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

Novartis

Status and phase: Completed; Phase 3

Conditions: Juvenile Psoriatic Arthritis; Enthesitis Related Arthritis

Treatments: Drug: Secukinumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT03769168

2018-002521-30 (EudraCT Number)

CAIN457F2304E1

Details and patient eligibility

About

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).

Full 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

Enrollment: 55 patients

Sex: All

Ages: 2 to 100 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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55 participants in 2 patient groups

Group 1- Secukinumab 75 mg

Experimental group

Description:

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.

Treatment:

Drug: Secukinumab

Group 2 - Secukinumab 150 mg

Experimental group

Description:

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.

Treatment:

Drug: Secukinumab