Efficacy and Safety of Namilumab for Moderate-to-severe Axial Spondyloarthritis
Condition: Axial Spondyloarthritis
MeSH terms: Spondylitis; Spondylarthritis; Axial Spondyloarthritis
Intervention: Placebo; Namilumab
Intervention description: Placebo solution for subcutaneous injection.; Namilumab solution for subcutaneous injection
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 42.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No

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.