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Evaluation of Efficacy and Safety of Sarilumab in Patients With GCA

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ClinicalTrials.gov Identifier: NCT03600805
Recruitment Status : Recruiting
First Posted : July 26, 2018
Last Update Posted : November 19, 2019
Sponsor:
Collaborator:
Regeneron Pharmaceuticals
Information provided by (Responsible Party):
Sanofi

Tracking Information
First Submitted Date  ICMJE July 17, 2018
First Posted Date  ICMJE July 26, 2018
Last Update Posted Date November 19, 2019
Actual Study Start Date  ICMJE November 20, 2018
Estimated Primary Completion Date May 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 17, 2018)
Proportion of patients with sustained remission [ Time Frame: At Week 52 ]
Proportion of patients achieving sustained remission at Week 52.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03600805 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: July 17, 2018)
  • Components of sustained remission (composite measure) [ Time Frame: At Week 52 ]
    Summary of the components of the sustained remission composite measure at Week 52
  • Cumulative corticosteroid dose [ Time Frame: Up to Week 52 ]
    Total cumulative corticosteroid (including prednisone) dose over 52 weeks
  • Time to first GCA flare [ Time Frame: Up to Week 52 ]
    Duration of first GCA flare from clinical remission up to Week 52
  • Change in glucocorticoid toxicity index [ Time Frame: Up to Week 52 ]
    Changes from baseline in the glucocorticoid toxicity index and its components up to Week 52
  • Adverse events [ Time Frame: Up to Week 76 ]
    Number of adverse events
  • Pharmacokinetic [ Time Frame: Up to Week 58 ]
    Serum concentrations of sarilumab
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Evaluation of Efficacy and Safety of Sarilumab in Patients With GCA
Official Title  ICMJE A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Sarilumab in Patients With Giant Cell Arteritis
Brief Summary

Primary Objective:

To evaluate the efficacy of sarilumab in patients with giant cell arteritis (GCA) as assessed by the proportion of patients with sustained remission for sarilumab compared to placebo, in combination with a corticosteroid (CS) tapering course.

Secondary Objective:

  • To demonstrate the efficacy of sarilumab in patients with GCA compared to placebo, in combination with CS taper with regards to:
  • Clinical responses (such as responses based on disease remission rates, time to first disease flare) over time.
  • Cumulative CS (including prednisone) exposure.
  • To assess the safety (including immunogenicity) and tolerability of sarilumab in patients with GCA.
  • To measure sarilumab serum concentrations in patients with GCA.
  • To assess the effect of sarilumab on sparing glucocorticoid toxicity as measured by glucocorticoid toxicity index (GTI).
Detailed Description Study duration per participant is approximately 82 weeks, including an up to 6-week screening period, 52-week treatment period, and 24-week follow-up period.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Giant Cell Arteritis
Intervention  ICMJE
  • Drug: Sarilumab SAR153191
    Pharmaceutical form:solution for injection Route of administration: subcutaneous
  • Drug: Sarilumab matching placebo
    Pharmaceutical form:solution for injection Route of administration: subcutaneous
  • Drug: Prednisone
    Pharmaceutical form:tablets or capsules Route of administration: oral administration
  • Drug: Prednisone matching placebo
    Pharmaceutical form:capsules Route of administration: oral administration
Study Arms  ICMJE
  • Experimental: Group A
    Sarilumab dose 1, once every 2 weeks plus 26-week prednisone taper regimen
    Interventions:
    • Drug: Sarilumab SAR153191
    • Drug: Prednisone
    • Drug: Prednisone matching placebo
  • Experimental: Group B
    Sarilumab dose 2, once every 2 weeks plus 26-week prednisone taper regimen
    Interventions:
    • Drug: Sarilumab SAR153191
    • Drug: Prednisone
    • Drug: Prednisone matching placebo
  • Placebo Comparator: Group C
    Sarilumab matching placebo once every 2 weeks plus prednisone regimen 26 weeks
    Interventions:
    • Drug: Sarilumab matching placebo
    • Drug: Prednisone
    • Drug: Prednisone matching placebo
  • Placebo Comparator: Group D
    Sarilumab matching placebo once every 2 weeks plus prednisone regimen 52 weeks
    Interventions:
    • Drug: Sarilumab matching placebo
    • Drug: Prednisone
    • Drug: Prednisone matching placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: July 17, 2018)
360
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE November 2023
Estimated Primary Completion Date May 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion criteria :

  • Diagnosis of giant cell arteritis (GCA) according to European League Against Rheumatism/American College of Rheumatology classification criteria.
  • New onset active disease or refractory active disease.
  • At least one of the symptoms of GCA within 6 weeks of baseline.
  • Either erythrocyte sedimentation rate ≥30 mm/hour or C-reactive protein ≥10 mg/L within 6 weeks of baseline.
  • Receiving or able to receive prednisone 20-60 mg/day for the treatment of active GCA.

Exclusion criteria:

  • Organ transplantation recipient (except corneas, unless it is within 3 months prior to baseline visit).
  • Major ischemic event, unrelated to GCA, within 12 weeks of screening.
  • Any prior use of the following therapies, for the treatment of GCA:
  • Janus kinase inhibitor (e.g., tofacitinib) within 4 weeks of baseline.
  • Cell-depletion agents (e.g., anti CD20) without evidence of recovery of B cells to baseline level.
  • Abatacept within 8 weeks of baseline.
  • Anakinra within 1 week of baseline.
  • Tumor necrosis factor inhibitors within 2-8 weeks (etanercept within 2 weeks; infliximab, certolizumab, golimumab, or adalimumab within 8 weeks), or less than at least 5 half-lives have elapsed prior to baseline, whichever is longer.
  • Therapeutic failure, including inadequate response or intolerance, or contraindication, to biological IL-6/(R) antagonist (prior experience with IL-6/(R) antagonist that was terminated for reasons unrelated to therapeutic failure at least 3 months before baseline is not exclusionary).
  • Use of any alkylating agents including cyclophosphamide within 6 months of baseline.
  • Use of immunosuppressant, such as hydroxychloroquine, cyclosporine, azathioprine, mycophenolate mofetil or leflunomide within 4 weeks of baseline. (Use of methotrexate (MTX) not exceeding 25 mg per week and have been stable for at least 3 months prior to baseline is not exclusionary).
  • Concurrent use of systemic corticosteroids (CS) for conditions other than GCA.
  • Use of IV CS at a dose equivalent to 100 mg of methylprednisolone or higher within 8 weeks of baseline for GCA therapy.
  • Pregnant or breastfeeding woman.
  • Patients with active or untreated latent tuberculosis.
  • Patients with history of invasive opportunistic infections.
  • Patients with fever associated with infection or chronic, persistent or recurring infections requiring active treatment.
  • Patients with uncontrolled diabetes mellitus.
  • Patients with non-healed or healing skin ulcers.
  • Patients who received any live, attenuated vaccine within 3 months of baseline.
  • Patients who are positive for hepatitis B, hepatitis C and/or HIV.
  • Patients with a history of active or recurrent herpes zoster.
  • Patients with a history of or prior articular or prosthetic joint infection.
  • Prior or current history of malignancy.
  • Patients who have had surgery within 4 weeks of screening or planned surgery during study.
  • Patients with a history of inflammatory bowel disease or severe diverticulitis or previous gastrointestinal perforation..

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 50 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Trial Transparency email recommended (Toll free number for US & Canada) 800-633-1610 ext 1 then # Contact-US@sanofi.com
Listed Location Countries  ICMJE Argentina,   Australia,   Austria,   Belgium,   Canada,   Croatia,   Denmark,   Estonia,   France,   Germany,   Hungary,   Israel,   Italy,   Netherlands,   Portugal,   Russian Federation,   Slovenia,   Spain,   Sweden,   Switzerland,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03600805
Other Study ID Numbers  ICMJE EFC15068
2017-002988-18 ( EudraCT Number )
U1111-1200-2184 ( Other Identifier: UTN )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Sanofi
Study Sponsor  ICMJE Sanofi
Collaborators  ICMJE Regeneron Pharmaceuticals
Investigators  ICMJE
Study Director: Clinical Sciences & Operations Sanofi
PRS Account Sanofi
Verification Date November 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP