NCT03622658

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
42

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Sep 2018

Shorter than P25 for phase_2

Geographic Reach
1 country

9 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 17, 2018

Completed
23 days until next milestone

First Posted

Study publicly available on registry

August 9, 2018

Completed
28 days until next milestone

Study Start

First participant enrolled

September 6, 2018

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 4, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 4, 2020

Completed
2.1 years until next milestone

Results Posted

Study results publicly available

March 8, 2022

Completed
Last Updated

March 8, 2022

Status Verified

January 1, 2022

Enrollment Period

1.4 years

First QC Date

July 17, 2018

Results QC Date

December 6, 2021

Last Update Submit

January 5, 2022

Conditions

Axial Spondyloarthritis

Outcome Measures

Primary Outcomes (1)

  • 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.

    Weeks 12

Secondary Outcomes (4)

  • Proportion of Subjects Who Achieved ASAS40 Clinical Response at Week 12

    Week 12

  • Proportion of Subjects Who Achieved an ASAS20 Clinical Response at Week 6

    Week 6

  • Proportion of Subjects Who Achieved Ankylosing Spondylitis Disease Activity Score C-reactive Protein (ASDAS-CRP) Response at Weeks 6

    Week 6

  • Proportion of Subjects Who Achieved Clinically Important ASDAS-CRP Score at Week 12

    Week 12

Study Arms (2)

Placebo

PLACEBO COMPARATOR

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

Biological: Placebo

Namilumab

EXPERIMENTAL

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

Biological: Namilumab

Interventions

PlaceboBIOLOGICAL

Placebo solution for subcutaneous injection.

Placebo
NamilumabBIOLOGICAL

Namilumab solution for subcutaneous injection

Namilumab

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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).

You may not qualify if:

  • 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.
  • +3 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

Royal United Hospitals Bath

Bath, United Kingdom

Location

University Hospital Birmingham

Birmingham, United Kingdom

Location

University Hospital Coventry and Warwickshire

Coventry, United Kingdom

Location

Northwick Park Hospital

London, United Kingdom

Location

Whipps Cross Hospital

London, United Kingdom

Location

Norfolk and Norwich University Hospital

Norwich, United Kingdom

Location

Oxford University Hospital

Oxford, United Kingdom

Location

Royal Berkshire Hospital

Reading, United Kingdom

Location

Haywood Hospital

Stoke-on-Trent, United Kingdom

Location

Related Publications (1)

  • 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.

    PMID: 38942047DERIVED

MeSH Terms

Conditions

Axial Spondyloarthritis

Interventions

namilumab

Condition Hierarchy (Ancestors)

SpondylarthropathiesSpondylarthritisSpondylitisSpinal DiseasesBone DiseasesMusculoskeletal DiseasesAnkylosisJoint DiseasesArthritis

Results Point of Contact

Title
Dr. Simon Lowry, Chief Medical Officer
Organization
Kinevant Sciences Inc. on behalf of Kinevant Science GmbH
simon.lowry@roivant.com
646-495-5368

Study Officials

  • Peter C Taylor, PhD

    Botnar Research Centre, University of Oxford

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 17, 2018

First Posted

August 9, 2018

Study Start

September 6, 2018

Primary Completion

February 4, 2020

Study Completion

February 4, 2020

Last Updated

March 8, 2022

Results First Posted

March 8, 2022

Record last verified: 2022-01

Locations

GB(9)