A Study to Learn About the Safety of Litifilimab (BIIB059) Injections and Whether They Can Improve Symptoms of Adult Participants Who Have Systemic Lupus Erythematosus (NCT04961567) — UK Trial Details

Condition(s) studied

Lupus Erythematosus, Systemic

Investigational drug(s) / intervention(s)

LitifilimabPlacebo

Litifilimab: Administered as specified in the treatment arm.

Placebo: Administered as specified in the treatment arm.

Study summary

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 participants who have active disease and are already taking standard of care medications. These may include antimalarials, steroids, and immunosuppressants.

The main objective of the study is to learn about the effect litifilimab has on lowering the activity of the disease. The main question researchers want to answer is:

\- How many participants have an improvement in their symptoms after 52 weeks of treatment? Researchers will answer this and other questions by measuring the symptoms of SLE over time using a variety of scoring tools. These include the SLE Responder Index (SRI), the Systemic Lupus Erythematosus Disease Activity Index-2000 (SLEDAI-2K), the British Isles Lupus Activity Group-2004 index (BILAG-2004), and the BILAG-BASED Combined Lupus Assessment (BICLA), among others.

Researchers will also learn more about the safety of litifilimab. They will study how participants' immune systems respond to litifilimab. Additionally, they will measure the effect litifilimab and SLE have on the quality of life of participants using a group of questionnaires.

The study will be done as follows:

* After screening, participants will be randomized to receive either a high or low dose of litifilimab, or placebo. A placebo looks like the study drug but contains no real medicine.
* All participants will receive either litifilimab or placebo as injections under the skin once every 4 weeks. The treatment period will last 52 weeks. Participants will continue to take their standard of care medications.
* Neither the researchers nor the participants will know if the participants are receiving litifilimab or placebo.
* There will be a follow-up safety period that lasts up to 24 weeks.
* In total, participants will have up to 22 study visits. The total study duration for participants will be up to 80 weeks.

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

No

Key Inclusion Criteria: * Participant must be diagnosed with SLE at least 24 weeks prior to screening and must meet the 2019 European League Against Rheumatism (EULAR)/American College of Rheumatology (ACR) classification criteria for SLE, at screening by a qualified physician. * Participant has a modified Systemic Lupus Erythematosus Disease Activity Index-200 (SLEDAI-2K) score ≥6 (excluding alopecia, fever, lupus-related headache, and organic brain syndrome) at screening (adjudicated). * Participant has a modified clinical SLEDAI-2K score ≥4 (excluding anti-dsDNA, low complement component 3 \[C3\] and/or complement component 4 \[C4\], alopecia, fever, lupus-related headache, and organic brain syndrome) at screening (adjudicated) and randomization. * Participant has BILAG-2004 grade A in ≥1 organ system or BILAG-2004 grade B in ≥2 organ systems at screening (adjudicated) and randomization. * Participants must be treated with one of the following background nonbiologic lupus SOC therapies, initiated ≥12 weeks prior to screening and at stable dose ≥4 weeks prior to randomization: 1. Antimalarials as stand-alone treatment 2. Antimalarial treatment in combination with OCS and/or a single immunosuppressant 3. Treatment with OCS and/or a single immunosuppressant. Key Exclusion Criteria: * History of or positive test result for human immunodeficiency virus (HIV). * Current hepatitis C infection (defined as positive hepatitis C virus \[HCV\] antibody and detectable HCV ribonucleic acid \[RNA\]). * Current hepatitis B infection (defined as positive for antibody to hepatitis B surface antigen \[HBsAg\] and/or positive for total antibody to hepatitis B core antigen \[anti-HBc\] with positive reflex HBV DNA). * History of severe herpes infection. * Presence of uncontrolled or New York Heart Association class III or IV congestive heart failure. * Active severe lupus nephritis where, in the opinion of the investigator, protocol-specified SOC is insufficient and use of a more aggressive therapeutic approach, such as adding intravenous (IV) cyclophosphamide and/or high-dose IV pulse corticosteroid therapy or other treatments not permitted in the protocol, is indicated; or urine protein-creatinine ratio \>2.0 or severe chronic kidney disease (estimated glomerular filtration rate \<30 milliliters per minute per 1.73 meter square \[mL/min/1.73 m\^2\]) calculated using the abbreviated Modification of Diet in Renal Disease equation. * Any active skin conditions other than cutaneous lupus erythematosus (CLE) that may interfere with the study assessment of CLE such as but not limited to psoriasis, dermatomyositis, systemic sclerosis, non-LE skin lupus manifestation or drug-induced lupus. * History or current diagnosis of a clinically significant non-SLE-related vasculitis syndrome. * Active neuropsychiatric SLE. * Use of oral prednisone (or equivalent) above 20 mg/day. NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.

Primary outcome measure(s)

Percentage of Participants Who Achieved a Systemic Lupus Erythematosus Responder Index of 4 (SRI-4) Response at Week 52 — Week 52
An SRI-4 response is a composite endpoint defined by the following criteria: * Reduction from baseline of ≥4 points in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K). * No new organ system affected as defined by no new organ system with British Isles Lupus Assessment Group-2004 (BILAG-2004) grade A and no more than 1 new organ system with BILAG-2004 grade B compared with baseline. * No worsening from baseline in lupus disease activity as defined by \<0.3-point increase on 3-point Physician's Global Assessment (PGA) - Visual Analog Scale (VAS). * No violation to protocol-specified medication rules.

Trial sites (177)

Facility	City	Region
University of Alabama at Birmingham	Birmingham	Alabama
Arizona Arthritis & Rheumatology Associates, P.C.	Glendale	Arizona
Care Access Research - Huntington BeachCare Access Research - Huntington Beach	Huntington Beach	California
Valerius Medical Group	Los Alamitos	California
The Practice of Medicine	Los Angeles	California
R. Srinivasan, M.D., Inc. dba Monterey Park Medical Center	Monterey Park	California
Neurovations	Napa	California
Joo-Hyung Lee MD	Orange	California
Medvin Clinical Research	Whittier	California
RASF - Clinical Research Center	Boca Raton	Florida
University of Florida	Gainesville	Florida
Vida Clinical Research	Kissimmee	Florida
University of Miami Miller School of Medicine	Miami	Florida
HMD Research, LLC	Orlando	Florida
Clinical Research of West Florida, Inc.	Tampa	Florida
The Emory Clinic Emory University	Atlanta	Georgia
Jefrey Lieberman, M.D., P.C.	Decatur	Georgia
Southeastern Rheumatology Alliance dba Arthritis Center of North Georgia	Gainesville	Georgia
RNA America Health Sciences	Gainesville	Georgia
EBGS Clinical Trials	Snellville	Georgia
Rush University Medical Center	Chicago	Illinois
Boston University School of Medicine	Boston	Massachusetts
DM Clinical Research - Boston	Brookline	Massachusetts
University of Massachusetts	Worcester	Massachusetts
Saint Louis Rheumatology	St Louis	Missouri
Arthritis & Osteoporosis Associates, PA	Freehold	New Jersey
Arthritis and Osteoporosis Associates of New Mexico	Las Cruces	New Mexico
DJL Clinical Research, PLLC	Charlotte	North Carolina
Carolina Arthritis Associates	Wilmington	North Carolina
University of Cincinnati	Cincinnati	Ohio
STAT Research	Dayton	Ohio
Piedmont Arthritis Clinic, P.A.	Greenville	South Carolina
Low Country Rheumatology, PA	Summerville	South Carolina
West Tennessee Research Institute	Jackson	Tennessee
Arthritis & Rheumatology Institute	Allen	Texas
Office of John P. Lavery M.D., PA	Allen	Texas
Tekton Research	Austin	Texas
Precision Comprehensive Clinical Research Solutions	Colleyville	Texas
R and H Clinical Research	Katy	Texas
Prime Clinical Research	Mansfield	Texas

+ 137 more sites — see the full list on the official registry below.

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