In short
Clinical trials are studying Litifilimab in people with cutaneous lupus and systemic lupus erythematosus. These studies look at whether it can help reduce disease activity and whether it is safe over time. The trials include adults with active disease, including people who did not respond well to antimalarial therapy or who are taking background lupus standard care.
Key points
- Clinical trials of Litifilimab are studying both skin lupus and systemic lupus erythematosus. The skin lupus studies include people with subacute or chronic cutaneous lupus, including some with or without systemic manifestations and those who did not respond well to antimalarial therapy. The systemic lupus studies include adults with active SLE, often while they are receiving background standard care. Most of the trials are Phase 3, and one study is Phase 4. The main goals are to measure disease improvement and safety, using skin scores, lupus response scores, and reports of adverse events.
Trial overview
The available studies of Litifilimab are testing it in people with lupus, mainly cutaneous lupus erythematosus and systemic lupus erythematosus. These are interventional studies, which means researchers assign study treatment and compare results across groups.
All listed trials are authorised and include adults with active disease. Some studies compare Litifilimab with placebo, which is a look-alike treatment with no active medicine.
Studies in skin lupus
One major study, NCT05531565, is a Phase 4 trial in people with active subacute cutaneous lupus erythematosus and/or chronic cutaneous lupus erythematosus, with or without systemic manifestations, who are refractory or intolerant to antimalarial therapy. Refractory means the disease did not respond well to prior treatment, and intolerant means the person could not take the treatment because of side effects or other problems.
The primary goal in this skin lupus study is to see whether Litifilimab improves skin disease activity compared with placebo. In the US parts of the study, the main skin measure is the CLA-IGA-R erythema score, which tracks redness and overall skin activity. In the rest-of-world part, the study uses CLASI-70, which means at least a 70% drop in the skin activity score from the start of the study.
The long-term extension study, 2023-504863-17-00, follows adults who completed the parent skin lupus study and looks mainly at long-term safety and tolerability up to 128 weeks. This study helps researchers learn what happens with continued treatment over a longer period.
Studies in systemic lupus
Three Phase 3 studies focus on active systemic lupus erythematosus, also called SLE. These studies include adults with active SLE, and some participants receive background nonbiologic lupus standard of care, meaning their usual lupus treatment that is not a biologic medicine.
NCT05352919 is designed to evaluate the continuous safety and efficacy of Litifilimab in adults with active SLE, and it also includes a substudy on the safety of the device used to give the injections. The main safety outcomes are treatment-emergent adverse events and serious adverse events.
NCT04895241 and NCT04961567 both compare BIIB059, named as Litifilimab in the trial data, with placebo in adults with active SLE receiving background standard care. These trials are designed to show whether the treatment lowers disease activity better than placebo.
What the trials measure
The trials measure both efficacy, which means how well the treatment works, and safety, which means how often health problems happen during the study.
For skin lupus, the studies use skin-focused scores such as CLA-IGA-R and CLASI-A to see whether redness and skin activity improve. For systemic lupus, the studies use the SLE Responder Index of 4 (SRI-4) at Week 52, which is a combined way to measure whether lupus has improved enough to count as a response.
Safety outcomes include treatment-emergent adverse events and serious adverse events. A treatment-emergent adverse event is a health problem that starts or gets worse after treatment begins, while a serious adverse event is a more severe medical problem.
Who can participate
The skin lupus studies include adults with active subacute or chronic cutaneous lupus, with or without systemic manifestations. Some of these participants must also be refractory or intolerant to antimalarial therapy.
The systemic lupus studies include adults with active SLE, and some are receiving background lupus standard of care at the time they enter the study. The trial data do not give more detailed entry rules, so the exact eligibility requirements would need to be checked in each study record.
Trial phases and design
Most of the Litifilimab studies listed here are Phase 3 trials, which are usually large studies that test whether a treatment works and continues to be safe. One skin lupus study is a Phase 4 trial, which looks at treatment results after earlier testing has already been done.
The enrollment numbers are relatively large, ranging from 323 participants in the long-term skin lupus extension study to 948 participants in one systemic lupus trial. This suggests that the researchers want enough participants to compare groups and track both benefit and safety over time.