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Open-label Extension Study to Evaluate the Safety and Tolerability of WVE-120102 in Patients With Huntington's Disease
Phase 1, PHASE2 trial testing WVE-120102 in Huntington Disease in 36 participants. Terminated before completion.
| Lead sponsor | Wave Life Sciences Ltd. |
|---|---|
| Phase | Phase 1, PHASE2 |
| Status | Terminated |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 36 |
| Start date | 24 September 2019 |
| Primary completion | 29 April 2021 |
| Estimated completion | 29 April 2021 |
| Sites | 20 locations across Denmark, France, United Kingdom, Germany, Poland, Canada, Australia |
Wave Life Sciences Ltd. — full company profile →
Eligibility, any sex, with Huntington Disease. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
| Group | Value | 95% CI |
|---|---|---|
| 4 mg WVE-120102 | 7 | |
| 8 mg WVE-120102 | 14 | |
| 16 mg WVE-120102 | 34 | |
| 32 mg WVE-120102 | 17 |
| Group | Value | 95% CI |
|---|---|---|
| 4 mg WVE-120102 | 0 | |
| 8 mg WVE-120102 | 0 | |
| 16 mg WVE-120102 | 2 | |
| 32 mg WVE-120102 | 5 |
| Group | Value | 95% CI |
|---|---|---|
| 4 mg WVE-120102 | 0 | |
| 8 mg WVE-120102 | 1 | |
| 16 mg WVE-120102 | 5 | |
| 32 mg WVE-120102 | 3 |
| Group | Value | 95% CI |
|---|---|---|
| 4 mg WVE-120102 | 0 | |
| 8 mg WVE-120102 | 1 | |
| 16 mg WVE-120102 | 3 | |
| 32 mg WVE-120102 | 0 |
Time frame: Day 1 to Study Termination (maximum of 12 monthly doses). Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | 4 mg WVE-120102 | 8 mg WVE-120102 | 16 mg WVE-120102 | 32 mg WVE-120102 |
|---|---|---|---|---|---|
| Meningitis asceptic | Infections and infestations | — | — | — | — |
| Confusional state | Psychiatric disorders | — | — | — | — |
| Amnesia | Nervous system disorders | — | — | — | — |
| Pyrexia | General disorders | — | — | — | — |
| Meningitis | Infections and infestations | — | — | — | — |
| Nervous system disorder | Nervous system disorders | — | — | — | — |
| Aggression | Psychiatric disorders | — | — | — | — |
| Agitation | Psychiatric disorders | — | — | — | — |
| Reaction | System | 4 mg WVE-120102 | 8 mg WVE-120102 | 16 mg WVE-120102 | 32 mg WVE-120102 |
|---|---|---|---|---|---|
| Headache | Nervous system disorders | — | — | — | — |
| CSF protein increased | Investigations | — | — | — | — |
| Pyrexia | General disorders | — | — | — | — |
| Fatigue | General disorders | — | — | — | — |
| Back pain | Musculoskeletal and connective tissue disorders | — | — | — | — |
| Fall | Injury, poisoning and procedural complications | — | — | — | — |
| CSF lymphocyte count increased | Investigations | — | — | — | — |
| Pain in extremity | Musculoskeletal and connective tissue disorders | — | — | — | — |
| Confusional state | Psychiatric disorders | — | — | — | — |
| Procedural pain | Injury, poisoning and procedural complications | — | — | — | — |
| Dizziness | Nervous system disorders | — | — | — | — |
| Nausea | Gastrointestinal disorders | — | — | — | — |
| Vomiting | Gastrointestinal disorders | — | — | — | — |
| Pain | General disorders | — | — | — | — |
| CSF test abnormal | Investigations | — | — | — | — |
| Muscular weakness | Musculoskeletal and connective tissue disorders | — | — | — | — |
| Ataxia | Nervous system disorders | — | — | — | — |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | — | — | — | — |
| Gait disturbance | General disorders | — | — | — | — |
| Nasopharyngitis | Infections and infestations | — | — | — | — |
| Procedural headache | Injury, poisoning and procedural complications | — | — | — | — |
| CSF white blood cell count | Investigations | — | — | — | — |
| Lymphocyte count increased | Investigations | — | — | — | — |
| Neck pain | Musculoskeletal and connective tissue disorders | — | — | — | — |
| Myalgia | Musculoskeletal and connective tissue disorders | — | — | — | — |
| Balance disorder | Nervous system disorders | — | — | — | — |
| Memory impairment | Nervous system disorders | — | — | — | — |
| Somnolence | Nervous system disorders | — | — | — | — |
| Behavior disorder | Psychiatric disorders | — | — | — | — |
| Irritability | Psychiatric disorders | — | — | — | — |
| Restlessness | Psychiatric disorders | — | — | — | — |
| Tinnitus | Ear and labyrinth disorders | — | — | — | — |
| Dysphagia | Gastrointestinal disorders | — | — | — | — |
| Paresthesia oral | Gastrointestinal disorders | — | — | — | — |
| Injection site erythema | General disorders | — | — | — | — |
| Injection site hypersensitivity | General disorders | — | — | — | — |
| Cystitis | Infections and infestations | — | — | — | — |
| Oral candidiasis | Infections and infestations | — | — | — | — |
| Upper respiratory tract infection | Infections and infestations | — | — | — | — |
| Urinary tract infection | Infections and infestations | — | — | — | — |
Most-reported serious reactions: Meningitis asceptic, Confusional state, Amnesia, Pyrexia, Meningitis, Nervous system disorder, Aggression, Agitation.
Data from ClinicalTrials.gov NCT04617860 adverse events section.
WVE-HDSNP2-002 is an open-label extension (OLE) study to evaluate the safety, tolerability, PK, PD, and clinical effects of WVE-120102 in adult patients with early manifest HD who carry a targeted single nucleotide polymorphism, rs362331 (SNP2). To participate in the study, patients must have completed the Phase 1b/2a clinical study WVE-HDSNP2-001.
8 peer-reviewed publications reference this trial (live from Europe PMC):
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Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04617860.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing