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Study of BOS161721 in Systemic Lupus Erythematosus (SLE) Patients on a Background of Limited Standard of Care | Clinical Trials | Clareo Health

COMPLETEDPHASE1/PHASE2

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

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

NCT03371251•Boston Pharmaceuticals

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - 70 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Men and women, ages 18 to 70 years, inclusive
•Participants must be mentally capable of giving consent and there must be evidence of a personally signed and dated informed consent document indicating that the participant has been informed of all pertinent aspects of the study
•Participants must have Systemic Lupus Erythematosus (SLE) as defined by meeting 4 of the Systemic Lupus International Collaborating Clinics classification criteria for SLE (with at least 1 clinical and 1 immunologic criterion OR Lupus nephritis as the sole clinical criterion in the presence of anti-nuclear antibodies (ANA) or anti-double stranded deoxyribonucleic acid (dsDNA) antibodies), either sequentially or simultaneously
•At screening, participants must have at least 1 of the following:
•1. Elevated ANA ≥ 1:80 via immunofluorescent assay at the central laboratory
•2. Positive anti-dsDNA or anti-Smith (anti-Sm) above the normal level as determined by the central laboratory
•At screening, the total Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) score must be ≥ 8, including points from at least 1 of the following clinical components:
•a. Arthritis, rash, myositis, mucosal ulcers, pleurisy, pericarditis, and vasculitis Note: Points from lupus headache and organic brain syndrome will also be excluded from qualifying total and clinical SLEDAI-2K scores at screening and Day 0.
•A clinical SLEDAI-2K score of ≥ 6 at screening at Day 0. Clinical SLEDAI-2K score is defined as follows:
•1. Contains points from arthritis, rash, myositis, mucosal ulcers, pleurisy, pericarditis, or vasculitis
+17 more criteria

Exclusion Criteria

•Participants presenting with any of the following will not be included in this study:
•Drug-induced SLE, rather than "idiopathic" SLE
•Other systemic autoimmune disease (eg, erosive arthritis, rheumatoid arthritis \[RA\], multiple sclerosis \[MS\], systemic sclerosis, or vasculitis not related to SLE). RA-Lupus overlap (Rupus), and secondary Sjogren syndrome are allowed.
•Any major surgery within 6 weeks of study drug administration (Day 0) or any elective surgery planned during the course of the study
•Any history or risk for tuberculosis (TB), specifically those with:
•1. Current clinical, radiographic, or laboratory evidence of active TB
•2. History of active TB
•3. Latent TB defined as positive QuantiFERON-TB Gold In Tube or other diagnostic test in the absence of clinical manifestations. Latent TB is not excluded if the participant has documented completion of adequate course of prophylactic treatment with regimen recommended by local health authority guideline, or the participant has started treatment with isoniazid, or other regimen recommended by local health authority guidelines for at least 1 month before Day 0 and continues to receive the prophylactic treatment during study until the treatment course is completed
•Active or unstable lupus neuropsychiatric manifestations, including but not limited to any condition defined by BILAG A criteria, with the exception of mononeuritis multiplex and polyneuropathy, which are allowed
•Severe proliferative lupus nephritis (World Health Organization Class III, IV), which requires or may require induction treatment with cytotoxic agents or high dose CSs
+28 more criteria

Locations (68)

Pinnacle Research Group

Anniston, Alabama, United States

TriWest Research Associates

El Cajon, California, United States

Valerius Medical Group and Research Center

Los Alamitos, California, United States

Westlake Medical Research

Thousand Oaks, California, United States

Clinical Research of West Florida

Clearwater, Florida, United States

Omega Research Consultants

DeBary, Florida, United States

Centre for Rheumatology Immunology and Arthritis

Fort Lauderdale, Florida, United States

Millennium Research

Ormond Beach, Florida, United States

The Arthritis Center

Palm Harbor, Florida, United States

Clinical Research of West Florida

Tampa, Florida, United States

Key Dates

Start Date

January 10, 2018

Primary Completion Date

November 26, 2020

Completion Date

November 26, 2020

Last Updated

March 14, 2022

Enrollment

143

ACTUAL participants

Conditions

Systemic Lupus Erythematosus

Interventions

BOS161721

DRUG

Placebo

DRUG

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Systemic Lupus Erythematosus (SLE)Rheumatoid Arthritis (RA)

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 14, 2022Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

A Study to Evaluate the Safety and Activity of SAR448501/DR-0201 in Patients With Autoimmune Rheumatic Diseases

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