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
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.
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 →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.
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:
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:
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:
Exclusion Criteria:
Note: Other protocol-specified Inclusion/Exclusion criteria may apply.
Participants will receive VIS171 dose via SC injection, from Week 1 to Week 21.
Drug: VIS171
VIS171 will be administered as a SC injection.
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)
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
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
Serum Concentration of VIS171 Over Time
Time frame: Up to Week 21
Number of Participants with Confirmed Positive or Negative Anti-drug Antibody (ADA) Titers
Time frame: Up to Week 21
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
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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Lupus Erythematosus, Systemic→
Otsuka Pharmaceutical Development & Commercialization, Inc.