO Investigational Site	Warszawa		Poland	02-953
49	LEO Investigational Site	Salford	Greater Manchester	United Kingdom	M6 8HD
50	LEO Investigational Site	Leicester	Leicestershire	United Kingdom	LE1 5WW
51	LEO Investigational Site	London	Leytonstone	United Kingdom	E11 1NR
52	LEO Investigational Site	Middlesborough	North Yorkshire	United Kingdom	TS4 3BW
53	LEO Investigational Site	Redhill	Surrey	United Kingdom	RH1 5RH
54	LEO Investigational Site	London		United Kingdom	SE1 9RT

Sponsors and Collaborators

• LEO Pharma

Investigators

• Study Director: Medical Expert, LEO Pharma

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: LEO Pharma
• ClinicalTrials.gov Identifier: NCT04871711
• Other Study ID Numbers: LP0133-1401; 2020-002960-30
• First Posted: May 4, 2021
• Last Update Posted: Jul 21, 2022
• Last Verified: Jul 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Eczema

Study Results

No Results Posted as of Jul 21, 2022