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Small Molecule

A Dose Range Finding Study With Open-Label Extension to Evaluate the Safety of Oral LMI070/Branaplam in Early Manifest Huntington's Disease (VIBRANT-HD Trial)

Phase 2
Waitlist Available
Research Sponsored by Novartis Pharmaceuticals
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up pre-dose and 4, 7, 12, 22, 72 and 168 hours after branaplam dose at week 1

Summary

This trial tests branaplam, a drug aimed at lowering harmful protein levels, in adults with early-stage Huntington's Disease. The goal is to see if reducing these proteins can help manage the disease by slowing its progression. Branaplam is being investigated for its potential to lower harmful protein levels in Huntington's Disease.

Eligible Conditions
  • Huntington's disease

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~pre-dose and 4, 7, 12, 22, 72 and 168 hours after branaplam dose at week 1 and week 17
This trial's timeline: 3 weeks for screening, Varies for treatment, and pre-dose and 4, 7, 12, 22, 72 and 168 hours after branaplam dose at week 1 and week 17 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Percentage Change From Baseline to Week 17 in mHTT Protein in CSF
Secondary study objectives
Area Under the Plasma Concentration-time Curve From Time Zero to 168 Hours (AUC0-168h) of Branaplam and Its Metabolite UFB112
Area Under the Plasma Concentration-time Curve From Time Zero to Infinity (AUCinf) of Branaplam and Its Metabolite UFB112
Change From Baseline in the Unified Huntington's Disease Rating Scales (UHDRS) Independence Scale (IS)
+17 more
Other study objectives
Number of Participants With NfL Increase and Recovery

Trial Design

4Treatment groups
Experimental Treatment
Placebo Group
Group I: Treatment Arm C or X or YExperimental Treatment1 Intervention
(C) Branaplam 154 mg oral solution once weekly, OR (X) Branaplam 84 mg oral solution once weekly OR (Y) Branaplam 28 mg oral solution once weekly
Group II: Treatment Arm BExperimental Treatment1 Intervention
Branaplam 112 mg oral solution once weekly
Group III: Treatment Arm AExperimental Treatment1 Intervention
Branaplam 56 mg oral solution once weekly
Group IV: PlaceboPlacebo Group1 Intervention
Matching placebo oral solution once weekly

Find a Location

Who is running the clinical trial?

Novartis PharmaceuticalsLead Sponsor
2,916 Previous Clinical Trials
4,253,827 Total Patients Enrolled

Media Library

Huntington's disease Research Study Groups: Treatment Arm A, Treatment Arm B, Treatment Arm C or X or Y, Placebo
Huntington's disease Clinical Trial 2023: Branaplam Highlights & Side Effects. Trial Name: NCT05111249 — Phase 2
~6 spots leftby Dec 2025
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