DELTA3: Open-label Multi-site Extension Trial in Subjects Who Completed the DELTA 1 or DELTA 2 Trials

• Sponsor: LEO Pharma (Industry)
• Overall Status: Enrolling by invitation
• CT.gov ID: NCT04949841
• Collaborator: (none)
• Enrollment: 600
• Locations: 93
• Arm: 1
• Anticipated Duration (Months): 24.3
• Patients Per Site: 6.5
• Patients Per Site Per Month: 0.3

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Chronic Hand Eczema	Drug: Delgocitinib	Phase 3

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).

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 600 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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)
• Actual Study Start Date: Aug 23, 2021
• Anticipated Primary Completion Date: Sep 1, 2023
• Anticipated Study Completion Date: Sep 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: As-needed treatment with delgocitinib Subjects will be treated with delgocitinib cream 20 mg/g twice daily as needed.	Drug: Delgocitinib; Delgocitinib cream 20 mg/g

Outcome Measures

Primary Outcome Measures

1. Number of treatment-emergent adverse events from baseline up to Week 38 [From baseline to Week 38]

Secondary Outcome Measures

1. IGA-CHE score at each scheduled visit from baseline up to Week 36 [From baseline to Week 36]

   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 chronic hand eczema (CHE) and is based on a 5-point scale ranging from 0 (clear) to 4 (severe).

2. IGA-CHE score of 0 (clear) or 1 (almost clear) at each scheduled visit from baseline up to Week 36. [From baseline to Week 36]

   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 chronic hand eczema (CHE) and is based on a 5-point scale ranging from 0 (clear) to 4 (severe).

3. HECSI score at each scheduled visit from baseline up to Week 36 [From baseline to Week 36]

   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).

4. HECSI-75 at each scheduled visit from baseline up to Week 36 [From baseline to Week 36]

   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 parent trial baseline.

5. HECSI-90 at each scheduled visit from baseline up to Week 36 [From baseline to Week 36]

   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 parent trial baseline.

Eligibility Criteria

Criteria

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

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	LEO Investigational Site	Brussel		Belgium	1000
2	LEO Investigational Site	Gent		Belgium	9000
3	Leo Investigational Site	Kortrijk		Belgium	8500
4	LEO Investigational Site	Maldegem		Belgium	9990
5	LEO Investigational Site	Calgary	Alberta	Canada	T2J 7E1
6	LEO Investigational Site	Calgary	Alberta	Canada	T3E 0B2
7	LEO Investigational Site	Edmonton	Alberta	Canada	T5J 3S9
8	LEO Investigational Site	Edmonton	Alberta	Canada	T6G 1C3
9	LEO Investigational Site	Red Deer	Alberta	Canada	T4P 1K4
10	LEO Investigational Site	Surrey	British Columbia	Canada	V3R 6A7
11	LEO Investigational Site	Vancouver	British Columbia	Canada	V6 4E1
12	LEO Investigational Site	Fredericton	New Bruswick	Canada	E3B 1G9
13	LEO Investigational Site	Ajax	Ontario	Canada	L1S 7K8
14	LEO Investigational Site	Cobourg	Ontario	Canada	K9A 4J9
15	LEO Investigational Site	Etobicoke	Ontario	Canada	M8X 1Y9
16	LEO Investigational Site	Hamilton	Ontario	Canada	L8S 1G5
17	LEO Investigational Site	Kingston	Ontario	Canada	K7L 2V7
18	LEO Investigational Site	London	Ontario	Canada	N6A 3H7
19	LEO Investigational Site	Markham	Ontario	Canada	L3P 1X3
20	LEO Investigational Site	Toronto	Ontario	Canada	M2M 4J5
21	LEO Investigational Site	Toronto	Ontario	Canada	M3H 5Y8
22	LEO Investigational Site	Windsor	Ontario	Canada	N8W 1E6
23	LEO Investigational Site	Montreal	Quebec	Canada	H2X 2V1
24	LEO Investigational Site	Aarhus N		Denmark	8200
25	LEO investigational site	Copenhagen		Denmark	2400
26	LEO Pharma Investigational Site	Hellerup		Denmark	2900
27	LEO Investigational Site	Bordeaux		France	33000
28	LEO Investigational Site	Dijon		France	21000
29	LEO Investigational Site	Le Mans		France	72037
30	LEO Investigational Site	Lille		France	5900
31	LEO Investigational Site	Martigues		France	13500
32	LEO Pharma Investigational Site	Nantes		France	44093
33	LEO Investigational Site	Nice		France	06000
34	LEO Investigational Site	Nice		France	06202
35	LEO Investigational Sites	Paris		France	75014
36	LEO Investigational Site	Paris		France	75014
37	LEO Investigational Site	Reims		France	51100
38	LEO Investigational Site	Toulouse		France	31000
39	LEO Investigational Site	Aachen		Germany	52074
40	Leo Investigational Site	Bad Bentheim		Germany	48455
41	Leo Investigational Site	Berlin		Germany	10115
42	LEO Investigational Site	Dresden		Germany	01307
43	Leo Investigational Site	Frankfurt am Main		Germany	60590
44	LEO Investigational Site	Friedrichshafen		Germany	88045
45	LEO Investigational Site	Gera		Germany	07548
46	Leo Investigational Site	Göttingen		Germany	37073
47	Leo Investigational Site	Hamburg		Germany	22391
48	LEO Investigational Site	Hannover		Germany	30159
49	LEO Investigational Site	Hassfurt		Germany	97437
50	LEO Investigational Site	Jena		Germany	07743
51	LEO Investigational Site	Luebeck		Germany	23538
52	LEO Investigational Site	Mahlow		Germany	15831
53	LEO Investigational Site	Mainz-Bretzenheim		Germany	55128
54	LEO Pharma Investigational Site	Memmingen		Germany	87700
55	Leo Investigational Site	München		Germany	80802
56	Leo Investigational Site	Münster		Germany	48149
57	LEO Investigational Site	Osnabrück		Germany	49074
58	LEO Investigational Site	Stuttgart		Germany	70178
59	LEO Investigational Site	Brescia		Italy	25123
60	LEO Investigational Site	Rome		Italy	00168
61	LEO Investigational Site	Vicenza		Italy	36100
62	LEO Investigational Site	Amsterdam		Netherlands	1105 AZ
63	Leo Investigational Site	Bergen Op Zoom		Netherlands	4614 VT
64	LEO Investigational Site	Groningen		Netherlands	9713 GZ
65	LEO Investigational Site	Hoofddorp		Netherlands	2134 TM
66	LEO Investigational Site	Utrecht		Netherlands	3584 CX
67	LEO Investigitional Site	Białystok		Poland	15-375
68	LEO Investigational Site	Białystok		Poland	15-794
69	Leo Investigational Site	Gdansk		Poland	80-546
70	LEO Investigational Site	Kraków		Poland	30-033
71	LEO Investigational Site	Kraków		Poland	31-011
72	LEO Investigational Site	Lublin		Poland	20-081
73	Leo Investigational Site	Lublin		Poland	20-406
74	LEO Investigational Site	Osielsko		Poland	86-031
75	LEO Pharma Investigational Site	Rzeszów		Poland	35-055
76	LEO Investigational Site	Warsaw		Poland	02-953
77	LEO Investigational Site	Warsaw		Poland	02-962
78	LEO Investigational Site	Warszawa		Poland	02-507
79	LEO Investigational Site	Warszawa		Poland	02-625
80	LEO Investigational Site	Wrocław		Poland	50-566
81	LEO Investigational Site	Wrocław		Poland	51-318
82	LEO Investigational Site	Łódź		Poland	90-436
83	LEO Investigational Site	Alicante		Spain	03010
84	LEO Investigational Site	Badalona		Spain	08915
85	LEO Investigitional Site	Barcelona		Spain	08041
86	LEO Investigational Site	Bilbao		Spain	48013
87	LEO Investigational Site	Madrid		Spain	28031
88	LEO Investigational Site	Mieres		Spain	33611
89	LEO Investigational Site	Sevilla		Spain	41009
90	LEO Investigational Sites	Redhill	Surrey	United Kingdom	RH1 5RH
91	Leo Investigational Site	London		United Kingdom	SE1 7EH
92	LEO Investigational Site	Middlesborough		United Kingdom	TS4 3BW
93	LEO Investigational Site	Salford		United Kingdom	M6 8HD

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: NCT04949841
• Other Study ID Numbers: LP0133-1403; 2020-002962-15
• First Posted: Jul 2, 2021
• Last Update Posted: Jul 13, 2022
• Last Verified: Jun 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 13, 2022