NCT03761537|CompletedPhase 3ResultsFDA Drug

Tralokinumab in Combination With Topical Corticosteroids in Subjects With Severe Atopic Dermatitis - ECZTRA 7

ECZTRA 7

A Randomised, Double-blind, Placebo-controlled, Parallel-group, Multi-centre, Phase 3 Trial Investigating the Efficacy, Safety, and Tolerability of Tralokinumab Administered in Combination With Topical Corticosteroids to Adult Subjects With Severe Atopic Dermatitis

LEO Pharma ClinicalTrials.gov

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1 other identifier

LP0162-1346

Study Type

interventional

Target

277

Locations

7 countries

Sites

Timeline

RegisteredDec 2018

StartedDec 2018

CompletionSep 2020

Brief Summary

Primary objective: To demonstrate that tralokinumab in combination with topical corticosteroids (TCS) is superior to placebo in combination with TCS in treating severe AD in subjects who are not adequately controlled with or have contraindications to oral cyclosporine A (CSA). Secondary objectives: To evaluate the efficacy of tralokinumab in combination with TCS on severity and extent of AD, itch, and health-related quality of life compared to placebo in combination with TCS. To evaluate the safety of tralokinumab in combination with TCS when treating severe AD in subjects who are not adequately controlled with or have contraindications to oral CSA compared to placebo in combination with TCS.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

277

participants targeted

Target at P50-P75 for phase_3

Timeline

Completed

Started Dec 2018

Geographic Reach

7 countries

74 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

1.8 years study duration

First Submitted

Initial submission to the registry

November 30, 2018

Completed

3 days until next milestone

First Posted

Study publicly available on registry

December 3, 2018

Completed

10 days until next milestone

Study Start

First participant enrolled

December 13, 2018

Completed

1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 21, 2020

Completed

5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 28, 2020

Completed

1.1 years until next milestone

Results Posted

Study results publicly available

October 26, 2021

Completed

Last Updated

March 11, 2025

Status Verified

May 1, 2023

Enrollment Period

1.4 years

First QC Date

November 30, 2018

Results QC Date

September 27, 2021

Last Update Submit

February 21, 2025

Conditions

Atopic Dermatitis

Outcome Measures

Primary Outcomes (1)

At Least 75% Reduction in Eczema Area and Severity Index (EASI75) From Week 0 to Week 16
EASI (Eczema Area and Severity Index) is a validated measure used in clinical practice and clinical trials to assess the severity and extent of AD. The EASI is a composite index with scores ranging from 0 to 72, with higher values indicating more severe and/or more extensive condition.
Week 0 to Week 16

Secondary Outcomes (11)

Reduction of Worst Daily Pruritus Numeric Rating Scale (NRS) (Weekly Average) of at Least 4 From Week 0 to Week 16
Week 0 to Week 16
Change in Scoring Atopic Dermatitis (SCORAD) From Week 0 to Week 16
Week 0 to Week 16
Change in Dermatology Life Quality Index (DLQI) Score From Week 0 to Week 16
Week 0 to Week 16
Investigator's Global Assessment (IGA) Score of 0 (Clear) or 1 (Almost Clear) at Week 16
Week 16
At Least 75% Reduction in Eczema Area and Severity Index (EASI75) From Week 0 to Week 26
Week 0 to Week 26
+6 more secondary outcomes

Study Arms (2)

Tralokinumab + TCS

EXPERIMENTAL

4 subcutaneous (SC) injections of tralokinumab 150 mg as a loading dose on Day 0, followed by 2 SC injections of tralokinumab 150 mg every 2 weeks (Q2W) regimen for 26 weeks. The last administration of the Investigational Medicinal Product (IMP) occurred at Week 24. From Day 0 to Week 24, a Topical corticosteroid (TCS) cream was dispensed to the participants at each IMP dosing visit (e.g., Q2W). Participants were instructed to treat active lesions as needed and to discontinue the TCS treatment when control was achieved.

Drug: Tralokinumab

Placebo + TCS

PLACEBO COMPARATOR

4 subcutaneous (SC) injections of placebo as a loading dose on Day 0, followed by 2 SC injections of placebo every 2 weeks (Q2W) regimen for 26 weeks. The last administration of the Investigational Medicinal Product (IMP) occurred at Week 24. From Day 0 to Week 24, a Topical corticosteroid (TCS) cream was dispensed to the participants at each IMP dosing visit (e.g., Q2W). Participants were instructed to treat active lesions as needed and to discontinue the TCS treatment when control was achieved.

Other: Placebo

Interventions

TralokinumabDRUG

Tralokinumab is a human recombinant monoclonal antibody of the IgG4 subclass that specifically binds to human IL-13 and blocks interaction with the IL-13 receptors. It is presented as a liquid formulation for subcutaneous (SC) administration.

Tralokinumab + TCS

PlaceboOTHER

Placebo contains the same excipients in the same concentration only lacking tralokinumab.

Placebo + TCS

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Age 18 and above
Diagnosis of AD as defined by the Hanifin and Rajka (1980) criteria for AD
History of AD for 1 year or more
Subjects with a history within 1 year prior to screening of inadequate response to treatment with topical medications or subjects for whom topical treatments are otherwise medically inadvisable
AD involvement of 10% (or more) body surface area at screening and baseline (visit 3) according to component A of SCORAD
Documented history of either no previous CSA exposure and not currently a candidate for CSA treatment OR previous exposure to CSA in which case CSA treatment should not be continued or restarted
Subjects must have applied a stable dose of emollient twice daily (or more, as needed) for at least 14 days before randomisation

You may not qualify if:

Subjects for whom TCSs are medically inadvisable in the opinion of the investigator
Use of tanning beds or phototherapy (NBUVB, UVB, UVA1, PUVA), within 6 weeks prior to randomisation
Treatment with immunomodulatory medications or bleach baths within 4 weeks prior to randomisation
Treatment with topical phosphodiesterase-4 (PDE-4) inhibitor within 2 weeks prior to randomisation
Receipt of any marketed or investigational biologic agent (e.g. cell-depleting agents or dupilumab) within 6 months prior to randomisation or until cell counts return to normal, whichever is longer
History of any active skin infection within 1 week prior to randomisation
History of a clinically significant infection (systemic infection or serious skin infection requiring parenteral treatment) within 4 weeks prior to randomisation
A helminth parasitic infection within 6 months prior to the date informed consent is obtained that has not been treated with, or has failed to respond to, standard of care therapy
Tuberculosis requiring treatment within the 12 months prior to screening. Evaluation will be according to local guidelines as per local standard of care
History of any known primary immunodeficiency disorder including a positive HIV test at screening, or the subject taking antiretroviral medications

Contact the study team to confirm eligibility.