Ankylosing Spondylitis
Conditions
Brief summary
ABY-035-204 is a clinical study to assess the efficacy of IL-17 blocker ABY-035 in ankylosing spondylitis(AS). 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.
Detailed 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 Week 16 in subjects with active AS. The study will include the following 3 periods: 1. Screening Period: Up to 35 days prior to baseline randomization. 2. Treatment Period 1: Day 0-Week 16 Cohort 1: Eligible subjects will be randomized 1:1:1:1 to receive 1 of 4 treatments (ABY-035 High Dose every 2 weeks (Q2W), ABY-035 Low Dose every 2 weeks (Q2W), ABY-035 High Dose every 4 weeks (Q4W), or placebo Q2W), and will remain on their allowable background medication. Cohort 2: Eligible subjects will be randomized 1:1:1 to receive 1 of 3 treatments (ABY-035 High Dose every week (QW), ABY-035 Low Dose every week (QW), or placebo QW), and will remain on their allowable background medication. Randomization will be stratified by region (North Eastern Asia and North America) and previous tumor necrosis factor alpha (TNFα) inhibitor exposure (TNFα inhibitor treated or TNFα inhibitor naïve). Maximum 30% of subjects will be TNFα inhibitor-treated subjects to ensure a representative population for the assessment of efficacy and safety. 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. 3. Treatment Period 2 (Extension Period): Week 16-Week 52 Cohort 1: Subjects will receive ABY-035 High Dose Q2W treatment in an open-label manner. Cohort 2: Subjects will receive ABY-035 High Dose QW treatment in an open-label manner. At Week24, subjects who could not achieve an ASAS20 response from baseline are defined as non-responders and will discontinue the study treatment.
Interventions
DRUGABY-035
ABY-035 Solution for injection
DRUGPlacebo
Normal Saline for injection
Sponsors
Affibody
Inmagene LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Male or female at least 18 years of age. 2. Subjects with active AS, determined by documented radiologic evidence (X-ray) fulfilling the Modified New York criteria for AS (1984). AND At least one SpA feature, according to ASAS criteria. 3. Subjects have moderate to severe active disease 4. Subjects must have inadequate response or intolerance to at least 2 NSAIDs, or contraindication to NSAID therapy. 5. Subjects may be TNFα inhibitor-naïve or may have received up to 2 prior TNFα inhibitor(s)..
Exclusion criteria
1. Subjects have active fibromyalgia or total spinal ankylosis ('bamboo spine'), or any other inflammatory arthritis. 2. Subjects have used medications in the manner as detailed by the
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of subjects achieving an ASAS40 response | 16 weeks | The treatment effect |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in BASFI | 16 weeks | The treatment effect |
| Proportion of subjects reaching ASDAS-MI | 16 weeks | The treatment effect |
| Incidence of AEs | 74 weeks | Safety information |
| Incidence of serious adverse events (SAEs) and adverse events of special interests (AESIs) | 74 weeks | Safety information |
| AEs leading to withdrawal from investigational medicinal product (IMP) | 74 weeks | Safety information |
| Change in safety laboratory parameters and vital signs compared to baseline | 74 weeks | Safety information |
| Change from baseline in BASDAI | 16 weeks | The treatment effect |
| Change from baseline in BASDAI and BASFI at required timepoints | 52 weeks | The treatment effect |
| Proportion of subjects reaching BASDAI50 and ASDAS-MI at required timepoints | 52 weeks | The treatment effect |
| Proportion of subjects experiencing clinically important improvement at required timepoints | 52 weeks | The treatment effect |
| ASDAS-CRP and ASDAS status at required timepoints | 52 weeks | The treatment effect |
| Change from baseline in total and nocturnal pain at required timepoints | 52 weeks | The treatment effect |
| Proportion of subjects achieving an ASAS40 response, ASAS20 response, ASAS partial remission, and ASAS 5/6 response respectively at required timepoints | 52 weeks | The treatment effect |
Countries
China, South Korea, United States
Outcome results
None listed