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A Repeated Dose-finding Study of Sarilumab in Children and Adolescents With Systemic Juvenile Idiopathic Arthritis (SKYPS)

ConditionJuvenile Idiopathic Arthritis
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age1-17
SponsorSanofi

About this trial

Primary Objective:

To describe the pharmacokinetic (PK) profile of sarilumab in patients aged 1-17 years with Systemic Juvenile Idiopathic Arthritis (sJIA) in order to identify the dose and regimen for adequate treatment of this population.

Secondary Objective:

To describe the pharmacodynamics (PD) profile, the efficacy, and the long term safety of sarilumab in patients with sJIA.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Male and female patients aged ≥1 and ≤17 years (or country specified age requirement, ≥6 to ≤17 years for Russia) at the time of the screening visit.

Diagnosis of systemic JIA subtype according to the International Associations against Rheumatism (ILAR) 2001 Juvenile Idiopathic Arthritis (JIA) Classification Criteria OR According to 2024 EULAR/PReS recommendation at Screening.

Patient with an inadequate response to current treatment and considered as a candidate for a biologic disease modifying anti rheumatic drug (DMARD) as per investigator's judgment.

Disqualifiers

Body weight <10 kg or >60 kg for patients enrolled in the ascending dose cohorts, then body weight <10 kg for patients subsequently enrolled at the selected dose.

Uncontrolled severe systemic symptoms and/or Macrophage Activation Syndrome (MAS) within 6 months prior to screening.

History of or ongoing interstitial lung disease, pulmonary hypertension, pulmonary alveolar proteinosis.

If nonsteroidal anti-inflammatory drugs (NSAIDs) (including cyclo oxygenase-2 inhibitors [COX-2]) taken, dose stable for less than 2 weeks prior to the baseline visit and/or dosing prescribed outside of approved label.

Trial design

Design model

Single group

Treatments tested in this trial

  • Sarilumab SAR153191 (REGN88)

    Drug

    Pharmaceutical form: Solution Route of administration: Subcutaneous

Treatment groups

51 Participants
are divided into 1 treatment group
Group A: SarilumabExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Assessment of PK parameter: maximum serum concentration observed (Cmax)

Time frame
Up to Week 12
2

Assessment of PK parameter: Area under the serum concentration versus time curve calculated using the trapezoidal method during a dose interval (AUC0-t)

Time frame
Up to Week 12
3

Assessment of PK parameter: Concentration observed before treatment administration during repeated dosing (Ctrough)

Time frame
Up to Week 12

Secondary outcomes

1

Number of patients with adverse events

Time frame
Core treatment phase: Up to Week 12. Extension phase: Up to Week 162
2

Proportion of participants with local reactions after injection

Time frame
Core treatment phase: Up to Week 12. Extension phase: Up to Week 156
3

Proportion of participants with Investigator Global Assessment (IGA) of disease activity below a defined value on 1-100 VAS scale

Time frame
Core treatment phase: Up to Week 12. Extension phase: At weeks 24, 48, and every 24 weeks up to Week 156
4

Proportion of participants with Parent / patient Global Assessment (PGA) of well-being below a defined value on 1-100 VAS scale

Time frame
Core treatment phase: Up to Week 12. Extension phase: At weeks 24, 48, and every 24 weeks up to Week 156

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Sanofi

Lead sponsor

Regeneron Pharmaceuticals

Collaborator

Source ClinicalTrials.gov
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