Evaluation of Efficacy and Safety of Sarilumab in Patients With GCA
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ClinicalTrials.gov Identifier: NCT03600805 |
Recruitment Status :
Terminated
(Protracted recruitment timeline exacerbated by COVID-19 pandemic)
First Posted : July 26, 2018
Results First Posted : January 14, 2022
Last Update Posted : March 28, 2022
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Sponsor:
Sanofi
Collaborator:
Regeneron Pharmaceuticals
Information provided by (Responsible Party):
Sanofi
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Study Type | Interventional |
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Study Design | Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment |
Condition |
Giant Cell Arteritis |
Interventions |
Drug: Sarilumab SAR153191 Drug: Sarilumab matching placebo Drug: Prednisone Drug: Prednisone matching placebo |
Enrollment | 83 |
Participant Flow
Recruitment Details | Study was conducted at 48 active centers in 19 countries. A total of 125 participants were screened between 20 November 2018 and 19 March 2020, of whom 42 participants were screen failures. Screen failures were mainly due to not meeting inclusion criteria. A total of 83 participants were enrolled and randomized in the study. |
Pre-assignment Details | Participants were randomized to 4 treatments arms in 2:1:1:2 ratio by interactive response technology stratified by starting dose of prednisone at Baseline (less than [<] 30 milligrams per day (mg/day) or greater than or equal to [>=] 30 mg/day). |
Arm/Group Title | Placebo+52 Week Taper | Placebo+26 Week Taper | Sarilumab 150mg q2w+26 Week Taper | Sarilumab 200mg q2w+26 Week Taper |
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Participants received sarilumab-matching placebo as subcutaneous (SC) injection every 2 weeks (q2w) up to 52 weeks along with the combination of prednisone and/or prednisone-matching placebo according to the protocol-defined schedule. Participants received prednisone/prednisone-matching placebo tapering oral daily doses for 52 weeks. | Participants received sarilumab-matching placebo as SC injection q2w up to 52 weeks along with the combination of prednisone and/or prednisone-matching placebo according to the protocol-defined schedule. Participants received prednisone tapering oral daily doses during the first 26 weeks and prednisone-matching placebo from Week 26 up to Week 52. | Participants received sarilumab 150 mg as SC injection q2w up to 52 weeks along with the combination of prednisone and/or prednisone-matching placebo according to the protocol-defined schedule. Participants received prednisone tapering oral daily doses during the first 26 weeks and prednisone-matching placebo from Week 26 up to Week 52. | Participants received sarilumab 200 mg as SC injection q2w up to 52 weeks along with the combination of prednisone and/or prednisone-matching placebo according to the protocol-defined schedule. Participants received prednisone tapering oral daily doses during the first 26 weeks and prednisone-matching placebo from Week 26 up to Week 52. |
Period Title: Overall Study | ||||
Started | 28 | 14 | 14 | 27 |
Week 52 Analysis Set Population [1] | 10 | 6 | 7 | 13 |
Completed | 9 | 6 | 6 | 8 |
Not Completed | 19 | 8 | 8 | 19 |
Reason Not Completed | ||||
Adverse Event | 2 | 1 | 1 | 7 |
Lack of Efficacy | 2 | 1 | 0 | 0 |
Withdrawal by Subject | 1 | 0 | 0 | 1 |
Other unspecified | 14 | 6 | 7 | 11 |
[1]
Randomized participants who had opportunity to complete the 52-week treatment period (randomized prior to October 16th, 2019).
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Baseline Characteristics
Arm/Group Title | Placebo+52 Week Taper | Placebo+26 Week Taper | Sarilumab 150mg q2w+26 Week Taper | Sarilumab 200mg q2w+26 Week Taper | Total Title | |
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Participants received sarilumab-matching placebo as subcutaneous (SC) injection every 2 weeks (q2w) up to 52 weeks along with the combination of prednisone and/or prednisone-matching placebo according to the protocol-defined schedule. Participants received prednisone/prednisone-matching placebo tapering oral daily doses for 52 weeks. | Participants received sarilumab-matching placebo as SC injection q2w up to 52 weeks along with the combination of prednisone and/or prednisone-matching placebo according to the protocol-defined schedule. Participants received prednisone tapering oral daily doses during the first 26 weeks and prednisone-matching placebo from Week 26 up to Week 52. | Participants received sarilumab 150 mg as SC injection q2w up to 52 weeks along with the combination of prednisone and/or prednisone-matching placebo according to the protocol-defined schedule. Participants received prednisone tapering oral daily doses during the first 26 weeks and prednisone-matching placebo from Week 26 up to Week 52. | Participants received sarilumab 200 mg as SC injection q2w up to 52 weeks along with the combination of prednisone and/or prednisone-matching placebo according to the protocol-defined schedule. Participants received prednisone tapering oral daily doses during the first 26 weeks and prednisone-matching placebo from Week 26 up to Week 52. | [Not Specified] | |
Overall Number of Baseline Participants | 28 | 14 | 14 | 27 | 83 | |
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Analysis was performed on randomized population.
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Age, Continuous
Mean (Standard Deviation) Unit of measure: Years |
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Number Analyzed | 28 participants | 14 participants | 14 participants | 27 participants | 83 participants | |
71.4 (7.7) | 69.5 (5.4) | 67.1 (7.9) | 73.4 (8.6) | 71.0 (7.9) | ||
Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 28 participants | 14 participants | 14 participants | 27 participants | 83 participants | |
Female |
22 78.6%
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9 64.3%
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13 92.9%
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23 85.2%
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67 80.7%
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Male |
6 21.4%
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5 35.7%
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1 7.1%
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4 14.8%
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16 19.3%
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Race (NIH/OMB)
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 28 participants | 14 participants | 14 participants | 27 participants | 83 participants | |
American Indian or Alaska Native |
0 0.0%
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0 0.0%
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0 0.0%
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0 0.0%
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0 0.0%
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Asian |
0 0.0%
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0 0.0%
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0 0.0%
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0 0.0%
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0 0.0%
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Native Hawaiian or Other Pacific Islander |
0 0.0%
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0 0.0%
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0 0.0%
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0 0.0%
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0 0.0%
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Black or African American |
0 0.0%
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0 0.0%
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1 7.1%
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0 0.0%
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1 1.2%
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White |
23 82.1%
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13 92.9%
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11 78.6%
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25 92.6%
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72 86.7%
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More than one race |
0 0.0%
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0 0.0%
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0 0.0%
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0 0.0%
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0 0.0%
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Unknown or Not Reported |
5 17.9%
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1 7.1%
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2 14.3%
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2 7.4%
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10 12.0%
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Outcome Measures
Adverse Events
Limitations and Caveats
Study was prematurely discontinued due to protracted enrolment exacerbated by Covid-19 pandemic situation and not due to any safety issues from administration of sarilumab.
More Information
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts
the PI's rights to discuss or publish trial results after the trial is completed.
The Sponsor supports publication of clinical trial results but may request that investigators temporarily delay or alter publications in order to protect proprietary information. The Sponsor may also require that the results of multicenter studies be published only in their entirety and not as individual site data.
Results Point of Contact
Name/Title: | Trial Transparency Team |
Organization: | Sanofi aventis recherche & développement |
Phone: | 800-633-1610 ext 6# |
EMail: | Contact-US@sanofi.com |
Responsible Party: | Sanofi |
ClinicalTrials.gov Identifier: | NCT03600805 |
Other Study ID Numbers: |
EFC15068 2017-002988-18 ( EudraCT Number ) U1111-1200-2184 ( Other Identifier: UTN ) |
First Submitted: | July 17, 2018 |
First Posted: | July 26, 2018 |
Results First Submitted: | November 18, 2021 |
Results First Posted: | January 14, 2022 |
Last Update Posted: | March 28, 2022 |