Testing a new injectable treatment for lupus in healthy people and lupus patients

Plain-English translation of NCT06625671 on ClinicalTrials.gov ↗ · Source last updated June 2026 · Translation generated June 2026 · How we translate trials

Phase 1/2 — A combined trial that checks safety and dosing while also starting to look at whether the treatment works.

What is this trial?

This trial is testing a new injectable medication called in two groups: healthy adults and people who have been diagnosed with systemic lupus erythematosus (SLE) or cutaneous lupus erythematosus (CLE). Researchers want to understand how safe the medication is, how your body processes it, and whether it helps reduce lupus symptoms.

Lupus is a chronic disease where the immune system attacks the body's own tissues, causing skin rashes, joint pain, and other serious problems. This trial exists to find out if this new treatment might offer patients a safer or more effective option than currently available therapies.

Do you qualify?

You likely qualify if…

you are between 18 and 70 years old
you have been diagnosed with systemic or cutaneous lupus and meet specific medical criteria
you have active lupus skin disease or rash at the time of screening
you have been on a stable lupus medication regimen for at least 1 month before joining
you are willing to use effective contraception during the study if you can become pregnant or father children
you are able and willing to follow the study protocol and complete all required visits and evaluations

You likely don't qualify if…

you have active lupus affecting your kidneys or moderate-to-severe kidney disease
you have active neuropsychiatric lupus symptoms within the past 8 weeks
you have other active skin conditions like psoriasis or arthritis unrelated to lupus that might interfere with the study
you have a history of cancer or ongoing cancer treatment
you have a recent history of active infections, herpes zoster (shingles), or recurrent cold sores

What participation looks like

You will receive injections of either the new medication or a placebo (inactive substance) at various dose levels during study visits. The trial has two parts: Part A involves healthy volunteers to test basic safety, and Part B involves people with lupus to evaluate both safety and how well the treatment works. You will have blood tests, physical exams, and skin assessments at multiple visits over several weeks to months to monitor your response and any side effects.

AI-generated summary from trial data · Jun 5, 2026 · Not medical advice

Trial locations(7 sites)

United States

US06-0, La Palma, California

US03-0, Clearwater, Florida

US05-0, Orlando, Florida

US08-0, Syracuse, New York

US04-0, Irving, Texas