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| ID | Type | Description | Link |
|---|---|---|---|
| 2024-518976-30 | Other Identifier | EU Trial Number |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| VIS171 | Experimental | Participants will receive VIS171 dose via SC injection, from Week 1 to Week 21. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| VIS171 | Drug | VIS171 will be administered as a SC injection. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants with Treatment Emergent Adverse Events (TEAEs) Graded by Severity | From first dose of the study drug up to end of the study (up to Week 45) |
| Measure | Description | Time Frame |
|---|---|---|
| Change from Baseline in Absolute Number of Regulatory T (Treg) Cells, Total T Helper Cells, Cytotoxic T Cells, and Natural Killer Cells in Blood | 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 |
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Inclusion Criteria:
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 scalp involvement between 25% and 95%, inclusive (Severity of Alopecia Tool [SALT] score between 25 and 95, inclusive), at screening.
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:
Prior biopsy (no time limit) showing histologic minimal change disease (MCD), FSGS, or MCD/FSGS spectrum.
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).
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:
Note: Other protocol-specified Inclusion/Exclusion criteria may apply.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Visterra Inc. Clinical Trial Lead | Contact | 617-498-1070 | clinicaltrials@visterrainc.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Visterra Investigational Site | Recruiting | Sofia | 1404 | Bulgaria | ||
| Visterra Investigational Site |
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.
Data will be available after marketing approval in global markets,or beginning 1-3 years following article publication. There is no end date to the availability of the data.
Otsuka will share data on the Vivli data sharing platform which can be found here: https://vivli.org/ourmember/Otsuka/
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| From baseline up to Week 21 |
| Serum Concentration of VIS171 Over Time | Up to Week 21 |
| Number of Participants with Confirmed Positive or Negative Anti-drug Antibody (ADA) Titers | Up to Week 21 |
| Recruiting |
| Chisinau |
| MD-2025 |
| Moldova |
| Visterra Investigational Site | Recruiting | Bucharest | 11658 | Romania |
| Visterra Investigational Site | Recruiting | Cluj-Napoca | 40006 | Romania |
| Visterra Investigational Site | Not yet recruiting | Barcelona | 8035 | Spain |
| Visterra Investigational Site | Not yet recruiting | Granada | 18014 | Spain |
| ID | Term |
|---|---|
| D008180 | Lupus Erythematosus, Systemic |
| D000506 | Alopecia Areata |
| ID | Term |
|---|---|
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D000505 | Alopecia |
| D007039 | Hypotrichosis |
| D006201 | Hair Diseases |
| D012871 | Skin Diseases |
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