Clinical trial NCT03622658: Efficacy and Safety of Namilumab for Moderate-to-severe Axial Spondyloarthritis
Official title: A Phase 2a Study to Evaluate the Safety and Efficacy of Namilumab in Subjects With Moderate-to-severely Active Axial Spondyloarthritis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Axial Spondyloarthritis
Lead sponsor: Izana Bioscience Ltd.
Sponsor class: INDUSTRY
Collaborators: name: Iqvia Pty Ltd
name: Innovate UK
First posted: 2018-08-09
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed description: A phase 2a proof-of-concept, randomised, double-blind, placebo-controlled study to evaluate the safety/tolerability and efficacy of 4 subcutaneous injections of namilumab (150 mg) given over 10 weeks in subjects with moderate-to-severely active axial spondyloarthritis including those previously exposed to anti- TNF therapy (NAMASTE study).

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.

Primary outcomes:
measure: The Proportion of Subjects Who Achieved ASAS20 Clinical Response
timeFrame: Weeks 12
Secondary outcomes:
measure: Proportion of Subjects Who Achieved ASAS40 Clinical Response at Week 12
timeFrame: Week 12
measure: Proportion of Subjects Who Achieved an ASAS20 Clinical Response at Week 6
timeFrame: Week 6
measure: Proportion of Subjects Who Achieved Ankylosing Spondylitis Disease Activity Score C-reactive Protein (ASDAS-CRP) Response at Weeks 6
timeFrame: Week 6
measure: Proportion of Subjects Who Achieved Clinically Important ASDAS-CRP Score at Week 12
timeFrame: Week 12
Other outcomes:
Locations:
city: Bath
country: United Kingdom
facility: Royal United Hospitals Bath
city: Birmingham
country: United Kingdom
facility: University Hospital Birmingham
city: Coventry
country: United Kingdom
facility: University Hospital Coventry and Warwickshire
city: London
country: United Kingdom
facility: Northwick Park Hospital
city: London
country: United Kingdom
facility: Whipps Cross Hospital
city: Norwich
country: United Kingdom
facility: Norfolk and Norwich University Hospital
city: Oxford
country: United Kingdom
facility: Oxford University Hospital
city: Reading
country: United Kingdom
facility: Royal Berkshire Hospital
city: Stoke-on-Trent
country: United Kingdom
facility: Haywood Hospital
Study officials:
affiliation: Botnar Research Centre, University of Oxford
name: Peter C Taylor, PhD
role: PRINCIPAL_INVESTIGATOR
References: