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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03622658
Recruitment Status : Completed
First Posted : August 9, 2018
Results First Posted : March 8, 2022
Last Update Posted : March 8, 2022
Sponsor:
Collaborators:
Iqvia Pty Ltd
Innovate UK
Information provided by (Responsible Party):
Izana Bioscience Ltd.

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.

Condition or disease Intervention/treatment Phase
Axial Spondyloarthritis Biological: Placebo Biological: Namilumab Phase 2

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).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 42 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 2a Study to Evaluate the Safety and Efficacy of Namilumab in Subjects With Moderate-to-severely Active Axial Spondyloarthritis
Actual Study Start Date : September 6, 2018
Actual Primary Completion Date : February 4, 2020
Actual Study Completion Date : February 4, 2020

Arm Intervention/treatment
Placebo Comparator: Placebo
Placebo solution administered by subcutaneous injection on 4 occasions over 10 weeks
Biological: Placebo
Placebo solution for subcutaneous injection.

Experimental: Namilumab
Namilumab (150 mg) administered by subcutaneous injection on 4 occasions over 10 weeks
Biological: Namilumab
Namilumab solution for subcutaneous injection




Primary Outcome Measures :
  1. The Proportion of Subjects Who Achieved ASAS20 Clinical Response [ Time Frame: Weeks 12 ]

    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 :
  1. Proportion of Subjects Who Achieved ASAS40 Clinical Response at Week 12 [ Time Frame: Week 12 ]
    Proportion of subjects who achieved Assessment in Ankylosing Spondylitis with 40% improvement (ASAS40) response at Week 12

  2. Proportion of Subjects Who Achieved an ASAS20 Clinical Response at Week 6 [ Time Frame: Week 6 ]
    Proportion of subjects who achieved an ASAS20 clinical response at Week 6

  3. Proportion of Subjects Who Achieved Ankylosing Spondylitis Disease Activity Score C-reactive Protein (ASDAS-CRP) Response at Weeks 6 [ Time Frame: Week 6 ]
    Proportion (percentage) of subjects who achieved Ankylosing Spondylitis Disease Activity Score C-reactive Protein (ASDAS-CRP) response at Week 6, Clinically Important Improvement

  4. Proportion of Subjects Who Achieved Clinically Important ASDAS-CRP Score at Week 12 [ Time Frame: Week 12 ]
    Proportion of Subjects Who Achieved Clinically Important ASDAS-CRP Score at Week 12, Clinically Important Improvement



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03622658


Locations
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United Kingdom
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
Sponsors and Collaborators
Izana Bioscience Ltd.
Iqvia Pty Ltd
Innovate UK
Investigators
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Principal Investigator: Peter C Taylor, PhD Botnar Research Centre, University of Oxford
  Study Documents (Full-Text)

Documents provided by Izana Bioscience Ltd.:
Study Protocol  [PDF] July 5, 2018
Statistical Analysis Plan  [PDF] May 7, 2019

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Responsible Party: Izana Bioscience Ltd.
ClinicalTrials.gov Identifier: NCT03622658    
Other Study ID Numbers: IZN-101
First Posted: August 9, 2018    Key Record Dates
Results First Posted: March 8, 2022
Last Update Posted: March 8, 2022
Last Verified: January 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Spondylitis
Spondylarthritis
Bone Diseases, Infectious
Infections
Bone Diseases
Musculoskeletal Diseases
Spinal Diseases
Arthritis
Joint Diseases