Phase 3
N=55
An Extension Study of Subcutaneous Secukinumab in Patients With Juvenile Psoriatic Arthritis (JPsA) and Enthesitis Related Arthritis (ERA)
Juvenile Psoriatic Arthritis · Enthesitis Related Arthritis
Bottom Line
View on ClinicalTrials.gov: NCT03769168 ↗Enrolled (actual)
55
Serious AEs
6.1%
Results posted
May 2025
Primary outcome: Primary: Percentage of Participants With Juvenile Idiopathic Arthritis American College of Rheumatology (JIA ACR) 30 Response — 100; 100; 100; 100 Percentage of Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Secukinumab (Drug)
- Age
- Pediatric, Adult, Older Adult · 2+ yrs
- Sex
- All
- Sponsor
- Novartis Pharmaceuticals
- Primary completion
- Nov 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Juvenile Idiopathic Arthritis American College of Rheumatology (JIA ACR) 30 Response |
100; 100; 100; 100; 96.9; 98.9 | — |
| SECONDARY Percentage of Participants With JIA ACR 50 Response |
94.7; 94.3; 94.4; 100; 93.8; 96.1 | — |
| SECONDARY Percentage of Participants With JIA ACR 70 Response |
94.7; 82.9; 87.0; 94.7; 90.6; 92.2 | — |
| SECONDARY Percentage of Participants With JIA ACR 90 Response |
84.2; 74.3; 77.8; 73.7; 75.0; 74.5 | — |
| SECONDARY Percentage of Participants With JIA ACR 100 Response |
63.2; 57.1; 59.3; 63.2; 62.5; 62.7 | — |
| SECONDARY Number of Participants With Inactive Disease Status |
63.2; 65.7; 64.8; 68.4; 71.9; 70.6 | — |
| SECONDARY Change From Baseline of Core Study CAIN457F2304 in JIA ACR Core Component - Physician Global Assessment of Disease Activity |
-40.0; -42.2; -41.4; -40.3; -41.1; -40.8 | — |
| SECONDARY Change From Baseline of Core Study CAIN457F2304 in JIA ACR Core Component - Parent's or Patients' Global Assessment of Overall Well-being |
-47.1; -38.6; -41.6; -45.4; -37.7; -40.5 | — |
| SECONDARY Change From Baseline of Core Study CAIN457F2304 in JIA ACR Core Component - Functional Ability (CHAQ) |
-0.599; -0.636; -0.623; -0.605; -0.617; -0.613 | — |
| SECONDARY Change From Baseline of Core Study CAIN457F2304 in JIA ACR Core Component - Number of Joints With Active Arthritis |
-8.4; -6.9; -7.4; -8.4; -6.6; -7.3 | — |
| SECONDARY Change From Baseline of Core Study CAIN457F2304 in JIA ACR Core Component - Number of Joints With Limited Range of Motion |
-5.5; -5.3; -5.4; -5.4; -5.7; -5.6 | — |
| SECONDARY Change From Baseline of Core Study CAIN457F2304 in JIA ACR Core Component - CRP Levels |
-15.238; -19.788; -18.187; -11.201; -21.795; -17.848 | — |
| SECONDARY Change From Baseline of Core Study CAIN457F2304 of 27-joint Juvenile Arthritis Disease Activity Score (JADAS-27) |
-14.436; -13.731; -13.979; -13.984; -13.632; -13.763 | — |
| SECONDARY Change From Baseline of Core Study CAIN457F2304 of 71-joint Juvenile Arthritis Disease Activity Score (JADAS-71) |
-17.962; -16.503; -17.016; -17.510; -16.226; -16.704 | — |
| SECONDARY Change From Baseline of Core Study CAIN457F2304 in Total Enthesitis Count |
-2.5; -2.3; -2.4; -2.4; -2.3; -2.4 | — |
| SECONDARY Change From Baseline of Core Study CAIN457F2304 in Total Dactylitis Count |
-1.3; -0.4; -0.7; -1.5; -0.5; -0.9 | — |
| SECONDARY Serum Concentrations of Secukinumab Over Time |
21.4; 26.4; 24.8; 20.8; 26.6; 24.3 | — |
| SECONDARY Number of Participants With Treatment-emergent Anti-Drug Antibodies (ADAs) of Secukinumab |
0; 6; 6 | — |
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).
Eligibility Criteria
Key Inclusion Criteria
- 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
- 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.
Data sourced from ClinicalTrials.gov (NCT03769168). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.