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NCT05032196 (WVE-003 in Huntington's Disease): BVCT ex-ante prediction vs. reported outcome

On 21 Nov 2023, BioinvestGPT's BVCT predicted technical partial success and commercial failure for this trial. The 25 Jun 2024 readout is classified on the dashboard as True Negative (TN), a correct prediction. Recorded clinical-benefit conclusion: statistically significant in mHTT and commercially insufficient in TMS.

Clinical Trial

NCTID
NCT05032196
Acronym
SELECT-HD
Drug Name
WVE-003
Drug MoA
SNP3 mtHTT mRNA oligonucleotide
Drug Modality
stereopure antisense oligonucleotide
Drug Class
First-In-Class
Therapeutic Area
Nervous System Diseases
Indication
Huntington's Disease
Human Patients
47
Sponsor
Wave Life Sciences
Phase
Phase 1 Phase 2

Prediction of , index 1246

Prospective Prediction
Prediction Index
1246
Prediction Date
Commercial Prediction
FAILURE (commercially insufficient clinical benefit in modifying disease progression despite significant reduction in mHTT protein)
Technical Prediction
partial SUCCESS (statistically significant clinical benefit in reducing mHTT protein level); partial FAILURE (statistically insignificant clinical benefit in modifying disease progression)

Readout of

Prediction Validation
Readout Date
Prediction To Readout
217 days in advance
Readout Data Interpretation
-46% mean reduction in mHTT yet insignificant improvement for TMS.
Press Release
Prediction Result
Prediction Accuracy
Correct Prediction
Clinical Benefit Conclusion
statistically significant in mHTT and commercially insufficient in TMS
Prediction Classification
True Negative (TN)

ClinicalTrials.gov record

ClinicalTrials.gov record, retrieved 2026-09-24. Third-party data.

Official title
A Multicenter, Randomized, Double-blind, Placebo Controlled, Phase 1b/2a Study of WVE-003 Administered Intrathecally in Patients With Huntington's Disease (SELECT-HD)
Phase
Phase 1, Phase 2
Status
Completed
Enrollment
47
Lead sponsor
Wave Life Sciences USA, Inc.
Conditions
Huntington Disease
Interventions
DRUG: SAD: 30mg WVE-003; DRUG: SAD: 60mg WVE-003; DRUG: SAD: 90mg WVE-003; DRUG: SAD: Pooled Placebo; DRUG: MD: 30mg WVE-003; DRUG: MD: Placebo
Design
Randomized · Sequential · Double
Primary purpose
Treatment
Start
2021-09-06
Primary completion
2024-05-24
Completion
2024-05-24
Results first posted
2025-08-12
Primary outcomes
  • Safety: Proportion of Patients With Treatment Emergent Adverse Events (TEAEs) Related to Study Drug (Day 1 through Week 24 (single ascending dose Period 1); Day 1 through Week 28 (multi dose Period 2))

NCT05032196 on ClinicalTrials.gov

Return to the dashboardClinicalTrials.gov

How to read these records: evidence · methodology · all trials