Actively Recruiting
A Phase 1 Open-label Trial to Evaluate the Safety, Tolerability, Pharmacodynamics, Pharmacokinetics, and Immunogenicity of Subcutaneous 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
12 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This trial evaluates the safety and tolerability of a drug called VIS171, given by subcutaneous injection, in people with autoimmune diseases such as systemic lupus erythematosus (SLE), alopecia areata (AA), and immune-mediated focal segmental glomerulosclerosis (FSGS). The study is a Phase 1 trial conducted by Otsuka Pharmaceutical Development & Commercialization, Inc., aiming to assess how the body responds to VIS171 in combination with standard care. Participants will receive VIS171 injections weekly from Week 1 through Week 21. The trial is open-label, meaning everyone receives the study drug and knows the treatment being given. The treatment period lasts about 21 weeks, followed by additional monitoring to assess safety and immune responses, including measuring specific immune cell changes and drug levels. Throughout the study, participants will have regular visits to monitor side effects and evaluate their immune system, including blood tests to measure regulatory T cells and other immune cells. The main outcome measured is the number of participants experiencing adverse events from the first dose up to Week 45. The total participation time is about 9 to 12 months, including treatment and follow-up.
CONDITIONS
Brief 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 systemic lupus erythematosus (SLE) participants: confirmed diagnosis according to classification criteria at least 24 weeks before consent.
- For alopecia areata (AA) participants: scalp involvement between 25% and 95% at screening.
- For AA participants: current episode longer than 24 weeks but no more than 5 years with less than 10% hair regrowth.
- For focal segmental glomerulosclerosis (FSGS) participants: prior biopsy showing MCD, FSGS, or spectrum.
- For FSGS participants: history of nephrotic syndrome 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 remission or relapse as defined by managing physician.
You will not qualify if you...
- Receipt of high-dose corticosteroid therapy within 4 weeks before screening.
- Receipt of blood products within 6 months before screening.
- Previous exposure to VIS171 or drugs targeting IL-2 or regulatory T cells.
- History or current diagnosis of severe anti-phospholipid syndrome within 1 year before consent.
- Known primary immunodeficiency disorder.
- History of Class V lupus nephritis.
- Use of certain immunosuppressants or therapies other than specified drugs within 6 months before screening.
- Presence of other types of hair loss besides alopecia areata.
- Recent use of systemic or topical therapies for alopecia areata within specified time frames before Day 1.
- Steroid-resistant nephrotic syndrome as defined by lack of remission after corticosteroid therapy.
- Use of immunosuppressants like anifrolumab, TNF-alpha monoclonal antibodies, or JAK inhibitors within 6 months before screening.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 21 weeks
Participants receive VIS171 by subcutaneous injection from Week 1 to Week 21 to evaluate safety, tolerability, and immune effects.
Weekly visits for up to 21 weeks
Duration - Up to 24 weeks after treatment
Participants are monitored for safety and adverse events up to Week 45 after the first dose.
Approximately 6 post-treatment visits
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
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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