Trial · NCT03131648
Outcomes17
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 17 of 17
Download this page as JSON| 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; 802 subjects were randomised to initial treatment and 798 received IMP, thus the FAS comprised of 798 subjects. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Subjects Achieving at Least 75% Reduction in Eczema Area and Severity Index [EASI] at Week 16 | 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.~Subjects who were treated with placebo during initial treatment period (tralokinumab naïve arm) and who continued to the maintenance period were not part of the analysis of maintenance endpoints and therefore this arm is not included for outcome measures. | 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 inital treatment with tralokinumab without use of rescue medication.~Subjects who were treated with placebo during initial treatment period (tralokinumab naïve arm) and who continued to the maintenance period were not part of the analysis of maintenance endpoints and therefore this arm is not included for outcome measures. | 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 |
| SECONDARY | Subjects Achieving at Least 90% Reduction in Eczema Area and Severity Index [EASI] at Week 16 | At Week 16 | Full analysis set | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Change From Baseline to Week 16 in Eczema Area and Severity Index [EASI] Score | Week 0 to Week 16 | Full analysis set | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Subjects Achieving at Least 75% Reduction in Scoring Atopic Dermatitis (SCORAD) at Week 16 | At Week 16 | Full analysis set | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Subjects Achieving at Least 50% Reduction in Scoring Atopic Dermatitis (SCORAD) at Week 16 | At Week 16 | Full analysis set | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Change From Baseline to Week 16 in Worst Daily Pruritus NRS (Weekly Average) | Week 0 to Week 16 | Full analysis set | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Reduction of Worst Daily Pruritus NRS (Weekly Average) ≥3 From Baseline to Week 16 | Week 0 to Week 16 | Full analysis set. Number of subjects analysed = subjects with baseline Pruritus NRS weekly average of at least 3 | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Reduction From Baseline to Week 16 of Dermatology Life Quality Index (DLQI) of ≥4 Points Among Subjects With Baseline DLQI ≥4 | Week 0 to Week 16 | Full analysis set. Number of subjects analysed = subjects with baseline DLQI ≥4. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
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 list from software.
Twenty rows a page, as JSON. No key.
GET https://conductscience.org/api/trials/v1/NCT03131648/outcomes