ABY-035 in the Treatment of Subjects With Ankylosing Spondylitis
Last updated on July 2021Recruitment
- Recruitment Status
- Not yet recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Ankylosing Spondylitis
- Type
- Interventional
- Phase
- Phase 2
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: Treatment Period 1: Day 0-Week 16 Eligible subjects will be randomized 1:1:1:1 to receive 1 of 4 treatments (ABY-035 80 mg Q2W, ABY-035 160 mg Q4W, ABY-035 40 mg Q2W, or placebo), and will remain on their allowable background medication. Treatment Period 1 ends at Week 16 after all trial assessments have been done and Treatment Period 2 starts at Week 16 with the IMP injection. Treatment Period 2 (Extension Period): Week 16-Week 52 Subjects will continue their original treatment of Treatment Period 1 in a double-blinded manner. Subjects who could not achieve an ASAS20 response from baseline are defined as non-responders and eligible for rescue treatment after Week 16 (Visit 9).Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
Description
ABY-035-204 is a double-blind, randomized, parallel-group, placebo-controlled study. The primary objective is to estimate the relationship between different dose regimens of ABY-035 and clinical response as assessed by Assessment of Spondyloarthritis International Society 40 (ASAS40) response at Wee...
ABY-035-204 is a double-blind, randomized, parallel-group, placebo-controlled study. The primary objective is to estimate the relationship between different dose regimens of ABY-035 and clinical response as assessed by Assessment of Spondyloarthritis International Society 40 (ASAS40) response at Week 16 in subjects with active AS. The study will include the following 3 periods: Screening Period: Up to 35 days prior to baseline randomization. Treatment Period 1: Day 0-Week 16 Eligible subjects will be randomized 1:1:1:1 to receive 1 of 4 treatments (ABY-035 80 mg Q2W, ABY-035 160 mg Q4W, ABY-035 40 mg Q2W, or placebo). Treatment Period 1 ends at Week 16 after all trial assessments have been done and Treatment Period 2 starts at Week 16 with the IMP injection. Treatment Period 2 (Extension Period): Week 16-Week 52 Subjects will continue their original treatment of Treatment Period 1 in a double-blinded manner. Subjects who could not achieve an ASAS20 response from baseline are defined as non-responders and eligible for rescue treatment after Week 16 (Visit 9).
Tracking Information
- NCT #
- NCT04795141
- Collaborators
- Affibody
- Investigators
- Study Director: Sammy Zhu Clinical medical director
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