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Completed PHASE2 INTERVENTIONAL NCT00570661

Open Label, Multicentre Trial to Assess Safety and Efficacy of ITF2357 in Active Systemic Juvenile Idiopathic Arthritis

View on ClinicalTrials.gov Updated Dec 15, 2025

Brief Summary

This study has the following objectives: Primary objective: \- To determine the safety and tolerability of oral ITF2357 in patients with active SOJIA with inadequate response or intolerance to standard therapy with oral steroids and methotrexate, with or without previously used biologic agents. Secondary objectives: * to evaluate the effect of ITF2357 on disease activity in patients with active SOJIA * to investigate the possibility of steroid dose tapering in patients with active SOJIA during ITF2357 treatment * to assess the effect of ITF2357 on levels of circulating cytokines * to assess the pharmacokinetic properties of ITF2357

Detailed Description

The present study has been designed in order to evaluate safety and tolerability of ITF2357 in patients with active SOJIA with inadequate response or intolerance to standard therapy with oral steroids and methotrexate, with or without previously used biologic agents, and to have a preliminary evaluation of efficacy of ITF2357 in the treatment of SOJIA. ITF2357 will be administered orally at the daily cumulative dose of 1.5 mg/kg: this dose in children/young adults is considered roughly equivalent to the dose of 1 mg/kg/day in adults, which so far has been proven to be free of any relevant safety concerns both in healthy volunteers and in patients.

Interventions

Name: ITF2357

Type: DRUG

Description: ITF2357 orally administered at the cumulative daily dose of 1.5 mg/kg, achieved by administration of different dose strengths identifiable by different colours.

Primary Outcomes

Measure: Number of Patients Completing Week 12 of Treatment

TimeFrame: At week 12

Description: The primary endpoint describes the number of patients who has completed week 12 of treatment with ITF2357, both in the Per protocol (PP) population and in the Intention to treat (ITT) population. ITF2357 hard gelatine capsules were administered orally, in fed conditions, at the cumulative daily dose of 1.5 mg/kg achieved by administration of 0.75 mg/kg at 12-hour interval for 4 weeks initially. The doses of 1.5 mg/kg/day were achieved by administration of an appropriate number of capsules of definite strength. Treatment was further prolonged up to 12 weeks in total if so suggested by the observed benefits and the lack of treatment-limiting toxicity.

Trial Information

NCT ID

NCT00570661

Status

Completed

Study Type

INTERVENTIONAL

Phases

PHASE2

Sponsor

Italfarmaco

Last Updated

December 15, 2025