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

Primary Purpose

Axial Spondyloarthritis

Status
Completed
Phase
Phase 2
Locations
United Kingdom
Study Type
Interventional
Intervention
Placebo
Namilumab
Sponsored by
Izana Bioscience Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Axial Spondyloarthritis

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Royal United Hospitals Bath
  • University Hospital Birmingham
  • University Hospital Coventry and Warwickshire
  • Northwick Park Hospital
  • Whipps Cross Hospital
  • Norfolk and Norwich University Hospital
  • Oxford University Hospital
  • Royal Berkshire Hospital
  • Haywood Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Placebo

Namilumab

Arm Description

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

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

Outcomes

Primary Outcome Measures

The Proportion of Subjects Who Achieved ASAS20 Clinical Response
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.

Secondary Outcome Measures

Proportion of Subjects Who Achieved ASAS40 Clinical Response at Week 12
Proportion of subjects who achieved Assessment in Ankylosing Spondylitis with 40% improvement (ASAS40) response at Week 12
Proportion of Subjects Who Achieved an ASAS20 Clinical Response at Week 6
Proportion of subjects who achieved an ASAS20 clinical response at Week 6
Proportion of Subjects Who Achieved Ankylosing Spondylitis Disease Activity Score C-reactive Protein (ASDAS-CRP) Response at Weeks 6
Proportion (percentage) of subjects who achieved Ankylosing Spondylitis Disease Activity Score C-reactive Protein (ASDAS-CRP) response at Week 6, Clinically Important Improvement
Proportion of Subjects Who Achieved Clinically Important ASDAS-CRP Score at Week 12
Proportion of Subjects Who Achieved Clinically Important ASDAS-CRP Score at Week 12, Clinically Important Improvement

Full Information

First Posted
July 17, 2018
Last Updated
January 5, 2022
Sponsor
Izana Bioscience Ltd.
Collaborators
Iqvia Pty Ltd, Innovate UK
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1. Study Identification

Unique Protocol Identification Number
NCT03622658
Brief Title
Efficacy and Safety of Namilumab for Moderate-to-severe Axial Spondyloarthritis
Acronym
NAMASTE
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

2. Study Status

Record Verification Date
January 2022
Overall Recruitment Status
Completed
Study Start Date
September 6, 2018 (Actual)
Primary Completion Date
February 4, 2020 (Actual)
Study Completion Date
February 4, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Izana Bioscience Ltd.
Collaborators
Iqvia Pty Ltd, Innovate UK

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Axial Spondyloarthritis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
42 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo solution administered by subcutaneous injection on 4 occasions over 10 weeks
Arm Title
Namilumab
Arm Type
Experimental
Arm Description
Namilumab (150 mg) administered by subcutaneous injection on 4 occasions over 10 weeks
Intervention Type
Biological
Intervention Name(s)
Placebo
Intervention Description
Placebo solution for subcutaneous injection.
Intervention Type
Biological
Intervention Name(s)
Namilumab
Intervention Description
Namilumab solution for subcutaneous injection
Primary Outcome Measure Information:
Title
The Proportion of Subjects Who Achieved ASAS20 Clinical Response
Description
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.
Time Frame
Weeks 12
Secondary Outcome Measure Information:
Title
Proportion of Subjects Who Achieved ASAS40 Clinical Response at Week 12
Description
Proportion of subjects who achieved Assessment in Ankylosing Spondylitis with 40% improvement (ASAS40) response at Week 12
Time Frame
Week 12
Title
Proportion of Subjects Who Achieved an ASAS20 Clinical Response at Week 6
Description
Proportion of subjects who achieved an ASAS20 clinical response at Week 6
Time Frame
Week 6
Title
Proportion of Subjects Who Achieved Ankylosing Spondylitis Disease Activity Score C-reactive Protein (ASDAS-CRP) Response at Weeks 6
Description
Proportion (percentage) of subjects who achieved Ankylosing Spondylitis Disease Activity Score C-reactive Protein (ASDAS-CRP) response at Week 6, Clinically Important Improvement
Time Frame
Week 6
Title
Proportion of Subjects Who Achieved Clinically Important ASDAS-CRP Score at Week 12
Description
Proportion of Subjects Who Achieved Clinically Important ASDAS-CRP Score at Week 12, Clinically Important Improvement
Time Frame
Week 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peter C Taylor, PhD
Organizational Affiliation
Botnar Research Centre, University of Oxford
Official's Role
Principal Investigator
Facility Information:
Facility Name
Royal United Hospitals Bath
City
Bath
Country
United Kingdom
Facility Name
University Hospital Birmingham
City
Birmingham
Country
United Kingdom
Facility Name
University Hospital Coventry and Warwickshire
City
Coventry
Country
United Kingdom
Facility Name
Northwick Park Hospital
City
London
Country
United Kingdom
Facility Name
Whipps Cross Hospital
City
London
Country
United Kingdom
Facility Name
Norfolk and Norwich University Hospital
City
Norwich
Country
United Kingdom
Facility Name
Oxford University Hospital
City
Oxford
Country
United Kingdom
Facility Name
Royal Berkshire Hospital
City
Reading
Country
United Kingdom
Facility Name
Haywood Hospital
City
Stoke-on-Trent
Country
United Kingdom

12. IPD Sharing Statement

Learn more about this trial

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

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