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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 below

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My diagnosis of cutaneous lupus erythematosus is confirmed by tissue examination.

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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

This trial's timeline: 3 weeks for screening, Varies for treatment, and 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 for reporting.

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 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 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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

BIIB059 (litifilimab)

2016

Completed Phase 2

~380

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

BiogenLead Sponsor

639 Previous Clinical Trials

466,848 Total Patients Enrolled

Medical DirectorStudy DirectorBiogen

2,777 Previous Clinical Trials

8,063,270 Total Patients Enrolled

Media Library

BIIB059 (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT05531565 — Phase 2 & 3

Systemic Lupus Erythematosus Research Study Groups: Part A (Phase 2): BIIB059, Part A (Phase 2): Placebo, Part B (Phase 3): BIIB059, Part B (Phase 3): Placebo

Systemic Lupus Erythematosus Clinical Trial 2023: BIIB059 Highlights & Side Effects. Trial Name: NCT05531565 — Phase 2 & 3

BIIB059 (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05531565 — Phase 2 & 3

Frequently Asked Questions

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

Are there any recruitment opportunities currently available for this clinical trial?

"Yes, as per information available on clinicaltrials.gov this trial is still recruiting participants. The listing was created on 9/13/2022 and updated on 11/11/2022."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Study to Assess the Efficacy and Safety of BIIB059 (Litifilimab) in Participants With Active Subacute Cutaneous Lupus Erythematosus (SCLE) and/or Chronic Cutaneous Lupus Erythematosus (CCLE) With or Without Systemic Manifestations and Refractory and/or Intolerant to Antimalarial Therapy

2022. "A Study to Assess the Efficacy and Safety of BIIB059 (Litifilimab) in Participants With Active Subacute Cutaneous Lupus Erythematosus (SCLE) and/or Chronic Cutaneous Lupus Erythematosus (CCLE) With or Without Systemic Manifestations and Refractory and/or Intolerant to Antimalarial Therapy". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05531565.

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