Trial · NCT05856526
Outcomes12
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 12 of 12
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | IASI Response, Defined as a Decrease of at Least 50% Absolute Change in IASI Score From Baseline at Week 16 (Yes/No) | At baseline and at Week 16. | FAS (EC-NRI). This patient set included all patients who were randomised and received at least one study treatment in this trial. EC= primary estimand where use of restricted medications and treatments for NS is considered as non-response. NRI=Imputes missing data as failure, unless there are successful observations at visits both before and after the missing outcome. | proportion of participants | NUMBER |
| SECONDARY | Key Secondary Endpoint: IGA Response, Defined as a Decrease of at Least 1-grade Absolute Change in IGA Score From Baseline at Week 16 (Yes/No) | Baseline and at Week 16 after start of study treatment administration. | FAS (EC-NRI). This patient set included all patients who were randomised and received at least one study treatment in this trial. EC= primary estimand where use of restricted medications and treatments for NS is considered as non-response. NRI=Imputes missing data as failure, unless there are successful observations at visits both before and after the missing outcome. | proportion of participants | NUMBER |
| SECONDARY | IGA Score of 0 or 1 at Weeks 4, 8, 12 and 16 (Yes/No) | At Week 4, at Week 8, at Week 12, at Week 16 after start of study treatment administration. | FAS (EC-NRI). This patient set included all patients who were randomised and received at least one study treatment in this trial. EC= primary estimand where use of restricted medications and treatments for NS is considered as non-response. NRI=Imputes missing data as failure, unless there are successful observations at visits both before and after the missing outcome. | proportion of participants | NUMBER |
| SECONDARY | IASI Response, Defined as a Decrease of at Least 50% Absolute Change in IASI Score From Baseline at Weeks 4, 8, and 12 (Yes/No) | At baseline and at Week 4, at Week 8, at Week 12 after start of study treatment administration. | FAS (EC-NRI). This patient set included all patients who were randomised and received at least one study treatment in this trial. EC= primary estimand where use of restricted medications and treatments for NS is considered as non-response. NRI=Imputes missing data as failure, unless there are successful observations at visits both before and after the missing outcome. | proportion of participants | NUMBER |
| SECONDARY | IASI-E Subscore Response, Defined as a Decrease of at Least 50% Absolute Change in IASI-E Subscore at Weeks 4, 8, 12, and 16 (Yes/No) | At baseline and at Week 4, at Week 8, at Week 12, at Week 16 after start of study treatment administration. | FAS (EC-NRI). This patient set included all patients who were randomised and received at least one study treatment in this trial. EC= primary estimand where use of restricted medications and treatments for NS is considered as non-response. NRI=imputes missing data as failure, unless there are successful observations at visits both before and after the missing outcome. | proportion of participants | NUMBER |
| SECONDARY | IASI-S Subscore Response, Defined as a Decrease of at Least 50% Absolute Change in IASI-S Subscore From Baseline at Weeks 4, 8, 12, and 16 (Yes/No) | At baseline and at Week 4, at Week 8, at Week 12, at Week 16 after start of study treatment administration. | FAS (EC-NRI). This patient set included all patients who were randomised and received at least one study treatment in this trial. EC= primary estimand where use of restricted medications and treatments for NS is considered as non-response. NRI=imputes missing data as failure, unless there are successful observations at visits both before and after the missing outcome. | proportion of participants | MEAN |
| SECONDARY | Percent Change From Baseline in IASI Score at Weeks 4, 8, 12 and 16 | MMRM model included measurements from baseline and Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 60, 68 after study treatment administration. MMRM values of percent change from baseline at Week 4, 8, 12, 16 are presented. | FAS (EH-MMRM). This patient set included all patients who were randomised and received at least one study treatment in this trial. EH=estimand where data after any use of restricted medications and treatments for NS and treatment discontinuation is censored. | percent change | LEAST_SQUARES_MEAN |
| SECONDARY | Absolute Change From Baseline in NRS Pain at Weeks 4, 8, 12 and 16 | MMRM model included measurements from baseline and Week 4, 8, 12, 16, 20, 24, 28, 32, 40, 52, 64 after study treatment administration. MMRM values of absolute change from baseline in NRS pain at Week 4, 8, 12, 16 are presented. | FAS (EH-MMRM). This patient set included all patients who were randomised and received at least one study treatment in this trial. EH=estimand where data after any use of restricted medications and treatments for NS and treatment discontinuation is censored. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Absolute Change From Baseline in NRS Itch at Weeks 4, 8, 12 and 16 | MMRM model included measurements from baseline and Week 4, 8, 12, 16, 20, 24, 28, 32, 40, 52, 64 after study treatment administration. MMRM values of absolute change from baseline in NRS itch at Week 4, 8, 12, 16 are presented. | FAS (EH-MMRM). This patient set included all patients who were randomised and received at least one study treatment in this trial. EH=estimand where data after any use of restricted medications and treatments for NS and treatment discontinuation is censored. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Absolute Change From Baseline in DLQI Score at Weeks 8 and 16 | MMRM model included measurements from baseline and Week 8, 16, 24, 32, 52, after study treatment administration. MMRM values of absolute change from baseline in DLQI score at Week 8, 16 are presented. | FAS (EH-MMRM). This patient set included all patients who were randomised and received at least one study treatment in this trial. EH=estimand where data after any use of restricted medications and treatments for NS and treatment discontinuation is censored. Participants \>= 18 years and with a baseline DLQI score value are reported. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Absolute Change From Baseline in CDLQI Score at Weeks 8 and 16 | At baseline and at Week 8 and at Week 16 after study treatment administration. | FAS (EH). This patient set included all patients who were randomised and received at least one study treatment in this trial. EH=estimand where data after any use of restricted medications and treatments for NS and treatment discontinuation is censored.~Only paediatric (\>= 12 to \< 18 years) participants with data available for the CDLQI score at Week 8 and at Week 16 are reported. | units on a scale | MEAN |
| SECONDARY | The Occurrence of Treatment Emergent Adverse Events Including Serious and/or Opportunistic Infections | From first study treatment administration until end of randomised period (Week 16) plus 16 weeks of residual effect period, up to 32 weeks. | Safety Analysis Set (SAF): This patient set included all patients who were randomised and received at least one study treatment in this trial. | percentage of participants | NUMBER |
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.
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GET https://conductscience.org/api/trials/v1/NCT05856526/outcomes