Juvenile Idiopathic ArthritisPhase 2SKYPSNCT02991469
A Repeated Dose-finding Study of Sarilumab in Children and Adolescents With Systemic Juvenile Idiopathic Arthritis (SKYPS)
A Phase 2 study testing Sarilumab SAR153191 (REGN88) in people with Juvenile Idiopathic Arthritis, run by Sanofi at 40 sites in 14 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 1 year to 17 years
- Conditions the study is for
- Juvenile Idiopathic Arthritis
- What is being tested?
- Sarilumab SAR153191 (REGN88)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- 40 sitesin 14 countries
- Study dates
- 9 Aug 2018to 17 Jan 2031
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
- If non-biologic DMARD taken, dose stable for less than 6 weeks prior to the baseline visit or at a dose exceeding the recommended dose as per local labeling.
- If oral glucocorticoid taken, dose exceeding equivalent prednisone dose 1 mg/kg/day (or 60 mg/day) within 3 days prior to baseline.
Show all 18Show fewer
- Use of parenteral or intra-articular glucocorticoid injection within 4 weeks prior to baseline.
- Prior treatment with anti-interleukin 6 (IL-6) or IL-6 receptor (IL-6R) antagonist therapies, including but not limited to tocilizumab or sarilumab.
- Treatment with any biologic treatment for sJIA within 5 half-lives prior to the first dose of sarilumab (the required off treatment periods and procedures may vary according to local requirements).
- Treatment with a Janus kinase inhibitor within 4 weeks prior to the first dose of sarilumab; and treatment with growth hormone within 4 weeks prior to the first dose of sarilumab (the required off treatment periods and procedures may vary according to local requirements).
- Treatment with any investigational biologic or non-biologic product within 8 weeks or 5 half-lives prior to baseline, whichever is longer.
- Exclusion criteria related to past or current infection other than tuberculosis.
- Any live, attenuated vaccine within 4 weeks prior to the baseline visit, such as varicella-zoster, oral polio, rubella vaccines. Killed or inactive vaccine may be permitted based on the Investigator's judgment.
- Exclusion related to history of a systemic hypersensitivity reaction to any biologic drug and known hypersensitivity to any constituent of the product.
- Laboratory abnormalities at the screening visit (identified by the central laboratory).
- Severe cardiac disease due to sJIA.
- Pregnant or breast-feeding female adolescent patients.
- The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Trial locations and contacts
40 sites in 14 countries. Contact the study team or a site near you to ask about taking part.
Trial Transparency email recommended (Toll free for US & Canada) contact
40 sites in 14 countries
Spain7 sites, 7 recruiting
- Recruiting
Investigational Site Number : 7240055
Barcelona, Catalunya [Cataluña], 08035
- Recruiting
Investigational Site Number : 7240056
Chamberí, Madrid, Comunidad de, 28010
- Recruiting
Investigational Site Number : 7240050
Esplugues de Llobregat, Barcelona [Barcelona], 08950
- Recruiting
Investigational Site Number : 7240058
Madrid, 28041
- Recruiting
Investigational Site Number : 7240054
Málaga, 29010
- Recruiting
Investigational Site Number : 7240057
Sabadell, 08208
- Recruiting
Investigational Site Number : 7240051
Valencia, 46026
Germany5 sites, 4 recruiting
- Recruiting
Investigational Site Number : 2760064
Berlin, 13125
- Recruiting
Investigational Site Number : 2760065
Berlin, 13353
- Recruiting
Investigational Site Number : 2760062
Hamburg, 22081
- Recruiting
Investigational Site Number : 2760060
Sankt Augustin, 53757
- Completed
Investigational Site Number : 2760063
Sendenhorst, 48324
Greece4 sites, 4 recruiting
- Recruiting
Investigational Site Number : 3000001
Athens, 115 27
- Recruiting
Investigational Site Number : 3000004
Athens, 115 27
- Recruiting
Investigational Site Number : 3000003
Athens, 124 62
- Recruiting
Investigational Site Number : 3000002
Thessaloniki, 546 42
Russia4 sites
- Completed
Investigational Site Number : 6430001
Moscow, 115522
- Completed
Investigational Site Number : 6430062
Moscow, 117997
- Completed
Investigational Site Number : 6430063
Moscow, 119991
- Completed
Investigational Site Number : 6430065
Ufa, 450083
France3 sites, 3 recruiting
- Recruiting
Investigational Site Number : 2500041
Bron, 69500
- Recruiting
Investigational Site Number : 2500042
Montpellier, 34295
- Recruiting
Investigational Site Number : 2500040
Paris, 75015
Italy3 sites, 3 recruiting
- Recruiting
Investigational Site Number : 3800051
Genoa, Genova, 16147
- Recruiting
Investigational Site Number : 3800054
Milan, Milano, 20122
- Recruiting
Investigational Site Number : 3800052
Rome, Roma, 00165
Portugal3 sites, 3 recruiting
- Recruiting
Investigational Site Number : 6200003
Lisbon, 1150-199
- Recruiting
Investigational Site Number : 6200005
Lisbon, 1500-650
- Recruiting
Investigational Site Number : 6200001
Lisbon, 1649-035
United Kingdom3 sites, 1 recruiting
- Recruiting
Investigational Site Number : 8260034
Leeds, LS1 3EX
- Completed
Investigational Site Number : 8260033
Liverpool, L12 2AP
- Completed
Investigational Site Number : 8260031
London, London, City of, WC1N 3JH
Argentina2 sites, 2 recruiting
- Recruiting
Investigational Site Number : 0320005
Buenos Aires, 1023
- Recruiting
Investigational Site Number : 0320004
San Miguel de Tucumán, Tucumán Province, T4000
Mexico2 sites, 2 recruiting
- Recruiting
Investigational Site Number : 4840004
Mérida, Yucatán, 97070
- Recruiting
Investigational Site Number : 4840001
Mexico City, 06700
Canada1 site, 1 recruiting
- Recruiting
Investigational Site Number : 1240110
Calgary, Alberta, T3B 6A9
Finland1 site, 1 recruiting
- Recruiting
Investigational Site Number : 2460040
Helsinki, 00029
Hungary1 site, 1 recruiting
- Recruiting
Investigational Site Number : 3480001
Budapest, 1085
Ireland1 site, 1 recruiting
- Recruiting
Investigational Site Number : 3720001
Crumlin, Dublin, D12 N512
About this study
Official title: An Open-label, Sequential, Ascending, Repeated Dose-finding Study of Sarilumab, Administered With Subcutaneous (SC) Injection, in Children and Adolescents, Aged 1 to 17 Years, With Systemic Juvenile Idiopathic Arthritis (sJIA), Followed by an Extension Phase
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.
Read the detailed description
The total study duration per patient will be 166 weeks that will consist of a 4- week screening, a 12-week core treatment phase, a 144-week extension phase, and a 6-week post-treatment follow-up.
- Conditions
- Juvenile Idiopathic Arthritis
- Being tested
- Sarilumab SAR153191 (REGN88)
- Medical subject headings
- Arthritis, Juvenile
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sarilumab SAR153191 (REGN88)Drug
Pharmaceutical form: Solution
Route of administration: Subcutaneous
| Study group | Role | What they receive |
|---|---|---|
| Sarilumab | Experimental | Participants will receive one of two ascending doses (or an additional intermediate dose based on available data) of sarilumab by subcutaneous (SC) injection based on body weight. All the participants will receive the selected dose once the selected dose is identified. Sarilumab will be given during 12-week core treatment phase followed by a 144- week extension treatment phase. Receives: Drug: Sarilumab SAR153191 (REGN88) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of PK parameter: maximum serum concentration observed (Cmax)
Measured: Up to Week 12
Assessment of PK parameter: Area under the serum concentration versus time curve calculated using the trapezoidal method during a dose interval (AUC0-t)
Measured: Up to Week 12
Assessment of PK parameter: Concentration observed before treatment administration during repeated dosing (Ctrough)
Measured: Up to Week 12
Secondary outcomes (11)
Number of patients with adverse events
Measured: Core treatment phase: Up to Week 12. Extension phase: Up to Week 162
Proportion of participants with local reactions after injection
Measured: Core treatment phase: Up to Week 12. Extension phase: Up to Week 156
Proportion of participants with Investigator Global Assessment (IGA) of disease activity below a defined value on 1-100 VAS scale
Measured: Core treatment phase: Up to Week 12. Extension phase: At weeks 24, 48, and every 24 weeks up to Week 156
Proportion of participants with Parent / patient Global Assessment (PGA) of well-being below a defined value on 1-100 VAS scale
Measured: Core treatment phase: Up to Week 12. Extension phase: At weeks 24, 48, and every 24 weeks up to Week 156
Proportion of participants with clinically inactive disease (CID)
Measured: Core treatment phase: Up to Week 12. Extension phase: At weeks 24, 48, and every 24 weeks up to Week 156
Changes in glucocorticoid use
Measured: Core treatment phase: Up to Week 12. Extension phase: At weeks 24, 48, and every 24 weeks up to Week 156
Juvenile Idiopathic Arthritis ACR30/50/70/90/100 (in the absence of fever) response rate
Population according to the 2001 ILAR classification
Measured: Core treatment phase: Up to Week 12. Extension phase: At weeks 24, 48, and every 24 weeks up to Week 156
Change from baseline in individual JIA ACR components
Population according to the 2001 ILAR classification
Measured: Core treatment phase: Up to Week 12. Extension phase: At weeks 24, 48, and every 24 weeks up to Week 156
Change from baseline in Systemic Juvenile Arthritis Disease Activity Score-10 (sJADAS-10)
Population according to the 2001 ILAR classification
Measured: Core treatment phase: Up to Week 12. Extension phase: At weeks 24, 48, and every 24 weeks up to Week 156
Assessment of participants with disease-related symptoms
Population according to the 2024 EULAR / PReS
Measured: At Week 4
Changes in IL-6 associated biomarkers
Population according to the 2001 ILAR classification and the 2024 EULAR / PReS
Measured: Up to Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2016 (estimated)
- Study start9 Aug 2018
- Primary completion1 Mar 2028 (estimated)
- Study completion17 Jan 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Juvenile Idiopathic ArthritisStudies of the same condition, open and under way.
- More trials run by SanofiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 51 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Regeneron Pharmaceuticals
- Responsible party
- Sponsor
- Investigators
- Clinical Sciences & Operations, Study director, Sanofi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02991469
- Sponsor's protocol ID
- DRI13926
- Other IDs
- U1111-1177-3584, 2024-512701-11
- Acronym
- SKYPS
- Status last verified
- Oct 2026
- First submitted
- 14 Oct 2016
- Last updated
- 19 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Sequential, Ascending, Repeated Dose-finding Study of Sarilumab, Administered With Subcutaneous (SC) Injection, in Children and Adolescents, Aged 1 to 17 Years, With Systemic Juvenile Idiopathic Arthritis (sJIA), Followed by an Extension Phase
- ClinicalTrials.gov ID
- NCT02991469
- Acronym / sponsor ID
- SKYPS / DRI13926
- Conditions
- Juvenile Idiopathic Arthritis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 51 participants (estimated)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Collaborators
- Regeneron Pharmaceuticals
- Study start
- 9 Aug 2018 (actual)
- Primary completion
- 1 Mar 2028 (estimated)
- Study completion
- 17 Jan 2031 (estimated)
- First posted
- 13 Dec 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The total study duration per patient will be 166 weeks that will consist of a 4- week screening, a 12-week core treatment phase, a 144-week extension phase, and a 6-week post-treatment follow-up.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Sarilumab | Experimental | Drug: Sarilumab SAR153191 (REGN88)Participants will receive one of two ascending doses (or an additional intermediate dose based on available data) of sarilumab by subcutaneous (SC) injection based on body weight. All the participants will receive the selected dose once the selected dose is identified. Sarilumab will be given during 12-week core treatment phase followed by a 144- week extension treatment phase. |
Who may qualify
- Ages
- 1 year to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (18 listed)
- 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.
- If non-biologic DMARD taken, dose stable for less than 6 weeks prior to the baseline visit or at a dose exceeding the recommended dose as per local labeling.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sarilumab SAR153191 (REGN88)Pharmaceutical form: Solution Route of administration: Subcutaneous | Drug | Sarilumab |
Primary outcome
Assessment of PK parameter: maximum serum concentration observed (Cmax)
Time frame: Up to Week 12
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
Assessment of PK parameter: Concentration observed before treatment administration during repeated dosing (Ctrough)
Time frame: Up to Week 12
11 secondary outcomes
Number of patients with adverse events
Time frame: Core treatment phase: Up to Week 12. Extension phase: Up to Week 162
Proportion of participants with local reactions after injection
Time frame: Core treatment phase: Up to Week 12. Extension phase: Up to Week 156
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
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
Proportion of participants with clinically inactive disease (CID)
Time frame: Core treatment phase: Up to Week 12. Extension phase: At weeks 24, 48, and every 24 weeks up to Week 156
Changes in glucocorticoid use
Time frame: Core treatment phase: Up to Week 12. Extension phase: At weeks 24, 48, and every 24 weeks up to Week 156
Juvenile Idiopathic Arthritis ACR30/50/70/90/100 (in the absence of fever) response rate
Time frame: Core treatment phase: Up to Week 12. Extension phase: At weeks 24, 48, and every 24 weeks up to Week 156
Change from baseline in individual JIA ACR components
Time frame: Core treatment phase: Up to Week 12. Extension phase: At weeks 24, 48, and every 24 weeks up to Week 156
Change from baseline in Systemic Juvenile Arthritis Disease Activity Score-10 (sJADAS-10)
Time frame: Core treatment phase: Up to Week 12. Extension phase: At weeks 24, 48, and every 24 weeks up to Week 156
Assessment of participants with disease-related symptoms
Time frame: At Week 4
Changes in IL-6 associated biomarkers
Time frame: Up to Week 12
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2026.
- DRI13926 Plain Language Results SummaryLink provided by the sponsor.
- For EU sites click here and navigate to 'Locations and contact points'Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Trial Transparency email recommended (Toll free for US & Canada) contact
Clinical Sciences & Operations study director
Sanofi
40 sites in 14 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Sarilumab SAR153191 (REGN88) in people with Juvenile Idiopathic Arthritis, run by Sanofi at 40 sites in 14 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 19 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 40 sites in Spain, Germany, Greece, Russia, France and 9 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Trial Transparency email recommended (Toll free for US & Canada) (800-633-1610 ext. option 6, Contact-Us@sanofi.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of PK parameter: maximum serum concentration observed (Cmax) (time frame: Up to Week 12). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2026.