Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03622658 | Efficacy and Safety of Namilumab for Moderate-to-severe Axial Spondyloarthritis | PHASE2 | COMPLETED | 42 | — | — | Sep 6, 2018 | Feb 4, 2020 | Mar 8, 2022 | 9 | United Kingdom |
The primary endpoint was the proportion of subjects who achieved an Assessment in Ankylosing Spondylitis with 20% improvement (ASAS20) clinical response at Week 12. An ASAS20 clinical response was defined as an improvement of at least 20% and an absolute improvement of at least 10 units on a 0 to 100 scale in at least three of the following four domains collected in the electronic case report form (eCRF) and no worsening in the fourth domain: Subject's Global Assessment of Disease Status, Subject's Assessment of Spinal Pain, function (Bath Ankylosing Spondylitis Functional Index \[BASFI\]) and inflammation (last two questions of the BASDAI). Lower values within the individual domains represent less severe symptoms.
| Arm | Type | Description |
|---|---|---|
| Placebo | PLACEBO_COMPARATOR | Placebo solution administered by subcutaneous injection on 4 occasions over 10 weeks |
| Namilumab | EXPERIMENTAL | Namilumab (150 mg) administered by subcutaneous injection on 4 occasions over 10 weeks |
| Name | Type | Description |
|---|---|---|
| Placebo | BIOLOGICAL | Placebo solution for subcutaneous injection. |
| Namilumab | BIOLOGICAL | Namilumab solution for subcutaneous injection |
Inclusion Criteria: * Age ≥ 18 and ≤ 75 years of age. * Diagnosis of axSpA by an appropriately qualified physician and classified using ASAS criteria ≥ 3 months prior to Baseline. * Bath Ankylosing Spondylitis Disease Activity Index score ≥ 4 and spinal pain score ≥ 40, at screening and Baseline. *...