Actively Recruiting
A Phase 1 Trial to Evaluate the Safety, Tolerability, Pharmacodynamics, Pharmacokinetics, and Immunogenicity of VIS171 in Participants With Autoimmune Disease(s)
Led by Otsuka Pharmaceutical Development & Commercialization, Inc. · Updated on 2025-09-17
30
Participants Needed
6
Research Sites
102 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
A Phase 1 Trial to Evaluate the Safety, Tolerability, Pharmacodynamics, Pharmacokinetics, and Immunogenicity of VIS171 in Participants With Autoimmune Disease(s)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Estimated glomerular filtration rate (eGFR) greater than 30 mL/min/1.73 m2 at screening
- For SLE participants: Confirmed diagnosis of SLE according to European League Against Rheumatism/American College of Rheumatology criteria at least 24 weeks before consent
- For AA participants: Current scalp involvement between 25% and 95% (SALT score 25-95) at screening
- For AA participants: Current episode duration of more than 24 weeks but no more than 5 years with no more than 10% spontaneous hair regrowth
- For FSGS participants: Prior biopsy showing minimal change disease, FSGS, or both
- For FSGS participants: History of at least one nephrotic syndrome episode with 24-hour urine protein over 3.5 g/day and serum albumin below 3.5 g/dL
- For FSGS participants: History of steroid responsive nephrotic syndrome, including complete or partial remission or steroid-dependent/relapsing syndrome
You will not qualify if you...
- Received high-dose corticosteroids (IV pulse or oral ≥1 mg/kg or up to 40 mg/day prednisone equivalent) within 4 weeks before screening
- Received blood products within 6 months before screening
- Previous exposure to VIS171 or drugs targeting IL-2, IL-2 receptor, or T regulatory cells
- History or current diagnosis of severe or catastrophic anti-phospholipid syndrome (APS) within 1 year before consent, except controlled cases
- Known primary immunodeficiency disorder
- History of Class V lupus nephritis
- Received anifrolumab, TNF-alpha monoclonal antibodies, immunoglobulins, plasmapheresis, or immunosuppressants (except hydroxychloroquine, mycophenolic acid, corticosteroids) within 6 months before screening
- Concomitant hair loss conditions other than AA
- Received certain systemic or topical therapies for AA within specified time frames before Day 1
- Steroid resistant nephrotic syndrome without history of remission after corticosteroid therapy
- Receipt of immunosuppressive treatments such as anifrolumab, TNF-alpha mAb, immunoglobulins, plasmapheresis, or kinase inhibitors
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 6 locations
1
Visterra Investigational Site
Sofia, Bulgaria, 1404
Actively Recruiting
2
Visterra Investigational Site
Chisinau, Moldova, MD-2025
Actively Recruiting
3
Visterra Investigational Site
Bucharest, Romania, 11658
Actively Recruiting
4
Visterra Investigational Site
Cluj-Napoca, Romania, 40006
Actively Recruiting
5
Visterra Investigational Site
Barcelona, Spain, 8035
Not Yet Recruiting
6
Visterra Investigational Site
Granada, Spain, 18014
Not Yet Recruiting
Research Team
V
Visterra Inc. Clinical Trial Lead
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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