Active Digestion, Kidneys & Other Organs NIHR-supported project Lungs & Breathing

A 2-Part Seamless Part A (Phase 2)/Part B (Phase 3) Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy and Safety of BIIB059 in Participants with Active Subacute …

Funder NIHR (part of DHSC)
Recipient organisation NIHR Barts Clinical Research Facility
NIHR support Recorded as supported by this research centre
Period Mar 2025 — Mar 2027

In plain English

AI plain-English summary

Adults with a painful, itchy skin disease called cutaneous lupus erythematosus (CLE) will receive an experimental drug or a placebo for 24 weeks, then all will receive the drug for another 24 weeks, to see if it safely reduces skin inflammation. CLE causes skin lesions, fatigue, and sleep problems, and can progress to affect organs like the kidneys and heart. No drugs are approved specifically for CLE, and existing treatments often fail or cause intolerable side effects. This trial tests BIIB059, a targeted therapy, in patients whose standard antimalarial medicines have not worked. If BIIB059 proves effective and safe, it would become the first approved drug designed specifically for CLE. That would give patients a treatment option that directly reduces skin disease activity, potentially improving quality of life by easing pain, itching, and fatigue. It could also prevent progression to systemic lupus erythematosus, reducing long-term organ damage. The trial runs at about 225 sites worldwide, so results could change clinical practice globally.

View original technical description
This study is for adult patients with an autoimmune disease known as cutaneous lupus erythematosus (CLE). CLE affects the skin causing skin lesions. Other CLE symptoms include fatigue, pain, and itchy skin that can cause sleep problems. CLE can sometimes also have effects on the organs in the body, such as kidneys, joints, and heart. This is called systemic lupus erythematosus (SLE). Currently there are no approved drugs that are targeted to work specifically against CLE. Existing medications used in the treatment of CLE often do not work well and/or cause intolerable side effects. So there is a high need for new drugs that can reduce the impact of CLE on people’s quality of life.Only people who have specific types of CLE called subacute cutaneous lupus erythematosus (SCLE) or chronic cutaneous lupus erythematosus (CCLE) can take part in the study. Participants must also have been receiving standard care antimalarial medicines that do not work for them. This study is a randomised, double-blind, parallel-group, placebo-controlled study. This means that the participant may receive BIIB059 (the study drug) or a placebo for the first 24 weeks of the study. Randomised means participants will be put into the study drug group or the placebo group by chance. Participants have a 2:1 chance of receiving the study drug or placebo, respectively. Double-blind means that neither the participant nor the study team will know which study group the participant has been put in. For the next 24 weeks of the study (Week 24–Week 48), all participants will receive the study drug.The main purpose of the study is to investigate if the study drug can reduce disease activity and inflammation in people with active CLE compared to a placebo. The study will also investigate how safe the study drug is in a larger number of people with CLE.The study is being carried out at about 225 sites globally.

Researchers

Anthony Bewley (Principal Investigator)

Related Research

Grants with similar aims, by meaning.

A Multicenter, Open-Label, Single-Arm, Phase 3, Long-Term Extension Study to Evaluate Continuous Safety and Efficacy of BIIB059 (Litifilimab) in Adult Participants With Active Subacute Erythematosus and/or Chronic Cutaneous Lupus Erythematosus With or Without Systemic Manifestations and Refractory and/or Intolerant to Antimalarial Therapy (AMETHYST LTE)
Systemic Lupus Erythematosus: A Phase 2 Study to Investigate the Safety and Efficacy of ABBV-105 and Upadacitinib Given Alone or in Combination (ABBV-599 Combination) in Subjects with Moderately to Severely Active Systemic Lupus Erythematosus
A Phase 2, Multicenter, Randomized, Double-blind, Placebo-Controlled, Study to Evaluate the Efficacy and Safety of BMS-986256 in Participants with Active Systemic Lupus Erythematosus
Abbvie-M19-130: Systemic Lupus Erythematosus: A Phase 2 Study to Investigate the Safety and Efficacy of ABBV-105 and Upadacitinib Given Alone or in Combination (ABBV-599 Combination) in Subjects with Moderately to Severely Active Systemic Lupus Erythematosus
A phase 2, multicentre, randomised, double-blind, placebo-controlled study to evaluate the efficacy and safety of BMS-986256 in participants with active Systemic Lupus Erythematosus

Plain English summaries and category classifications on this site are generated by AI and may not perfectly reflect the original research.