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)
Sponsored by Biogen
About this trial
Last updated 3 months ago
Study ID
Status
Type
Phase
Placebo
Accepting
Not accepting
Trial Timing
Started 2 years ago
What is this trial about?
What are the Participation Requirements?
Key Inclusion Criteria:
- Participants who completed the parent study (230LE301 [NCT05531565], Part A or Part
B) on study treatment (received treatment through Week 48 and attended the last
study assessment visit at Week 52).
- Ability of the participant to understand the purpose and risks of the study, to
provide informed consent, and to authorize the use of confidential health
information in accordance with national and local privacy regulations.
Key Exclusion Criteria:
- Early Part A or Part B parent study (230LE301 [NCT05531565]) treatment terminators
(participants who discontinued study treatment before Week 48).
- Early Part A or Part B parent study terminators [participants who withdrew from
parent study participation before Week 52 and did not complete the parent study
extended treatment period (ETP)].
- Participants who have developed any other medical diseases, conditions, or
abnormalities, rendering their participation in the long-term extension (LTE) study
unsuitable in the opinion of the Investigator.
NOTE: Other protocol- defined Inclusion/Exclusion criteria may apply.
For more information, view the full study details:
NCT06044337