Trials / Recruiting
RecruitingNCT06799520
A Phase 1 Trial to Evaluate the Safety, Tolerability, Pharmacodynamics, Pharmacokinetics, and Immunogenicity of VIS171 in Participants With Autoimmune Disease(s)
A Phase 1 Open-label Trial to Evaluate the Safety, Tolerability, Pharmacodynamics, Pharmacokinetics, and Immunogenicity of Subcutaneous VIS171 in Participants With Autoimmune Disease(s)
- Status
- Recruiting
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 30 (estimated)
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc. · Industry
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this trial is to measure safety and tolerability of subcutaneous (SC) VIS171 in combination with standard of care in participants with autoimmune disease(s). The total duration of the clinical trial for each participant will be up to approximately 9 to 12 months.
Conditions
- Systemic Lupus Erythematosus (SLE)
- Alopecia Areata (AA)
- Immune-mediated Focal Segmental Glomerulosclerosis (FSGS)
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | VIS171 | VIS171 will be administered as a SC injection. |
Timeline
- Start date
- 2025-03-17
- Primary completion
- 2026-12-01
- Completion
- 2027-03-01
- First posted
- 2025-01-29
- Last updated
- 2025-09-17
Locations
6 sites across 4 countries: Bulgaria, Moldova, Romania, Spain
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT06799520. Inclusion in this directory is not an endorsement.