At a glance
ClinicalIndex Comparison Record- ✓Age 18–70 years
- ✓SLE diagnosis by meeting 4 of Systemic Lupus International Collaborating Clinics classification criteria (≥1 clinical and ≥1 immunologic, or lupus nephritis with ANA/anti-dsDNA)
- ✓Elevated ANA ≥1:80 OR positive anti-dsDNA or anti-Smith above normal at screening
- ✓SLEDAI-2K score ≥8 at screening with ≥1 clinical component (arthritis, rash, myositis, mucosal ulcers, pleurisy, pericarditis, or vasculitis)
- ✕Drug-induced SLE (not idiopathic)
- ✕Other systemic autoimmune disease (erosive arthritis, RA, MS, systemic sclerosis, vasculitis not related to SLE) except RA-Lupus overlap and secondary Sjögren syndrome
- ✕Major surgery within 6 weeks or elective surgery planned during study
- ✕Active or unstable lupus neuropsychiatric manifestations (BILAG A criteria), except mononeuritis multiplex and polyneuropathy
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 2 clinical trial evaluating BOS161721 and Placebo for Systemic Lupus Erythematosus. Completed, enrolled 143 participants across 68 sites in 12 countries.
Detailed 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.
Study Details
Timeline
Interventions
SC administration
SC administration