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Evaluation of Efficacy and Safety of Sarilumab in Patients With GCA

NCT03600805 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 83

Last updated 2022-03-28

Study results available
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Summary

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.
* To measure sarilumab serum concentrations in participants with GCA.
* To assess the effect of sarilumab on sparing glucocorticoid toxicity as measured by glucocorticoid toxicity index (GTI).

Conditions

  • Giant Cell Arteritis

Interventions

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

Sponsors & Collaborators

Principal Investigators

  • Clinical Sciences & Operations · Sanofi

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-11-20
Primary Completion
2020-11-24
Completion
2020-11-24
FDA Drug
Yes

Countries

  • United States
  • Argentina
  • Australia
  • Belgium
  • Canada
  • Croatia
  • Denmark
  • Estonia
  • France
  • Germany
  • Hungary
  • Israel
  • Italy
  • Netherlands
  • Portugal
  • Russia
  • Slovenia
  • Spain
  • Sweden
  • Switzerland
  • United Kingdom

Study Locations

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Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03600805 on ClinicalTrials.gov