Drugs / Litifilimab
Trials 9
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 13 trials | ||||||
| Phase 1 | NCT06741657 | Jan 2025 → Mar 2026 | — | Biogen | Completed | No outcome recorded |
| Phase 1 | NCT03224793 | Oct 2017 → Jun 2018 | — | Biogen | Completed | No outcome recorded |
| Phase 1 | NCT02106897 | Apr 2014 → May 2016 | systemic lupus erythematosus | Biogen | Completed | No outcome recorded |
| Phase 21 trial · 1 met primary | ||||||
| Phase 2 | NCT02847598 | Oct 2016 → Aug 2019 | cutaneous lupus erythematosus, systemic lupus erythematosus | Biogen | Completed | Met primary |
| Phase 2/31 trial · 1 met primary | ||||||
| Phase 2/3 | NCT05531565 | Sep 2022 → Oct 2026 expected | chronic cutaneous lupus erythematosus, subacute cutaneous lupus erythematosus | Biogen | Active not recruiting | Met primary |
| Phase 34 trials | ||||||
| Phase 3 | NCT06044337 | Oct 2023 → Jun 2029 expected | chronic cutaneous lupus erythematosus, subacute cutaneous lupus erythematosus | Biogen | Enrolling by invitation | No outcome recorded |
| Phase 3 | NCT05352919 | Jun 2022 → Mar 2030 expected | systemic lupus erythematosus | Biogen | Enrolling by invitation | No outcome recorded |
| Phase 3 | NCT04961567 | Jul 2021 → Sep 2026 overdue | systemic lupus erythematosus | Biogen | Active not recruiting | No outcome recorded |
| Phase 3 | NCT04895241 | May 2021 → Sep 2026 overdue | systemic lupus erythematosus | Biogen | Active not recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 7
| Date | Issuer | Release |
|---|---|---|
| 2026-03-28 | Biogen | Results Biogen Announces Second Positive Phase 2 Litifilimab Trial in Cutaneous Lupus Erythematosus at 2026 American Academy of Dermatology Annual Meeting, Showing a Significant Reduction in Skin Disease Activity biogen.com ↗
In the Phase 2 part of the AMETHYST study, litifilimab met the primary endpoint of reduction of disease activity in people living with CLE at Week 16, with more litifilimab participants achieving clear / almost clear skin |
| 2026-01-28 | Biogen | Regulatory Biogen’s Litifilimab Receives FDA Breakthrough Therapy Designation for Cutaneous Lupus Erythematosus, a Disease With No Targeted Treatment Options biogen.com ↗
Biogen Inc. (Nasdaq: BIIB) – announced today that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation for litifilimab (BIIB059) for the treatment of cutaneous lupus erythematosus (CLE). |
| 2022-09-07 | Biogen | Results The New England Journal of Medicine Publishes Second Manuscript Reporting Positive Phase 2 Results for Biogen’s Litifilimab (BIIB059) in Lupus biogen.com ↗
Results from the SLE portion of the study (Part A) published today show litifilimab met the study’s primary endpoint by significantly reducing total active joint count compared to placebo. |
| 2022-07-28 | Biogen | Results The New England Journal of Medicine Publishes Positive Phase 2 Data on Litifilimab (BIIB059) in Cutaneous Lupus Erythematosus biogen.com ↗
Litifilimab met its primary endpoint by demonstrating superior efficacy to placebo in reducing skin disease activity. |
| 2020-11-03 | Biogen | Results Biogen to Present Positive Phase 2 Systemic Lupus Erythematosus Data at American College of Rheumatology 2020 Meeting biogen.com ↗
Today, Biogen Inc. (Nasdaq: BIIB) announced positive data from the 24-week systemic lupus erythematosus (SLE) portion of the Phase 2 LILAC study (part A) demonstrating that BIIB059 (anti-BDCA2) was associated with a statistically significant reduction in total active joint count. |
| 2020-06-04 | Biogen | Results Biogen Presents Positive Phase 2 Cutaneous Lupus Erythematosus (CLE) Data at European E-Congress of Rheumatology (EULAR) 2020 biogen.com ↗
Today, Biogen Inc. (Nasdaq: BIIB) shared positive data from the 16-week cutaneous lupus erythematosus (CLE) portion of the Phase 2 LILAC study. |
| 2019-12-03 | Biogen | Results Biogen Announces Positive Phase 2 Study Results for Cutaneous Lupus Erythematosus (CLE) and Systemic Lupus Erythematosus (SLE) biogen.com ↗
The Phase 2 LILAC study met its primary endpoints, demonstrating statistically significant reduction of disease activity in patients with CLE and SLE who received BIIB059 compared to placebo |
All press releases naming this drug 9 releases
Evidence & citations 8 cited values
Every value below carries the sentence it was read from. 12 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | litifilimab | “Litifilimab (BIIB059), a promising investigational drug for cutaneous lupus erythematosus.” PMID 37148249 ↗ May 2023 |
| Known as | 24F4A | ChEMBL registry synonym — accepted as the source's own label CHEMBL3833308 ↗ |
| Known as | anti-BDCA2 | ChEMBL registry synonym — accepted as the source's own label CHEMBL3833308 ↗ |
| Known as | BIIB059 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT02847598 ↗ |
| Action | Inhibit | “C-type lectin domain family 4 member C inhibitor” CHEMBL3833308 ↗ |
| Modality | Monoclonal antibody | “BIIB059 is a humanized mAb” PMID 30645203 ↗ Feb 2019 |
| Route | Intravenous | “single-ascending intravenous (IV) doses” NCT02106897 ↗ |
| Target | CLEC4C | “C-type lectin domain family 4 member C inhibitor” CHEMBL3833308 ↗ |