2025-524640-35-00招募中2 期
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
Spyre Therapeutics Inc.150 个研究点 分布在 8 个国家目标入组 228 人开始时间: 2026年7月15日最近更新:
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 228
- 试验地点
- 150
研究概览
简要总结
To assess the safety and tolerability of study drug treatment regimens
研究设计
- 分配方式
- Na
- 主要目的
- Safety Follow Up period
- 盲法
- None
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •Participants must meet 1 of the following criteria from Study SPY123-201: a. Completed Part A and deemed to be receiving clinical benefit by the judgement of the Investigator b. Completed Part B c. 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: a. Immunosuppressants (eg, azathioprine, 6-MP, or methotrexate) b. 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 c. Any marketed advanced therapy (ie, biologic or small molecule) d. Any investigational therapy other than SPY123-201 study drug e. 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. This includes any clinically significant abnormalities in laboratory (such as ALT or AST>3×ULN, total white blood cell count [WBC]<1000/µL, and absolute neutrophil count [ANC]<500/µL), vital signs, or ECG (such as a prolongation of QTcF interval ≥450 msec for males and ≥470 msec for females) during the last evaluation of Study SPY123-201 which, in the opinion of the Investigator, may suggest that participation is not in the best interest of the participant, confound study results, or interfere with the study conduct or compliance. Note that for laboratory or ECG abnormalities, a retest can be performed once during the LTE Eligibility Period, as per Investigator judgement.
- •Ongoing infection requiring oral or IV antimicrobial therapy on Day 1.
研究组 & 干预措施
SPY003
Test
干预措施: SPY003 (Drug)
SPY002
Test
干预措施: SPY002 (Drug)
SPY001-001
Test
干预措施: SPY001-001 (Drug)
SPYPBO-101
Placebo
干预措施: SPYPBO-101 (Drug)
研究者
SKYLINE-UC Trial Center
Scientific
Spyre Therapeutics Inc.
研究点 (150)
Loading locations...
相似试验
招募中
2 期
A long-term study to monitor the health status of people with cystic fibrosis who took part in a previous study with BI 3720931 (LenticlairTM-ON)Cystic fibrosis2023-504909-37-00Boehringer Ingelheim International GmbH, Boehringer Ingelheim Espana S.A.12
Enrolling By Invitation
不适用
"Real-world Assessment of BP Control in Patients With Hypertension by the Netrod RDN System" - REACH-RDNHypertensionNCT07273877Shanghai Golden Leaf MedTec Co. Ltd1,000
已完成
1 期
Safety, Tolerability and Pharmacokinetics of Benfo-Oxythiamine (B-OT) in Healthy VolunteersNCT07450833Benfovir AG48
招募中
1 期
JY232(JY232) Injection in Relapsed/Refractory Multiple MyelomaMultiple MyelomaNCT07336823Shenzhen Genocury Biotech Co., Ltd.9
招募中
2 期
A Phase II Study to Evaluate the Efficacy and Safety of HLX43 + Serplulimab as Neoadjuvant Therapy in Subjects With NSCLCNCT07269782Shanghai Henlius Biotech60