Trial · NCT03987295
Registered outcomes13
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 13 of 13
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Severity of TEAEs | 197 weeks | Number of TEAEs categorized by severity |
| Primary | Severity of Treatment-Related TEAEs | 197 weeks | Number of treatment-related TEAEs categorized by severity |
| Primary | Any TEAE Leading to Study Drug Discontinuation | 197 weeks | Number of TEAEs leading to study drug discontinuation |
| Primary | Immunogenicity Antidrug Antibodies (ADA) Titer | 97 weeks | Titer values of antidrug antibodies (ADAs) in participants receiving latozinemab at week 97/Part 1 end of study |
| Primary | Confirmatory Immunogenicity Antidrug Antibodies (ADA) Responses | 97 weeks | Presence of confirmatory antidrug antibodies (ADAs) in participants who test positive for ADA at week 97 (Part 1 End of Study). |
| Primary | Change From Baseline in Sheehan Suicidality Tracking Scale | 197 weeks | The Sheehan Suicidality Tracking Scale (S-STS) is a structured assessment tool used to evaluate the presence, severity, and frequency of suicidal ideation and behavior. It includes items that address passive thoughts of death, active suicidal ideation, intent, planning, suicide attempts, and non-suicidal self-injury. The S-STS total score ranges from 0 to 64, based on 16 items each rated from 0 (not at all) to 4 (extremely), with higher scores indicating greater severity of suicidal ideation, intent, or behavior. The total score provides a quantitative measure of suicidality severity and is sensitive to change over time, making it suitable for clinical monitoring and research use. |
| Secondary | Longitudinal Percent Change From Baseline of CSF PGRN | 97 weeks | The percent change from baseline to specified timepoints of PGRN in CSF. The baseline visit is labeled as week 1 and therefore the 96th week is labeled as week 97. |
| Secondary | Longitudinal Percent Change From Baseline in Plasma PGRN | 97 weeks | The percent change from baseline to specified timepoints for PGRN in plasma. The baseline visit is labeled as week 1 and therefore the 96th week is labeled as week 97. |
| Secondary | Longitudinal Levels of Sortilin in WBCs | 97 weeks | The overall change from baseline in Sortilin in WBCs. |
| Secondary | Latozinemab Concentration in Serum | 97 weeks | Serum concentration of Latozinemab at week 97. |
| Secondary | Cmax of Latozinemab at Specified Timepoints | 97 weeks | Maximum observed concentration of Latozinemab at week 96 of treatment. |
| Secondary | Ctrough of Latozinemab at Specified Timepoints | 97 weeks | Trough concentration of Latozinemab at week 96 of treatment |
| Secondary | ARCmax of Latozinemab | 61 weeks | Ratio of latozinemab Cmax at week 61 to the Cmax at week 1 |
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/NCT03987295/registered