A Study to Evaluate the Long-term Safety and Efficacy of Long-acting Antibodies as Single Agents and in Combinations in Participants With Inflammatory Bowel Disease
试验速览
- 阶段
- 2 期
- 状态
- Enrolling By Invitation
- 入组人数
- 645
- 试验地点
- 52
研究概览
简要总结
This is a multicenter, long-term extension (LTE) study in participants with ulcerative colitis (UC) from Study SPY123-201 (The SKYLINE-UC study).
详细描述
This is a multicenter, long-term extension (LTE) study in participants with ulcerative colitis (UC) from Study SPY123-201 (The SKYLINE-UC study) who have completed Part A and are deemed to be receiving clinical benefit, completed Part B, or met escape criteria in Part B. The primary aim of this LTE study is to characterize the long-term safety of various investigational drugs, to offer participants the option to extend treatment if they are clinically benefiting, or if they have not achieved sufficient clinical benefit (particularly placebo insufficient responders), to offer the opportunity to receive investigational drug.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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]).
排除标准
- •Met any treatment discontinuation criteria from Study SPY123-
- •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
- •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.
研究组 & 干预措施
SPY001 & SPY003
Participants will receive SPY001 and SPY003
干预措施: SPY001 (Drug)
SPY002 Dosing Regimen 2
Participants will receive SPY002
干预措施: SPY002 (Drug)
SPY001 & SPY002
Participants will receive SPY001 and SPY002
干预措施: SPY002 (Drug)
SPY002 Dosing Regimen 1
Participants will receive SPY002
干预措施: SPY002 (Drug)
SPY001 & SPY003
Participants will receive SPY001 and SPY003
干预措施: SPY003 (Drug)
SPY001 Dosing Regimen 1
Participants will receive SPY001
干预措施: SPY001 (Drug)
SPY001 Dosing Regimen 2
Participants will receive SPY001
干预措施: SPY001 (Drug)
SPY002 & SPY003
Participants will receive SPY002 and SPY003
干预措施: SPY002 (Drug)
SPY003 Dosing Regimen 1
Participants will receive SPY003
干预措施: SPY003 (Drug)
SPY002 & SPY003
Participants will receive SPY002 and SPY003
干预措施: SPY003 (Drug)
SPY002 Dosing Regimen 3
Participants will receive SPY002
干预措施: SPY002 (Drug)
SPY003 Dosing Regimen 2
Participants will receive SPY003
干预措施: SPY003 (Drug)
SPY001 & SPY002
Participants will receive SPY001 and SPY002
干预措施: SPY001 (Drug)