Trial · NCT02481674
A Study in Subjects With Late Prodromal & Early Manifest HD to Assess the Safety, Tolerability, pk, and Efficacy of Pepi
NCT02481674, Phase 2, Completed, Vaccinex Inc.
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Study in Subjects With Late Prodromal & Early Manifest HD to Assess the Safety, Tolerability, pk, and Efficacy of Pepi. Trials, record NCT02481674. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02481674
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study in Subjects With Late Prodromal & Early Manifest HD to Assess the Safety, Tolerability, pk, and Efficacy of Pepi
- NCT number
- NCT02481674
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 301 participants, actual
- Lead sponsor
- Vaccinex Inc.
- Conditions
- Huntington's Disease
- Interventions
- VX15/2503, Placebo
- First posted
- 2015-06-25
- Last updated
- 2022-05-02
Source ClinicalTrials.gov
Registered outcomes26
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| 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 |
1 to 10 of 26Source ClinicalTrials.gov
See all 26 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers4
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
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 trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02481674
GET https://conductscience.org/api/trials/v1/NCT02481674/registered?page=2