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Monoclonal Antibodies
Litifilimab for Lupus (TOPAZ-1 Trial)
Phase 3
Recruiting
Research Sponsored by Biogen
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Participant must be diagnosed with systemic lupus erythematosus (SLE) at least 24 weeks prior to screening and must meet the 2019 European League Against Rheumatism (EULAR) / American College of Rheumatology (ACR) classification criteria for SLE at screening by a qualified physician
Participant has BILAG-2004 grade A in ≥ 1 organ system or BILAG-2004 grade B in ≥ 2 organ systems at Screening (adjudicated) and randomization
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 40 to week 52
Awards & highlights
TOPAZ-1 Trial Summary
This trial is testing a new drug for Lupus called BIIB059. The goal is to see if it is effective in reducing disease activity, and if it has any other benefits compared to placebo. There are many secondary objectives to this study, including assessing the safety and immunogenicity of the drug.
Who is the study for?
Adults diagnosed with systemic lupus erythematosus (SLE) for at least 24 weeks, meeting specific criteria and having active disease despite standard treatments. They must not be on high-dose steroids or have severe kidney issues, uncontrolled heart failure, certain infections like HIV or hepatitis, other skin conditions that could affect assessments, or a history of severe herpes infection.Check my eligibility
What is being tested?
The trial is testing the effectiveness and safety of BIIB059 (litifilimab) versus placebo in reducing SLE activity while participants continue their usual lupus medications. It aims to show benefits in overall disease control, organ-specific outcomes like joint and skin health, reduced need for steroids, and improved quality of life.See study design
What are the potential side effects?
While the side effects are not detailed here, litifilimab may cause reactions similar to other immune-modulating drugs such as infusion-related reactions, increased risk of infections due to immune system suppression, potential liver enzyme changes, and possible impact on blood cell counts.
TOPAZ-1 Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I was diagnosed with lupus more than 24 weeks ago and meet the 2019 lupus criteria.
Select...
My lupus affects at least one organ severely or two organs moderately.
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My lupus activity score is 6 or more, not counting hair loss, fever, headaches, or brain symptoms.
TOPAZ-1 Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ week 40 to week 52
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 40 to week 52
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Percentage of Participants Who Achieved a Systemic Lupus Erythematosus Responder Index of 4 (SRI-4) Response at Week 52
Secondary outcome measures
Annualized Flare Rate Through Week 52
Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) Score
Change From Baseline in Patient Health Questionnaire-9 (PHQ-9) Score
+22 moreTOPAZ-1 Trial Design
3Treatment groups
Experimental Treatment
Placebo Group
Group I: Litifilimab Low DoseExperimental Treatment1 Intervention
Participants who are receiving background nonbiologic lupus SOC therapy will receive low dose of litifilimab, SC Q4W, up to Week 48 with an additional dose at Week 2.
Group II: Litifilimab High DoseExperimental Treatment1 Intervention
Participants who are receiving background nonbiologic lupus SOC therapy will receive high dose of litifilimab, subcutaneously (SC) every 4 weeks (Q4W), up to Week 48 with an additional dose at Week 2.
Group III: PlaceboPlacebo Group1 Intervention
Participants who are receiving background nonbiologic lupus SOC therapy will receive litifilimab-matching placebo, SC Q4W, up to Week 48 with an additional dose at Week 2.
Find a Location
Who is running the clinical trial?
BiogenLead Sponsor
639 Previous Clinical Trials
466,817 Total Patients Enrolled
Medical DirectorStudy DirectorBiogen
2,777 Previous Clinical Trials
8,063,324 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have severe heart failure that is not under control.I have been on a stable lupus treatment for at least 4 weeks.I have severe lupus affecting my kidneys or very poor kidney function.I am taking more than 20 mg/day of oral prednisone or its equivalent.I was diagnosed with lupus more than 24 weeks ago and meet the 2019 lupus criteria.I have a skin condition, but it's not one that would affect the study's lupus skin assessment.I have active brain-related symptoms due to lupus.I have or had a significant blood vessel inflammation not related to lupus.I am currently infected with hepatitis C.My lupus affects at least one organ severely or two organs moderately.My lupus activity score is 6 or more, not counting hair loss, fever, headaches, or brain symptoms.
Research Study Groups:
This trial has the following groups:- Group 1: Litifilimab High Dose
- Group 2: Litifilimab Low Dose
- Group 3: Placebo
Awards:
This trial has 1 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Has the FDA greenlit BIIB059 for public consumption?
"There is evidence from past trials to support the efficacy of BIIB059 as well as its safety, so it received a score of 3."
Answered by AI
Are patients still being accepted into this particular clinical trial?
"That is correct. The clinicaltrials.gov website currently lists this trial as recruiting patients. This trial was originally posted on May 25, 2021 and was updated on October 21, 2022. The trial is looking to enroll 540 participants at 20 locations."
Answered by AI
How many different research hospitals are currently participating in this clinical trial?
"There are 20 sites that are recruiting patients for this clinical trial. If you enroll, it is important to try and choose a location nearest to you to limit travel. The sites are located in Webster, Charlotte, Brooklyn, and other cities."
Answered by AI
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