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

← catalyst calendar

NCT05531565 · readout in 62 d

Sponsored by Biogen (industry) · BIIB — their whole pipeline →.

Phase

Phase 2/3

Status

Active, not recruiting

Study type

Interventional

Design

Randomized · Quadruple · Treatment

Enrollment

450estimated

Sites

315

Countries

Argentina, Belgium, Brazil +27

Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →

Source: ClinicalTrials.gov, retrieved 2026-08-19

Dates

each axis at the precision it was filed, with the registry's own basis

Date

Filed

Basis

What it is

Start

2022-09-13

actual

When the study began enrolling

Primary completion

2026-10-20

estimated

The date the last participant is measured for the primary outcome — the readout window

Study completion

2027-12-14

estimated

The whole study's end, after follow-up

First posted

2022-09-08

actual

When this record first appeared on the registry

Results posted

—

When the sponsor posted results to the registry

Record updated

2026-08-13

actual

The sponsor's own last edit to this record — every projection above is as current as this date

What it studies

Conditions

Subacute Cutaneous Lupus Erythematosus
Chronic Cutaneous Lupus Erythematosus

Interventions

Drug: Litifilimab — also filed as BIIB059
Drug: Placebo

Primary outcomes

what the primary-completion date above is the date OF

Parts A: Percentage of Participants who Achieve a Cutaneous Lupus Activity of Physician's Global Assessment-Revised (CLA-IGA-R) Erythema Score of 0 or 1

measured Week 16

Part B: Percentage of Participants who Achieve Cutaneous Lupus Erythematosus Disease Area and Severity Index Activity Score (CLASI-70) Response, Defined as ≥ 70% Decrease in CLASI-A Score From Baseline

measured Baseline to Week 24

Permalink · BIIB's whole pipeline · Catalyst calendar · Every registered study · What changed