Long-term Safety and Efficacy of Multiple Long-acting Antibodies Alone and in Combinations for IBD

Prior treatment

• Is on any of the following prohibited medications:
  • Immunosuppressants (eg, azathioprine, 6-mercaptopurine \[6-MP\], or methotrexate)
  • Systemic tacrolimus, systemic cyclosporine, oral mycophenolate mofetil (MMF), immunoadsorption columns (such as Prosorba columns), penicillamine, leflunomide, thalidomide, or any other medications that may have immunosuppressive effects
  • Any marketed advanced therapy (ie, biologic or small molecule)
  • Any investigational therapy other than SPY123-201 study drug
  • Total parenteral nutrition

Other illness

• Development of any new, unstable, or uncontrolled metabolic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological (including current and past neurological symptoms suggestive of demyelinating disease), respiratory, endocrine, or psychiatric disorder, acute or chronic infectious diseases, suspected or confirmed immunodeficiency, and suspected or confirmed malignancies, as determined by the Investigator that is likely to unfavorably alter the risk of study participation, confound study results, or interfere with the study conduct or compliance.
• Ongoing infection requiring oral or intravenous antimicrobial therapy on Day 1.

Other

• Met any treatment discontinuation criteria from Study SPY123-201.

• Participants must meet 1 of the following criteria from Study SPY123-201:
• Completed Part A and deemed to be receiving clinical benefit by the judgement of the Investigator
• Completed Part B
• Participated in Part B and met escape criteria per the SPY123-201 protocol (ie, did not achieve sufficient improvement after the induction treatment period \[ITP\] or experienced disease worsening during the maintenance treatment period \[MTP\]).