An Extension Study of Subcutaneous Secukinumab in Patients With Juvenile Psoriatic Arthritis (JPsA) and Enthesitis Related Arthritis (ERA)

NCT03769168 | Completed Phase 3 Results FDA Drug

• 2 other identifiers: CAIN457F2304E12018-002521-30
• Study Type: interventional
• Target: 55
• Locations: 9 countries
• Sites: 23

Brief 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).

Conditions

Juvenile Psoriatic Arthritis; Enthesitis Related Arthritis

Keywords

JIA; JPsA; ERA; Secukinumab; ILAR; Juvenile Psoriatic Arthritis; Enthesitis Related Arthritis

Outcome Measures

Primary Outcomes (1)

• 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%

  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

  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

  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

  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

  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

  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.

Study Arms (2)

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.

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.

Drug: Secukinumab

Interventions

Secukinumab DRUG

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.

Also known as: AIN457

Group 1- Secukinumab 75 mg; Group 2 - Secukinumab 150 mg

Eligibility Criteria

• Age: 2 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (23)

St Lukes Intermountain Research Center

Boise, Idaho, 83702, United States

Location

Cincinnati Childrens Hospital

Cincinnati, Ohio, 45229, United States

Location

Legacy Emanuel Research Hospital Portland

Portland, Oregon, 97232, United States

Location

Novartis Investigative Site

Brussels, 1200, Belgium

Location

Novartis Investigative Site

Ghent, 9000, Belgium

Location

Novartis Investigative Site

Freiburg im Breisgau, 79106, Germany

Location

Novartis Investigative Site

Hamburg, 22081, Germany

Location

Novartis Investigative Site

Saint Augustin, 53757, Germany

Location

Novartis Investigative Site

Genova, GE, 16147, Italy

Location

Novartis Investigative Site

Napoli, 80131, Italy

Location

Novartis Investigative Site

Krakow, 31503, Poland

Location

Novartis Investigative Site

Moscow, 119991, Russia

Location

Novartis Investigative Site

Saint Petersburg, 194100, Russia

Location

Novartis Investigative Site

Voronezh, 394036, Russia

Location

Novartis Investigative Site

Yekaterinburg, 620149, Russia

Location

Novartis Investigative Site

Panorama, Western Cape, 7500, South Africa

Location

Novartis Investigative Site

Cape Town, 7925, South Africa

Location

Novartis Investigative Site

Santiago de Compostela, Galicia, 15706, Spain

Location

Novartis Investigative Site

Valencia, 46026, Spain

Location

Novartis Investigative Site

Istanbul, Halkali, 34303, Turkey (Türkiye)

Location

Novartis Investigative Site

Istanbul, TUR, 34098, Turkey (Türkiye)

Location

Novartis Investigative Site

Ankara, 06230, Turkey (Türkiye)

Location

Novartis Investigative Site

Istanbul, 34093, Turkey (Türkiye)

Location

Related Links

• A Plain Language Trial Summary is available on www.novctrd.com

MeSH Terms

Conditions

Arthritis, Juvenile

Interventions

secukinumab

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Results Point of Contact

• Title: Study Director
• Organization: Novartis Pharmaceuticals

novartis.email@novartis.com

862-778-8300

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Masking Details: Open-label
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 21, 2018
• First Posted: December 7, 2018
• Study Start: June 7, 2019
• Primary Completion: November 7, 2024
• Study Completion: November 7, 2024
• Last Updated: October 16, 2025
• Results First Posted: May 23, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will share

Locations

TU (4); US (3); IT (2); PL (1); RU (4); DE (3); ES (2); ZA (2); BE (2)