Clinical Trials

Inclusion Criteria:

Participants are eligible to be included in the study only if all of the following criteria apply:

• Participants who have completed the treatment period and have not been prematurely discontinued from IP in the predecessor studies.
• Participants who received their last dose of IP in the predecessor studies within the previous 12 weeks and were not withdrawn from the predecessor study.
• FOCBP must have a negative urine pregnancy test at Visit 1.
• Participants who are willing to continue using contraceptive methods as agreed to for the predecessor OBERON or TITANIA studies. Contraceptive use by men or women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
• Male participants: Non-sterile male participants who are sexually active with a FOCPB partner must agree to use a male condom while engaging in sexual activity from enrolment throughout the study duration and until 14 weeks after last dose of IP. In countries where spermicide is available, it is strongly recommended. It is also strongly recommended for the female partner of a male participant to use a highly effective method of contraception throughout this period. Non-sterilised male patients should also refrain from biologically fathering a child or donating sperm during the same period.
• Female participants: FOCBP who are sexually active with a non-sterilised male partner must agree to use one highly effective method of birth control, as defined below, from enrolment throughout the study and until at least 14 weeks after last dose of IP. Cessation of contraception after this point should be discussed with a responsible physician. Periodic abstinence (calendar, symptothermal, post-ovulation methods), withdrawal (coitus interruptus), spermicides only, and lactational amenorrhoea method are not acceptable methods of contraception. Female condom and male condom should not be used together. A highly effective method of contraception is defined as one that can achieve a failure rate of less than 1% per year when used consistently and correctly. Highly effective birth control methods can be found in Appendix E. It is highly recommended for the male partner of a FOCBP participant to use a male condom whilst engaging in sexual activity throughout this period. Note that there are no contraception requirements for female participants who are not of childbearing potential. However, all female participants should refrain from egg cell donation and breastfeeding throughout the study.
• Capable of giving signed informed consent as described in Appendix A, which includes compliance with the requirements and restrictions listed in the ICF and in the protocol.

Exclusion Criteria:

Participants are excluded from the study if any of the following criteria apply. Diagnostic Assessments/Medical Conditions.

• Any clinically significant disorder or abnormal findings (clinical, laboratory, instrumental, etc) or major physical and/or cognitive impairment, which, in the opinion of the Investigator, may put the participant at risk because of his/her participation in the study or impact the interpretation of the study results, or otherwise makes the participation of the participant inappropriate.
• Participant meeting criteria for IP discontinuation as judged by the Investigator or the Sponsor.
• Concurrent enrolment in other interventional clinical study or treatment with another IP, with the exception of the OBERON and TITANIA predecessor studies.
• Known history of: (a) Severe allergic reaction to any monoclonal and polyclonal antibody. (b) Allergy or reaction to any component of the IP formulation.
• Chronic use (or expected need for chronic use during the study) of immunosuppressive medications (including, but not limited to, systemic corticosteroids), marketed or investigational biologic, or another prohibited medication that, in the opinion of the Investigator or the Sponsor, may put the participant's safety at risk and/or impact the interpretation of the study results.
• Involvement in the planning and/or conduct of the study (applies to both staff employed by the Sponsor and/or staff at the study site).
• Participants who are not able to comply with the study requirements, procedures, and restrictions, as judged by the Investigator or the Sponsor.

Note: Other protocol defined Inclusion/Exclusion Criteria may apply.

Eligibility last updated 1/11/2024. Questions regarding updates should be directed to the study team contact.