A Study to Learn More About the Long-Term Safety of Litifilimab (BIIB059) Injections and it's Effects on Symptoms in Adults With Systemic Lupus Erythematosus (SLE) (EMERALD)

Biogen

Status and phase: Invitation-only; Phase 3

Conditions: Systemic Lupus Erythematosus (SLE)

Treatments: Drug: Litifilimab-matching placebo; Drug: Litifilimab

Study type: Interventional

Funder types: Industry

Identifiers

NCT05352919

230LE306

2021-006378-22 (EudraCT Number)

2023-505635-13 (Other Identifier)

2023

Details and patient eligibility

About

In this study, researchers will learn more about a study drug called litifilimab (BIIB059) in participants with systemic lupus erythematosus (SLE). The study will focus on adults who have active disease and are already taking standard of care medications. These may include antimalarials, steroids, and immunosuppressants. This is an extension study of 230LE303 and 230LE304 (TOPAZ-1 and TOPAZ-2). It will include participants who completed the treatment periods of either one of those parent studies.

The main goal of the study is to learn more about the long-term safety of litifilimab in adults. The main question researchers want to answer is:

- How many participants have adverse events and serious adverse events during the study? Adverse events are health problems that may or may not be caused by the study drug.

Researchers will also learn about:

• The effect of litifilimab on controlling symptoms of SLE and lowering its activity.
• How participants' immune systems respond to litifilimab.
• The effect of litifilimab on the quality of life of participants.

The study will be done as follows:

• This study begins when the participant has finished 1 of the parent studies (either 230LE303 or 230LE304).
• Participants who were getting either a high or low dose of litifilimab in either parent study will continue getting the same doses.
• Participants who were getting the placebo in the parent studies will be randomized to get either a high or low dose of litifilimab.
• Neither the researchers nor the participants will know which doses of litifilimab the participants are getting.
• All participants will get litifilimab as injections under the skin once every 4 weeks. The treatment period will last up to 260 weeks. Participants may continue to take their standard of care medications.
• There will be a follow-up safety period that lasts up to 24 weeks.
• In total, participants will have up to 67 study visits. At these visits, the study doctor will do tests to check the participants' overall health, including the status of their SLE symptoms. They will also measure the participants' height, weight, and vital signs and collect blood and urine samples. Participants will also complete questionnaires or answer questions about how they are feeling and about their daily lives.
• Each participant will be in the study for up to 284 weeks.

Optional Substudy:

• Some participants may be invited to join an optional "substudy" after being in the main study for at least 4 months.
• This substudy will test a new injector device for delivering litifilimab. The injector device is an automatic device that delivers the full dose in 1 injection without needing to push a plunger.
• Researchers will learn more about the safety of the injector device and how the body reacts to it. This will be compared to the current prefilled syringe method.
• The substudy will last up to 3 months and will include about 120 participants.

Full description

This is an extension study for all participants who completed study 230LE303 (NCT04895241) and 230LE304 (NCT04961567) (parent phase 3 studies) through Week 52 and did not discontinue litifilimab or placebo. Eligible participants from parent phase 3 studies will be followed for up to 284 weeks.

The primary objective of this study is to evaluate the long-term safety and tolerability of litifilimab in participants with active systemic lupus erythematosus (SLE).

The secondary objectives of this study are to evaluate the long-term effect of litifilimab on disease activity in participants with SLE, to evaluate the long-term effect of litifilimab in participants with SLE in maintaining low disease activity, to evaluate the effect of litifilimab in participants with active SLE in preventing irreversible organ damage, to assess long-term use of oral corticosteroid (OCS) with participants receiving litifilimab treatment, to assess the impact of litifilimab on participant-reported Health-Related Quality-of-Life Questionnaire (HRQoL), symptoms, and impacts of SLE, to evaluate long-term effect of litifilimab on laboratory parameters, and to evaluate immunogenicity of litifilimab.

A phase-3, randomized, dose-blind, substudy is added in this extension study for all participants who have been enrolled in the 230LE306 Phase 3 LTE study for a minimum of 4 months and have at least four remaining visits in the Phase 3 LTE study.

The primary objective of this substudy is to evaluate the safety of injector device used for administering litifilimab in participants with active SLE.

The secondary objective of this substudy is to evaluate the tolerability of injector device used for administering litifilimab in participants with active SLE.

Enrollment: 864 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria:

• Participants who completed 1 of the 52-week of the double-blind placebo-controlled, parent Phase 3 studies (230LE303 (NCT04895241) and 230LE304 (NCT04961567)) on study treatments with either litifilimab or placebo to Week 48 and attended the last study assessment visit at Week 52.

Key Exclusion Criteria:

• Early parent Phase 3 studies treatment terminators (participants who discontinued study treatment before Week 52)
• Early parent Phase 3 studies terminators (participants who withdrew from study participation and did not complete the 52-week treatment period)
• Participants who developed moderate-to-severe worsening of organ-specific lupus manifestations that would require a change in antimalarials and/or immunosuppressive therapy (initiation of new treatment or increase in dose above the allowed maximum dose)
• Use of other investigational drugs or off-label drugs used to treat SLE, cutaneous lupus, or lupus nephritis during the parent Phase 3 studies.

NOTE: Other inclusion/exclusion criteria may apply.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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864 participants in 2 patient groups

Litifilimab Low Dose

Experimental group

Description:

Participants who are receiving background nonbiologic lupus standard of care (SOC) therapy and received litifilimab low dose, subcutaneously (SC), every 4 weeks (Q4W) during the parent Phase 3 studies (i.e. studies 230LE303 \[NCT04895241\] or 230LE304 \[NCT04961567\]) will continue to receive litifilimab low dose, SC, Q4W from Day 1 to 260 weeks with an additional dose of litifilimab-matching placebo at Week 2. Participants who are receiving background nonbiologic lupus SOC therapy and received litifilimab-matching placebo in the parent Phase 3 studies (i.e. studies 230LE303 \[NCT04895241\] or 230LE304 \[NCT04961567\]) will be randomized to receive litifilimab low dose, SC, Q4W from Day 1 to 260 weeks with an additional dose at Week 2.

Treatment:

Drug: Litifilimab

Drug: Litifilimab-matching placebo

Litifilimab High Dose

Experimental group

Description:

Participants who are receiving background nonbiologic lupus SOC therapy and received litifilimab high dose, SC, Q4W during the parent Phase 3 studies (i.e. studies 230LE303 \[NCT04895241\] or 230LE304 \[NCT04961567\]) will continue to receive litifilimab high dose, SC, Q4W from Day 1 to 260 weeks with an additional dose of litifilimab-matching placebo at Week 2. Participants who are receiving background nonbiologic lupus SOC therapy and received litifilimab-matching placebo in the parent Phase 3 studies (i.e. studies 230LE303 \[NCT04895241\] or 230LE304 \[NCT04961567\]) will be randomized to receive litifilimab high dose, SC, Q4W from Day 1 to 260 weeks with an additional dose at Week 2.

Treatment:

Drug: Litifilimab

Drug: Litifilimab-matching placebo