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

StatusActive, Not Recruiting

PhasePhase 4

SponsorNovartis Pharmaceuticals

Started2023-03-28

View on ClinicalTrials.gov ↗

Amendment history

2026-08-20

Study Status, Contacts/Locations v41

Study sitesdetails revised at 3 of 62 sites

2026-07-17

Study Status, Contacts/Locations v40

Study sitesdetails revised at 13 of 62 sites

2026-06-01

Study Status, Contacts/Locations v39

Primary completion moved earlier: 2028-04-19 → 2028-02-08

Completion moved earlier: 2028-06-13 → 2028-04-04

Study sites63→62

2026-03-10

Study Status, Study Design, Contacts/Locations v38

Enrollment target241→240

Study sites65→63

2025-12-11

Recruiting→Active, Not Recruiting Study Status, Study Design, Contacts/Locations v37

Trial statusRecruiting→Active, Not Recruiting

Primary completion date2030-04-26→2028-04-19

Completion date2030-06-21→2028-06-13

Enrollment targetestimated 340→confirmed 241

Study sites88→65

Show 36 earlier versions

2025-09-29

Study Status, Contacts/Locations v36

Study sites87→88

2025-07-28

Study Status, Contacts/Locations v35

Study sites86→87

2025-06-27

Study Status, Contacts/Locations v34

Study sites84→86

2025-06-03

Study Status, Contacts/Locations v33

Study sitesdetails revised at 11 of 84 sites

2025-03-05

Study Status, Contacts/Locations v32

Study sitesdetails revised at 6 of 84 sites

2025-01-24

Study Status, Contacts/Locations v31

Study sitesdetails revised at 1 of 84 sites

2024-12-19

Study Status, Eligibility, Contacts/Locations v30

Primary completion date2030-04-24→2030-04-26

Completion date2030-06-19→2030-06-21

Study sitesdetails revised at 10 of 84 sites

2024-09-13

Study Status, Contacts/Locations v29

Study sitesdetails revised at 1 of 84 sites

2024-08-12

Study Identification, Study Status v28

Re-verified, no change to tracked fields

2024-08-09

Study Status, Contacts/Locations v27

Study sitesdetails revised at 6 of 84 sites

2024-05-17

Study Status, Contacts/Locations v26

Study sites83→84

2024-02-26

Study Status, Contacts/Locations v25

Study sites82→83

2024-02-22

Study Status, Contacts/Locations v24

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2024-02-07

Study Status, Contacts/Locations v23

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2024-02-02

Study Status, Contacts/Locations v22

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2024-02-01

Study Status, Contacts/Locations v21

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2024-01-26

Study Status, Contacts/Locations v20

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2024-01-08

Study Status, Contacts/Locations v19

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2023-12-15

Study Status, Contacts/Locations v18

Study sites74→75

2023-12-08

Study Status, Contacts/Locations v17

Study sites73→74

2023-11-30

Study Status, Contacts/Locations v16

Study sites71→73

2023-11-17

Study Status, Contacts/Locations v15

Study sites70→71

2023-10-31

Study Status, Contacts/Locations v14

Study sites69→70

2023-10-25

Study Status, Contacts/Locations v13

Study sites68→69

2023-10-06

Study Status, Contacts/Locations v12

Study sites67→68

2023-10-02

Study Status, Contacts/Locations v11

Study sites66→67

2023-09-28

Study Status, Contacts/Locations v10

Study sites63→66

2023-09-22

Study Status, Contacts/Locations v9

Study sites62→63

2023-09-20

Study Status, Contacts/Locations v8

Study sites61→62

2023-09-11

Study Status, Contacts/Locations v7

Study sites60→61

2023-09-07

Study Status, Contacts/Locations v6

Study sites59→60

2023-09-06

Study Status, Contacts/Locations v5

Study sites58→59

2023-09-05

Study Status, Contacts/Locations v4

Study sites57→58

2023-08-30

Study Status, Contacts/Locations v3

Study sites53→57

2023-07-26

Study Status, Contacts/Locations v2

Study sites7→53

2023-03-31

Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v1

Trial statusNot Yet Recruiting→Recruiting

Start dateestimated 2023-03-27→confirmed 2023-03-28

Study sites0→7

2022-11-16

Original filing

Novartis

552 trials monitored

See 32 trials at risk

Ankylosing Spondylitis

176 trials monitored

See 6 trials at risk

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.

Trial Details

NCT Number	NCT05622708
Lead Sponsor	Novartis Pharmaceuticals
Conditions	Non-radiographic Axial Spondyloarthritis
Enrollment	240 participants
Start Date	2023-03-28
Primary Completion	2028-02-08 (estimated)
Study Completion	2028-04-04 (estimated)
Updated on ClinicalTrials.gov	2026-08-21