Trial · NCT03587805
Long-term Extension Trial in Subjects With Atopic Dermatitis Who Participated in Previous Tralokinumab Trials - ECZTEND
NCT03587805, Phase 3, Completed, LEO Pharma; results first posted 2025-01-16
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Long-term Extension Trial in Subjects With Atopic Dermatitis Who Participated in Previous Tralokinumab Trials - ECZTEND. Trials, record NCT03587805. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03587805
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Long-term Extension Trial in Subjects With Atopic Dermatitis Who Participated in Previous Tralokinumab Trials - ECZTEND
- NCT number
- NCT03587805
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 1,672 participants, actual
- Lead sponsor
- LEO Pharma
- Conditions
- Atopic Dermatitis
- Interventions
- Tralokinumab
- First posted
- 2018-07-16
- Last updated
- 2025-03-11
- Other registries' IDs
- eudract:2018-000746-19
- Results first posted
- 2025-01-16
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Adverse Events From Baseline Through the Last Treatment Visit (up to Week 268) | From Week 0 up to Week 268 | |
| Secondary | Investigator's Global Assessment (IGA) Score of 0 (Clear) or 1 (Almost Clear) at Weeks 16, 56, 88, 104, 136, 152, 184, 216, and 248 | From Week 16 up to Week 248 | 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 | At Least 75% Reduction in Eczema Area and Severity Index (EASI75) Relative to Baseline in Parent Trial, at Weeks 16, 56, 88, 104, 136, 152, 184, 216, and 248 | From Week 16 up to Week 248 | 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 or more extensive condition. |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Adverse Events From Baseline Through the Last Treatment Visit (up to Week 268) | From Week 0 up to Week 268 | events | NUMBER | |
| SECONDARY | Investigator's Global Assessment (IGA) Score of 0 (Clear) or 1 (Almost Clear) at Weeks 16, 56, 88, 104, 136, 152, 184, 216, and 248 | From Week 16 up to Week 248 | Modified non-responder analysis with data multiply imputed using a hypothetical strategy. Response is based on observed and multiply imputed data. If a participant permanently discontinued IMP due to lack of efficacy or adverse event before the analyzed visit, they are considered non-responders. | percentage of responders | NUMBER |
| SECONDARY | At Least 75% Reduction in Eczema Area and Severity Index (EASI75) Relative to Baseline in Parent Trial, at Weeks 16, 56, 88, 104, 136, 152, 184, 216, and 248 | From Week 16 up to Week 248 | Modified non-responder analysis with data multiply imputed using a hypothetical strategy. Response is based on observed and multiply imputed data. If a participant permanently discontinued IMP due to lack of efficacy or adverse event before the analyzed visit, they are considered non-responders. | percentage of responders | NUMBER |
Source ClinicalTrials.gov
Results by group19
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Adverse Events From Baseline Through the Last Treatment Visit (up to Week 268) | Tralokinumab, All Subjects | 8119 | events | ||
| Investigator's Global Assessment (IGA) Score of 0 (Clear) or 1 (Almost Clear) at Weeks 16, 56, 88, 104, 136, 152, 184, 216, and 248 | Tralokinumab, All Subjects | IGA 0/1 at Week 16 | 47.3 | 95% Confidence Interval 44.9 to 49.8 | percentage of responders |
| Investigator's Global Assessment (IGA) Score of 0 (Clear) or 1 (Almost Clear) at Weeks 16, 56, 88, 104, 136, 152, 184, 216, and 248 | Tralokinumab, All Subjects | IGA 0/1 at Week 56 | 48.5 | 95% Confidence Interval 45.9 to 51.1 | percentage of responders |
| Investigator's Global Assessment (IGA) Score of 0 (Clear) or 1 (Almost Clear) at Weeks 16, 56, 88, 104, 136, 152, 184, 216, and 248 | Tralokinumab, All Subjects | IGA 0/1 at Week 88 | 48.6 | 95% Confidence Interval 46.1 to 51.1 | percentage of responders |
| Investigator's Global Assessment (IGA) Score of 0 (Clear) or 1 (Almost Clear) at Weeks 16, 56, 88, 104, 136, 152, 184, 216, and 248 | Tralokinumab, All Subjects | IGA 0/1 at Week 104 | 47.1 | 95% Confidence Interval 44.6 to 49.6 | percentage of responders |
| Investigator's Global Assessment (IGA) Score of 0 (Clear) or 1 (Almost Clear) at Weeks 16, 56, 88, 104, 136, 152, 184, 216, and 248 | Tralokinumab, All Subjects | IGA 0/1 at Week 136 | 48.7 | 95% Confidence Interval 46.2 to 51.3 | percentage of responders |
| Investigator's Global Assessment (IGA) Score of 0 (Clear) or 1 (Almost Clear) at Weeks 16, 56, 88, 104, 136, 152, 184, 216, and 248 | Tralokinumab, All Subjects | IGA 0/1 at Week 152 | 46.8 | 95% Confidence Interval 44.1 to 49.4 | percentage of responders |
| Investigator's Global Assessment (IGA) Score of 0 (Clear) or 1 (Almost Clear) at Weeks 16, 56, 88, 104, 136, 152, 184, 216, and 248 | Tralokinumab, All Subjects | IGA 0/1 at Week 184 | 46.7 | 95% Confidence Interval 44.1 to 49.3 | percentage of responders |
| Investigator's Global Assessment (IGA) Score of 0 (Clear) or 1 (Almost Clear) at Weeks 16, 56, 88, 104, 136, 152, 184, 216, and 248 | Tralokinumab, All Subjects | IGA 0/1 at Week 216 | 47.2 | 95% Confidence Interval 44.4 to 50.0 | percentage of responders |
| Investigator's Global Assessment (IGA) Score of 0 (Clear) or 1 (Almost Clear) at Weeks 16, 56, 88, 104, 136, 152, 184, 216, and 248 | Tralokinumab, All Subjects | IGA 0/1 at Week 248 | 46.9 | 95% Confidence Interval 44.1 to 49.7 | percentage of responders |
1 to 10 of 19Source ClinicalTrials.gov
See all 19 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Tralokinumab, All Subjects | 1,672 | |
| Overall Study | COMPLETED | Tralokinumab, All Subjects | 1,143 | |
| Overall Study | NOT COMPLETED | Tralokinumab, All Subjects | 529 |
Source ClinicalTrials.gov
Adverse events145
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 | Conjuctivitis | Infections and infestations | Tralokinumab, All Subjects | 103 | 1,672 | 131 |
| other | Covid-19 | Infections and infestations | Tralokinumab, All Subjects | 295 | 1,672 | 317 |
| other | Nasopharyngitis | Infections and infestations | Tralokinumab, All Subjects | 372 | 1,672 | 599 |
| other | Upper respiratory tract infection | Infections and infestations | Tralokinumab, All Subjects | 147 | 1,672 | 233 |
| other | Headache | Nervous system disorders | Tralokinumab, All Subjects | 114 | 1,672 | 143 |
| other | Atopic dermatitis | Skin and subcutaneous tissue disorders | Tralokinumab, All Subjects | 351 | 1,672 | 620 |
| serious | Angina pectoris | Cardiac disorders | Tralokinumab, All Subjects | 2 | 1,672 | 2 |
| serious | Acute myocardial infarction | Cardiac disorders | Tralokinumab, All Subjects | 1 | 1,672 | 1 |
| serious | Atrial fibrillation | Cardiac disorders | Tralokinumab, All Subjects | 2 | 1,672 | 2 |
| serious | Atrial flutter | Cardiac disorders | Tralokinumab, All Subjects | 1 | 1,672 | 1 |
1 to 10 of 145Source ClinicalTrials.gov
See all 145 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Tralokinumab, All Subjects | 1 | 1,672 |
| Total, other adverse events | Tralokinumab, All Subjects | 924 | 1,672 |
| Total, serious adverse events | Tralokinumab, All Subjects | 151 | 1,672 |
Source ClinicalTrials.gov
Papers7
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 comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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.
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/NCT03587805
GET https://conductscience.org/api/trials/v1/NCT03587805/events?page=2