Open-Label Extension of RPC1063 as Therapy for Moderate to Severe Ulcerative Colitis

Open to people ages 18 years and up

1. Previously participated in a trial of RPC1063 for UC and meet the criteria for participation in the open label extension as outlined in the prior trial
2. Female patients of childbearing potential:

Must agree to practice a highly effective method of contraception throughout the trial until completion of the safety follow-up visit. Highly effective methods of contraception are those that alone or in combination result in a failure rate of a Pearl index of less than 1% per year when used consistently and correctly. Acceptable methods of birth control in the trial are the following:

• combined hormonal (oestrogen and progestogen containing) contraception, which may be oral, intravaginal, or transdermal
• progestogen-only hormonal contraception associated with inhibition of ovula-tion, which may be oral, injectable, or implantable
• placement of an intrauterine device (IUD)
• placement of an intrauterine hormone-releasing system (IUS)
• bilateral tubal occlusion
• vasectomised partner
• sexual abstinence

Male patients:

Must agree to use a latex condom during sexual contact with women of childbearing po-tential while participating in the trial until completion of the safety follow-up visit.

All patients:

Periodic abstinence (calendar, symptothermal, post-ovulation methods), withdrawal (coitus interruptus), spermicides only, and lactational amenorrhoea method are not ac-ceptable methods of contraception. Female condom and male condom should not be used together.

1. Must provide written informed consent and have the ability to be compliant with the schedule of protocol assessments, which must be obtained prior to any trial-related procedures.