A Long-Term Extension Study to Learn More About the Safety of Litifilimab (BIIB059) Injections and Whether They Can Improve Symptoms of Adult Participants Who Have Active Cutaneous Lupus Erythematosus (LTE AMETHYST)
Study Purpose
In this study, researchers will learn more about a study drug called litifilimab (BIIB059) in participants with cutaneous lupus erythematosus (CLE). The study will focus on participants who have either active subacute CLE or chronic CLE, or both. They may also have systemic lupus erythematosus (SLE). The participants did not respond to antimalarial therapy or had problems with the treatment that made it hard to continue. The study will enroll only those participants who have completed treatment with litifilimab in the parent study, 230LE301. The main objective of the study is learning more about the long-term safety of litifilimab. The main question researchers want to answer is:
- - How many participants have adverse events and serious adverse events after taking litifilimab? Adverse events are unwanted medical problems that may or may not be caused by the study drug.
- - The last visit of parent study 230LE301 will be the first visit of study 230LE305.
- - All participants will receive litifilimab as an injection under the skin once every 4 weeks.
- - The treatment period will last up to 104 weeks, or 2 years.
- - There will be a follow-up safety period that lasts up to 24 weeks.
- - In total, participants will have up to 33 study visits.
- - The total study duration for participants will be up to 128 weeks.
Recruitment Criteria
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Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms |
No |
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Study Type
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies. |
Interventional |
| Eligible Ages | 18 Years and Over |
| Gender | All |
Trial Details
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Trial ID:
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries. |
NCT06044337 |
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Phase
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use. |
Phase 3 |
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Lead Sponsor
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data. |
Biogen |
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Principal Investigator
The person who is responsible for the scientific and technical direction of the entire clinical study. |
Medical Director |
| Principal Investigator Affiliation | Biogen |
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Agency Class
Category of organization(s) involved as sponsor (and collaborator) supporting the trial. |
Industry |
| Overall Status | Enrolling by invitation |
| Countries | Argentina, Brazil, Bulgaria, Canada, Chile, France, Germany, Hungary, Italy, Korea, Republic of, Mexico, Serbia, Slovakia, Spain, Sweden, Switzerland, Taiwan, United Kingdom, United States |
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Conditions
The disease, disorder, syndrome, illness, or injury that is being studied. |
Subacute Cutaneous Lupus Erythematosus, Chronic Cutaneous Lupus Erythematosus |
Contact a Trial Team
If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.
