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Evaluation of Efficacy and Safety of Sarilumab in Patients With GCA

Terminated · Phase 3 · NCT03600805

Conditions: Giant Cell Arteritis

At a glance

Research payments reported, 2025
$7,455
U.S. investigators named
1
Sites paid
1
Planned or actual enrollment
83

About the trial

Sponsor
Sanofi (with Regeneron Pharmaceuticals)
Tested
Sarilumab SAR153191 (drug), Sarilumab matching placebo (drug), Prednisone (drug), Prednisone matching placebo (drug)
Dates
Started 2018-11-20; completion 2020-11-24
Results posted
Yes

Primary Objective: To evaluate the efficacy of sarilumab in participants with giant cell arteritis (GCA) as assessed by the proportion of participants 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 participants 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 participants with GCA. * …

From ClinicalTrials.gov, last updated 2022-03-28. Full record, eligibility and contacts (opens in a new tab)

Industry funding

Sanofi US Services Inc. reported $7,455 in research payments for this study in 2025 (1 payments).

Products named: Kevzara

Research payments usually go to hospitals, universities and research sites to run a study, not to the investigators personally. A payment is not evidence of wrongdoing.

U.S. investigators named on this study

Clinicians the company named as principal investigators in its Open Payments reports.

Sites paid to run it

  • New York University NYU Grossman School of Medicine An Administrative Unit of New York University $7,455

Sources: CMS Open Payments research payments (program year 2025) and ClinicalTrials.gov, U.S. National Library of Medicine.