Trials / Terminated
TerminatedNCT05435742
SON-080 in Patients With Persistent Chemotherapy-induced Peripheral Neuropathy (CIPN)
A Randomized, Double-blind, Placebo-controlled Phase 1b/2a Study to Evaluate the Safety, Tolerability, and Efficacy of Repeated Subcutaneous Administration of SON-080 in Patients With Persistent Chemotherapy-induced Peripheral Neuropathy (CIPN) After the End of Chemotherapeutic Treatment
- Status
- Terminated
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 9 (actual)
- Sponsor
- Sonnet BioTherapeutics · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The study will be conducted in adult patients with Chemotherapy-induced Peripheral Neuropathy (CIPN) that has been persistent for at least 3 months following completion of chemotherapy. A total of 60 patients will be enrolled in equal numbers of a placebo group and two different SON-080 dose groups. Treatment period will be 12 weeks long and patients will be followed-up for an additional 12 weeks.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | SON-080 | Recombinant human interleukin-6 (rhIL-6) |
Timeline
- Start date
- 2022-10-27
- Primary completion
- 2024-03-17
- Completion
- 2024-03-17
- First posted
- 2022-06-28
- Last updated
- 2024-04-12
Locations
1 site across 1 country: Australia
Source: ClinicalTrials.gov record NCT05435742. Inclusion in this directory is not an endorsement.