Phase 2
N=42
Efficacy and Safety of Namilumab for Moderate-to-severe Axial Spondyloarthritis
Axial Spondyloarthritis
Bottom Line
View on ClinicalTrials.gov: NCT03622658 ↗Enrolled (actual)
42
Serious AEs
2.4%
Results posted
Mar 2022
Primary outcome: Primary: The Proportion of Subjects Who Achieved ASAS20 Clinical Response — 3; 14 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Placebo (Biological); Namilumab (Biological)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Izana Bioscience Ltd.
- Primary completion
- Feb 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Proportion of Subjects Who Achieved ASAS20 Clinical Response |
3; 14 | — |
| SECONDARY Proportion of Subjects Who Achieved ASAS40 Clinical Response at Week 12 |
3; 9 | — |
| SECONDARY Proportion of Subjects Who Achieved an ASAS20 Clinical Response at Week 6 |
0; 12 | — |
| SECONDARY Proportion of Subjects Who Achieved Ankylosing Spondylitis Disease Activity Score C-reactive Protein (ASDAS-CRP) Response at Weeks 6 |
0; 10 | — |
| SECONDARY Proportion of Subjects Who Achieved Clinically Important ASDAS-CRP Score at Week 12 |
1; 10 | — |
Summary
The study will assess the effect of namilumab, a GM-CSF inhibitor, on the clinical response in subjects with axial spondyloarthritis. Subjects will receive treatment with either namilumab or placebo.
Eligibility Criteria
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.
- MRI evidence of active axSpA ≤ 6 (ideally ≤ 3) months prior to randomisation using ASAS criteria.
- Stable NSAID use prior to study entry.
- Stable use of MTX, sulfasalazine or leflunomide prior to study entry.
- Stable oral corticosteroid dose prior to study entry.
- Capable of giving signed informed consent.
- Inadequately responded to or experienced intolerance to previous treatment with an anti-TNF agent (some subjects).
Exclusion Criteria
- Current diagnosis of axSpA with a BASDAI > 4 but no evidence of inflammation on MRI.
- Discontinued biologic therapy < 8 weeks prior to Baseline.
- Previous or current use of oral corticosteroid as defined in protocol.
- Received intra-articular or i.v. corticosteroids prior to or during Screening.
- Received anti-IL-17A or anti-IL-12/23 therapy.
- Received cyclosporine, tacrolimus or mycophenolate mofetil prior to Baseline.
- Previously received stem cell transplantation.
- Infection(s) requiring treatment with i.v. anti-infectives or oral anti-infectives prior to Baseline.
- Abnormal screening laboratory and other analyses.
- Receipt of any live vaccine within 2 weeks prior to randomisation, or will require live vaccination during study participation.
- Evidence of current or prior dysplasia or history of malignancy.
- Has had any uncontrolled and/or clinically significant illness, hospitalisation, or any surgical procedure requiring general anaesthesia prior to Screening, or any planned surgical procedure within 6 months after randomisation.
- Known current or previous interstitial lung disease.
- Positive pregnancy test at Screening (serum) or Baseline (urine).
- Female subjects who are breastfeeding or considering becoming pregnant during the study.
- Considered by the Investigator to be an unsuitable candidate for the study.
- Received any investigational agent or procedure within 30 days or 5 half-lives prior to Baseline.
- Related to or a dependent of the site staff, or a member of the site staff.
Data sourced from ClinicalTrials.gov (NCT03622658). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.