P140

Evidence in perspective

The early response signal must be read alongside an unscheduled interim analysis, a subgroup defined after study start, and the phase III failure reported in a later journal review. Phase II does not establish lupus efficacy.

Who was studied

Patients with systemic lupus erythematosus in early phase 2 trials.

What the sources found

A phase 2b study found a response signal for one schedule added to standard care.

What remains unknown

The phase IIb study stopped enrollment after an unscheduled interim analysis; its highlighted target population was not defined at study start, and the week-24 difference was not significant. A 2018 journal review reports that phase III missed its primary endpoint (p=0.2631 versus placebo). That secondary report does not replace the full phase III trial report, which remains needed.

How it works

An antigen-derived peptide investigated for modulation of autoimmune responses.

An antigen-derived peptide investigated for modulation of autoimmune responses. This historical study is not a complete account of subsequent development or proof of current approval.

Human trials

This catalog identifies human research. A trial can be early, small or negative; its existence does not establish approval or benefit for every proposed use. Check the study population and outcomes.

Understanding the evidence

Reported adverse effects

• Mild injection-site redness was the most commonly reported adverse event in the phase 2b report.