Trial · NCT03160885
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; 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 |
| 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 | At 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). | Baseline 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. | Baseline 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. | Baseline 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
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GET https://conductscience.org/api/trials/v1/NCT03160885/outcomes