Ignite Creation Date:
2024-05-06 @ 10:01 AM
Last Modification Date:
2024-10-26 @ 12:23 PM
Study NCT ID:
NCT03131648
Status:
COMPLETED
Last Update Posted:
2023-02-23
First Post:
2017-04-24
Brief Title:
Tralokinumab Monotherapy for Moderate to Severe Atopic Dermatitis - ECZTRA 1 ECZema TRAlokinumab Trial no 1
Sponsor:
LEO Pharma
Organization:
LEO Pharma
Study Overview
Official Title:
A Randomised Double-blind Placebo-controlled Phase 3 Trial to Evaluate the Efficacy and Safety of Tralokinumab Monotherapy in Subjects With Moderate to Severe Atopic Dermatitis Who Are Candidates for Systemic Therapy
Status:
COMPLETED
Status Verified Date:
2023-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ECZTRA 1
Brief Summary:
Primary objective
To evaluate the efficacy of tralokinumab compared with placebo in treating moderate to severe atopic dermatitis AD
Secondary objectives
To evaluate the efficacy of tralokinumab on severity and extent of AD itch and health related quality of life compared with placebo
Maintenance objective
To evaluate maintenance of effect with continued tralokinumab dosing up to 52 weeks compared to placebo for subjects achieving clinical response at Week 16
To evaluate the efficacy of tralokinumab compared with placebo in treating moderate to severe atopic dermatitis AD
Secondary objectives
To evaluate the efficacy of tralokinumab on severity and extent of AD itch and health related quality of life compared with placebo
Maintenance objective
To evaluate maintenance of effect with continued tralokinumab dosing up to 52 weeks compared to placebo for subjects achieving clinical response at Week 16
Detailed Description:
Subjects found eligible following the screening period were randomized 31 to initial treatment with tralokinumab 300 mg every 2 weeks Q2W or placebo Randomization was stratified by region North America Europe and Japan and disease severity Investigators Global Assessment IGA 3 or 4
Subjects achieving a clinical response at Week 16 defined as IGA of 0 or 1 on a 5-point scale ranging from 0 clear to 4 severe or at least 75 reduction in Eczema Area and Severity Index EASI score from baseline EASI75 continued into maintenance treatment that continued until Week 52
Subjects randomized to tralokinumab in the initial treatment period and who achieved a clinical response at Week 16 defined by IGA 0 or 1 or EASI75 were re-randomized 221 to one of the following Q2W maintenance regimens stratified by region North America Europe and Japan and IGA response at Week 16 IGA 01 or IGA 1
Tralokinumab 300 mg Q2W
Tralokinumab 300 mg Q4W alternating dose administrations tralokinumab 300 mg and placebo
Placebo Subjects randomized to placebo in the initial treatment period who achieved a clinical response at Week 16 defined by IGA 0 or 1 or EASI75 continued to receive placebo Q2W in the maintenance treatment period
Subjects not achieving a clinical response at Week 16 as well as those who met the criteria listed below during maintenance treatment were transferred to open-label tralokinumab 300 mg Q2W treatment with optional use of topical corticosteroid TCS up to Week 52
Transfer to open-label treatment during maintenance
Subjects with IGA0 at Week 16 IGA of at least 2 and not achieved EASI75 over at least a 4-week period ie over 3 consecutive visits
Subjects with IGA1 at Week 16 IGA of at least 3 and not achieved EASI75 over at least a 4-week period ie over 3 consecutive visits
Subjects with IGA 1 at Week 16 not achieved EASI75 over at least a 4-week period ie over 3 consecutive visits
Subjects transferring to open-label treatment had the option to self-administer tralokinumab in their home after adequate training at 3 dosing visits in the open-label period after additional consent has been obtained by site staff at the investigators discretion
After completion of the maintenance treatment period or open-label treatment all subjects except for those who entered the open-label long-term extension trial continued in a 14-week off-treatment follow-up period for the assessment of safety and anti-drug antibody ADA
Subjects achieving a clinical response at Week 16 defined as IGA of 0 or 1 on a 5-point scale ranging from 0 clear to 4 severe or at least 75 reduction in Eczema Area and Severity Index EASI score from baseline EASI75 continued into maintenance treatment that continued until Week 52
Subjects randomized to tralokinumab in the initial treatment period and who achieved a clinical response at Week 16 defined by IGA 0 or 1 or EASI75 were re-randomized 221 to one of the following Q2W maintenance regimens stratified by region North America Europe and Japan and IGA response at Week 16 IGA 01 or IGA 1
Tralokinumab 300 mg Q2W
Tralokinumab 300 mg Q4W alternating dose administrations tralokinumab 300 mg and placebo
Placebo Subjects randomized to placebo in the initial treatment period who achieved a clinical response at Week 16 defined by IGA 0 or 1 or EASI75 continued to receive placebo Q2W in the maintenance treatment period
Subjects not achieving a clinical response at Week 16 as well as those who met the criteria listed below during maintenance treatment were transferred to open-label tralokinumab 300 mg Q2W treatment with optional use of topical corticosteroid TCS up to Week 52
Transfer to open-label treatment during maintenance
Subjects with IGA0 at Week 16 IGA of at least 2 and not achieved EASI75 over at least a 4-week period ie over 3 consecutive visits
Subjects with IGA1 at Week 16 IGA of at least 3 and not achieved EASI75 over at least a 4-week period ie over 3 consecutive visits
Subjects with IGA 1 at Week 16 not achieved EASI75 over at least a 4-week period ie over 3 consecutive visits
Subjects transferring to open-label treatment had the option to self-administer tralokinumab in their home after adequate training at 3 dosing visits in the open-label period after additional consent has been obtained by site staff at the investigators discretion
After completion of the maintenance treatment period or open-label treatment all subjects except for those who entered the open-label long-term extension trial continued in a 14-week off-treatment follow-up period for the assessment of safety and anti-drug antibody ADA
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2016-004200-65 | EUDRACT_NUMBER | None | None |