An Open-Label Study to Evaluate the Long-Term Safety, Tolerability and Efficacy of OMS906 in Patients with Paroxysmal Nocturnal Hemoglobinuria (PNH)

You may be able to join if

• Have completed the last dosing visit of the prior OMS906-PNH-001 and OMS906-PNH-002 studies. Patients who have tolerated zaltenibart well and had an adequate clinical response will be eligible.
• Female patients of child-bearing potential (CBP) must have a negative result from a highly sensitive urine pregnancy test prior to each dose of zaltenibart.
• Females must use highly effective birth control to prevent pregnancy during the clinical trial and for 20 weeks (140 days) following their last dose of study drug; If a female, must be sterile (either surgically or biologically)* or at least one year postmenopausal**, or have a monogamous partner who is surgically sterile, or have a same sex partner, or if in a heterosexual relationship, must agree to comply with the following contraception guidelines: Practice abstinence (only considered a highly effective method of contraception when it is in line with the patient’s usual and preferred lifestyle and the patient agrees to refrain from heterosexual intercourse during the entire period of risk associated with the study treatments, including during the clinical trial and for 20 weeks [140 days] following their last dose of study drug), or Use at least 1 of the following medically highly effective methods of birth control: hormonal methods (combined estrogen-andprogestogen- containing hormonal contraception associated with inhibition of ovulation [oral, intravaginal, transdermal] or progestogen only hormonal contraception associated with inhibition of ovulation [oral, injectable, implantable]), intrauterine devices, intrauterine hormone-releasing systems, bilateral salpingectomy or bilateral tubal ligation/occlusion, or a vasectomized partner. * Defined as having had a hysterectomy and/or bilateral oophorectomy at least 6 weeks prior to the Evaluation Period; or have a congenital or acquired condition that prevents child-bearing. ** Defined as at least 12 months with no menses without an alternative medical cause (confirmed with follicle stimulating hormone level [FSH] in the postmenopausal range [FSH levels ≥ 40 mIU/mL during the Evaluation Period] if the patient is not using hormonal contraception or on hormonal replacement therapy). In the absence of 12 months of amenorrhea, a single FSH measurement is insufficient.
• Males must use highly effective birth control with a female partner to prevent pregnancy during the clinical trial and for 20 weeks (140 days) following their last dose of study drug that include the following: Practice abstinence (only considered a highly effective method of contraception when it is in line with the patient's usual and preferred lifestyle and the patient agrees to refrain from heterosexual intercourse during the entire period of risk associated with the study treatments, including during the clinical trial and for 20 weeks [140 days] following their last dose of study drug), or Use (or have their partner use) highly effective contraception (see Criterion #3) during heterosexual activity.
• Have current vaccination status for Neisseria meningitidis, Streptococcus pneumonia and Haemophilus influenzae (for S. pneumoniae and H. influenzae vacination, if locally available and/or part of standard of care) and agree to maintain vaccination throughout the study.
• Have provided informed consent.