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Monoclonal Antibodies

Litifilimab for Systemic Lupus Erythematosus (AMETHYST LTE Trial)

Phase 3
Waitlist Available
Research Sponsored by Biogen
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Participants who completed the parent study (230LE301 [NCT05531565], Part A or Part B) on study treatment (received treatment through Week 48 and attended the last study assessment visit at Week 52).
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
Pivotal Trial
No Placebo-Only Group

Summary

This trial will assess the long-term safety & effectiveness of litifilimab for treating lupus, incl. effects on disease activity, preventing flares, & HRQoL.

Who is the study for?
This trial is for adults who finished the parent study (230LE301) with active subacute or chronic cutaneous lupus erythematosus, and are not responding well to antimalarial therapy. They should understand the study's risks, give informed consent, and allow use of their health information. Those with new medical issues or who left the earlier study early can't join.
What is being tested?
The trial tests long-term safety and effectiveness of BIIB059 (litifilimab) in patients from a previous study. It looks at how litifilimab affects disease activity over time, prevents damage and flares, impacts steroid use, quality of life, lab parameters, immune response to treatment, and drug levels in the body.
What are the potential side effects?
While specific side effects aren't listed here for litifilimab (BIIB059), common ones may include reactions at injection site, infections due to weakened immune system responses, potential liver issues indicated by blood tests changes; individual experiences will vary.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I completed a specific study treatment and attended all required visits.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Side effects data

From 2019 Phase 2 trial • 264 Patients • NCT02847598
17%
Neutrophil count increased
17%
Diarrhoea
17%
Nausea
17%
Neutrophilia
17%
Cystitis
17%
Urticaria
17%
Pruritus
17%
Rhinitis
17%
Nasopharyngitis
17%
Headache
100%
80%
60%
40%
20%
0%
Study treatment Arm
Part A: Placebo
Part A: BIIB059 50 mg
Part A: BIIB059 150 mg
Part A: BIIB059 450 mg
Part B: Placebo
Part B: BIIB059 50 mg
Part B: BIIB059 150 mg
Part B: BIIB059 450 mg

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: BIIB059Experimental Treatment1 Intervention
Participants will receive BIIB059 subcutaneously, once every 4 weeks up to Week 100.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
BIIB059 (litifilimab)
2016
Completed Phase 2
~380

Find a Location

Who is running the clinical trial?

BiogenLead Sponsor
645 Previous Clinical Trials
467,071 Total Patients Enrolled
Medical DirectorStudy DirectorBiogen
2,881 Previous Clinical Trials
8,087,880 Total Patients Enrolled
~215 spots leftby Jun 2029
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