Trial · NCT03562377

Vaccine Responses in Tralokinumab-Treated Atopic Dermatitis - ECZTRA 5 (ECZema TRAlokinumab Trial No. 5)

NCT03562377, Phase 2, Completed, LEO Pharma; results first posted 2021-03-05

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Vaccine Responses in Tralokinumab-Treated Atopic Dermatitis - ECZTRA 5 (ECZema TRAlokinumab Trial No. 5). Trials, record NCT03562377. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03562377

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Vaccine Responses in Tralokinumab-Treated Atopic Dermatitis - ECZTRA 5 (ECZema TRAlokinumab Trial No. 5)
NCT number: NCT03562377
Status: Completed
Phases: Phase 2
Enrollment: 215 participants, actual
Lead sponsor: LEO Pharma
Conditions: Atopic Dermatitis
Interventions: Tralokinumab, Placebo, Tdap vaccine, Meningococcal vaccine
First posted: 2018-06-19
Last updated: 2025-03-11
Results first posted: 2021-03-05

Source ClinicalTrials.gov

Registered outcomes6

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Positive Anti-tetanus Response at Week 16	Week 12 to Week 16	The antibody response to Tdap vaccine will be assessed by measuring serum anti-tetanus IgG by an immunoassay. A positive response is defined as a 3-fold IgG increase compared to Week 12 if IgG ≤1.0 IU/mL at Week 12; or IgG ≥2.5 IU/mL if IgG \>1.0 IU/mL at Week 12.
Primary	Positive Anti-meningococcal Response at Week 16	Week 12 to Week 16	The antibody response to meningococcal vaccine will be assessed by measuring serum anti-meningococcal IgG by an immunoassay. A positive response is defined as at least a 3-fold increase compared to Week 12.
Secondary	Participants With Investigator's Global Assessment (IGA) Score of 0 (Clear) or 1 (Almost Clear) at Week 16	Week 0 to Week 16	The IGA is an instrument used in clinical trials to rate the severity of the subject's global atopic dermatitis and is based on a 5-point scale ranging from 0 (clear) to 4 (severe).
Secondary	Participants Achieving at Least 75% Reduction in Eczema Area and Severity Index (EASI) at Week 16.	Week 0 to Week 16	The EASI is a validated measure used in clinical practice and clinical trials to assess the severity and extent of atopic dermatitis. \> The EASI is a composite index with scores ranging from 0 to 72, with higher values indicating more severe and/or more extensive condition.
Secondary	Number of AEs.	Week 0 to Week 16	Overall summary of AEs during the treatment period is presented. For list of SAEs and frequent AEs by MedDRA system organ class (SOC) and preferred term (PT) during the entire trial period (including safety follow-up), see Adverse Events Overview section.
Secondary	Presence of Anti-drug Antibodies (ADA).	Week 0 to Week 16	ADA levels were measured using a validated bioanalytical method. Data were reported in the following categories: positive (presence of ADA at baseline and/or presence of ADA at at least 1 post-baseline assessment), perishing (presence of ADA at baseline and absence of ADA at all post-baseline assessments), negative (absence of ADA at all assessments), no post-baseline ADA assessment.

Source ClinicalTrials.gov

Outcomes6

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Positive Anti-tetanus Response at Week 16	Week 12 to Week 16	The per protocol analysis set was used for the primary analysis, excluding participants who did not provide vaccine response data at Week 12 (1 participant in the tralokinumab group and 2 participants in the placebo group).	Participants	COUNT_OF_PARTICIPANTS
PRIMARY	Positive Anti-meningococcal Response at Week 16	Week 12 to Week 16	The per protocol analysis set was used for the primary analysis, excluding participants who did not provide vaccine response data at Week 12 (2 participants in each treatment group).	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Participants With Investigator's Global Assessment (IGA) Score of 0 (Clear) or 1 (Almost Clear) at Week 16	Week 0 to Week 16	The analysis of the secondary outcome measures was done for the full analysis set, i.e. all subjects who were randomised and exposed to IMP (tralokinumab/placebo). 1 subject in the tralokinumab group was randomised in error and not exposed to IMP and therefore excluded from the full analysis set.	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Participants Achieving at Least 75% Reduction in Eczema Area and Severity Index (EASI) at Week 16.	Week 0 to Week 16	The analysis of the secondary outcome measures was done for the full analysis set, i.e. all participants who were randomised and exposed to IMP (tralokinumab/placebo). 1 participant in the tralokinumab group was randomised in error and not exposed to IMP and therefore excluded from the full analysis set.	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Number of AEs.	Week 0 to Week 16	The descriptive analysis was performed on the safety analysis set. The safety analysis set was defined as all participants who received at least 1 dose of IMP during the trial. Subjects who received at least 1 dose of tralokinumab were analysed in the tralokinumab group.	AEs	NUMBER
SECONDARY	Presence of Anti-drug Antibodies (ADA).	Week 0 to Week 16	All subjects in the safety analysis set were included.	Participants	COUNT_OF_PARTICIPANTS

Source ClinicalTrials.gov

Results by group18

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Units
Positive Anti-tetanus Response at Week 16	Tralokinumab	80	Participants
Positive Anti-tetanus Response at Week 16	Placebo	73	Participants
Positive Anti-meningococcal Response at Week 16	Tralokinumab	74	Participants
Positive Anti-meningococcal Response at Week 16	Placebo	64	Participants
Participants With Investigator's Global Assessment (IGA) Score of 0 (Clear) or 1 (Almost Clear) at Week 16	Tralokinumab	33	Participants
Participants With Investigator's Global Assessment (IGA) Score of 0 (Clear) or 1 (Almost Clear) at Week 16	Placebo	21	Participants
Participants Achieving at Least 75% Reduction in Eczema Area and Severity Index (EASI) at Week 16.	Tralokinumab	52	Participants
Participants Achieving at Least 75% Reduction in Eczema Area and Severity Index (EASI) at Week 16.	Placebo	39	Participants
Number of AEs.	Tralokinumab	112	AEs
Number of AEs.	Placebo	133	AEs

1 to 10 of 18Source ClinicalTrials.gov

See all 18 results by group

Participant flow18

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Treatment Period	STARTED	Tralokinumab	107
Treatment Period	STARTED	Placebo	108
Treatment Period	Safety Analysis Set	Tralokinumab	107
Treatment Period	Safety Analysis Set	Placebo	107
Treatment Period	Per Protocol Anaysis Set	Tralokinumab	88
Treatment Period	Per Protocol Anaysis Set	Placebo	78
Treatment Period	Full Analysis Set	Tralokinumab	106
Treatment Period	Full Analysis Set	Placebo	108
Treatment Period	COMPLETED	Tralokinumab	100
Treatment Period	COMPLETED	Placebo	89

1 to 10 of 18Source ClinicalTrials.gov

See all 18 participant flow

Adverse events42

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Abdominal pain	Gastrointestinal disorders	Tralokinumab	1	107	1
other	Abdominal pain	Gastrointestinal disorders	Placebo	3	107	3
other	Nausea	Gastrointestinal disorders	Tralokinumab	1	107	1
other	Nausea	Gastrointestinal disorders	Placebo	3	107	3
other	Seasonal allergy	Immune system disorders	Tralokinumab	3	107	4
other	Seasonal allergy	Immune system disorders	Placebo	0	107	0
other	Upper respiratory tract infection	Infections and infestations	Tralokinumab	2	107	2
other	Upper respiratory tract infection	Infections and infestations	Placebo	5	107	7
other	Viral upper respiratory tract infection	Infections and infestations	Tralokinumab	10	107	10
other	Viral upper respiratory tract infection	Infections and infestations	Placebo	3	107	4

1 to 10 of 42Source ClinicalTrials.gov

See all 42 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Tralokinumab	1	107
Total, all-cause mortality	Placebo	0	107
Total, other adverse events	Tralokinumab	27	107
Total, other adverse events	Placebo	25	107
Total, serious adverse events	Tralokinumab	3	107
Total, serious adverse events	Placebo	3	107

Source ClinicalTrials.gov

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons6

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
Tralokinumab vs Placebo: Participants With Investigator's Global Assessment (IGA) Score of 0 (Clear) or 1 (Almost Clear) at Week 16	Trial comparisons
Tralokinumab vs Placebo: Positive Anti-meningococcal Response at Week 16	Trial comparisons
Tralokinumab vs Placebo: Positive Anti-tetanus Response at Week 16	Trial comparisons
Tralokinumab vs Placebo: Participants Achieving at Least 75% Reduction in Eczema Area and Severity Index (EASI) at Week 16.	Trial comparisons
Tralokinumab vs Placebo: deaths from any cause	Trial comparisons
Tralokinumab vs Placebo: serious adverse events	Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT03562377

GET https://conductscience.org/api/trials/v1/NCT03562377/events?page=2

API reference For AI assistants