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

Primary Purpose

Chronic Hand Eczema

Status
Enrolling by invitation
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Delgocitinib
Sponsored by
LEO Pharma
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Hand Eczema

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • LEO Investigational Site
  • LEO Investigational Site
  • Leo Investigational Site
  • LEO Investigational Site
  • Leo Investigational Site
  • LEO Investigational Site
  • LEO Investigational Site
  • LEO Investigational Site
  • LEO Investigational Site
  • LEO Investigational Site
  • LEO Investigational Site
  • LEO Investigational Site
  • LEO Investigational Site
  • LEO Investigational Site
  • LEO Investigational Site
  • LEO Investigational Site
  • LEO Investigational Site
  • LEO Investigational Site
  • LEO Investigational Site
  • LEO Investigational Site
  • LEO Investigational Site
  • LEO Investigational Site
  • LEO Investigational Site
  • LEO Investigational Site
  • LEO Investigational Site
  • LEO Investigational Site
  • LEO Investigational Site
  • LEO investigational site
  • LEO Pharma Investigational Site
  • LEO Investigational Site
  • LEO Investigational Site
  • LEO Investigational Site
  • LEO Investigational Site
  • LEO Investigational Site
  • LEO Pharma Investigational Site
  • LEO Investigational Site
  • LEO Investigational Site
  • LEO Investigational Sites
  • LEO Investigational Site
  • LEO Investigational Site
  • LEO Investigational Site
  • LEO Investigational Site
  • Leo Investigational Site
  • Leo Investigational Site
  • LEO Investigational Site
  • Leo Investigational Site
  • LEO Investigational Site
  • LEO Investigational Site
  • Leo Investigational Site
  • Leo Investigational Site
  • LEO Investigational Site
  • LEO Investigational Site
  • LEO Investigational Site
  • LEO Investigational Site
  • LEO Investigational Site
  • LEO Investigational Site
  • LEO Pharma Investigational Site
  • Leo Investigational Site
  • Leo Investigational Site
  • LEO Investigational Site
  • LEO Investigational Site
  • LEO Investigational Site
  • LEO Investigational Site
  • LEO Investigational Site
  • LEO Investigational Site
  • LEO Investigational Site
  • Leo Investigational Site
  • LEO Investigational Site
  • LEO Investigational Site
  • LEO Investigational Site
  • LEO Investigitional Site
  • LEO Investigational Site
  • Leo Investigational Site
  • LEO Investigational Site
  • LEO Investigational Site
  • LEO Investigational Site
  • Leo Investigational Site
  • LEO Investigational Site
  • LEO Pharma Investigational Site
  • LEO Investigational Site
  • LEO Investigational Site
  • LEO Investigational Site
  • LEO Investigational Site
  • LEO Investigational Site
  • LEO Investigational Site
  • LEO Investigational Site
  • LEO Investigational Site
  • LEO Investigational Site
  • LEO Investigitional Site
  • LEO Investigational Site
  • LEO Investigational Site
  • LEO Investigational Site
  • LEO Investigational Site
  • LEO Investigational Sites
  • Leo Investigational Site
  • LEO Investigational Site
  • LEO Investigational Site

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

As-needed treatment with delgocitinib

Arm Description

Subjects will be treated with delgocitinib cream 20 mg/g twice daily as needed.

Outcomes

Primary Outcome Measures

Number of treatment-emergent adverse events from baseline up to Week 38

Secondary Outcome Measures

IGA-CHE score at each scheduled visit from baseline up 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).
IGA-CHE score of 0 (clear) or 1 (almost clear) at each scheduled visit from baseline up 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).
HECSI score at each scheduled visit from baseline up 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 at each scheduled visit from baseline up 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.
HECSI-90 at each scheduled visit from baseline up 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.

Full Information

First Posted
June 29, 2021
Last Updated
September 19, 2023
Sponsor
LEO Pharma
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1. Study Identification

Unique Protocol Identification Number
NCT04949841
Brief Title
Open-label Multi-site Extension Trial in Subjects Who Completed the DELTA 1 or DELTA 2 Trials
Acronym
DELTA3
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)
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
August 23, 2021 (Actual)
Primary Completion Date
September 2023 (Anticipated)
Study Completion Date
September 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
LEO Pharma

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Hand Eczema

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
600 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
As-needed treatment with delgocitinib
Arm Type
Experimental
Arm Description
Subjects will be treated with delgocitinib cream 20 mg/g twice daily as needed.
Intervention Type
Drug
Intervention Name(s)
Delgocitinib
Intervention Description
Delgocitinib cream 20 mg/g
Primary Outcome Measure Information:
Title
Number of treatment-emergent adverse events from baseline up to Week 38
Time Frame
From baseline to Week 38
Secondary Outcome Measure Information:
Title
IGA-CHE score at each scheduled visit from baseline up to Week 36
Description
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).
Time Frame
From baseline to Week 36
Title
IGA-CHE score of 0 (clear) or 1 (almost clear) at each scheduled visit from baseline up to Week 36.
Description
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).
Time Frame
From baseline to Week 36
Title
HECSI score at each scheduled visit from baseline up to Week 36
Description
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).
Time Frame
From baseline to Week 36
Title
HECSI-75 at each scheduled visit from baseline up to Week 36
Description
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.
Time Frame
From baseline to Week 36
Title
HECSI-90 at each scheduled visit from baseline up to Week 36
Description
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.
Time Frame
From baseline to Week 36

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Expert
Organizational Affiliation
LEO Pharma
Official's Role
Study Director
Facility Information:
Facility Name
LEO Investigational Site
City
Brussel
ZIP/Postal Code
1000
Country
Belgium
Facility Name
LEO Investigational Site
City
Gent
ZIP/Postal Code
9000
Country
Belgium
Facility Name
Leo Investigational Site
City
Kortrijk
ZIP/Postal Code
8500
Country
Belgium
Facility Name
LEO Investigational Site
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Facility Name
Leo Investigational Site
City
Loverval
ZIP/Postal Code
6280
Country
Belgium
Facility Name
LEO Investigational Site
City
Maldegem
ZIP/Postal Code
9990
Country
Belgium
Facility Name
LEO Investigational Site
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2J 7E1
Country
Canada
Facility Name
LEO Investigational Site
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T3E 0B2
Country
Canada
Facility Name
LEO Investigational Site
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T5J 3S9
Country
Canada
Facility Name
LEO Investigational Site
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 1C3
Country
Canada
Facility Name
LEO Investigational Site
City
Red Deer
State/Province
Alberta
ZIP/Postal Code
T4P 1K4
Country
Canada
Facility Name
LEO Investigational Site
City
Surrey
State/Province
British Columbia
ZIP/Postal Code
V3R 6A7
Country
Canada
Facility Name
LEO Investigational Site
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V6 4E1
Country
Canada
Facility Name
LEO Investigational Site
City
Fredericton
State/Province
New Bruswick
ZIP/Postal Code
E3B 1G9
Country
Canada
Facility Name
LEO Investigational Site
City
Ajax
State/Province
Ontario
ZIP/Postal Code
L1S 7K8
Country
Canada
Facility Name
LEO Investigational Site
City
Cobourg
State/Province
Ontario
ZIP/Postal Code
K9A 4J9
Country
Canada
Facility Name
LEO Investigational Site
City
Etobicoke
State/Province
Ontario
ZIP/Postal Code
M8X 1Y9
Country
Canada
Facility Name
LEO Investigational Site
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8S 1G5
Country
Canada
Facility Name
LEO Investigational Site
City
Kingston
State/Province
Ontario
ZIP/Postal Code
K7L 2V7
Country
Canada
Facility Name
LEO Investigational Site
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 3H7
Country
Canada
Facility Name
LEO Investigational Site
City
Markham
State/Province
Ontario
ZIP/Postal Code
L3P 1X3
Country
Canada
Facility Name
LEO Investigational Site
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M2M 4J5
Country
Canada
Facility Name
LEO Investigational Site
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M3H 5Y8
Country
Canada
Facility Name
LEO Investigational Site
City
Waterloo
State/Province
Ontario
ZIP/Postal Code
N2J 1C4
Country
Canada
Facility Name
LEO Investigational Site
City
Windsor
State/Province
Ontario
ZIP/Postal Code
N8W 1E6
Country
Canada
Facility Name
LEO Investigational Site
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2X 2V1
Country
Canada
Facility Name
LEO Investigational Site
City
Aarhus N
ZIP/Postal Code
8200
Country
Denmark
Facility Name
LEO investigational site
City
Copenhagen
ZIP/Postal Code
2400
Country
Denmark
Facility Name
LEO Pharma Investigational Site
City
Hellerup
ZIP/Postal Code
2900
Country
Denmark
Facility Name
LEO Investigational Site
City
Bordeaux
ZIP/Postal Code
33000
Country
France
Facility Name
LEO Investigational Site
City
Dijon
ZIP/Postal Code
21000
Country
France
Facility Name
LEO Investigational Site
City
Le Mans
ZIP/Postal Code
72037
Country
France
Facility Name
LEO Investigational Site
City
Lille
ZIP/Postal Code
5900
Country
France
Facility Name
LEO Investigational Site
City
Martigues
ZIP/Postal Code
13500
Country
France
Facility Name
LEO Pharma Investigational Site
City
Nantes
ZIP/Postal Code
44093
Country
France
Facility Name
LEO Investigational Site
City
Nice
ZIP/Postal Code
06000
Country
France
Facility Name
LEO Investigational Site
City
Nice
ZIP/Postal Code
06202
Country
France
Facility Name
LEO Investigational Sites
City
Paris
ZIP/Postal Code
75014
Country
France
Facility Name
LEO Investigational Site
City
Paris
ZIP/Postal Code
75014
Country
France
Facility Name
LEO Investigational Site
City
Reims
ZIP/Postal Code
51100
Country
France
Facility Name
LEO Investigational Site
City
Toulouse
ZIP/Postal Code
31000
Country
France
Facility Name
LEO Investigational Site
City
Aachen
ZIP/Postal Code
52074
Country
Germany
Facility Name
Leo Investigational Site
City
Bad Bentheim
ZIP/Postal Code
48455
Country
Germany
Facility Name
Leo Investigational Site
City
Berlin
ZIP/Postal Code
10115
Country
Germany
Facility Name
LEO Investigational Site
City
Dresden
ZIP/Postal Code
01307
Country
Germany
Facility Name
Leo Investigational Site
City
Frankfurt am Main
ZIP/Postal Code
60590
Country
Germany
Facility Name
LEO Investigational Site
City
Friedrichshafen
ZIP/Postal Code
88045
Country
Germany
Facility Name
LEO Investigational Site
City
Gera
ZIP/Postal Code
07548
Country
Germany
Facility Name
Leo Investigational Site
City
Göttingen
ZIP/Postal Code
37073
Country
Germany
Facility Name
Leo Investigational Site
City
Hamburg
ZIP/Postal Code
22391
Country
Germany
Facility Name
LEO Investigational Site
City
Hannover
ZIP/Postal Code
30159
Country
Germany
Facility Name
LEO Investigational Site
City
Hassfurt
ZIP/Postal Code
97437
Country
Germany
Facility Name
LEO Investigational Site
City
Jena
ZIP/Postal Code
07743
Country
Germany
Facility Name
LEO Investigational Site
City
Luebeck
ZIP/Postal Code
23538
Country
Germany
Facility Name
LEO Investigational Site
City
Mahlow
ZIP/Postal Code
15831
Country
Germany
Facility Name
LEO Investigational Site
City
Mainz-Bretzenheim
ZIP/Postal Code
55128
Country
Germany
Facility Name
LEO Pharma Investigational Site
City
Memmingen
ZIP/Postal Code
87700
Country
Germany
Facility Name
Leo Investigational Site
City
München
ZIP/Postal Code
80802
Country
Germany
Facility Name
Leo Investigational Site
City
Münster
ZIP/Postal Code
48149
Country
Germany
Facility Name
LEO Investigational Site
City
Osnabrück
ZIP/Postal Code
49074
Country
Germany
Facility Name
LEO Investigational Site
City
Stuttgart
ZIP/Postal Code
70178
Country
Germany
Facility Name
LEO Investigational Site
City
Brescia
ZIP/Postal Code
25123
Country
Italy
Facility Name
LEO Investigational Site
City
L'Aquila
ZIP/Postal Code
67100
Country
Italy
Facility Name
LEO Investigational Site
City
Rome
ZIP/Postal Code
00168
Country
Italy
Facility Name
LEO Investigational Site
City
Vicenza
ZIP/Postal Code
36100
Country
Italy
Facility Name
LEO Investigational Site
City
Amsterdam
ZIP/Postal Code
1105 AZ
Country
Netherlands
Facility Name
Leo Investigational Site
City
Bergen Op Zoom
ZIP/Postal Code
4614 VT
Country
Netherlands
Facility Name
LEO Investigational Site
City
Groningen
ZIP/Postal Code
9713 GZ
Country
Netherlands
Facility Name
LEO Investigational Site
City
Hoofddorp
ZIP/Postal Code
2134 TM
Country
Netherlands
Facility Name
LEO Investigational Site
City
Utrecht
ZIP/Postal Code
3584 CX
Country
Netherlands
Facility Name
LEO Investigitional Site
City
Białystok
ZIP/Postal Code
15-375
Country
Poland
Facility Name
LEO Investigational Site
City
Białystok
ZIP/Postal Code
15-794
Country
Poland
Facility Name
Leo Investigational Site
City
Gdansk
ZIP/Postal Code
80-546
Country
Poland
Facility Name
LEO Investigational Site
City
Kraków
ZIP/Postal Code
30-033
Country
Poland
Facility Name
LEO Investigational Site
City
Kraków
ZIP/Postal Code
31-011
Country
Poland
Facility Name
LEO Investigational Site
City
Lublin
ZIP/Postal Code
20-081
Country
Poland
Facility Name
Leo Investigational Site
City
Lublin
ZIP/Postal Code
20-406
Country
Poland
Facility Name
LEO Investigational Site
City
Osielsko
ZIP/Postal Code
86-031
Country
Poland
Facility Name
LEO Pharma Investigational Site
City
Rzeszów
ZIP/Postal Code
35-055
Country
Poland
Facility Name
LEO Investigational Site
City
Warsaw
ZIP/Postal Code
02-953
Country
Poland
Facility Name
LEO Investigational Site
City
Warsaw
ZIP/Postal Code
02-962
Country
Poland
Facility Name
LEO Investigational Site
City
Warszawa
ZIP/Postal Code
02-507
Country
Poland
Facility Name
LEO Investigational Site
City
Warszawa
ZIP/Postal Code
02-625
Country
Poland
Facility Name
LEO Investigational Site
City
Wrocław
ZIP/Postal Code
50-566
Country
Poland
Facility Name
LEO Investigational Site
City
Wrocław
ZIP/Postal Code
51-318
Country
Poland
Facility Name
LEO Investigational Site
City
Łódź
ZIP/Postal Code
90-436
Country
Poland
Facility Name
LEO Investigational Site
City
Alicante
ZIP/Postal Code
03010
Country
Spain
Facility Name
LEO Investigational Site
City
Badalona
ZIP/Postal Code
08915
Country
Spain
Facility Name
LEO Investigitional Site
City
Barcelona
ZIP/Postal Code
08041
Country
Spain
Facility Name
LEO Investigational Site
City
Bilbao
ZIP/Postal Code
48013
Country
Spain
Facility Name
LEO Investigational Site
City
Madrid
ZIP/Postal Code
28031
Country
Spain
Facility Name
LEO Investigational Site
City
Mieres
ZIP/Postal Code
33611
Country
Spain
Facility Name
LEO Investigational Site
City
Sevilla
ZIP/Postal Code
41009
Country
Spain
Facility Name
LEO Investigational Sites
City
Redhill
State/Province
Surrey
ZIP/Postal Code
RH1 5RH
Country
United Kingdom
Facility Name
Leo Investigational Site
City
London
ZIP/Postal Code
SE1 7EH
Country
United Kingdom
Facility Name
LEO Investigational Site
City
Middlesborough
ZIP/Postal Code
TS4 3BW
Country
United Kingdom
Facility Name
LEO Investigational Site
City
Salford
ZIP/Postal Code
M6 8HD
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
De-identified IPD can be made available to researchers in a closed environment for a specified period of time.
IPD Sharing Time Frame
Data is available to request after results of the trial are available on leopharmatrials.com
IPD Sharing Access Criteria
Data-sharing is subject to approved scientifically sound research proposal and signed data-sharing agreement.
IPD Sharing URL
http://leopharmatrials.com/for-professionals

Learn more about this trial

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

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