Evaluating VIS171 for autoimmune diseases

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

This study is testing a new treatment called VIS171 to see if it is safe and works well for people with autoimmune diseases like lupus and alopecia when used alongside their regular care.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 30 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc. (Industry-sponsored)
• Drugs / interventions: anifrolumab, methotrexate, prednisone
• Locations: 6 sites (Sofia and 5 other locations)
• Trial ID: NCT06799520 on ClinicalTrials.gov

What this trial studies

This trial aims to assess the safety and tolerability of VIS171, administered subcutaneously, in combination with standard care for participants suffering from autoimmune diseases such as Systemic Lupus Erythematosus, Alopecia Areata, and Immune-mediated Focal Segmental Glomerulosclerosis. Participants will be monitored over a period of approximately 9 to 12 months to evaluate the pharmacodynamics, pharmacokinetics, and immunogenicity of the treatment. The study will include specific eligibility criteria based on the severity and duration of the conditions being treated.

Who should consider this trial

Good fit: Ideal candidates include individuals diagnosed with Systemic Lupus Erythematosus, Alopecia Areata with significant scalp involvement, or those with a history of Immune-mediated Focal Segmental Glomerulosclerosis.

Not a fit: Patients with autoimmune diseases not specified in the trial or those with severe renal impairment (eGFR ≤ 30 mL/min/1.73 m²) may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with autoimmune diseases.

How similar studies have performed: While there have been studies on treatments for these autoimmune conditions, the specific approach with VIS171 is novel and has not been extensively tested.

Eligibility criteria

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.

Where this trial is running

Sofia and 5 other locations

• Visterra Investigational Site — Sofia, Bulgaria (Recruiting)
• Visterra Investigational Site — Chisinau, Moldova (Recruiting)
• Visterra Investigational Site — Bucharest, Romania (Recruiting)
• Visterra Investigational Site — Cluj-Napoca, Romania (Recruiting)
• Visterra Investigational Site — Barcelona, Spain (Not_yet_recruiting)
• Visterra Investigational Site — Granada, Spain (Not_yet_recruiting)

Study contacts

• Study coordinator: Visterra Inc. Clinical Trial Lead

Conditions Systemic Lupus Erythematosus; Alopecia Areata; Immune-mediated Focal Segmental Glomerulosclerosis