Study of BOS161721 in Systemic Lupus Erythematosus (SLE) Patients on a Background of Limited Standard of Care
Public ClinicalTrials.gov record NCT03371251. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Randomized Double-Blind Phase 1b/2 Combined Staggered Multiple Dose Escalation Study of BOS161721 in Systemic Lupus Erythematosus (SLE) Patients on a Background of Limited Standard of Care
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This study will be conducted to assess the safety, tolerability, and immunogenicity of repeat doses of BOS161721 (20 milligrams \[mg\], 60 mg, and 120 mg) administered subcutaneously in adult participants with moderately to severely active Systemic Lupus Erythematosus (SLE) on limited background standard of care treatment, in order to estimate the optimal dose. BOS161721 at the chosen dose will be compared to placebo for response on the SLE Responder Index 4, with sustained reduction of oral corticosteroids, in the same participant population.
Study identification
- NCT ID
- NCT03371251
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 1, Phase 2
- Enrollment
- 143 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years to 70 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jan 9, 2018
- Primary completion
- Nov 25, 2020
- Completion
- Nov 25, 2020
- Last update posted
- Mar 13, 2022
2018 – 2020
United States locations
- U.S. sites
- 17
- U.S. states
- 9
- U.S. cities
- 17
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Pinnacle Research Group | Anniston | Alabama | 36207 | — |
| TriWest Research Associates | El Cajon | California | 92020-4124 | — |
| Valerius Medical Group and Research Center | Los Alamitos | California | 90720-5403 | — |
| Westlake Medical Research | Thousand Oaks | California | 91360-3994 | — |
| Clinical Research of West Florida | Clearwater | Florida | 33765-2616 | — |
| Omega Research Consultants | DeBary | Florida | 32713-2260 | — |
| Centre for Rheumatology Immunology and Arthritis | Fort Lauderdale | Florida | 33309-1715 | — |
| Millennium Research | Ormond Beach | Florida | 32174 | — |
| The Arthritis Center | Palm Harbor | Florida | 34684 | — |
| Clinical Research of West Florida | Tampa | Florida | 33603 | — |
| Clinic of Robert Hozman/Clinical Investigation Specialists, Inc. | Skokie | Illinois | 60076-1238 | — |
| Indiana University School of Medicine | Indianapolis | Indiana | 46202 | — |
| Aa Mrc Llc | Grand Blanc | Michigan | 48439 | — |
| June DO PC | Lansing | Michigan | 48910-8595 | — |
| Joint and Muscle Research Institute | Charlotte | North Carolina | 28204-3130 | — |
| Ramesh C. Gupta M.D. | Memphis | Tennessee | 38119-5214 | — |
| Accurate Clinical Research Inc | Houston | Texas | 77089 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 51 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03371251, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Mar 13, 2022 · Synced Sep 13, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT03371251 live on ClinicalTrials.gov.