Trial · NCT05885737
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 | Change From Baseline in the Weekly Mean of the Daily 24-hour WI-NRS Score at Week 4 of the DB Period | From Baseline to Week 4 | Analysis was performed on the FAS. The FAS included all participants who were randomized to treatment, received at least 1 dose of investigational product and had a non-missing baseline assessment for the weekly mean of the daily 24-hour WI-NRS score. Here, 'overall number of participants analyzed', 'N' = participants with available data for this outcome measure. | score on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Percentage of Participants Achieving Greater Than or Equal to (>=) 3-point Improvement From Baseline With Respect to the Weekly Mean of the Daily 24-hour WI-NRS in the DB Period | From Baseline, and at Weeks 4, 8, and 12 | Analysis was performed on FAS. The FAS included all participants who were randomized to treatment, received at least 1 dose of investigational product and had a non-missing baseline assessment for the weekly mean of the daily 24-hour WI-NRS score. Here, 'number analyzed', 'n' = participants with available data for each specified timepoint. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Achieving at Least 4-point Improvement From Baseline With Respect to the Weekly Mean of the Daily 24-hour WI-NRS in the DB Period | From Baseline, and at Weeks 4, 8, and 12 | Analysis was performed on FAS. The FAS included all participants who were randomized to treatment, received at least 1 dose of investigational product and had a non-missing baseline assessment for the weekly mean of the daily 24-hour WI-NRS score. Here, 'number analyzed', 'n' = participants with available data for each specified timepoint. | percentage of participants | NUMBER |
| SECONDARY | Change From Baseline in the Weekly Mean of the 24-hour WI-NRS Score at Each Week of the DB Period | From Baseline to Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, and 12 | Analysis was performed on FAS. The FAS included all participants who were randomized to treatment, received at least 1 dose of investigational product and had a non-missing baseline assessment for the weekly mean of the daily 24-hour WI-NRS score. Here, 'number analyzed', 'n' = participants with available data for each specified timepoint. | score on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Itch-related Quality-of-life (QoL) as Assessed by the 5-D Itch Scale Total Score (DB Period) | From Baseline to Weeks 4, 8, and 12 | Analysis was performed on FAS. The FAS included all participants who were randomized to treatment, received at least 1 dose of investigational product and had a non-missing baseline assessment for the weekly mean of the daily 24-hour WI-NRS score. Here, 'number analyzed', 'n' = participants with available data for each specified timepoint. | score on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Itch-related QoL as Assessed by the 5-D Itch Scale Total Score (OLE Period) | From Baseline to OLE Period - Weeks 4, 8, 12, and 14 | Analysis was performed on the OLE Safety Analysis Set, which included all participants who received at least 1 dose of IP in the OLE period. Here, 'number analyzed', 'n' = participants with available data for each specified timepoint. | score on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Itch-related QoL as Assessed by the Skindex-10 Scale Total Score (DB Period) | From Baseline to Weeks 4, 8, and 12 | Analysis was performed on FAS. The FAS included all participants who were randomized to treatment, received at least 1 dose of investigational product and had a non-missing baseline assessment for the weekly mean of the daily 24-hour WI-NRS score. Here, 'number analyzed', 'n' = participants with available data for each specified timepoint. | score on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Itch-related QoL as Assessed by the Skindex-10 Scale Total Score (OLE Period) | From Baseline to OLE Period - Weeks 4, 8, 12, and 14 | For the OLE period analysis was performed on OLE-SAS, which included all participants who received at least 1 dose of IP in the OLE period. Here, 'number analyzed', 'n' = participants with available data for each specified timepoint. | score on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Patient Global Impression of Change | At Week 12 | Analysis was performed on FAS. The FAS included all participants who were randomized to treatment, received at least 1 dose of investigational product and had a non-missing baseline assessment for the weekly mean of the daily 24-hour WI-NRS score. Here, 'overall number of participants analyzed', 'N' = participants with available data for the outcome measure. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Adverse Events (AEs) | Up to Week 27 (12 weeks in DB + 14 weeks in OLE +1 week of follow up) | Analysis was performed on safety analysis set in DB period (DB-SAF). DB-SAF included all randomized participants who received at least 1 dose of investigational product during the DB period. For the OLE period analysis was performed on OLE Safety Analysis Set, which included all participants who received at least 1 dose of IP in the OLE period. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Clinically Significant Abnormal 12-lead Electrocardiogram (ECG) | Up to Week 27 (12 weeks in DB + 14 weeks in OLE +1 week of follow up) | The DB and OLE SAS consisted of all participants who received at least 1 dose of investigational product during the DB period and OLE period, respectively. Participants were analysed according to the actual treatment received. Here, 'number analyzed', 'n' = participants with available data for each specified timepoint. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Clinically Relevant Change From Baseline in Vital Signs and Laboratory Evaluations | From baseline to Week 27 (12 weeks in DB + 14 weeks in OLE +1 week of follow up) | The DB and OLE SAS consisted of all participants who received at least 1 dose of investigational product during the DB period and OLE period, respectively. Participants were analysed according to the actual treatment received. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.govtrials-2026-11-12-0.4.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNone 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/NCT05885737/outcomes