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Study of BOS161721 in Systemic Lupus Erythematosus (SLE) Patients on a Background of Limited Standard of Care

NCT03371251 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 143

Last updated 2022-03-14

Study results available
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Summary

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.

Conditions

Interventions

DRUG

BOS161721

SC administration

DRUG

Placebo

SC administration

Sponsors & Collaborators

  • Boston Pharmaceuticals

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-01-10
Primary Completion
2020-11-26
Completion
2020-11-26
FDA Drug
Yes

Countries

  • United States
  • Argentina
  • Bulgaria
  • Colombia
  • Georgia
  • Hungary
  • Mexico
  • Peru
  • Philippines
  • Poland
  • Romania
  • Ukraine

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03371251 on ClinicalTrials.gov