Juvenile Psoriatic ArthritisPhase 3NCT03769168
An Extension Study of Subcutaneous Secukinumab in Patients With Juvenile Psoriatic Arthritis (JPsA) and Enthesitis Related Arthritis (ERA)
A Phase 3 study testing Secukinumab in people with Juvenile Psoriatic Arthritis and Enthesitis Related Arthritis, run by Novartis Pharmaceuticals at 23 sites in 9 countries.
Trial summary
Optional open label, roll over extension study to investigate the efficacy and safety of secukinumab treatment in Juvenile Idiopathic Arthritis (JIA) subtypes of Juvenile Psoriatic Arthritis (JPsA) and Enthesitis Related Arthritis (ERA). Read more about this study
- Who is it for?
- Ages 2 to 100 years
- Conditions the study is for
- Juvenile Psoriatic Arthritis, Enthesitis Related Arthritis
- What is being tested?
- Secukinumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 23 sitesin 9 countries
- Study dates
- 7 Jun 2019to 7 Nov 2024
- Phase
- Phase 3
- 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 2 to 100 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients had to have participated in the core study CAIN457F2304 and completed the entire treatment period up to and including Week 104.
- Patients had to be deemed by the investigator to benefit from continued secukinumab therapy.
Who cannot join
- Patients with plans for administration of live vaccines during the extension study period were excluded.
- Patients taking any other concomitant biologic immunomodulating agent(s) except secukinumab were excluded.
- Patients who were deemed not to be benefiting from the study treatment based on lack of improvement or worsening of their symptoms were excluded.
Trial locations and contacts
23 sites in 9 countries.
23 sites in 9 countries
Russia4 sites
Novartis Investigative Site
Moscow, 119991
Novartis Investigative Site
Saint Petersburg, 194100
Novartis Investigative Site
Voronezh, 394036
Novartis Investigative Site
Yekaterinburg, 620149
Turkey (Türkiye)4 sites
Novartis Investigative Site
Ankara, 06230
Novartis Investigative Site
Istanbul, Halkali, 34303
Novartis Investigative Site
Istanbul, TUR, 34098
Novartis Investigative Site
Istanbul, 34093
United States3 sites
St Lukes Intermountain Research Center
Boise, Idaho, 83702
Cincinnati Childrens Hospital
Cincinnati, Ohio, 45229
Legacy Emanuel Research Hospital Portland
Portland, Oregon, 97232
Germany3 sites
Novartis Investigative Site
Freiburg im Breisgau, 79106
Novartis Investigative Site
Hamburg, 22081
Novartis Investigative Site
Saint Augustin, 53757
Belgium2 sites
Novartis Investigative Site
Brussels, 1200
Novartis Investigative Site
Ghent, 9000
Italy2 sites
Novartis Investigative Site
Genova, GE, 16147
Novartis Investigative Site
Naples, 80131
South Africa2 sites
Novartis Investigative Site
Cape Town, 7925
Novartis Investigative Site
Panorama, Western Cape, 7500
Spain2 sites
Novartis Investigative Site
Santiago de Compostela, Galicia, 15706
Novartis Investigative Site
Valencia, 46026
About this study
Official title: An Extension Study of Subcutaneous Secukinumab to Evaluate the Long-term Efficacy, Safety and Tolerability up to 4 Years in Patients With Juvenile Idiopathic Arthritis Subtypes of Juvenile Psoriatic Arthritis and Enthesitis Related Arthritis
Optional open label, roll over extension study to investigate the efficacy and safety of secukinumab treatment in Juvenile Idiopathic Arthritis (JIA) subtypes of Juvenile Psoriatic Arthritis (JPsA) and Enthesitis Related Arthritis (ERA).
Read the detailed description
This study is an extension of a previous core study (NCT03031782 [CAIN457F2304]) aiming to assess the long-term efficacy, safety, and tolerability of secukinumab treatment in patients who completed the core study and chose to participate in the extension study. The primary objective was to gather comprehensive data on the efficacy and safety of secukinumab over an extended period.
At Week 104 of the core study, all eligible patients could opt to roll over to the extension study and continue receiving secukinumab at either 75 mg or 150 mg, as they were at the Week 100 visit of the core study. The treatment involved subcutaneous injections using pre-filled syringes (PFS). The duration of patient participation could range from a minimum of one year to a maximum of four years, or until one of the following conditions was met: the drug was locally approved, marketed, and reimbursed, secukinumab could be provided free of charge to patients in compliance with local guidelines, or a maximum of 4 years study duration.
During the extension study (starting from Week 108), to maintain a high proportion of clinically meaningful response during the entire duration of the extension study, the dosing options available, at the Investigator's discretion, were as follows:
- The dose could be escalated from 75 mg to 150 mg for patients whose signs and symptoms were not fully controlled with the current dose of 75 mg and might improve with a higher dose as judged by the investigator
- Further, the dose could be escalated to 300 mg for patients weighing 50 kg and over currently on the 150 mg dose whose signs and symptoms were not fully controlled and might improve further with an increase in dose as judged by the investigator
- Dose escalation from secukinumab 75 mg to 300 mg had to be done in two steps (first 150 mg then 300 mg if the patient weighed 50 kg or over and based on the investigator's judgement), also considering the gap between the two escalations to review the response
- Being tested
- Secukinumab
- Keywords
- JIA, JPsA, ERA, Secukinumab, ILAR, Juvenile Psoriatic Arthritis, Enthesitis Related Arthritis
- Medical subject headings
- Arthritis, Juvenile
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SecukinumabDrug
Also called AIN457
Secukinumab solution for subcutaneous injections was provided in PFS. Initially, participants continued to receive secukinumab at either 75 mg (in 0.5mL) or 150 mg (in 1mL) every 4 weeks, consistent with their dosage at the Week 100 visit of the core study. The dose could be escalated from 75 mg to 150 mg for patients whose signs and symptoms were not fully controlled, as judged by the investigator, with the current 75 mg dose. Furthermore, the dose could also be escalated to 300 mg every 4 weeks for patients weighing 50kg and over who were currently on the 150 mg dose and whose signs and symptoms were not well-controlled, as judged by the investigator. The dose escalation from secukinumab 75 mg to 300 mg was to be implemented in two steps (first 150 mg and then 300 mg based on the investigator's judgment). At each study treatment time point, one or two subcutaneous injections in the form of PFS were administered.
| Study group | Role | What they receive |
|---|---|---|
| Group 1- Secukinumab 75 mg | Experimental | Participants initially received secukinumab 75mg subcutaneously once every four weeks in the extension study. If the signs and symptoms of the participants were not adequately controlled with the 75mg dose, as determined by the investigator, the dose could be escalated to 150mg subcutaneously. For patients weighing 50kg and over, the dose could further be escalated to 300mg subcutaneously every four weeks. The dose escalation from secukinumab 75mg subcutaneously to 300mg subcutaneously was to be implemented in two steps, with the first step being an increase to 150mg subcutaneously, followed by another escalation to 300mg subcutaneously, based on the judgement of the investigator. Receives: Drug: Secukinumab |
| Group 2 - Secukinumab 150 mg | Experimental | Participants initially received secukinumab 150mg subcutaneously once every four weeks in the extension study. If the signs and symptoms of the participants were not adequately controlled with the 150mg dose, as determined by the investigator, the dose could be escalated to 300mg subcutaneously. Receives: Drug: Secukinumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants With Juvenile Idiopathic Arthritis American College of Rheumatology (JIA ACR) 30 Response
The JIA ACR response criteria consisted of 6 core criteria:
- Physician global assessment of disease activity on a 0-100 mm VAS (0=very good and 100=very poor).
- Parent's or patients' global assessment of overall well-being on a 0-100 mm VAS (0=very well and 100=very poor).
- Functional ability (CHAQ: Childhood Health Assessment Questionnaire): 30 questions across 8 domains assessing the child's functional abilities. The total score was calculated as the average of the scores for each domain. It ranged from 0 (no disability) to 3 (very severe disability).
- Number of joints with active arthritis (as per ACR definition), ranging from 0 to 73.
- Number of joints with limited range of motion, ranging from 0 to 69.
- Index of inflammation: C-reactive Protein (CRP) levels The JIA ACR 30 response was achieved if 3 of any 6 core set variables improved by at least 30% from baseline of the core study, and no more than 1 variable worsening more than 30%
Measured: Baseline of the core study, Week 104 (start of extension study), 116, 128, 140, 156, 180, 208, 232, 260, 284 , 308 and 312. Study week is defined with respect to the core study.
Secondary outcomes (17)
Percentage of Participants With JIA ACR 50 Response
The JIA ACR response criteria consisted of 6 core criteria:
- Physician global assessment of disease activity on a 0-100 mm VAS (0=very good and 100=very poor).
- Parent's or patients' global assessment of overall well-being on a 0-100 mm VAS (0=very well and 100=very poor).
- Functional ability (CHAQ): 30 questions across 8 domains assessing the child's functional abilities. The total score was calculated as the average of the scores for each domain (0 [no disability] to 3 [very severe disability]).
- Number of joints with active arthritis (as per ACR definition), ranging from 0 to 73.
- Number of joints with limited range of motion, ranging from 0 to 69.
- Index of inflammation: CRP levels The JIA ACR 50 responses were achieved if 3 of any 6 core set variables improved by at least 50% from baseline of the core study, and no more than 1 variable worsening > 30%
Measured: Baseline of the core study, Week 104 (start of extension study), 116, 128, 140, 156, 180, 208, 232, 260, 284 , 308 and 312. Study week is defined with respect to the core study.
Percentage of Participants With JIA ACR 70 Response
The JIA ACR response criteria consisted of 6 core criteria:
- Physician global assessment of disease activity on a 0-100 mm VAS (0=very good and 100=very poor).
- Parent's or patients' global assessment of overall well-being on a 0-100 mm VAS (0=very well and 100=very poor).
- Functional ability (CHAQ): 30 questions across 8 domains assessing the child's functional abilities. The total score was calculated as the average of the scores for each domain (0 [no disability] to 3 [very severe disability]).
- Number of joints with active arthritis (as per ACR definition), ranging from 0 to 73.
- Number of joints with limited range of motion, ranging from 0 to 69.
- Index of inflammation: CRP levels The JIA ACR 70 responses were achieved if 3 of any 6 core set variables improved by at least 70%, from baseline of the core study, and no more than 1 variable worsening > 30%
Measured: Baseline of the core study, Week 104 (start of extension study), 116, 128, 140, 156, 180, 208, 232, 260, 284 , 308 and 312. Study week is defined with respect to the core study.
Percentage of Participants With JIA ACR 90 Response
The JIA ACR response criteria consisted of 6 core criteria:
- Physician global assessment of disease activity on a 0-100 mm VAS (0=very good and 100=very poor).
- Parent's or patients' global assessment of overall well-being on a 0-100 mm VAS (0=very well and 100=very poor).
- Functional ability (CHAQ): 30 questions across 8 domains assessing the child's functional abilities. The total score was calculated as the average of the scores for each domain (0 [no disability] to 3 [very severe disability]).
- Number of joints with active arthritis (as per ACR definition), ranging from 0 to 73.
- Number of joints with limited range of motion, ranging from 0 to 69.
- Index of inflammation: CRP levels The JIA ACR 90 responses were achieved if 3 of any 6 core set variables improved by at least 90% from baseline of the core study, and no more than 1 variable worsening > 30%
Measured: Baseline of the core study, Week 104 (start of extension study), 116, 128, 140, 156, 180, 208, 232, 260, 284 , 308 and 312. Study week is defined with respect to the core study.
Percentage of Participants With JIA ACR 100 Response
The JIA ACR response criteria consisted of 6 core criteria:
- Physician global assessment of disease activity on a 0-100 mm VAS (0=very good and 100=very poor).
- Parent's or patients' global assessment of overall well-being on a 0-100 mm VAS (0=very well and 100=very poor).
- Functional ability (CHAQ): 30 questions across 8 domains assessing the child's functional abilities. The total score was calculated as the average of the scores for each domain (0 [no disability] to 3 [very severe disability]).
- Number of joints with active arthritis (as per ACR definition), ranging from 0 to 73.
- Number of joints with limited range of motion, ranging from 0 to 69.
- Index of inflammation: CRP levels The JIA ACR 100 responses were achieved if 3 of any 6 core set variables improved with 100% from baseline of the core study, and no more than 1 variable worsening > 30%
Measured: Baseline of the core study, Week 104 (start of extension study), 116, 128, 140, 156, 180, 208, 232, 260, 284 , 308 and 312. Study week is defined with respect to the core study.
Number of Participants With Inactive Disease Status
Inactive disease status was confirmed in a patient when all the following conditions were met:
- No joints with active arthritis
- No uveitis
- CRP value within normal limits for the laboratory where tested or, if elevated, not attributable to JIA
- Physician's global assessment of disease activity score ≤ 10mm
- Duration of morning stiffness attributable to JIA lasting ≥15 minutes.
Measured: Baseline of the core study, Week 104 (start of extension study), 116, 128, 140, 156, 180, 208, 232, 260, 284 , 308 and 312. Study week is defined with respect to the core study.
Change From Baseline of Core Study CAIN457F2304 in JIA ACR Core Component - Physician Global Assessment of Disease Activity
The JIA ACR response criteria consisted of 6 core criteria, one of which was the physician global assessment of disease activity. this assessment was conducted using a 100 mm VAS score, where 0 represented the best disease activity and 100 the worst. The change from baseline of the core study of the physician global assessment of disease activity was measured, with a negative change indicating improvement.
Measured: Baseline of the core study, Week 104 (start of extension study), 116, 128, 140, 156, 180, 208, 232, 260, 284 , 308 and 312. Study week is defined with respect to the core study.
Change From Baseline of Core Study CAIN457F2304 in JIA ACR Core Component - Parent's or Patients' Global Assessment of Overall Well-being
The JIA ACR response criteria included six core components, one of which was the parent's or patients' global assessment of overall well-being. This assessment was conducted using a 100 mm VAS score, where 0 represented "very well" and 100 "very poor". The change from baseline of the core study in the parent's or patients' global assessment of overall well-being was measured, with a negative change indicating improvement
Measured: Baseline of the core study, Week 104 (start of extension study), 116, 128, 140, 156, 180, 208, 232, 260, 284 , 308 and 312. Study week is defined with respect to the core study.
Change From Baseline of Core Study CAIN457F2304 in JIA ACR Core Component - Functional Ability (CHAQ)
The JIA ACR response criteria included six core components, one of which was the functional ability, measured by the CHAQ. The CHAQ questionnaire consisted of 30 questions across 8 domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities. Each domain was scored on a 4-point scale, and the total score was calculated as the average of the scores for each domain. The total score ranged from 0 (no disability) to 3 (very severe disability). The change from baseline of the core study in the CHAQ was measured, with a negative change indicating improvement.
Measured: Baseline of the core study, Week 104 (start of extension study), 116, 128, 140, 156, 180, 208, 232, 260, 284 , 308 and 312. Study week is defined with respect to the core study.
Change From Baseline of Core Study CAIN457F2304 in JIA ACR Core Component - Number of Joints With Active Arthritis
The JIA ACR response criteria included six core components, one of which was the number of joints with active arthritis. This was determined using the ACR definition, which identifies active arthritis as any joint with swelling or, in the absence of swelling, limitation of motion accompanied by either pain on motion or tenderness not due to deformity. The active joint count ranged from 0 to 73. The change from baseline of the core study in the number of active joints was measured, with a negative change indicating improvement.
Measured: Baseline of the core study, Week 104 (start of extension study), 116, 128, 140, 156, 180, 208, 232, 260, 284 , 308 and 312. Study week is defined with respect to the core study.
Change From Baseline of Core Study CAIN457F2304 in JIA ACR Core Component - Number of Joints With Limited Range of Motion
The JIA ACR response criteria included six core components, one of which was the number of joints with limited range of motion. A total of 69 joints were assessed for limitation of motion. The change from baseline of the core study in the number of joints with limited range of motion was measured, with a negative change indicating improvement.
Measured: Baseline of the core study, Week 104 (start of extension study), 116, 128, 140, 156, 180, 208, 232, 260, 284 , 308 and 312. Study week is defined with respect to the core study.
Change From Baseline of Core Study CAIN457F2304 in JIA ACR Core Component - CRP Levels
The JIA ACR response criteria included six core components, one of which was CRP levels, an inflammation biomarker. Serum concentrations of CRP were determined, and the change from baseline of the core study was assessed, with negative changes indicating improvement.
Measured: Baseline of the core study, Week 104 (start of extension study), 116, 128, 140, 156, 180, 208, 232, 260, 284 , 308 and 312. Study week is defined with respect to the core study.
Change From Baseline of Core Study CAIN457F2304 of 27-joint Juvenile Arthritis Disease Activity Score (JADAS-27)
The JADAS-27 was used for assessment of disease activity, and it included 4 measures:
- Physician global assessment of disease activity (VAS range: 0 to 10; where 0=very good and 100=very poor)
- Parent/participant global assessment of well-being (VAS range: 0 to 10; 0=very well and 100=very poor)
- Count of joints with active disease (range: 0 to 27; where 0= no disease activity and 27= maximum disease activity)
- Index of inflammation determined by CRP concentration, calculated as: (CRP (mg/l) -10)/10. Before calculation, CRP values <10 mg/l were converted to 10 and CRP values >110 mg/l were converted to 110. The normalized scale ranged from 0 to 10; where 0= no disease activity and 10= maximum disease activity.
JADAS-27 score was calculated as the sum of the score of its 4 components, ranging from 0 to 57 where 0= no disease activity and 57= maximum disease activity. The change from baseline of the core study was assessed. A negative change from baseline indicated improvement.
Measured: Baseline of the core study, Week 104 (start of extension study), 116, 128, 140, 156, 180, 208, 232, 260, 284 , 308 and 312. Study week is defined with respect to the core study.
Change From Baseline of Core Study CAIN457F2304 of 71-joint Juvenile Arthritis Disease Activity Score (JADAS-71)
The JADAS-27 was used for assessment of disease activity, and it included 4 measures:
- Physician global assessment of disease activity (VAS range: 0 to 10; where 0=very good and 100=very poor)
- Parent/participant global assessment of well-being (VAS range: 0 to 10; 0=very well and 100=very poor)
- Count of joints with active disease (range: 0 to 71; where 0= no disease activity and 71= maximum disease activity)
- Index of inflammation determined by CRP concentration, calculated as: (CRP (mg/l) -10)/10. Before calculation, CRP values <10 mg/l were converted to 10 and CRP values >110 mg/l were converted to 110. The normalized scale ranged from 0 to 10; where 0= no disease activity and 10= maximum disease activity.
JADAS-27 score was calculated as the sum of the score of its 4 components, ranging from 0 to 101 where 0= no disease activity and 101= maximum disease activity. The change from baseline of the core study was assessed. A negative change from baseline indicated improvement.
Measured: Baseline of the core study, Week 104 (start of extension study), 116, 128, 140, 156, 180, 208, 232, 260, 284 , 308 and 312. Study week is defined with respect to the core study.
Change From Baseline of Core Study CAIN457F2304 in Total Enthesitis Count
The following 16 entheseal sites were assessed for the presence or absence of tenderness (enthesitis) on each side of the body:
- Anterior Entheses: Greater trochanter of the Femur; Medial condyle of the femur; Lateral condyle of the femur
- Posterior Entheses: Greater tuberosity of humerus; medial epicondyle of humerus; lateral epicondyle of humerus, Achilles tendon; and calcaneal insertion of the plantar fascia.
Tenderness on examination was recorded as either present (1) or absent (0) for each of the 16 sites, The total enthesitis count ranged from 0 to 16.
The change from baseline of the core study was assessed. A negative change from baseline indicated improvement
Measured: Baseline of the core study, Week 104 (start of extension study), 116, 128, 140, 156, 180, 208, 232, 260, 284 , 308 and 312. Study week is defined with respect to the core study.
Change From Baseline of Core Study CAIN457F2304 in Total Dactylitis Count
The dactylitis count was the number of fingers and toes presenting with swelling and inflammation.
Swelling and inflammation on examination was recorded as either present (1) or absent (0) for each of the 20 sites, The total dactylitis count ranged from 0 to 20.
The change from baseline of the core study was assessed. A negative change from baseline indicated improvement
Measured: Baseline of the core study, Week 104 (start of extension study), 116, 128, 140, 156, 180, 208, 232, 260, 284 , 308 and 312. Study week is defined with respect to the core study.
Serum Concentrations of Secukinumab Over Time
Serum concentration of secukinumab over time. Blood samples for pharmacokinetics were taken pre-dose at the scheduled time points.
Measured: Pre-dose at Week 128, 140, 156, 180, 208, 232, 260, 284 , 308 and 312. Study week is defined with respect to the core study.
Number of Participants With Treatment-emergent Anti-Drug Antibodies (ADAs) of Secukinumab
Number of participants with treatment-emergent Anti-Drug Antibodies (ADAs) of secukinumab. Blood samples were collected for immunogenicity (anti-AIN457 antibodies) assessments.
Measured: From baseline of the core study up to Week 312. Study week is defined with respect to the core study.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2018
- Study start7 Jun 2019
- Primary completion7 Nov 2024
- Study completion7 Nov 2024
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 Juvenile Psoriatic ArthritisStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 55 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
- NCT03769168
- Sponsor's protocol ID
- CAIN457F2304E1
- Other IDs
- 2018-002521-30, 2018
- Status last verified
- Oct 2025
- First submitted
- 21 Nov 2018
- Last updated
- 16 Oct 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- 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
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Extension Study of Subcutaneous Secukinumab to Evaluate the Long-term Efficacy, Safety and Tolerability up to 4 Years in Patients With Juvenile Idiopathic Arthritis Subtypes of Juvenile Psoriatic Arthritis and Enthesitis Related Arthritis
- ClinicalTrials.gov ID
- NCT03769168
- Acronym / sponsor ID
- CAIN457F2304E1
- Keywords
- JIA, JPsA, ERA, Secukinumab, ILAR, Juvenile Psoriatic Arthritis, Enthesitis Related Arthritis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 7 Jun 2019 (actual)
- Primary completion
- 7 Nov 2024 (actual)
- Study completion
- 7 Nov 2024 (actual)
- First posted
- 7 Dec 2018 (actual)
- Results
- Posted 23 May 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Optional open label, roll over extension study to investigate the efficacy and safety of secukinumab treatment in Juvenile Idiopathic Arthritis (JIA) subtypes of Juvenile Psoriatic Arthritis (JPsA) and Enthesitis Related Arthritis (ERA).
Detailed description
This study is an extension of a previous core study (NCT03031782 [CAIN457F2304]) aiming to assess the long-term efficacy, safety, and tolerability of secukinumab treatment in patients who completed the core study and chose to participate in the extension study. The primary objective was to gather comprehensive data on the efficacy and safety of secukinumab over an extended period.
At Week 104 of the core study, all eligible patients could opt to roll over to the extension study and continue receiving secukinumab at either 75 mg or 150 mg, as they were at the Week 100 visit of the core study. The treatment involved subcutaneous injections using pre-filled syringes (PFS). The duration of patient participation could range from a minimum of one year to a maximum of four years, or until one of the following conditions was met: the drug was locally approved, marketed, and reimbursed, secukinumab could be provided free of charge to patients in compliance with local guidelines, or a maximum of 4 years study duration.
During the extension study (starting from Week 108), to maintain a high proportion of clinically meaningful response during the entire duration of the extension study, the dosing options available, at the Investigator's discretion, were as follows:
- The dose could be escalated from 75 mg to 150 mg for patients whose signs and symptoms were not fully controlled with the current dose of 75 mg and might improve with a higher dose as judged by the investigator
- Further, the dose could be escalated to 300 mg for patients weighing 50 kg and over currently on the 150 mg dose whose signs and symptoms were not fully controlled and might improve further with an increase in dose as judged by the investigator
- Dose escalation from secukinumab 75 mg to 300 mg had to be done in two steps (first 150 mg then 300 mg if the patient weighed 50 kg or over and based on the investigator's judgement), also considering the gap between the two escalations to review the response
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1- Secukinumab 75 mg | Experimental | Drug: SecukinumabParticipants initially received secukinumab 75mg subcutaneously once every four weeks in the extension study. If the signs and symptoms of the participants were not adequately controlled with the 75mg dose, as determined by the investigator, the dose could be escalated to 150mg subcutaneously. For patients weighing 50kg and over, the dose could further be escalated to 300mg subcutaneously every four weeks. The dose escalation from secukinumab 75mg subcutaneously to 300mg subcutaneously was to be implemented in two steps, with the first step being an increase to 150mg subcutaneously, followed by another escalation to 300mg subcutaneously, based on the judgement of the investigator. |
| Group 2 - Secukinumab 150 mg | Experimental | Drug: SecukinumabParticipants initially received secukinumab 150mg subcutaneously once every four weeks in the extension study. If the signs and symptoms of the participants were not adequately controlled with the 150mg dose, as determined by the investigator, the dose could be escalated to 300mg subcutaneously. |
Who may qualify
- Ages
- 2 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Patients had to have participated in the core study CAIN457F2304 and completed the entire treatment period up to and including Week 104.
- Patients had to be deemed by the investigator to benefit from continued secukinumab therapy.
Key exclusion criteria (3 listed)
- Patients with plans for administration of live vaccines during the extension study period were excluded.
- Patients taking any other concomitant biologic immunomodulating agent(s) except secukinumab were excluded.
- Patients who were deemed not to be benefiting from the study treatment based on lack of improvement or worsening of their symptoms were excluded.
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 |
|---|---|---|
| SecukinumabAlso: AIN457Secukinumab solution for subcutaneous injections was provided in PFS. Initially, participants continued to receive secukinumab at either 75 mg (in 0.5mL) or 150 mg (in 1mL) every 4 weeks, consistent with their dosage at the Week 100 visit of the core study. The dose could be escalated from 75 mg to 150 mg for patients whose signs and symptoms were not fully controlled, as judged by the investigator, with the current 75 mg dose. Furthermore, the dose could also be escalated to 300 mg every 4 weeks for patients weighing 50kg and over who were currently on the 150 mg dose and whose signs and symptoms were not well-controlled, as judged by the investigator. The dose escalation from secukinumab 75 mg to 300 mg was to be implemented in two steps (first 150 mg and then 300 mg based on the investigator's judgment). At each study treatment time point, one or two subcutaneous injections in the form of PFS were administered. | Drug | Group 1- Secukinumab 75 mg, Group 2 - Secukinumab 150 mg |
Primary outcome
Percentage of Participants With Juvenile Idiopathic Arthritis American College of Rheumatology (JIA ACR) 30 Response
Time frame: Baseline of the core study, Week 104 (start of extension study), 116, 128, 140, 156, 180, 208, 232, 260, 284 , 308 and 312. Study week is defined with respect to the core study.
The JIA ACR response criteria consisted of 6 core criteria: * Physician global assessment of disease activity on a 0-100 mm VAS (0=very good and 100=very poor). * Parent's or patients' global assessment of overall well-being on a 0-100 mm VAS (0=very well and 100=very poor). * Functional ability (CHAQ: Childhood Health Assessment Questionnaire): 30 questions across 8 domains assessing the child's functional abilities. The total score was calculated as the average of the scores for each domain. It ranged from 0 (no disability) to 3 (very severe disability). * Number of joints with active arthritis (as per ACR definition), ranging from 0 to 73. * Number of joints with limited range of motion, ranging from 0 to 69. * Index of inflammation: C-reactive Protein (CRP) levels The JIA ACR 30 response was achieved if 3 of any 6 core set variables improved by at least 30% from baseline of the core study, and no more than 1 variable worsening more than 30%
17 secondary outcomes
Percentage of Participants With JIA ACR 50 Response
Time frame: Baseline of the core study, Week 104 (start of extension study), 116, 128, 140, 156, 180, 208, 232, 260, 284 , 308 and 312. Study week is defined with respect to the core study.
Percentage of Participants With JIA ACR 70 Response
Time frame: Baseline of the core study, Week 104 (start of extension study), 116, 128, 140, 156, 180, 208, 232, 260, 284 , 308 and 312. Study week is defined with respect to the core study.
Percentage of Participants With JIA ACR 90 Response
Time frame: Baseline of the core study, Week 104 (start of extension study), 116, 128, 140, 156, 180, 208, 232, 260, 284 , 308 and 312. Study week is defined with respect to the core study.
Percentage of Participants With JIA ACR 100 Response
Time frame: Baseline of the core study, Week 104 (start of extension study), 116, 128, 140, 156, 180, 208, 232, 260, 284 , 308 and 312. Study week is defined with respect to the core study.
Number of Participants With Inactive Disease Status
Time frame: Baseline of the core study, Week 104 (start of extension study), 116, 128, 140, 156, 180, 208, 232, 260, 284 , 308 and 312. Study week is defined with respect to the core study.
Change From Baseline of Core Study CAIN457F2304 in JIA ACR Core Component - Physician Global Assessment of Disease Activity
Time frame: Baseline of the core study, Week 104 (start of extension study), 116, 128, 140, 156, 180, 208, 232, 260, 284 , 308 and 312. Study week is defined with respect to the core study.
Change From Baseline of Core Study CAIN457F2304 in JIA ACR Core Component - Parent's or Patients' Global Assessment of Overall Well-being
Time frame: Baseline of the core study, Week 104 (start of extension study), 116, 128, 140, 156, 180, 208, 232, 260, 284 , 308 and 312. Study week is defined with respect to the core study.
Change From Baseline of Core Study CAIN457F2304 in JIA ACR Core Component - Functional Ability (CHAQ)
Time frame: Baseline of the core study, Week 104 (start of extension study), 116, 128, 140, 156, 180, 208, 232, 260, 284 , 308 and 312. Study week is defined with respect to the core study.
Change From Baseline of Core Study CAIN457F2304 in JIA ACR Core Component - Number of Joints With Active Arthritis
Time frame: Baseline of the core study, Week 104 (start of extension study), 116, 128, 140, 156, 180, 208, 232, 260, 284 , 308 and 312. Study week is defined with respect to the core study.
Change From Baseline of Core Study CAIN457F2304 in JIA ACR Core Component - Number of Joints With Limited Range of Motion
Time frame: Baseline of the core study, Week 104 (start of extension study), 116, 128, 140, 156, 180, 208, 232, 260, 284 , 308 and 312. Study week is defined with respect to the core study.
Change From Baseline of Core Study CAIN457F2304 in JIA ACR Core Component - CRP Levels
Time frame: Baseline of the core study, Week 104 (start of extension study), 116, 128, 140, 156, 180, 208, 232, 260, 284 , 308 and 312. Study week is defined with respect to the core study.
Change From Baseline of Core Study CAIN457F2304 of 27-joint Juvenile Arthritis Disease Activity Score (JADAS-27)
Time frame: Baseline of the core study, Week 104 (start of extension study), 116, 128, 140, 156, 180, 208, 232, 260, 284 , 308 and 312. Study week is defined with respect to the core study.
Change From Baseline of Core Study CAIN457F2304 of 71-joint Juvenile Arthritis Disease Activity Score (JADAS-71)
Time frame: Baseline of the core study, Week 104 (start of extension study), 116, 128, 140, 156, 180, 208, 232, 260, 284 , 308 and 312. Study week is defined with respect to the core study.
Change From Baseline of Core Study CAIN457F2304 in Total Enthesitis Count
Time frame: Baseline of the core study, Week 104 (start of extension study), 116, 128, 140, 156, 180, 208, 232, 260, 284 , 308 and 312. Study week is defined with respect to the core study.
Change From Baseline of Core Study CAIN457F2304 in Total Dactylitis Count
Time frame: Baseline of the core study, Week 104 (start of extension study), 116, 128, 140, 156, 180, 208, 232, 260, 284 , 308 and 312. Study week is defined with respect to the core study.
Serum Concentrations of Secukinumab Over Time
Time frame: Pre-dose at Week 128, 140, 156, 180, 208, 232, 260, 284 , 308 and 312. Study week is defined with respect to the core study.
Number of Participants With Treatment-emergent Anti-Drug Antibodies (ADAs) of Secukinumab
Time frame: From baseline of the core study up to Week 312. Study week is defined with respect to the core study.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- A Plain Language Trial Summary is available on www.novctrd.comLink provided by the sponsor.
- Individual participant dataSharing planned: 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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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
23 sites in 9 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Secukinumab in people with Juvenile Psoriatic Arthritis and Enthesitis Related Arthritis, run by Novartis Pharmaceuticals at 23 sites in 9 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 2 inclusion and 3 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 16 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 23 sites in Russia, Turkey (Türkiye), United States, Germany, Belgium and 4 more countries. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 23 May 2025). 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?
Percentage of Participants With Juvenile Idiopathic Arthritis American College of Rheumatology (JIA ACR) 30 Response (time frame: Baseline of the core study, Week 104 (start of extension study), 116, 128, 140, 156, 180, 208, 232, 260, 284 , 308 and 312. Study week is defined with respect to the core study.). 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 16 Oct 2025.