What is the mechanism of action of this treatment?

Common treatments for Systemic Lupus Erythematosus (SLE) include monoclonal antibodies and immunomodulatory drugs that target specific immune pathways. For example, BIIB059 (litifilimab) is a monoclonal antibody targeting blood dendritic cell antigen 2 (BDCA2), which regulates plasmacytoid dendritic cells and reduces the production of type I interferons, key players in lupus pathogenesis. Other treatments like rituximab target CD20-positive B cells to reduce autoantibody production, while JAK inhibitors like tofacitinib block signaling pathways involved in immune cell activation. These mechanisms are crucial for SLE patients as they help to control the overactive immune response, reduce inflammation, and prevent organ damage, thereby improving quality of life and disease outcomes.

What side effects are associated with this type of intervention?

Common treatments for Systemic Lupus Erythematosus (SLE) that are similar to BIIB059 (litifilimab), which targets blood dendritic cell antigen 2 (BDCA2), often include monoclonal antibodies and therapies aimed at modulating the immune system. Known side effects of these treatments typically include infusion reactions, increased risk of infections due to immunosuppression, and the potential for developing antibodies against the treatment. Additionally, patients may experience specific side effects such as skin reactions or a temporary exacerbation of lupus symptoms.

What prior FDA approvals exist?

The FDA has approved several treatments for Systemic Lupus Erythematosus (SLE) that target the immune system. Belimumab, a monoclonal antibody that inhibits B-lymphocyte stimulator (BLyS), was the first drug approved for SLE in over 50 years. Anifrolumab, another monoclonal antibody, targets the type I interferon receptor and was approved for SLE in 2021. These treatments, like BIIB059 (litifilimab), focus on modulating the immune response, particularly the pathways involving B cells and type I interferons, which are crucial in the pathogenesis of lupus.

What other types of research exist?

Promising novel alternatives to BIIB059 for SLE patients include obinutuzumab, a next-generation humanized type-2 anti-CD20 antibody, which has shown efficacy in SLE patients with secondary non-response to rituximab. Additionally, therapies targeting the IL-23/IL-17 axis, such as ustekinumab and secukinumab, have shown potential in autoimmune conditions and may be considered for SLE treatment.

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Monoclonal Antibodies

Litifilimab for Cutaneous Lupus Erythematosus (AMETHYST Trial)

Phase 2 & 3

Recruiting

Research Sponsored by Biogen

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Histologically confirmed diagnosis of CLE with or without systemic manifestations

Must have active cutaneous manifestations that meet study criteria

Must not have

Active severe lupus nephritis

Use of immunosuppressive or disease-modifying treatments for SLE or CLE that were initiated less than 12 weeks prior to randomization, have not been at a stable and allowable dose

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Summary

This trial is testing BIIB059, a new medicine that targets specific immune cells, in patients with skin lupus who haven't responded to standard treatments. The goal is to see if it can reduce their skin symptoms by calming down these immune cells.

Who is the study for?

This trial is for people with active skin lupus (SCLE or CCLE) who haven't gotten better after using antimalarial treatments. They need to have a confirmed diagnosis of CLE, active skin symptoms that meet the study's requirements, and a CLASI-A score of 10 or more.

What is being tested?

The trial tests if BIIB059 (litifilimab) is better than a placebo at reducing skin disease activity in patients with SCLE/CCLE. It measures this by looking at changes in two scores: CLA-IGA-R and CLASI-A. The study also looks at safety, tolerability, and immune response to the drug.

What are the potential side effects?

Possible side effects include reactions where the drug is injected, increased risk of infections due to immune system suppression, potential liver issues indicated by blood test changes, allergic reactions, and possibly others not yet known.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My diagnosis of cutaneous lupus erythematosus is confirmed by tissue examination.

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I have skin symptoms that fit the study's requirements.

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I still have a skin lesion from lupus despite taking antimalarial medication.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have severe kidney inflammation due to lupus.

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I haven't started new SLE or CLE treatments in the last 12 weeks.

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I have active lupus affecting my nervous system.

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I have no skin conditions that could affect the study, except for CLE.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Trial Design

4Treatment groups

Experimental Treatment

Placebo Group

Group I: Part B (Phase 3): LitifilimabExperimental Treatment1 Intervention

Participants will receive litifilimab SC Q4W from Week 0 to Week 20, with an additional dose of litifilimab at Week 2 during the DBPC treatment period. Following the DBPC treatment period, participants will receive litifilimab during the ETP from Week 24 to Week 48, with an additional dose of litifilimab-matching placebo at Week 26.

Group II: Part A (Phase 2): LitifilimabExperimental Treatment1 Intervention

Participants will receive litifilimab subcutaneously (SC) once every 4 weeks (Q4W) from Week 0 to Week 20, with an additional dose of litifilimab at Week 2 during the double-blind placebo-controlled (DBPC) treatment period. Following the DBPC treatment period, participants will receive litifilimab during the extended treatment period (ETP) from Week 24 to Week 48, with an additional dose of litifilimab-matching placebo at Week 26.

Group III: Part A (Phase 2): PlaceboPlacebo Group1 Intervention

Participants will receive litifilimab-matching placebo SC Q4W from Week 0 to Week 20, with an additional dose of litifilimab-matching placebo at Week 2 during the DBPC treatment period. Following the DBPC treatment period, participants will receive litifilimab during the ETP from Week 24 to Week 48, with an additional dose of litifilimab at Week 26.

Group IV: Part B (Phase 3): PlaceboPlacebo Group1 Intervention

0 / 7Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for Systemic Lupus Erythematosus (SLE) include monoclonal antibodies and immunomodulatory drugs that target specific immune pathways. For example, BIIB059 (litifilimab) is a monoclonal antibody targeting blood dendritic cell antigen 2 (BDCA2), which regulates plasmacytoid dendritic cells and reduces the production of type I interferons, key players in lupus pathogenesis. Other treatments like rituximab target CD20-positive B cells to reduce autoantibody production, while JAK inhibitors like tofacitinib block signaling pathways involved in immune cell activation. These mechanisms are crucial for SLE patients as they help to control the overactive immune response, reduce inflammation, and prevent organ damage, thereby improving quality of life and disease outcomes.