Trial · NCT03160885
Tralokinumab Monotherapy for Moderate to Severe Atopic Dermatitis - ECZTRA 2 (ECZema TRAlokinumab Trial no. 2)
NCT03160885, Phase 3, Completed, LEO Pharma; results first posted 2020-08-24
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Tralokinumab Monotherapy for Moderate to Severe Atopic Dermatitis - ECZTRA 2 (ECZema TRAlokinumab Trial no. 2). Trials, record NCT03160885. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03160885
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Tralokinumab Monotherapy for Moderate to Severe Atopic Dermatitis - ECZTRA 2 (ECZema TRAlokinumab Trial no. 2)
- NCT number
- NCT03160885
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 794 participants, actual
- Lead sponsor
- LEO Pharma
- Conditions
- Atopic Dermatitis
- Interventions
- Tralokinumab, Placebo
- First posted
- 2017-05-19
- Last updated
- 2025-03-11
- Other registries' IDs
- eudract:2016-004201-13
- Results first posted
- 2020-08-24
Source ClinicalTrials.gov
Registered outcomes17
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Subjects With Investigator's Global Assessment (IGA) Score of 0 (Clear) or 1 (Almost Clear) at Week 16. | At Week 16 | The IGA is an instrument used in clinical trials to rate the severity of the subject's global AD and is based on a 5-point scale ranging from 0 (clear) to 4 (severe). |
| Primary | Subjects Achieving at Least 75% Reduction in Eczema Area and Severity Index [EASI]. | At Week 16 | The EASI 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. |
| Secondary | Reduction of Worst Daily Pruritus Numeric Rating Scale (Weekly Average) of at Least 4 From Baseline to Week 16. | Week 0 to Week 16 | Subjects will assess their worst itch severity over the past 24 hours using an 11 point NRS ('Worst Daily Pruritus NRS') with 0 indicating 'no itch' and 10 indicating 'worst itch imaginable'. |
| Secondary | Change in Scoring Atopic Dermatitis (SCORAD) From Baseline to Week 16. | Week 0 to Week 16 | The SCORAD is a validated tool to evaluate the extent and severity of AD lesions, along with subjective symptoms. The maximum total score is 103, with higher values indicating more severe disease. |
| Secondary | Change in Dermatology Life Quality Index (DLQI) Score From Baseline to Week 16. | Week 0 to Week 16 | The DLQI is a validated questionnaire with content specific to those with dermatology conditions. It consists of 10 items addressing the subject's perception of the impact of their skin disease on different aspects of their quality of life (QoL) over the last week such as dermatology-related symptoms and feelings, daily activities, leisure, work or school, personal relationships, and the treatment. Each item is scored on a 4 point Likert scale (0 = not at all/not relevant; 1 = a little; 2 = a lot; 3 = very much). The total score is the sum of the 10 items (0 to 30); a high score is indicative of a poor QoL. |
| Secondary | Subjects With Investigator's Global Assessment (IGA) Score of 0 (Clear) or 1 (Almost Clear) at Week 52 Among Subjects With IGA of 0/1 at Week 16 | At Week 52 | The IGA is an instrument used in clinical trials to rate the severity of the subject's global AD and is based on a 5-point scale ranging from 0 (clear) to 4 (severe). |
| Secondary | Subjects With at Least 75% Reduction in Eczema Area and Severity Index [EASI] at Week 52 Among Subjects With EASI75 at Week 16 | At Week 52 | The EASI 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. |
| Secondary | Safety and Tolerability: Adverse Event (AE) /Serious Adverse Event (SAE) Frequency | Week 0 to Week 16 | Overall summary of AEs and SAEs during the Initial treatment period is presented. For list of AEs and SAEs 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 | Frequency of Anti-drug Antibodies | Week 0 to Week 16 | Anti-tralokinumab antibody levels were analysed using a validated bioanalytical method |
| Secondary | Subjects Achieving at Least 50% Reduction in Eczema Area and Severity Index [EASI] at Week 16 | At Week 16 | The EASI 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. |
1 to 10 of 17Source ClinicalTrials.gov
See all 17 registered outcomesOutcomes17
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Subjects With Investigator's Global Assessment (IGA) Score of 0 (Clear) or 1 (Almost Clear) at Week 16. | At Week 16 | The full analysis set (FAS: all subjects randomised to initial treatment who were exposed to IMP) was used for the primary analysis; 794 subjects were randomised to initial treatment and 792 received IMP, thus the FAS comprised 792 subjects. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Subjects Achieving at Least 75% Reduction in Eczema Area and Severity Index [EASI]. | At Week 16 | Full analysis set | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Reduction of Worst Daily Pruritus Numeric Rating Scale (Weekly Average) of at Least 4 From Baseline to Week 16. | Week 0 to Week 16 | Full analysis set (FAS). Number of subjects analysed = subjects with baseline pruritus NRS weekly average ≥4. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Change in Scoring Atopic Dermatitis (SCORAD) From Baseline to Week 16. | Week 0 to Week 16 | Full analysis set | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change in Dermatology Life Quality Index (DLQI) Score From Baseline to Week 16. | Week 0 to Week 16 | Full analysis set | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Subjects With Investigator's Global Assessment (IGA) Score of 0 (Clear) or 1 (Almost Clear) at Week 52 Among Subjects With IGA of 0/1 at Week 16 | At Week 52 | Maintenance analysis set - Subjects who achieved IGA 0/1 at Week 16 after initial treatment with tralokinumab without use of rescue medication | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Subjects With at Least 75% Reduction in Eczema Area and Severity Index [EASI] at Week 52 Among Subjects With EASI75 at Week 16 | At Week 52 | Maintenance analysis set: Subjects who achieved EASI75 at Week 16 after initial treatment with tralokinumab without use of rescue medication | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Safety and Tolerability: Adverse Event (AE) /Serious Adverse Event (SAE) Frequency | Week 0 to Week 16 | The analysis was performed on the safety analysis set. The safety analysis set comprised of participants who received at least 1 dose of IMP during the trial. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Frequency of Anti-drug Antibodies | Week 0 to Week 16 | All subjects in the safety analysis set are included | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Subjects Achieving at Least 50% Reduction in Eczema Area and Severity Index [EASI] at Week 16 | At Week 16 | Full analysis set | Participants | COUNT_OF_PARTICIPANTS |
1 to 10 of 17Source ClinicalTrials.gov
See all 17 outcomesResults by group48
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Subjects With Investigator's Global Assessment (IGA) Score of 0 (Clear) or 1 (Almost Clear) at Week 16. | Tralokinumab 300 mg Q2W | 131 | Participants | ||
| Subjects With Investigator's Global Assessment (IGA) Score of 0 (Clear) or 1 (Almost Clear) at Week 16. | Placebo Q2W | 22 | Participants | ||
| Subjects Achieving at Least 75% Reduction in Eczema Area and Severity Index [EASI]. | Tralokinumab 300 mg Q2W | 196 | Participants | ||
| Subjects Achieving at Least 75% Reduction in Eczema Area and Severity Index [EASI]. | Placebo Q2W | 23 | Participants | ||
| Reduction of Worst Daily Pruritus Numeric Rating Scale (Weekly Average) of at Least 4 From Baseline to Week 16. | Tralokinumab 300 mg Q2W | 144 | Participants | ||
| Reduction of Worst Daily Pruritus Numeric Rating Scale (Weekly Average) of at Least 4 From Baseline to Week 16. | Placebo Q2W | 19 | Participants | ||
| Change in Scoring Atopic Dermatitis (SCORAD) From Baseline to Week 16. | Tralokinumab 300 mg Q2W | -28.1 | Standard Error 0.92 | units on a scale | |
| Change in Scoring Atopic Dermatitis (SCORAD) From Baseline to Week 16. | Placebo Q2W | -14.0 | Standard Error 1.79 | units on a scale | |
| Change in Dermatology Life Quality Index (DLQI) Score From Baseline to Week 16. | Tralokinumab 300 mg Q2W | -8.8 | Standard Error 0.30 | units on a scale | |
| Change in Dermatology Life Quality Index (DLQI) Score From Baseline to Week 16. | Placebo Q2W | -4.9 | Standard Error 0.60 | units on a scale |
1 to 10 of 48Source ClinicalTrials.gov
See all 48 results by groupParticipant flow63
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Initial Treatment Period | STARTED | Initial Treatment Period - Tralokinumab 300 mg Q2W | 593 | |
| Initial Treatment Period | STARTED | Initial Treatment Period - Placebo Q2W | 201 | |
| Initial Treatment Period | STARTED | Maintenance Treatment Period - Tralokinumab 300 mg Q2W | 0 | |
| Initial Treatment Period | STARTED | Maintenance Treatment Period - Tralokinumab 300 mg Q4W | 0 | |
| Initial Treatment Period | STARTED | Maintenance Treatment Period - Placebo Q2W | 0 | |
| Initial Treatment Period | STARTED | Maintenance Treatment Period -Placebo Q2W - Tralokinumab Naive | 0 | |
| Initial Treatment Period | STARTED | Open-label Treatment -Tralokinumab 300 mg Q2W + Optional TCS | 0 | |
| Initial Treatment Period | COMPLETED | Initial Treatment Period - Tralokinumab 300 mg Q2W | 558 | |
| Initial Treatment Period | COMPLETED | Initial Treatment Period - Placebo Q2W | 179 | |
| Initial Treatment Period | COMPLETED | Maintenance Treatment Period - Tralokinumab 300 mg Q2W | 0 |
1 to 10 of 63Source ClinicalTrials.gov
See all 63 participant flowAdverse events368
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 | Dry eye | Eye disorders | Initial Period - Tralokinumab Q2W | 3 | 592 | 3 |
| other | Dry eye | Eye disorders | Initial Period - Placebo | 1 | 200 | 1 |
| other | Dry eye | Eye disorders | Maintenance Period - Tralokinumab Q2W | 1 | 91 | 1 |
| other | Dry eye | Eye disorders | Maintenance Period - Tralokinumab Q4W | 0 | 89 | 0 |
| other | Dry eye | Eye disorders | Maintenance Period - Placebo | 3 | 46 | 4 |
| other | Dry eye | Eye disorders | Maintenance Period - Placebo - Tralokinumab Naive | 0 | 31 | 0 |
| other | Dry eye | Eye disorders | Open-label Period - Tralokinumab Q2W + Optional TCS | 5 | 558 | 5 |
| other | Dry eye | Eye disorders | Safety Follow-up | 1 | 641 | 1 |
| other | Conjunctivitis | Infections and infestations | Initial Period - Tralokinumab Q2W | 18 | 592 | 21 |
| other | Conjunctivitis | Infections and infestations | Initial Period - Placebo | 3 | 200 | 3 |
1 to 10 of 368Source ClinicalTrials.gov
See all 368 adverse eventsAdverse event totals24
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Initial Period - Tralokinumab Q2W | 0 | 592 |
| Total, all-cause mortality | Initial Period - Placebo | 0 | 200 |
| Total, all-cause mortality | Maintenance Period - Tralokinumab Q2W | 0 | 91 |
| Total, all-cause mortality | Maintenance Period - Tralokinumab Q4W | 0 | 89 |
| Total, all-cause mortality | Maintenance Period - Placebo | 0 | 46 |
| Total, all-cause mortality | Maintenance Period - Placebo - Tralokinumab Naive | 0 | 31 |
| Total, all-cause mortality | Open-label Period - Tralokinumab Q2W + Optional TCS | 0 | 558 |
| Total, all-cause mortality | Safety Follow-up | 0 | 641 |
| Total, other adverse events | Initial Period - Tralokinumab Q2W | 202 | 592 |
| Total, other adverse events | Initial Period - Placebo | 89 | 200 |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 adverse event totalsPapers7
The papers the trial lists on ClinicalTrials.gov.
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 comparisons9
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Tralokinumab 300 mg Q2W vs Placebo Q2W: Reduction of Worst Daily Pruritus Numeric Rating Scale (Weekly Average) of at Least 4 From Baseline to Week 16. | Trial comparisons |
| Tralokinumab 300 mg Q2W vs Placebo Q2W: Subjects Achieving at Least 50% Reduction in Scoring Atopic Dermatitis (SCORAD) at Week 16. | Trial comparisons |
| Tralokinumab 300 mg Q2W vs Placebo Q2W: Reduction From Baseline to Week 16 of Dermatology Life Quality Index (DLQI) of ≥4 Points Among Subjects With Baseline DLQI ≥4. | Trial comparisons |
| Tralokinumab 300 mg Q2W vs Placebo Q2W: Reduction of Worst Daily Pruritus NRS (Weekly Average) ≥3 From Baseline to Week 16. | Trial comparisons |
| Tralokinumab 300 mg Q2W vs Placebo Q2W: Subjects Achieving at Least 90% Reduction in Eczema Area and Severity Index [EASI] at Week 16. | Trial comparisons |
| Tralokinumab 300 mg Q2W vs Placebo Q2W: Subjects Achieving at Least 50% Reduction in Eczema Area and Severity Index [EASI] at Week 16 | Trial comparisons |
| Tralokinumab 300 mg Q2W vs Placebo Q2W: Subjects Achieving at Least 75% Reduction in Eczema Area and Severity Index [EASI]. | Trial comparisons |
| Tralokinumab 300 mg Q2W vs Placebo Q2W: Subjects With Investigator's Global Assessment (IGA) Score of 0 (Clear) or 1 (Almost Clear) at Week 16. | Trial comparisons |
| Tralokinumab 300 mg Q2W vs Placebo Q2W: Subjects Achieving at Least 75% Reduction in Scoring Atopic Dermatitis (SCORAD) at Week 16. | 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.
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.
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