Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Namilumab · 1 trial · 1 indication
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. *...
Namilumab is an investigational monoclonal antibody being studied for the treatment of axial spondyloarthritis, a form of inflammatory arthritis affecting the spine and sacroiliac joints. It is currently in Phase 2 clinical development and has not been approved by regulatory authorities.
Namilumab is being developed by IQVIA Holdings, Inc., a company publicly traded under the ticker symbol IQV. The drug is currently in Phase 2 clinical development for axial spondyloarthritis.
Namilumab is in Phase 2 clinical development. It is an investigational drug and has not been approved by the FDA or other regulatory agencies. One Phase 2 clinical trial has been completed, and the drug is not currently in any active trials.
Namilumab has one completed Phase 2 clinical trial registered under NCT03622658, titled 'Efficacy and Safety of Namilumab for Moderate-to-severe Axial Spondyloarthritis.' This trial enrolled 42 participants in the United Kingdom and was a randomized, double-blind, placebo-controlled study.
No alternative names for Namilumab have been reported. It is referred to solely as Namilumab in clinical trial records and development documentation.