Long-term Safety And Efficacy Of Multiple Long-acting Antibodies Alone And In Combinations For IBD

Overview

About this study

This is a multicenter, long-term extension (LTE) study in participants with ulcerative colitis (UC) from Study SPY123-201 (The SKYLINE-UC study).

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

Participants must meet 1 of the following criteria from Study SPY123-201:

1. Completed Part A and deemed to be receiving clinical benefit by the judgement of the Investigator
2. Completed Part B
3. 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 \[MTP\]).

Exclusion Criteria:

1. Met any treatment discontinuation criteria from Study SPY123-201.
2. Is on any of the following prohibited medications:

1. Immunosuppressants (eg, azathioprine, 6-mercaptopurine \[6-MP\], or methotrexate)
2. 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
3. Any marketed advanced therapy (ie, biologic or small molecule)
4. Any investigational therapy other than SPY123-201 study drug
5. Total parenteral nutrition
3. 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.
4. Ongoing infection requiring oral or intravenous antimicrobial therapy on Day 1.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Contact us for the latest status

Contact information:

IBD Clinical Research Unit

(507) 284-5908

More information

Publications

Publications are currently not available