This study has been transitioned to CTIS with ID 2023-509320-17-00 check the CTIS register for the current data. * To evaluate whether continuous secukinumab treatment is superior to placebo in preventing flares during Treatment Period 2 in…
ID
Source
Brief title
Condition
- Autoimmune disorders
- Joint disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
* The proportion of participants remaining flare-free at Week 120
Secondary outcome
* Time to flare during Treatment Period 2
* Safety and tolerability demonstrated by assessing:
* Adverse events (AEs) and serious adverse events (SAEs) (incidence,
severity, and relationship with study drug)
* Clinically significant changes in laboratory parameters and vital
signs
Background summary
This study will establish whether prolonged chronic dosing with secukinumab is
needed in participants with nr-axSpA (non-radiographic axial spondyloarthritis)
who have achieved remission.
Study objective
This study has been transitioned to CTIS with ID 2023-509320-17-00 check the CTIS register for the current data.
* To evaluate whether continuous secukinumab treatment is superior to placebo
in preventing flares during Treatment Period 2 in participants who achieved a
state of remission in Treatment Period 1
* To evaluate efficacy of secukinumab on preventing the onset of flares in
participants in a state of remission during Treatment Period 2 in participants
who achieved a state of remission in Treatment Period 1
* To assess overall safety and tolerability of secukinumab over time up to
follow-up visit
Study design
This phase IV, multicenter study uses a double-blind, placebo-controlled,
randomized withdrawal design (Treatment Period 2) preceded by an open label
lead-in period (Treatment Period 1).
Intervention
Secukinumab (AIN457) 150 mg s.c. (subcutaneously) and placebo s.c.
All eligible participants who enter Treatment Period 1 will receive open-label
secukinumab 150 mg administered s.c. at Baseline, Weeks 1, 2, 3, and 4 and then
every 4 weeks up to and including Week 52.
During Treatment Period 2, participants will be randomized 1:1 at Week 56 to
one of the following groups and will receive the first dose of blinded
treatment at Week 56.
• Group 1: 150 mg secukinumab s.c. at Week 56 and every 4 weeks thereafter
through to Week 116 or until a flare
• Group 2: placebo s.c. at Week 56 and every 4 weeks thereafter through to Week
116 or until a flare
Participants who meet flare criteria in Treatment Period 2, regardless if they
were randomized to secukinumab or placebo, will receive an escape re-treatment
with an open-label 150 mg secukinumab s.c. every 4 weeks starting from the next
scheduled visit after the one at which a participant met flare criteria.
Study burden and risks
Visits: 25x (max), 1-2 hours
MRI: 1x (unless already performed in the 3 months prior to the screening)
X-ray sacroiliac joint: 1x (unless already performed in the 3 months prior to
the screening)
X-Thorax: 1x (unless already performed in the 3 months prior to the screening)
Physical exam: 7x in period 1, 18x in period 2
Height: 1x
Weight: 1x in period 1, 2x in period 2
Vital Signs: 7x in period 1, 18x in period 2
TB-test: 1x
Urinalysis: 7x in period 1, 7x in period 2
Pregnancytest (serum): 1x (in case patient can become pregnant)
Pregnancytest (urine): 6x in period 1, 8x in period 2 (in case patient can
become pregnant)
Hepatitis B/C and HIV: 1x in case locally required
ePROs (6x): 3-6x in period 1, 6-17x in period 2
Feedback questionnaire: 2x in period 1, 1x in period 2
Haaksbergweg 16
Amsterdam 1101 BX
NL
Haaksbergweg 16
Amsterdam 1101 BX
NL
Listed location countries
Age
Inclusion criteria
• Male or non-pregnant, non-lactating female participants at least 18 years of
age
• Clinical diagnosis of axSpA AND according to ASAS axSpA criteria:
a. Inflammatory back pain for at least 6 months
b. Onset before 45 years of age
c. Sacroiliitis on MRI (magnetic resonance imaging) (as assessed by central
reader) with >= 1 SpA feature OR HLA-B-27 positive with >=2 SpA features
• Objective signs of inflammation at screening, evident by either
MRI with Sacroiliac Joint inflammation (as assessed by central reader)
AND / OR
hsCRP > ULN (as defined by the central lab)
• Active axSpA as assessed by total BASDAI >= 4 cm (0-10 cm) at baseline.
• Spinal pain as measured by BASDAI question #2 >= 4 cm (0-10 cm) at baseline.
• Total back pain as measured by VAS (visual analog scale) >= 40 mm (0-100 mm)
at baseline.
• Participants should have been on at least 2 different NSAIDs (non-steroidal
anti-inflammatory drugs) at the highest recommended dose for at least 4 weeks
in total prior to baseline with an inadequate response or failure to respond,
or less if therapy had to be withdrawn due to intolerance, toxicity or
contraindications.
Exclusion criteria
Key Exclusion criteria
• Participants with radiographic evidence for sacroiliitis, grade >= 2
bilaterally or grade >= 3 unilaterally (radiological criterion according to the
modified New York diagnostic criteria for AS) as assessed by central reader.
• Participants taking high potency opioid analgesics (e.g., methadone,
hydromorphone, morphine).
• Previous exposure to secukinumab or any other biologic drug directly
targeting IL-17 or IL-17 receptor or previous treatment with immunomodulatory
biologic agents including those targeting TNFα (tumor necrosis factor α)
(unless participants discontinued the treatment with TNFα inhibitor due to a
reason other than efficacy [primary or secondary lack of efficacy, inadequate
response] and only after appropriate wash-out period prior to baseline was
observed).
• History of hypersensitivity to the study drug or its excipients or to drugs
of similar chemical classes.
• Active ongoing inflammatory diseases other than nr-axSpA that might confound
the evaluation of the benefit of secukinumab therapy, including uveitis.
• Active inflammatory bowel disease.
• History of ongoing, chronic or recurrent infectious disease or evidence of
tuberculosis infection.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EU-CTR | CTIS2023-509320-17-00 |
| EudraCT | EUCTR2022-001153-23-NL |
| CCMO | NL83135.056.22 |