A phase 3B, open-label, single-arm, rollover study to evaluate long-term safety of Luspatercept in subjects who have participated in other Luspatercept (ACE-536) clinical trials.

You may be able to join if

• Subjects must meet all the following criteria to be enrolled in this study: 1) Subject is ≥ 18 years at the time of signing the informed consent form (ICF).
• 2) Subject is willing and able to adhere to the study visit schedule and other protocol requirements.
• 3) Subject has been participating in a luspatercept trial and continues to fulfill all the requirements of the parent protocol and the subject has been either: a) Assigned to luspatercept treatment, continues to receive clinical benefit in the opinion of the investigator and should continue to receive luspatercept treatment, OR b) Assigned to placebo arm in the parent protocol (at the time of unblinding or in follow-up) and should cross over to luspatercept treatment, OR c) Assigned to the Follow-up Phase of the parent protocol, previously treated with luspatercept or placebo in the parent protocol who shall continue into Long-term Posttreatment Follow-up Phase in the rollover study until the follow-up commitments are met (unless requirements are met as per parent protocol to cross over to luspatercept treatment).
• 4) Subject understands and voluntarily signs an informed consent document prior to any studyrelated assessments or procedures being conducted.
• 5) Subject demonstrates compliance, as assessed by the investigator, with the parent study protocol requirements.
• 6) Applies to on treatment subjects only- females of childbearing potential (FCBP) defined as a sexually mature woman who: 1) has achieved menarche at some point, 2) has not undergone a hysterectomy or bilateral oophorectomy, or 3) has not been naturally postmenopausal (amenorrhea following cancer therapy or amenorrhea due to other medical reasons does not rule out childbearing potential) for at least 24 consecutive months (ie, has had menses at any time in the preceding 24 consecutive months) and must: a) Have two negative pregnancy tests as verified by the investigator prior to starting study therapy. A medically supervised serum pregnancy test (conducted locally) is to be obtained and verified negative in all female subjects of childbearing potential at enrollment (for details refer to Section 6.1.7). She must agree to ongoing pregnancy testing during the course of the study, and after end of study therapy. This applies even if the subject practices true abstinence* from heterosexual contact. b) Either commit to true abstinence* from heterosexual contact (which must be reviewed on a monthly basis and source documented) or agree to use, and be able to comply with highly effective, contraception without interruption, 35 days prior to starting investigational product (IP), during the study therapy (including dose interruptions), and for 84 days after discontinuation of study therapy.