Skip to main content
TTrialFinderData
TrialFinderData is for informational purposes only and does not provide medical advice. Always talk to your doctor.

Updated May 2026 · ClinicalTrials.gov

RECRUITINGPhase 1INTERVENTIONAL

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)

A Phase 1 Trial to Evaluate the Safety, Tolerability, Pharmacodynamics, Pharmacokinetics, and Immunogenicity of VIS171 in Participants With Autoimmune Disease(s) (NCT06799520) is a Phase 1 interventional studying Systemic Lupus Erythematosus (SLE) and Alopecia Areata (AA), sponsored by Otsuka Pharmaceutical Development & Commercialization, INC.. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

What Stage of Research Is This?

Phase 1 trials test a new treatment for the first time in humans, focusing on safety, dosing, and how the body processes the drug. For Systemic Lupus Erythematosus (SLE), a Phase 1 study typically enrolls a small number of participants — often healthy volunteers or patients who have exhausted standard treatment options. Phase 1 results determine whether a treatment moves into larger Phase 2 efficacy studies.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

With a target enrollment of 30 participants, this is a small study — typical of early-phase research, rare-disease trials, or pilot studies designed to generate preliminary signal before a larger study is launched.

Who May Be Eligible (Plain English)

Who May Qualify: 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 willing to sign a consent form 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). Who Should NOT Join This Trial: 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. ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language
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: 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.

Treatments Being Tested

DRUG

VIS171

VIS171 will be administered as a SC injection.

Locations (6)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

Visterra Investigational Site
Sofia, Bulgaria
Visterra Investigational Site
Chisinau, Moldova
Visterra Investigational Site
Bucharest, Romania
Visterra Investigational Site
Cluj-Napoca, Romania
Visterra Investigational Site
Barcelona, Spain
Visterra Investigational Site
Granada, Spain

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT06799520), the sponsor (Otsuka Pharmaceutical Development & Commercialization, INC.), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT06799520 clinical trial studying?

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. The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT06799520?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT06799520?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT06799520. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT06799520. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-05-08 · Data from ClinicalTrials.gov.