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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 day 0 (week 52 of parent study) up to 128 weeks

Awards & highlights

AMETHYST LTE Trial 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.Check my eligibility

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.See study design

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.

AMETHYST LTE Trial 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.

AMETHYST LTE Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ day 0 (week 52 of parent study) up to 128 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~day 0 (week 52 of parent study) up to 128 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and day 0 (week 52 of parent study) up to 128 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)

Secondary outcome measures

Absolute Change in Cutaneous Lupus Erythematosus Disease Area and Severity Index Damage (CLASI-D) Score From the Baseline (Parent Study [NCT05531565]) to Week 104

Annualized Mild/Moderate and Severe SFI Rates From Baseline Value (Parent Study [NCT05531565]) Through Week 104

Annualized Mild/Moderate and Severe Safety of Estrogens in Lupus Erythematosus National Assessment-SLE Disease Activity Index Flare Index (SFI) Rates From Baseline Value (Parent Study [NCT05531565]) Through Week 52

+35 more

Side effects data

From 2019 Phase 2 trial • 264 Patients • NCT02847598

17%

Nausea

17%

Neutrophilia

17%

Cystitis

17%

Neutrophil count increased

17%

Urticaria

17%

Diarrhoea

17%

Pruritus

17%

Rhinitis

17%

Nasopharyngitis

17%

Headache

100%

80%

60%

40%

20%

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

AMETHYST LTE 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

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

BiogenLead Sponsor

639 Previous Clinical Trials

467,000 Total Patients Enrolled

Medical DirectorStudy DirectorBiogen

2,777 Previous Clinical Trials

8,064,082 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What risks are posed to patients through the use of BIIB059?

"Our team at Power gave BIIB059 a score of 3, which reflects that there is already existing evidence substantiating its safety and efficacy from Phase 3 trials."

Answered by AI

Can individuals currently sign up for this experiment?

"Based on the information posted to clinicaltrials.gov, this particular trial is not currently admitting participants; it was initially listed in October of 2023 and its latest update took place three days later. Despite this, there are 145 other medical studies recruiting patients right now."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Long-Term Extension Study to Evaluate Continuous Safety and Efficacy of BIIB059 (Litifilimab) in Adults With Active Subacute Cutaneous Lupus Erythematosus (CLE) and/or Chronic CLE With or Without Systemic Manifestations and Refractory and/or Intolerant to Antimalarial Therapy

2023. "A Long-Term Extension Study to Evaluate Continuous Safety and Efficacy of BIIB059 (Litifilimab) in Adults With Active Subacute Cutaneous Lupus Erythematosus (CLE) and/or Chronic CLE With or Without Systemic Manifestations and Refractory and/or Intolerant to Antimalarial Therapy". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06044337.

All > Systemic Lupus Erythematosus > Malaria