Axial SpondyloarthritisPhase 2NAMASTENCT03622658
Efficacy and Safety of Namilumab for Moderate-to-severe Axial Spondyloarthritis
A Phase 2 study testing Namilumab in people with Axial Spondyloarthritis, run by Izana Bioscience Ltd. at 9 sites in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Axial Spondyloarthritis
- What is being tested?
- Namilumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 42 participants
- Where
- 9 sitesUnited Kingdom
- Study dates
- 6 Sep 2018to 4 Feb 2020
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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).
Who cannot join
- 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.
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- 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.
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
United Kingdom9 sites
Royal United Hospitals Bath
Bath
University Hospital Birmingham
Birmingham
University Hospital Coventry and Warwickshire
Coventry
Northwick Park Hospital
London
Whipps Cross Hospital
London
Norfolk and Norwich University Hospital
Norwich
Oxford University Hospital
Oxford
Royal Berkshire Hospital
Reading
Haywood Hospital
Stoke-on-Trent
About this study
Official title: A Phase 2a Study to Evaluate the Safety and Efficacy of Namilumab in Subjects With Moderate-to-severely Active Axial Spondyloarthritis
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.
Read the 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
- Being tested
- Placebo, Namilumab
- Medical subject headings
- Axial Spondyloarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboBiological
Placebo solution for subcutaneous injection.
NamilumabBiological
Namilumab solution for subcutaneous injection
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Placebo solution administered by subcutaneous injection on 4 occasions over 10 weeks Receives: Biological: Placebo |
| Namilumab | Experimental | Namilumab (150 mg) administered by subcutaneous injection on 4 occasions over 10 weeks Receives: Biological: Namilumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Weeks 12
Secondary outcomes (4)
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
Measured: 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
Measured: 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
Measured: Week 6
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
Measured: Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2018
- Study start6 Sep 2018
- Primary completion4 Feb 2020
- Study completion4 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Axial SpondyloarthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Izana Bioscience Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- IQVIA Pty Ltd, Innovate UK
- Responsible party
- Sponsor
- Investigators
- Peter C Taylor, PhD, Principal investigator, Botnar Research Centre, University of Oxford
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03622658
- Sponsor's protocol ID
- IZN-101
- Acronym
- NAMASTE
- Status last verified
- Jan 2022
- First submitted
- 17 Jul 2018
- Last updated
- 8 Mar 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 38942047
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2a Study to Evaluate the Safety and Efficacy of Namilumab in Subjects With Moderate-to-severely Active Axial Spondyloarthritis
- ClinicalTrials.gov ID
- NCT03622658
- Acronym / sponsor ID
- NAMASTE / IZN-101
- Conditions
- Axial Spondyloarthritis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Izana Bioscience Ltd.Industry (pharma, biotech, devices)
- Collaborators
- IQVIA Pty Ltd, Innovate UK
- Study start
- 6 Sep 2018 (actual)
- Primary completion
- 4 Feb 2020 (actual)
- Study completion
- 4 Feb 2020 (actual)
- First posted
- 9 Aug 2018 (actual)
- Results
- Posted 8 Mar 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Biological: PlaceboPlacebo solution administered by subcutaneous injection on 4 occasions over 10 weeks |
| Namilumab | Experimental | Biological: NamilumabNamilumab (150 mg) administered by subcutaneous injection on 4 occasions over 10 weeks |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (18 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PlaceboPlacebo solution for subcutaneous injection. | Biological | Placebo |
| NamilumabNamilumab solution for subcutaneous injection | Biological | Namilumab |
Primary outcome
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.
4 secondary outcomes
Proportion of Subjects Who Achieved ASAS40 Clinical Response at Week 12
Time frame: Week 12
Proportion of Subjects Who Achieved an ASAS20 Clinical Response at Week 6
Time frame: Week 6
Proportion of Subjects Who Achieved Ankylosing Spondylitis Disease Activity Score C-reactive Protein (ASDAS-CRP) Response at Weeks 6
Time frame: Week 6
Proportion of Subjects Who Achieved Clinically Important ASDAS-CRP Score at Week 12
Time frame: Week 12
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 38942047Worth 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Peter C Taylor, PhD principal investigator
Botnar Research Centre, University of Oxford
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Namilumab in people with Axial Spondyloarthritis, run by Izana Bioscience Ltd. at 9 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 8 Mar 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Proportion of Subjects Who Achieved ASAS20 Clinical Response (time frame: Weeks 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03622658, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Mar 2022.