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Monoclonal Antibodies
Litifilimab for Cutaneous Lupus Erythematosus (AMETHYST Trial)
Phase 2 & 3
Recruiting
Research Sponsored by Biogen
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Histologically confirmed diagnosis of CLE with or without systemic manifestations
Must have active cutaneous manifestations that meet study criteria
Timeline
Screening 3 weeks
Treatment Varies
Follow Up part a (us+row): weeks 16 and 24; part b (us): week 16; part b (row): week 24; part b (us+row): up to week 24
Awards & highlights
AMETHYST Trial Summary
This trial is testing a new drug to see if it's effective in reducing skin disease activity in people with lupus.
Who is the study for?
This trial is for people with active skin lupus (SCLE or CCLE) who haven't gotten better after using antimalarial treatments. They need to have a confirmed diagnosis of CLE, active skin symptoms that meet the study's requirements, and a CLASI-A score of 10 or more.Check my eligibility
What is being tested?
The trial tests if BIIB059 (litifilimab) is better than a placebo at reducing skin disease activity in patients with SCLE/CCLE. It measures this by looking at changes in two scores: CLA-IGA-R and CLASI-A. The study also looks at safety, tolerability, and immune response to the drug.See study design
What are the potential side effects?
Possible side effects include reactions where the drug is injected, increased risk of infections due to immune system suppression, potential liver issues indicated by blood test changes, allergic reactions, and possibly others not yet known.
AMETHYST Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My diagnosis of cutaneous lupus erythematosus is confirmed by tissue examination.
Select...
I have skin symptoms that fit the study's requirements.
Select...
I still have a skin lesion from lupus despite taking antimalarial medication.
AMETHYST Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ part a (us+row): weeks 16 and 24; part b (us): week 16; part b (row): week 24; part b (us+row): up to week 24
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~part a (us+row): weeks 16 and 24; part b (us): week 16; part b (row): week 24; part b (us+row): up to week 24
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Part B (ROW): 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
Parts A (US+ROW) and B (US): Percentage of Participants who Achieve a Cutaneous Lupus Activity of Physician's Global Assessment-Revised (CLA-IGA-R) Erythema Score of 0 or 1
Secondary outcome measures
Part A (US+ROW): Change From Baseline in Cutaneous Lupus Erythematosus Disease Area and Severity Index Damage (CLASI-D) Score
Complement H50
Part B (US+ROW): Absolute Change in CLASI-D Score
+32 moreSide effects data
From 2019 Phase 2 trial • 264 Patients • NCT0284759817%
Neutrophil count increased
17%
Neutrophilia
17%
Nausea
17%
Urticaria
17%
Cystitis
17%
Diarrhoea
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
AMETHYST Trial Design
4Treatment groups
Experimental Treatment
Placebo Group
Group I: Part B (Phase 3): BIIB059Experimental Treatment1 Intervention
Participants will receive BIIB059 SC Q4W from Week 0 to Week 20, with an additional dose of BIIB059 at Week 2 during the DBPC treatment period. Following the DBPC treatment period, participants will receive BIIB059 during the ETP from Week 24 to Week 48, with an additional dose of BIIB059-matching placebo at Week 26.
Group II: Part A (Phase 2): BIIB059Experimental Treatment1 Intervention
Participants will receive BIIB059 subcutaneously (SC) once every 4 weeks (Q4W) from Week 0 to Week 20, with an additional dose of BIIB059 at Week 2 during the double-blind placebo-controlled (DBPC) treatment period. Following the DBPC treatment period, participants will receive BIIB059 during the extended treatment period (ETP) from Week 24 to Week 48, with an additional dose of BIIB059-matching placebo at Week 26.
Group III: Part A (Phase 2): PlaceboPlacebo Group1 Intervention
Participants will receive BIIB059-matching placebo SC Q4W from Week 0 to Week 20, with an additional dose of BIIB59-matching placebo at Week 2 during the DBPC treatment period. Following the DBPC treatment period, participants will receive BIIB059 during the ETP from Week 24 to Week 48, with an additional dose of BIIB059 at Week 26.
Group IV: Part B (Phase 3): PlaceboPlacebo Group1 Intervention
Participants will receive BIIB059-matching placebo SC Q4W from Week 0 to Week 20, with an additional dose of BIIB59-matching placebo at Week 2 during the DBPC treatment period. Following the DBPC treatment period, participants will receive BIIB059 during the ETP from Week 24 to Week 48, with an additional dose of BIIB059 at Week 26.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
BIIB059 (litifilimab)
2016
Completed Phase 2
~380
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for Systemic Lupus Erythematosus (SLE) include monoclonal antibodies and immunomodulatory drugs that target specific immune pathways. For example, BIIB059 (litifilimab) is a monoclonal antibody targeting blood dendritic cell antigen 2 (BDCA2), which regulates plasmacytoid dendritic cells and reduces the production of type I interferons, key players in lupus pathogenesis.
Other treatments like rituximab target CD20-positive B cells to reduce autoantibody production, while JAK inhibitors like tofacitinib block signaling pathways involved in immune cell activation. These mechanisms are crucial for SLE patients as they help to control the overactive immune response, reduce inflammation, and prevent organ damage, thereby improving quality of life and disease outcomes.
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Who is running the clinical trial?
BiogenLead Sponsor
639 Previous Clinical Trials
466,621 Total Patients Enrolled
Medical DirectorStudy DirectorBiogen
2,793 Previous Clinical Trials
8,068,140 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have not used corticosteroids directly on my lesions in the week before screening or during the study.I have skin symptoms that fit the study's requirements.My diagnosis of cutaneous lupus erythematosus is confirmed by tissue examination.I have severe kidney inflammation due to lupus.I still have a skin lesion from lupus despite taking antimalarial medication.I haven't started new SLE or CLE treatments in the last 12 weeks.You need to have a CLASI-A score of 10 or higher.I have active lupus affecting my nervous system.I have no skin conditions that could affect the study, except for CLE.
Research Study Groups:
This trial has the following groups:- Group 1: Part A (Phase 2): BIIB059
- Group 2: Part A (Phase 2): Placebo
- Group 3: Part B (Phase 3): BIIB059
- Group 4: Part B (Phase 3): Placebo
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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