Clinical Trials List
2026-05-01 - 2031-07-20
Phase II
Recruiting6
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
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Trial Applicant
TAIWAN PSI HEALTH DEVELOPMENT COMPANY LIMITED
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Sponsor
Spyre Therapeutics, Inc.
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Trial scale
Multi-Regional Multi-Center
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Update
2026/08/30
Investigators and Locations
Co-Principal Investigator
- 陳彥年 無
- 陳介章 無
- SHU-CHEN WEI 無
The Actual Total Number of Participants Enrolled
0 Recruiting
The Actual Total Number of Participants Enrolled
0 Recruiting
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- 黃柏儒 無
The Actual Total Number of Participants Enrolled
0 Recruiting
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Recruiting
Condition/Disease
Objectives
Test Drug
SPY002-091
SPY003-207
Active Ingredient
SPY002-091
SPY003-207
Dosage Form
Dosage
400 mg/2ml
360 mg/2ml
Endpoints
Inclution Criteria
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]).
Exclusion Criteria
Met any treatment discontinuation criteria from Study SPY123-201.
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.
The Estimated Number of Participants
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Taiwan
12 participants
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Global
645 participants
