NCT03283085

Who might be able to join this trial:

If you have Ulcerative Colitis (UC):

• You (or your parent or legal representative) are willing and able to fully follow all study rules and procedures.
• You (or your parent or legal representative) are able to give written, signed, and dated consent to take part in the study.
• You previously took part in specific earlier studies (SHP647-301 or SHP647-302) and then the maintenance study (SHP647-303), and your UC symptoms improved with the study drug (ontamalimab) during those studies (confirm with trial site for specific response measures).
• Any UC medications you are currently taking have been at a stable, unchanged dose for the required period of time.

If you have Crohn's Disease (CD):

• You (or your parent or legal representative) are willing and able to fully follow all study rules and procedures.
• You (or your parent or legal representative) are able to give written, signed, and dated consent to take part in the study.
• You previously took part in specific earlier studies (SHP647-305 or SHP647-306) and then the maintenance study (SHP647-307), and your CD symptoms improved with the study drug (ontamalimab) during those studies (confirm with trial site for specific response measures).
• Any CD medications you are currently taking have been at a stable, unchanged dose for the required period of time.

Who may not be able to join:

If you have Ulcerative Colitis (UC):

• You seriously broke the rules of one of the earlier related studies, as decided by the study sponsor.
• You had to permanently stop taking the study drug because of a side effect in one of the earlier related studies.
• Your doctors think you are likely to need major surgery for your UC.
• You are a woman who became pregnant during one of the earlier related studies, are currently breastfeeding, are planning to become pregnant during this study, or you (male or female) are unwilling to use appropriate birth control throughout the study.
• You are unwilling to avoid donating organs, tissues, sperm, or eggs for the entire duration of the study and for 16 weeks after your last dose of the study drug.
• In the opinion of the study doctor or sponsor, you are unlikely to follow the study procedures.
• You have been newly diagnosed with cancer, or a previous cancer has come back (with some exceptions for certain treated skin or cervical cancers — confirm with trial site).
• You have developed a significant new illness or unstable health condition affecting organs such as the kidneys, liver, heart, or lungs, or you have an active infection that the study doctor believes would put you at risk.
• You have any other serious medical or psychiatric condition, or abnormal test results, that the study doctor believes would make it unsafe or unsuitable for you to participate.
• You have been exposed to tuberculosis (TB) since your screening tests in the earlier related studies, and you need treatment for TB but do not have an accepted treatment plan available.
• You are a member of staff at the study site, a relative of a staff member, or a sponsor employee directly involved in running this study.
• You are currently taking part in another clinical trial (other than the specific related studies listed) or plan to join another clinical trial during this study.

If you have Crohn's Disease (CD):

• You seriously broke the rules of one of the earlier related studies, as decided by the study sponsor.
• You had to permanently stop taking the study drug because of a side effect in one of the earlier related studies.
• Your doctors think you are likely to need major surgery for your CD, or you have had a serious sudden complication of CD requiring urgent treatment, or your disease activity score is very high (confirm with trial site).
• You are a woman who became pregnant during one of the earlier related studies, are currently breastfeeding, are planning to become pregnant during this study, or you (male or female) are unwilling to use appropriate birth control throughout the study.
• You are unwilling to avoid donating organs, tissues, sperm, or eggs for the entire duration of the study and for 16 weeks after your last dose of the study drug.

Important: Always verify eligibility with the trial site directly before applying.