Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Amgen
Approximately 156 participants will be enrolled to receive daxdilimab administered subcutaneously over 48 weeks. The maximum trial duration per participant is approximately 56 weeks, including the 48 weeks for the open-label treatment period where participants will receive daxdilimab and approximately 8 weeks for the follow-up period. Safety evaluations will be performed regularly throughout the course of the study.
Acquired from Horizon in 2024.
Age
18–72
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Willing and able to understand and provide written informed consent.
Must have completed the treatment period in the RECAST SLE study.
Women of childbearing potential must have a negative urine pregnancy test on Day 1.
Nonsterilized male subjects who are sexually active with a woman partner of childbearing potential must agree to use a condom with spermicide from Day 1 and until 3 months (approximately 5 half-lives) after receipt of the last dose.
You may not be if
Any condition or change during the RECAST SLE study that in the opinion of the Investigator or the Sponsor would interfere with evaluation and interpretation of subject safety or alter the risk-benefit associated with IP administration.
Participation in another clinical study with an IP during the RECAST SLE study period.
Planned elective surgeries that in the opinion of the Investigator or the Sponsor would interfere with evaluation and interpretation of subject safety.
Any herpes zoster, cytomegalovirus, or Epstein-Barr virus infection that was not completely resolved prior to Visit 1.
Clinically significant active infection at Visit 1, in the opinion of the Investigator.
