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Non-radiographic Axial SpondyloarthritisPhase 4NCT05622708

A Study of Secukinumab to Evaluate Maintenance of Response in Participants With Non-radiographic Axial Spondyloarthritis Who Achieved Remission

A Phase 4 study testing Secukinumab in people with Non-radiographic Axial Spondyloarthritis, run by Novartis Pharmaceuticals at 61 sites in 18 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record

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Trial summary

This study will establish whether prolonged chronic dosing with secukinumab is needed in participants with Non-radiographic axial spondyloarthritis, (nr-axSpA) who have achieved remission. Read more about this study

Who is it for?
Ages 18 to 100 years
Conditions the study is for
Non-radiographic Axial Spondyloarthritis
What is being tested?
Secukinumab
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
240 participants
Where
61 sitesin 18 countries
Study dates
28 Mar 2023to 4 Apr 2028
Phase
Phase 4

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 100 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Male or non-pregnant, non-lactating female participants at least 18 years of age
  • Clinical diagnosis of axSpA AND according to ASAS axSpA criteria:
  • Inflammatory back pain for at least 6 months
  • Onset before 45 years of age
  • 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)
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  • 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.

Who cannot join

  • 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.

Trial locations and contacts

61 sites in 18 countries.

61 sites in 18 countries

Germany6 sites

  • Novartis Investigative Site

    Bad Doberan, 18209

  • Novartis Investigative Site

    Berlin, 10777

  • Novartis Investigative Site

    Berlin, 13125

  • Novartis Investigative Site

    Hamburg, 22415

  • Novartis Investigative Site

    Herne, 44649

  • Novartis Investigative Site

    Ratingen, 40878

Other trials in Germany

Hungary6 sites

  • Novartis Investigative Site

    Debrecen, Hajdu Bihar Megye, 4032

  • Novartis Investigative Site

    Kistarcsa, 2143

  • Novartis Investigative Site

    Miskolc, 3526

  • Novartis Investigative Site

    Szeged, 6725

  • Novartis Investigative Site

    Székesfehérvár, Fejér, 8000

  • Novartis Investigative Site

    Veszprém, 8200

Other trials in Hungary

Poland6 sites

  • Novartis Investigative Site

    Bydgoszcz, 85-168

  • Novartis Investigative Site

    Krakow, Lesser Poland Voivodeship, 30-727

  • Novartis Investigative Site

    Krakow, 30-002

  • Novartis Investigative Site

    Sochaczew, 96-500

  • Novartis Investigative Site

    Torun, 87-100

  • Novartis Investigative Site

    Warsaw, Poland, 02-637

Other trials in Poland

Belgium4 sites

  • Novartis Investigative Site

    Bruges, 8000

  • Novartis Investigative Site

    Genk, Belgium, 3600

  • Novartis Investigative Site

    Ghent, 9000

  • Novartis Investigative Site

    Mons, 7000

Other trials in Belgium

Colombia4 sites

  • Novartis Investigative Site

    Bogota, Cundinamarca, 110111

  • Novartis Investigative Site

    Bogota, Cundinamarca, 110221

  • Novartis Investigative Site

    Bucaramanga, Santander Department, 680003

  • Novartis Investigative Site

    Chía, Cundinamarca, 250001

Other trials in Colombia

Czechia4 sites

  • Novartis Investigative Site

    Prague, 128 00

  • Novartis Investigative Site

    Prague, 148 00

  • Novartis Investigative Site

    Prague, 150 06

  • Novartis Investigative Site

    Uherské Hradiště, 686 01

Other trials in Czechia

France4 sites

  • Novartis Investigative Site

    Chambray-lès-Tours, 37170

  • Novartis Investigative Site

    Le Mans, 72000

  • Novartis Investigative Site

    Nice, 06000

  • Novartis Investigative Site

    Paris, 75012

Other trials in France

Italy4 sites

  • Novartis Investigative Site

    Ancona, AN, 60020

  • Novartis Investigative Site

    Negrar, VR, 37024

  • Novartis Investigative Site

    Torino, TO, 10128

  • Novartis Investigative Site

    Verona, VR, 37126

Other trials in Italy

Brazil3 sites

  • Novartis Investigative Site

    Barretos, São Paulo, 14784-400

  • Novartis Investigative Site

    Juiz de Fora, Minas Gerais, 36010-570

  • Novartis Investigative Site

    Porto Alegre, Rio Grande do Sul, 90480-000

Other trials in Brazil

Israel3 sites

  • Novartis Investigative Site

    Kfar Saba, 4428164

  • Novartis Investigative Site

    Ramat Gan, 5265601

  • Novartis Investigative Site

    Tel Aviv, 6423906

Other trials in Israel

Mexico3 sites

  • Novartis Investigative Site

    Chihuahua City, Chihuahua, 31000

  • Novartis Investigative Site

    Guadalajara, Jalisco, 44650

  • Novartis Investigative Site

    Guadalajara, Jalisco, 44690

Other trials in Mexico

Romania3 sites

  • Novartis Investigative Site

    Bucharest, 011055

  • Novartis Investigative Site

    Bucharest, 011172

  • Novartis Investigative Site

    Cluj-Napoca, Cluj, 400006

Other trials in Romania

Netherlands2 sites

  • Novartis Investigative Site

    Amsterdam, North Holland, 1105 AZ

  • Novartis Investigative Site

    Heerlen, Limburg, 6419 PC

Other trials in Netherlands

Philippines2 sites

  • Novartis Investigative Site

    Makati City, National Capital Region, 1218

  • Novartis Investigative Site

    Manila, 1008

Other trials in Philippines

Thailand2 sites

  • Novartis Investigative Site

    Bangkok, 10400

  • Novartis Investigative Site

    Bangkok, 10700

Other trials in Thailand

Turkey (Türkiye)2 sites

  • Novartis Investigative Site

    Adana, Yuregir, 01230

  • Novartis Investigative Site

    Konya, 42080

Other trials in Turkey (Türkiye)

Vietnam2 sites

  • Novartis Investigative Site

    Ho Chi Minh City, VNM, 700000

  • Novartis Investigative Site

    Ho Chi Minh City, 700000

Other trials in Vietnam

Malaysia1 site

  • Novartis Investigative Site

    Kuala Lumpur, 59100

Other trials in Malaysia

About this study

Official title: A Multicenter Study of Secukinumab, With a Randomized Double-blind, Placebo-controlled Withdrawal-retreatment Period, to Evaluate Maintenance of Response in Participants With Non-radiographic Axial Spondyloarthritis Who Achieved Remission

This study will establish whether prolonged chronic dosing with secukinumab is needed in participants with Non-radiographic axial spondyloarthritis, (nr-axSpA) who have achieved remission. Remission is defined as Ankylosing Spondylitis Disease Activity Score - C-reactive protein (ASDAS-CRP) Inactive Disease (ID) response (ASDAS-CRP < 1.3). Maintenance of remission on continued secukinumab treatment will be evaluated compared to placebo using a randomized withdrawal design. The primary outcome measure for this study is the proportion of participants remaining flare-free at Week 120.

Read the detailed description

This study will establish whether prolonged chronic dosing with secukinumab is needed in participants with nr-axSpA who have achieved remission. Remission is defined as Ankylosing Spondylitis Disease Activity Score - C-reactive protein (ASDAS-CRP) Inactive Disease (ID) response Inactive Disease (ID) response (ASDAS-CRP < 1.3). The maintenance of remission on continued secukinumab treatment will be evaluated compared to placebo using a randomized withdrawal design. The primary outcome measure for this study is the proportion of participants remaining flare-free at Week 120.

Study treatment will be as follows:

  • Open-label Secukinumab PFS (prefilled syringe) will be labeled as AIN457 150mg/1mL
  • Double-blind Secukinumab and Placebo PFS will be labeled as AIN457 150mg/1mL/Placebo.

Study duration will be up to 128 weeks from Baseline.

The treatment duration will be up to 120 weeks with last treatment administration at Week 116.

In the Treatment Period 1 participant will attend a site visit approximately 1 month after Baseline and approximately every 12 weeks thereafter. In the Treatment Period 2 participant will attend site visits approximately every 4 weeks.

Being tested
Secukinumab, Placebo
Keywords
nr-AxSpa, non-radiographic axial Spondyloarthritis, Secukinumab, remission, withdrawal, inflammatory back pain, sacroiliitis, AIN457
Medical subject headings
Non-Radiographic Axial Spondyloarthritis, Sacroiliitis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SecukinumabDrug

    Treatment Period 1: Open-label secukinumab 150 mg PFS s.c. at baseline, Weeks 1, 2, 3 and 4 followed by administration every four weeks up to Week 52.

  • PlaceboDrug

    Treatment Period 2: Double-blind placebo PFS s.c. every 4 weeks from Week 56 to Week 116.

  • SecukinumabDrug

    Treatment Period 2: Double-blind secukinumab 150 mg PFS s.c. every 4 weeks from Week 56 to Week 116.

    Escape re-treatment (during Treatment Period 2): Open-label secukinumab 150 mg PFS s.c.

Study groups in NCT05622708
Study groupRoleWhat they receive
Treatment Period 1ExperimentalOpen-label Secukinumab PFS (prefilled syringe) labeled as AIN457 150mg/1mL
Receives: Drug: Secukinumab
Treatment Period 2ExperimentalDouble-blind Secukinumab and Placebo PFS labeled as AIN457 150mg/1mL/Placebo
Receives: Drug: Placebo; Drug: Secukinumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The proportion of participants remaining flare-free during Treatment Period 2

    The primary efficacy endpoint is the proportion of participants in the randomized withdrawal population remaining flare-free at Week 120. A flare is defined as ASDAS-CRP ≥ 2.1 at 2 consecutive visits, or ASDAS-CRP > 3.5 at any visit during Treatment Period 2, starting at Week 60.

    Parameters used for ASDAS-CRP include:

    • Spinal pain (BASDAI question 2),
    • Patient's global assessment of disease activity,
    • Peripheral pain/swelling (BASDAI question 3),
    • Duration of morning stiffness (BASDAI question 6)
    • C-reactive protein (CRP) in mg/L

    Measured: Week 120

Secondary outcomes (2)

  1. Time to flare during Treatment Period 2

    A flare is defined as ASDAS-CRP ≥ 2.1 at 2 consecutive visits, or ASDAS-CRP > 3.5 at any visit during Treatment Period 2, starting at Week 60.

    Measured: From Week 56 to Week 120

  2. Number of participants with Adverse Events

    Safety and tolerability demonstrated by assessing:

    • Adverse events (AEs) and serious adverse events (SAEs)

    Measured: From Baseline to Week 128

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Nov 2022
  2. Study start28 Mar 2023
  3. Primary completion8 Feb 2028 (estimated)
  4. Study completion4 Apr 2028 (estimated)

Resources

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 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
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).
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
240 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05622708
Sponsor's protocol ID
CAIN457I2401
Other IDs
2022-001153-23, 2023-509320-17-00, 2023
Status last verified
Oct 2026
First submitted
9 Nov 2022
Last updated
14 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com

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