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Active, not recruitingNCT06799520Updated Jul 22, 2026

A Phase 1 Trial to Evaluate the Safety, Tolerability, Pharmacodynamics, Pharmacokinetics, and Immunogenicity of VIS171 in Participants With Autoimmune Disease(s)

A Phase 1 interventional study of VIS171 in Systemic Lupus Erythematosus (SLE), Alopecia Areata (AA) and Immune-mediated Focal Segmental Glomerulosclerosis (FSGS), sponsored by Otsuka Pharmaceutical Development & Commercialization, Inc.. Active, not recruiting at 6 sites in 4 countries. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-07-22.

Sponsored by Otsuka Pharmaceutical Development & Commercialization, Inc. · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
30
Allocation
Not applicable
Ages
18 Years to 75 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Systemic Lupus Erythematosus (SLE)
  • Alopecia Areata (AA)
  • Immune-mediated Focal Segmental Glomerulosclerosis (FSGS)
03

In context

Lupus Erythematosus, Systemic

1,202 studies on the registry are indexed under Lupus Erythematosus, Systemic; 399 are open to participants now.

This study's planned enrollment of 30 is below the median of 50 across 867 interventional studies indexed under Lupus Erythematosus, Systemic.

Browse Lupus Erythematosus, Systemic studies →

Lead sponsor

Otsuka Pharmaceutical Development & Commercialization, Inc. is the lead sponsor of 289 studies on the registry; 18 are open to participants now.

Of its 104 completed or terminated interventional studies of FDA-regulated products, 69 (66%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Estimated glomerular filtration rate (eGFR) >30 milliliters/minute/1.73 square meters (mL/min/1.73 m\^2) at the screening visit.

    For SLE participants:

  2. Participant has a confirmed diagnosis of SLE according to European League Against Rheumatism/American College of Rheumatology SLE classification criteria ≥ 24 weeks prior to signing the informed consent form (ICF).

    For AA participants:

  3. Current scalp involvement between 25% and 95%, inclusive (Severity of Alopecia Tool [SALT] score between 25 and 95, inclusive), at screening.
  4. Current episode of AA is of duration > 24 weeks (without evidence of spontaneous terminal hair regrowth at the time of screening and first treatment, i.e., no more than 10% regrowth), but ≤ 5 years from onset of current episode of severe scalp hair loss.

    For FSGS participants:

  5. Prior biopsy (no time limit) showing histologic minimal change disease (MCD), FSGS, or MCD/FSGS spectrum.
  6. History of at least one prior episode of nephrotic syndrome, defined as 24-hour urine protein > 3.5 grams per day (g/day) and serum albumin \< 3.5 grams per deciliter (g/dL).
  7. History of steroid responsive nephrotic syndrome, including participants who achieved complete remission, partial remission, had a course of steroid dependent nephrotic syndrome or relapsing nephrotic syndrome (all defined as per the managing physician at the time of the episode).

Exclusion criteria

Exclusion Criteria:

  1. Receipt of high-dose corticosteroid therapy within 4 weeks prior to screening as either (a) intravenous (IV) pulse corticosteroid therapy or (b) daily oral corticosteroid therapy of ≥ 1 milligrams per kilogram (mg/kg) or up to 40 milligrams per day (mg/day) prednisone (or equivalent).
  2. Receipt of blood products within 6 months prior to screening.
  3. Previous exposure to VIS171 or any other drug targeting interleukins (IL)-2 or the IL-2 receptor or T regulatory cells.
  4. History of or current diagnosis of catastrophic or severe anti-phospholipid syndrome (APS) within 1 year prior to signing ICF. SLE participants with APS adequately controlled by anticoagulant are eligible. SLE participants who are found to be triple positive for anti-phospholipid antibodies at screening (without clinical APS) will be excluded unless they are on stable anti-thrombotic therapy.
  5. Known primary immunodeficiency disorder.
  6. Participant has a history of Class V lupus nephritis.
  7. Receipt of anifrolumab, tumor necrosis factor-alpha monoclonal antibodies ([TNF]-α mAb), immunoglobulins (IV/SC) plasmapheresis, or any other immunosuppressants (calcineurin inhibitors, Janus kinase [JAK] inhibitors or other kinase inhibitors), other than hydroxychloroquine, mycophenolic acid (MPA)/mycophenolate mofetil (MMF) and corticosteroids, within 6 months prior to screening.
  8. Participant has concomitant hair loss of another form, including but not limited to traction alopecia, central centrifugal cicatricial alopecia, lichen planopilaris, frontal fibrosing alopecia, or androgenetic alopecia.
  9. Participant has received (1) Within 12 weeks prior to Day 1: Systemic therapies (oral or injection), such as corticosteroids, JAK inhibitors, methotrexate, calcineurin inhibitors, oral minoxidil, low-dose IL-2 and topical immunotherapies such as psoralen plus UVA (PUVA) , diphenylcyclopropenone (DPCP), dinitrochlorobenzene (DNCB), intralesional steroids or (2) Within 4 weeks prior to Day 1: Other topical therapies, such as topical minoxidil, clobetasol etc. These therapies will also not be allowed during this trial.
  10. Steroid resistant nephrotic syndrome defined as absence of history of at least 1 episode of complete or partial remission following at least 12 weeks of full dose corticosteroid therapy.
  11. Receipt of anifrolumab, TNF-α mAb, immunoglobulins (IV/SC) plasmapheresis, or any other immunosuppressants (JAK inhibitors or other kinase inhibitors).

Note: Other protocol-specified Inclusion/Exclusion criteria may apply.

05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
30 participants (estimated)

Study arms

  • Experimental
    VIS171

    Participants will receive VIS171 dose via SC injection, from Week 1 to Week 21.

    Drug: VIS171

Interventions

  • DrugVIS171

    VIS171 will be administered as a SC injection.

06

What researchers measure

Primary outcomes

  1. Number of Participants with Treatment Emergent Adverse Events (TEAEs) Graded by Severity

    Time frame: From first dose of the study drug up to end of the study (up to Week 45)

Secondary outcomes

  1. Change from Baseline in Absolute Number of Regulatory T (Treg) Cells, Total T Helper Cells, Cytotoxic T Cells, and Natural Killer Cells in Blood

    Time frame: From baseline up to Week 21

  2. Percent Change from Baseline in Treg Cells/CD4+ Cells, Total T Helper Cells, Cytotoxic T Cells, and Natural Killer Cells in Blood

    Time frame: From baseline up to Week 21

  3. Serum Concentration of VIS171 Over Time

    Time frame: Up to Week 21

  4. Number of Participants with Confirmed Positive or Negative Anti-drug Antibody (ADA) Titers

    Time frame: Up to Week 21

07

Study locations

6 sites
  • Visterra Investigational Site
    Sofia, 1404, Bulgaria
  • Visterra Investigational Site
    Chisinau, MD-2025, Moldova
  • Visterra Investigational Site
    Bucharest, 11658, Romania
  • Visterra Investigational Site
    Cluj-Napoca, 40006, Romania
  • Visterra Investigational Site
    Barcelona, 8035, Spain
  • Visterra Investigational Site
    Granada, 18014, Spain
08

References and documents

Individual participant data

Plan to share: Yes — Anonymized Individual participant data (IPD) that underlie the results of this study will be shared with researchers to achieve aims pre-specified in a methodologically sound research proposal. Small studies with less than 25 participants are excluded from data sharing.

Supporting information: Study protocol, Sap, Icf

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 22, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06799520
Lead sponsor
Otsuka Pharmaceutical Development & Commercialization, Inc.
Responsible party
Sponsor
First posted
Jan 29, 2025
Start date
Mar 17, 2025
Primary completion
Oct 19, 2026 (estimated)
Completion
Feb 19, 2027 (estimated)
Last update
Jul 22, 2026

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.

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