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ClinicalTrials.gov public records Last synced Oct 5, 2026, 2:30 AM EDT

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Showing 1–9 of 9 matching trials from the live ClinicalTrials.gov search.
Filters: Intervention: BIIB059 Clear all
Active, not recruiting Phase 3 Interventional

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

NCT04895241
View directory record Official record
Conditions
Lupus Erythematosus, Systemic
Interventions
Litifilimab, Placebo
Drug
Lead sponsor
Biogen
Industry
Eligibility
18 Years and older
Enrollment
548 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2021 – 2027
U.S. locations
53
States / cities
Homewood, Alabama • Beverly Hills, California • Los Angeles, California + 46 more
Source: ClinicalTrials.gov public record
Updated Feb 10, 2026 · Synced Oct 5, 2026, 2:30 AM EDT
Completed Phase 1 Interventional Accepts healthy volunteers

Study Evaluating the Safety, Tolerability, and Pharmacokinetics of Single Doses and Multiple Doses of BIIB059 (Litifilimab) in Healthy Volunteers and Participants With Systemic Lupus Erythematosus

NCT02106897
View directory record Official record
Conditions
Systemic Lupus Erythematosus, Healthy Volunteers
Interventions
BIIB059 (litifilimab), Placebo
Drug
Lead sponsor
Biogen
Industry
Eligibility
18 Years and older
Enrollment
109 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2014 – 2016
U.S. locations
5
States / cities
Anniston, Alabama • Birmingham, Alabama • Orlando, Florida + 2 more
Source: ClinicalTrials.gov public record
Updated Jan 31, 2023 · Synced Oct 5, 2026, 2:30 AM EDT
Active, not recruiting Phase 2Phase 3 Interventional

A 2-Part Study to Learn Whether Litifilimab (BIIB059) Injections Can Improve Symptoms of Adult Participants Who Have Active Cutaneous Lupus Erythematosus

NCT05531565
View directory record Official record
Conditions
Subacute Cutaneous Lupus Erythematosus, Chronic Cutaneous Lupus Erythematosus
Interventions
Litifilimab, Placebo
Drug
Lead sponsor
Biogen
Industry
Eligibility
18 Years and older
Enrollment
450 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2022 – 2027
U.S. locations
62
States / cities
Anniston, Alabama • Birmingham, Alabama • Phoenix, Arizona + 52 more
Source: ClinicalTrials.gov public record
Updated Oct 1, 2026 · Synced Oct 5, 2026, 2:30 AM EDT
Enrolling by invitation Phase 3 Interventional

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)

NCT05352919
View directory record Official record
Conditions
Systemic Lupus Erythematosus (SLE)
Interventions
Litifilimab, Litifilimab-matching placebo
Drug
Lead sponsor
Biogen
Industry
Eligibility
18 Years and older
Enrollment
864 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2022 – 2032
U.S. locations
37
States / cities
Phoenix, Arizona • Beverly Hills, California • Huntington Beach, California + 33 more
Source: ClinicalTrials.gov public record
Updated Sep 22, 2026 · Synced Oct 5, 2026, 2:30 AM EDT
Enrolling by invitation Phase 3 Interventional

A Long-Term Extension Study to Learn More About the Safety of Litifilimab (BIIB059) Injections and Whether They Can Improve Symptoms of Adult Participants Who Have Active Cutaneous Lupus Erythematosus

NCT06044337
View directory record Official record
Conditions
Subacute Cutaneous Lupus Erythematosus, Chronic Cutaneous Lupus Erythematosus
Interventions
BIIB059 (litifilimab)
Drug
Lead sponsor
Biogen
Industry
Eligibility
18 Years and older
Enrollment
306 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2023 – 2029
U.S. locations
13
States / cities
Birmingham, Alabama • Phoenix, Arizona • Los Angeles, California + 10 more
Source: ClinicalTrials.gov public record
Updated Aug 4, 2026 · Synced Oct 5, 2026, 2:30 AM EDT
Completed Phase 2 Interventional Results available

Study to Evaluate BIIB059 (Litifilimab) in Cutaneous Lupus Erythematosus (CLE) With or Without Systemic Lupus Erythematosus (SLE)

NCT02847598
View directory record Official record
Conditions
Systemic Lupus Erythematosus, Active Cutaneous Lupus Erythematosus
Interventions
BIIB059 (litifilimab), Placebo
Drug
Lead sponsor
Biogen
Industry
Eligibility
18 Years to 75 Years
Enrollment
264 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2016 – 2019
U.S. locations
53
States / cities
Anniston, Alabama • Phoenix, Arizona • Little Rock, Arkansas + 44 more
Source: ClinicalTrials.gov public record
Updated Nov 7, 2023 · Synced Oct 5, 2026, 2:30 AM EDT
Completed Phase 1 Interventional Accepts healthy volunteers

A Study to Find Out How Litifilimab is Processed in the Body in Healthy Participants When Given Under the Skin in 3 Different Ways

NCT06741657
View directory record Official record
Conditions
Healthy Volunteer
Interventions
Litifilimab, AI, OBI, PFS
Drug · Device
Lead sponsor
Biogen
Industry
Eligibility
18 Years to 55 Years
Enrollment
404 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2025 – 2026
U.S. locations
2
States / cities
Las Vegas, Nevada • Austin, Texas
Source: ClinicalTrials.gov public record
Updated May 26, 2026 · Synced Oct 5, 2026, 2:30 AM EDT
Active, not recruiting Phase 3 Interventional

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
View directory record Official record
Conditions
Lupus Erythematosus, Systemic
Interventions
Litifilimab, Placebo
Drug
Lead sponsor
Biogen
Industry
Eligibility
18 Years and older
Enrollment
562 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2021 – 2027
U.S. locations
44
States / cities
Birmingham, Alabama • Glendale, Arizona • Huntington Beach, California + 38 more
Source: ClinicalTrials.gov public record
Updated Jan 29, 2026 · Synced Oct 5, 2026, 2:30 AM EDT
Completed Phase 1 Interventional Accepts healthy volunteers

Safety, Tolerability, and Pharmacokinetics of Single Doses of BIIB059 in Healthy Japanese Subjects.

NCT03224793
View directory record Official record
Conditions
Healthy Subjects
Interventions
BIIB059, Placebo
Drug
Lead sponsor
Biogen
Industry
Eligibility
18 Years to 55 Years
Enrollment
32 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2017 – 2018
U.S. locations
1
States / cities
Cypress, California
Source: ClinicalTrials.gov public record
Updated Aug 31, 2018 · Synced Oct 5, 2026, 2:30 AM EDT