Ankylosing SpondylitisPhase 2NCT01109940
Safety and Tolerability of AIN457 in Adults (18-65 Years) With Moderate to Severe Ankylosing Spondylitis
A Phase 2 study testing AIN457A in people with Ankylosing Spondylitis, run by Novartis Pharmaceuticals at 15 sites in 4 countries.
Trial summary
This study is designed as an extension study to the proof-of-concept trial CAIN457A2209 in patients with moderate to severe ankylosing spondylitis and aims to provide continuous treatment with AIN457 for patients in the core trial, to obtain safety and tolerability information. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Ankylosing Spondylitis
- What is being tested?
- AIN457A
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 15 sitesin 4 countries
- Study dates
- Apr 2010to Dec 2012
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who took part and completed in the core CAIN457A2209 study
- Patients who discontinued the core study due to unsatisfactory therapeutic effect at their Visit 14 (Week 16) or later could enter the extension study within 3 weeks of completing the study discontinuation visit of the core study, provided that at their discontinuation visit they fulfilled either one of the criteria below. Patients who did not enter the extension study within 3 weeks of completing the study discontinuation visit of the core study, were required to come for an additional baseline visit (Visit 17) and were required to fulfill either one of the criteria below:
- No improvement (compared with the core study baseline) in two out of the following four domains: patient global assessment, pain, BASFI and the mean of the two morning stiffness questions from the BASDAI. OR
- Deterioration (compared with the core study baseline) in one of the four domains (deterioration defined as >=20% worsening and an absolute worsening of >=1 unit)
Who cannot join
- Patients for whom continued treatment with AIN457 is not considered appropriate by the treating physician.
- Patients who were non-compliant or who demonstrated a major protocol deviation in the core CAIN457A2209 study.
- Patients who discontinued from the core CAIN457A2209 study before Visit 14 (Week 16), and patients who completed the core study
- Pregnant or lactating women
- Presence of active infection
- Positive PPD or HIV test in patients where repeated testing was deemed appropriate due to their risk profile
- Other protocol-defined inclusion/exclusion criteria may apply
Trial locations and contacts
15 sites in 4 countries.
15 sites in 4 countries
United States9 sites
Novartis Investigative Site
Benbrook, Texas, 76126
Novartis Investigative Site
Duncansville, Pennsylvania, 16635
Novartis Investigative Site
Jackson, Tennessee, 38305
Novartis Investigative Site
Knoxville, Tennessee, 37909
Novartis Investigative Site
Oklahoma City, Oklahoma, 73112
Novartis Investigative Site
Paradise Valley, Arizona, 85253
Novartis Investigative Site
Spokane, Washington, 99204
Novartis Investigative Site
Springfield, Illinois, 62703
Novartis Investigative Site
Springfield, Illinois, 62704
Germany4 sites
Novartis Investigative Site
Berlin, 12203
Novartis Investigative Site
Hamburg, 22081
Novartis Investigative Site
Herne, 44625
Novartis Investigative Site
München, D-80639
United Kingdom1 site
Novartis Investigative Site
Newcastle upon Tyne, NE2 4HH
About this study
Official title: An Open Label Non-randomized Extension Study to Evaluate the Safety and Tolerability of AIN457 (Anti Interleukin-17 Monoclonal Antibody) in Patients With Moderate to Severe Ankylosing Spondylitis
This study is designed as an extension study to the proof-of-concept trial CAIN457A2209 in patients with moderate to severe ankylosing spondylitis and aims to provide continuous treatment with AIN457 for patients in the core trial, to obtain safety and tolerability information. The study will address the evaluation of efficacy following doses of Intravenous infusion (IV) of 3 mg/kg AIN457 given every 4 weeks over a period initially up to 6 months (Part 1) and based on the risk/benefit balance of AIN457 in ankylosing spondylitis a decision was taken to continue dosing for another 6 month period (Part 2).
- Conditions
- Ankylosing Spondylitis
- Being tested
- AIN457A
- Keywords
- Ankylosing spondylitis, IgG1K monoclonal antibody, Interleukin -17A neutralizing
- Medical subject headings
- Spondylitis, Ankylosing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AIN457ABiological
| Study group | Role | What they receive |
|---|---|---|
| AIN457 | Experimental | Not described Receives: Biological: AIN457A |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Reported Adverse Events (AE's)
AEs are defined as any unfavorable and unintended diagnosis, symptom, sign (including an abnormal laboratory finding), syndrome or disease which either occurs during study, having been absent at baseline, or, if present at baseline, appears to worsen.
Measured: From start of the study up to 64 weeks
Secondary outcomes (4)
Number of Participants Reported Positive Antibodies for Secukinumab
Immunogenicity (anti-drug antibodies) was assessed using an MSD bridging assay and a 3-tiered approach (screening, confirmation, titration).
Measured: Pre-dose, Week 0, 8, 24, 40 and Week 64
Total Interleukin (IL)- 17A Concentration in Blood at Steady-State
Total serum IL17A was not measured due to assay limitations.
Measured: Pre-dose and at the end of infusion (up to 64 weeks)
Maximum (Peak) Observed in Serum at Steady-State (Cmax,ss)
Concentration of Secukinumab at the end of infusion (Cmax,ss) was reported.
Measured: At end of infusion (Week 64)
Minimum (Trough) Observed in Serum at Steady State (Cmin,ss)
The concentration of secukinumab at pre-dose (Cmin,ss) in serum was reported.
Measured: Pre-dose (Week 0)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2010 (estimated)
- Study startApr 2010
- Primary completionDec 2012
- Study completionDec 2012
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.
- Other trials for Ankylosing SpondylitisStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01109940
- Sponsor's protocol ID
- CAIN457A2209E1
- Other IDs
- 2009-011591-30, 2009
- Status last verified
- Jun 2021
- First submitted
- 22 Apr 2010
- Last updated
- 24 Jun 2021
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label Non-randomized Extension Study to Evaluate the Safety and Tolerability of AIN457 (Anti Interleukin-17 Monoclonal Antibody) in Patients With Moderate to Severe Ankylosing Spondylitis
- ClinicalTrials.gov ID
- NCT01109940
- Acronym / sponsor ID
- CAIN457A2209E1
- Conditions
- Ankylosing Spondylitis
- Keywords
- Ankylosing spondylitis, IgG1K monoclonal antibody, Interleukin -17A neutralizing
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Apr 2010
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 23 Apr 2010 (estimated)
- Results
- Posted 24 Jun 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is designed as an extension study to the proof-of-concept trial CAIN457A2209 in patients with moderate to severe ankylosing spondylitis and aims to provide continuous treatment with AIN457 for patients in the core trial, to obtain safety and tolerability information. The study will address the evaluation of efficacy following doses of Intravenous infusion (IV) of 3 mg/kg AIN457 given every 4 weeks over a period initially up to 6 months (Part 1) and based on the risk/benefit balance of AIN457 in ankylosing spondylitis a decision was taken to continue dosing for another 6 month period (Part 2).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| AIN457 | Experimental | Biological: AIN457A |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients who took part and completed in the core CAIN457A2209 study
- Patients who discontinued the core study due to unsatisfactory therapeutic effect at their Visit 14 (Week 16) or later could enter the extension study within 3 weeks of completing the study discontinuation visit of the core study, provided that at their discontinuation visit they fulfilled either one of the criteria below. Patients who did not enter the extension study within 3 weeks of completing the study discontinuation visit of the core study, were required to come for an additional baseline visit (Visit 17) and were required to fulfill either one of the criteria below:
- No improvement (compared with the core study baseline) in two out of the following four domains: patient global assessment, pain, BASFI and the mean of the two morning stiffness questions from the BASDAI. OR
- Deterioration (compared with the core study baseline) in one of the four domains (deterioration defined as >=20% worsening and an absolute worsening of >=1 unit)
Key exclusion criteria (7 listed)
- Patients for whom continued treatment with AIN457 is not considered appropriate by the treating physician.
- Patients who were non-compliant or who demonstrated a major protocol deviation in the core CAIN457A2209 study.
- Patients who discontinued from the core CAIN457A2209 study before Visit 14 (Week 16), and patients who completed the core study
- Pregnant or lactating women
- Presence of active infection
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 |
|---|---|---|
| AIN457A | Biological | AIN457 |
Primary outcome
Number of Participants Reported Adverse Events (AE's)
Time frame: From start of the study up to 64 weeks
AEs are defined as any unfavorable and unintended diagnosis, symptom, sign (including an abnormal laboratory finding), syndrome or disease which either occurs during study, having been absent at baseline, or, if present at baseline, appears to worsen.
4 secondary outcomes
Number of Participants Reported Positive Antibodies for Secukinumab
Time frame: Pre-dose, Week 0, 8, 24, 40 and Week 64
Total Interleukin (IL)- 17A Concentration in Blood at Steady-State
Time frame: Pre-dose and at the end of infusion (up to 64 weeks)
Maximum (Peak) Observed in Serum at Steady-State (Cmax,ss)
Time frame: At end of infusion (Week 64)
Minimum (Trough) Observed in Serum at Steady State (Cmin,ss)
Time frame: Pre-dose (Week 0)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Novartis Pharmaceuticals study director
Novartis Pharmaceuticals
15 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing AIN457A in people with Ankylosing Spondylitis, run by Novartis Pharmaceuticals at 15 sites in 4 countries.
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 4 inclusion and 7 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 24 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in United States, Germany, Netherlands, 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. 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 24 Jun 2021). 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?
Number of Participants Reported Adverse Events (AE's) (time frame: From start of the study up to 64 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 Jun 2021.