Efficacy and Safety of Namilumab for Moderate-to-severe Axial Spondyloarthritis

NCT ID: NCT03622658

Last Updated: 2022-03-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 42 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-09-06
• Study Completion Date: 2020-02-04

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).

Conditions

Axial Spondyloarthritis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Placebo

Placebo solution administered by subcutaneous injection on 4 occasions over 10 weeks

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: BIOLOGICAL

Placebo solution for subcutaneous injection.

Namilumab

Namilumab (150 mg) administered by subcutaneous injection on 4 occasions over 10 weeks

Group Type: EXPERIMENTAL

Namilumab

Intervention Type: BIOLOGICAL

Namilumab solution for subcutaneous injection

Interventions

Placebo

Placebo solution for subcutaneous injection.

Intervention Type: BIOLOGICAL

Namilumab

Namilumab solution for subcutaneous injection

Intervention Type: BIOLOGICAL

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Iqvia Pty Ltd

INDUSTRY

Sponsor Role: collaborator

Innovate UK

OTHER_GOV

Sponsor Role: collaborator

Izana Bioscience Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Peter C Taylor, PhD

Role: PRINCIPAL_INVESTIGATOR

Botnar Research Centre, University of Oxford

Locations

Royal United Hospitals Bath

Bath, , United Kingdom

University Hospital Birmingham

Birmingham, , United Kingdom

University Hospital Coventry and Warwickshire

Coventry, , United Kingdom

Northwick Park Hospital

London, , United Kingdom

Whipps Cross Hospital

London, , United Kingdom

Norfolk and Norwich University Hospital

Norwich, , United Kingdom

Oxford University Hospital

Oxford, , United Kingdom

Royal Berkshire Hospital

Reading, , United Kingdom

Haywood Hospital

Stoke-on-Trent, , United Kingdom

Countries

United Kingdom

References

Worth C, Al-Mossawi MH, Macdonald J, Fisher BA, Chan A, Sengupta R, Packham J, Gaffney K, Gullick N, Cook JA, Corn TH, Teh J, Machado PM, Taylor PC, Bowness P. Granulocyte-macrophage colony-stimulating factor neutralisation in patients with axial spondyloarthritis in the UK (NAMASTE): a randomised, double-blind, placebo-controlled, phase 2 trial. Lancet Rheumatol. 2024 Aug;6(8):e537-e545. doi: 10.1016/S2665-9913(24)00099-7. Epub 2024 Jun 25.

Reference Type: DERIVED

PMID: 38942047 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

IZN-101

Identifier Type: -

Identifier Source: org_study_id