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Monoclonal Antibodies
Litifilimab for Systemic Lupus Erythematosus (TOPAZ-2 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
Are your SLE symptoms active now? Common symptoms include: ongoing fever, painful, swollen joints, increased fatigue, rash, or general swilling in the legs.
Have you been diagnosed by a doctor with Systemic Lupus Erythematosus (SLE)?
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 40 up to week 52
Awards & highlights
TOPAZ-2 Trial Summary
This trial is testing a new drug for Lupus called BIIB059. The objective is to see if it is more effective than a placebo in reducing disease activity. There are also secondary objectives to see if it has early onset of efficacy, if it works on specific parts of the body, and if it has other benefits. Finally, they will assess the safety and tolerability of the drug.
Who is the study for?
Adults with active Systemic Lupus Erythematosus (SLE) who are on standard nonbiologic lupus treatments can join. They must have been diagnosed at least 24 weeks ago, meet specific SLE criteria, and not be taking high doses of corticosteroids or certain other medications. People with severe kidney issues, serious infections like herpes or hepatitis, HIV, heart failure, or skin conditions other than CLE cannot participate.Check my eligibility
What is being tested?
The trial is testing the effectiveness and safety of a drug called BIIB059 (litifilimab) versus a placebo in reducing SLE activity while participants continue their usual lupus treatments. It also looks at how quickly it works for joint and skin symptoms, its impact on steroid use and quality of life up to Week 52.See study design
What are the potential side effects?
Possible side effects include reactions related to the immune system since litifilimab targets inflammation pathways involved in lupus. Specific side effects aren't listed but may resemble those seen with similar drugs such as infusion reactions, infections due to lowered immunity, or allergic responses.
TOPAZ-2 Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My SLE symptoms are currently active, including fever, joint pain, fatigue, rash, or leg swelling.
Select...
I have been diagnosed with Systemic Lupus Erythematosus (SLE).
Select...
I am currently on medication for SLE.
Select...
I am not taking steroids, or my dose is under 20 mg daily.
Select...
I am taking antimalarial medication for my lupus.
Select...
I am not currently taking and have not taken Saphnelo.
TOPAZ-2 Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ week 40 up to week 52
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 40 up 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 Lupus-Specific Health-Related Quality-of-Life Questionnaire (LupusQoL) Score
+22 moreSide effects data
From 2019 Phase 2 trial • 264 Patients • NCT0284759817%
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%
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
TOPAZ-2 Trial Design
3Treatment groups
Experimental Treatment
Placebo Group
Group I: BIIB059 Low DoseExperimental Treatment1 Intervention
Participants who are receiving background nonbiologic lupus SOC therapy will receive low dose of BIIB059, SC Q4W, up to Week 48 with an additional dose at Week 2.
Group II: BIIB059 High DoseExperimental Treatment1 Intervention
Participants who are receiving background nonbiologic lupus SOC therapy will receive high dose of BIIB059, 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 BIIB059 matching placebo, SC Q4W, up to Week 48 with an additional dose at Week 2.
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
639 Previous Clinical Trials
466,896 Total Patients Enrolled
Medical DirectorStudy DirectorBiogen
2,777 Previous Clinical Trials
8,062,946 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have had a serious herpes infection in the past.I have severe heart failure that is not under control.I am currently infected with hepatitis C.I am taking antimalarial medication for my lupus.I have severe lupus affecting my kidneys or very poor kidney function.I have skin conditions, but not those that could affect the study's lupus skin assessment.I am not currently taking and have not taken Saphnelo.I have or had a significant blood vessel inflammation not related to lupus.I take more than 20 mg/day of oral prednisone or its equivalent.I am not taking steroids, or my dose is under 20 mg daily.I have been diagnosed with Systemic Lupus Erythematosus (SLE).I was diagnosed with lupus more than 24 weeks ago and meet the 2019 EULAR/ACR lupus criteria.My lupus activity score is 6 or higher, not counting hair loss, fever, headaches, or brain symptoms.My lupus is active, affecting at least one organ severely or two organs moderately.I have been on a stable lupus treatment for at least 4 weeks.My SLE symptoms are currently active, including fever, joint pain, fatigue, rash, or leg swelling.I am currently on medication for SLE.I have HIV or tested positive for it.
Research Study Groups:
This trial has the following groups:- Group 1: BIIB059 High Dose
- Group 2: BIIB059 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.
Systemic Lupus Erythematosus Patient Testimony for trial: Trial Name: NCT04961567 — Phase 3
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are researchers still recruiting individuals for this experiment?
"This information is available on clinicaltrials.gov. The trial was posted on 7/16/2021 and was last edited on 11/3/2022."
Answered by AI
What have been the most severe adverse effects of BIIB059 in human trials?
"BIIB059 has received a 3 for safety. This is due to the fact that it is a Phase 3 trial, and thus there is both efficacy data and multiple rounds of safety data supporting this score."
Answered by AI
How many different hospitals are a part of this clinical trial?
"Currently, this experiment is being conducted at LSU Health Sciences Center in New Orleans, Louisiana, Emory University in Atlanta, Georgia, and Kotha in San Diego, California with an additional 36 sites planned."
Answered by AI
Who else is applying?
What state do they live in?
Arkansas
Texas
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
What site did they apply to?
University of Miami Miller School of Medicine
DJL Clinical Research, PLLC
Research Site
Other
How many prior treatments have patients received?
2
0
Why did patients apply to this trial?
Need new medication that will actually work. I’m tired of not feeling good. So tired all the time.
PatientReceived no prior treatments
I am at my whits end with symptoms not being alleviated. I’ve gaining weight and I want a medication that won’t make me gain weight.
PatientReceived 1 prior treatment
I've been on Plaquenil for almost 3 years and have only mild relief from my symptoms. I still deal with chronic inflammation and rashes regularly that impact my ability to enjoy life.
PatientReceived 1 prior treatment
How responsive is this trial?
Typically responds via
Phone Call
Most responsive sites:
- Research Site: < 24 hours
Average response time
- < 2 Days
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