Trial · NCT02481674
Registered outcomes26
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 26
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Revisions to SAP were made prior to un-blinding, on June 30, 2020, upon consultation with FDA. | Prior to DBL/Study Completion | If primary outcome, listed below (Outcome 3), does not reach its critical p-value, the secondary outcomes will not be formally tested. If both co-primary outcomes are statistically significant, the five secondary outcomes will be formally tested following a hierarchical testing procedure. |
| Primary | Safety and tolerability of monthly intravenous (IV) administration of pepinemab relative to placebo in subjects with early HD (Cohort B pooled, includes Cohort B1 Early Manifest and Cohort B2 Late Prodromal HD). | Up to 18 months | Measured by drug related adverse event frequency and laboratory test abnormalities in all subjects. |
| Primary | Efficacy of monthly IV administration of pepinemab relative to placebo in Early Manifest HD (Cohort B1) | Up to 18 months | Co-primary outcome measured by the change from baseline in the Huntington's Disease Two-item Cognitive Family (PTAP and OTS) selected from the Huntington's Disease |
| Secondary | Clinical feature of Early Manifest HD: motor function (Q-Motor) | Up to 18 months | Measured by change from baseline of Q-Motor Tap Speed IOI duration mean in Cohort B1 |
| Secondary | Clinical feature of Early Manifest HD: functional capacity (UHDRS-TFC) | Up to 18 months | Measured by change from baseline of UHDRS-TFC score in Cohort B1 |
| Secondary | Clinical feature of Early HD: functional capacity (UHDRS-TFC) | Up to 18 months | Measured by time to 1-point change in UHDRS-TFC score in Cohort B pooled |
| Secondary | Clinical Feature of Early HD: motor function (Q-Motor) | Up to 18 months | Measured by change from baseline of Q-Motor Tap Speed IOI duration mean in Cohort B pooled |
| Secondary | Clinical Feature of Early HD: cognition (Huntington's Disease Two-item Cognitive Family). | Up to 18 months | Measured by change from baseline in the two-item HD-CAB family (PTAP and OTS) in Cohort B pooled |
| Other | Clinical feature of HD: cognition | Up to 18 months | Measured by change from baseline in the HD-CAB composite score |
| Other | Impact of monthly IV administration of pepinemab relative to placebo on change in brain metabolic activity | Up to 18 months | Measured by change from baseline \[18F\]-Fluoro-2-Deoxy-D-Glucose positron emission tomography (FDG-PET) standardized uptake value ratio (SUVR) Cortical Composite Index averaging results over the right and left sides of the brain in a subset of both late prodromal and early manifest subjects |
| Other | Impact of monthly IV administration of pepinemab relative to placebo on change in brain volume | Up to 18 months | Measured by change from baseline in volumetric magnetic resonance imaging (MRI) averaging results over the right and left sides of the brain (BBSI, CBSI, VBSI, and change in white matter) |
| Other | Brain metabolic activity | Up to 18 months | Measured by change from baseline in \[11C\]-PBR28 translocator protein positron emission tomography (TSPO-PET) in a small subset of late prodromal subjects (Cohort B2) |
| Other | pepinemab and total sSEMA4D levels in cerebral spinal fluid (CSF) | Up to 18 months | PK parameter |
| Other | Immunogenicity of monthly IV administration of pepinemab relative to placebo | Up to 18 months | Measured by the frequency and titer of anti-drug antibodies and human anti-human antibodies |
| Other | Immunophenotyping of monthly IV administration of pepinemab relative to placebo | Up to 18 months | Measured by the levels of peripheral immune subsets in whole blood, including such lymphocyte subsets as B cells, T cells, and NK cells |
| Other | Peak serum concentration (Cmax) of monthly IV administration of pepinemab | Up to 18 months | PK parameter |
| Other | Area under the serum concentration versus time curve (AUC) of monthly IV administration of pepinemab | Up to 18 months | PK parameter |
| Other | Half-life of VX15/2503 of monthly IV administration of pepinemab | Up to 18 months | PK parameter |
| Other | SEMA4D saturation in whole blood of monthly IV administration of pepinemab | Up to 18 months | PD parameter to determine T-cell receptor occupancy |
| Other | T-cell SEMA4D levels in whole blood of monthly IV administration of pepinemab | Up to 18 months | PD parameter |
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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