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Monoclonal Antibodies

Sarilumab for Juvenile Arthritis (SKYPP Trial)

Phase 2
Waitlist Available
Research Sponsored by Sanofi
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up core treatment phase: up to week(w) 12. extension phase: up to end of study (w162 for dose-finding and second portions or w102 for third portion)
Awards & highlights

SKYPP Trial Summary

This trial is testing a new drug, sarilumab, for treating juvenile arthritis. The goal is to find a dose and treatment plan that is safe and effective for this population. Secondary objectives include describing how the drug works in the body and how well it works to treat the arthritis.

Who is the study for?
This trial is for children and teens aged 2-17 with polyarticular Juvenile Idiopathic Arthritis (pcJIA) who haven't responded well to current treatments. They must have at least 5 active joints and not exceed certain medication doses or have used specific drugs recently, including other biologics or IL-6 inhibitors.Check my eligibility
What is being tested?
The study tests Sarilumab's effects, dosage, and safety in young patients with pcJIA. It aims to understand how the drug behaves in the body (pharmacokinetics), its impact on the disease process (pharmacodynamics), effectiveness, and long-term safety.See study design
What are the potential side effects?
While side effects are not detailed here, similar medications can cause immune system changes leading to increased infection risk, reactions at injection sites, abnormal liver tests, low blood cell counts, and potential allergic reactions.

SKYPP Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~core treatment phase: up to week(w) 12. extension phase: up to end of study (w162 for dose-finding and second portions or w102 for third portion)
This trial's timeline: 3 weeks for screening, Varies for treatment, and core treatment phase: up to week(w) 12. extension phase: up to end of study (w162 for dose-finding and second portions or w102 for third portion) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Assessment of PK parameter: Area under the serum concentration versus time curve calculated using the trapezoidal method during a dose interval (AUC0-t)
Assessment of PK parameter: Concentration observed before treatment administration during repeated dosing (Ctrough)
Assessment of PK parameter: maximum serum concentration observed (Cmax)
Secondary outcome measures
Change from baseline in JIA ACR Component: Childhood Health Assessment Questionnaire (CHAQ) - Disability Index
Change from baseline in JIA ACR Component: High sensitivity C-reactive protein (hs-CRP)
Change from baseline in JIA ACR Component: Number of joints with active arthritis
+9 more

Side effects data

From 2016 Phase 3 trial • 217 Patients • NCT02057250
13%
Upper respiratory tract infection
6%
Neutropenia
6%
Sinusitis
5%
Alanine aminotransferase increased
5%
Urinary tract infection
4%
Injection site erythema
4%
Accidental overdose
4%
Bronchitis
3%
Injection site pruritus
2%
Thrombocytopenia
2%
Nasopharyngitis
2%
Contusion
1%
Arthralgia
1%
Anaemia
1%
Lumbar spinal stenosis
1%
Leukopenia
1%
Coronary artery occlusion
1%
Wolff-Parkinson-White syndrome
1%
Transient ischaemic attack
1%
Vertebrobasilar insufficiency
1%
Chronic obstructive pulmonary disease
1%
Small intestinal obstruction
1%
Nephrolithiasis
1%
Cataract
1%
Thrombophlebitis superficial
1%
Vomiting
1%
Endometrial hyperplasia
1%
Traumatic arthritis
1%
Hypertension
1%
Pneumonia
1%
Pancreatic carcinoma metastatic
1%
Osteoarthritis
1%
Rheumatoid lung
1%
Pharyngitis
1%
Femoral neck fracture
100%
80%
60%
40%
20%
0%
Study treatment Arm
Sarilumab 150 mg by PFS (Extension Phase)
Sarilumab 150 mg by AID (AID Assessment Phase)
Sarilumab 150 mg by PFS (AID Assessment Phase)
Sarilumab 200 mg by PFS (AID Assessment Phase)
Sarilumab 200 mg by AID (AID Assessment Phase)

SKYPP Trial Design

1Treatment groups
Experimental Treatment
Group I: SarilumabExperimental Treatment1 Intervention
Participants will receive one of three ascending dose regimens of sarilumab by subcutaneous (SC) injection based on body weight. All the participants will receive the selected dose regimen once this is identified. Sarilumab will be given during 12-week core treatment phase followed by an extension treatment phase (144 weeks for approximately 72 patients enrolled in dose-finding and second portions and 84 weeks for approximately 28 patients enrolled in third portion)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Sarilumab
2020
Completed Phase 3
~5980

Find a Location

Who is running the clinical trial?

SanofiLead Sponsor
2,164 Previous Clinical Trials
3,514,878 Total Patients Enrolled
Regeneron PharmaceuticalsIndustry Sponsor
620 Previous Clinical Trials
380,283 Total Patients Enrolled
Clinical Sciences & OperationsStudy DirectorSanofi
862 Previous Clinical Trials
2,019,736 Total Patients Enrolled

Media Library

Sarilumab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT02776735 — Phase 2
Juvenile Idiopathic Arthritis Research Study Groups: Sarilumab
Juvenile Idiopathic Arthritis Clinical Trial 2023: Sarilumab Highlights & Side Effects. Trial Name: NCT02776735 — Phase 2
Sarilumab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02776735 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there numerous health centers conducting this clinical investigation in the urban area?

"Currently, there are 10 trial centres conducting this study. These include the Investigational Site Number 8400418 in Cincinnati, Investiagtional Site Number 1240110 in Calgary and Investigational Site Number 1240112 in Los Angeles, along with 7 other sites distributed throughout various cities."

Answered by AI

Are there any criteria I must meet to be eligible for this research venture?

"This juvenile arthritis study is seeking approximately 100 participants between the ages of 2 and 17."

Answered by AI

Is Sarilumab an effective and safe option for patients?

"Clinical data has yet to definitively prove the efficacy of Sarilumab, meaning it received a safety score of 2."

Answered by AI

What is the total capacity of participants for this experiment?

"At this time, patient recruitment for the clinical trial has ceased. Initially posted on September 6th 2016 and last updated May 10th 2022, there are presently 368 studies in search of juvenile arthritis patients and 7 actively recruiting individuals to test sarilumab."

Answered by AI

Could you provide a summary of other research efforts involving Sarilumab?

"Initially researched at the University of Nebraska Medical Center in 2007, sarilumab has been part of 26 finished trials. Currently, 7 active clinical experiments are underway with numerous studies being conducted out of Cincinnati and Alberta."

Answered by AI

Is this experiment in progress, and are there openings for participants?

"This experiment is no longer participating in patient recruitment. Having been initially published on September 6th, 2016 and last updated on May 10th 2022, the trial has since closed its doors for new patients. However, there are 368 trials recruiting participants with juvenile arthritis and 7 studies looking for people to take part of Sarilumab's clinical research."

Answered by AI

Is there an age restriction for the recruitment process of this study?

"This medical trial is open to patients between the ages of 2 and 17, with 57 trials for minors and 319 specifically targeting elderly people."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
An Open-label, Ascending, Repeated Dose-finding Study of Sarilumab in Children and Adolescents With Polyarticular-course Juvenile Idiopathic Arthritis (pcJIA)
2016. "An Open-label, Ascending, Repeated Dose-finding Study of Sarilumab in Children and Adolescents With Polyarticular-course Juvenile Idiopathic Arthritis (pcJIA)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02776735.
~12 spots leftby Apr 2025
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