Condition or disease | Intervention/treatment | Phase |
---|---|---|
Sarcoidosis | Drug: Sarilumab 200 MG/1.14 ML Subcutaneous Solution [KEVZARA]_#1 Drug: Placebos | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 15 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Intervention Model Description: | All subjects will all receive sarilumab 200 mg subcutaneously every two weeks for the first 16 weeks of the study. At Week 16, those patients who were able to successfully taper off of prednisone will then be assigned randomly to receive either sarilumab 200 mg subcutaneously every two weeks (study drug) or placebo subcutaneously for an additional 12 weeks. |
Masking: | Triple (Participant, Care Provider, Investigator) |
Masking Description: | study doctor and personnel will not know whether you are assigned to the sarilumab group or the placebo group after Week 16. |
Primary Purpose: | Treatment |
Official Title: | A Phase II, Single-Site, Double-Blind, Placebo-Controlled Randomized Withdrawal Study Assessing the Efficacy and Safety of Sarilumab in Patients With Glucocorticoid-Dependent Sarcoidosis |
Actual Study Start Date : | September 3, 2019 |
Estimated Primary Completion Date : | July 2025 |
Estimated Study Completion Date : | July 2027 |
Arm | Intervention/treatment |
---|---|
Experimental: Study drug
sarilumab 200 mg subcutaneously every two weeks
|
Drug: Sarilumab 200 MG/1.14 ML Subcutaneous Solution [KEVZARA]_#1
Sarilumab vs Placebo
|
Placebo Comparator: placebo
placebo subcutaneously every two weeks
|
Drug: Placebos
Placebo
|
extrapulmonary physician organ severity tool (ePOST)
Score Description:
FACIT-F score
Scale:
0: Not at all
Joint evaluation
Score:
0: Absent
1: Present 9: Not applicable
Ages Eligible for Study: | 18 Years to 80 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Marty Covarrubias, BA | 650-723-7416 | mcovarru@stanford.edu | |
Contact: donna Adelman, MA | 650-724-3121 | donnaa@stanford.edu |
United States, California | |
Stanford University | Recruiting |
Palo Alto, California, United States, 94304 | |
Contact: Marty covarrubias, BA 650-723-7416 mcovarru@stanford.edu | |
Principal Investigator: Matthew Baker, MD |
Principal Investigator: | Mark Genovese, MD | Stanford University |
Tracking Information | |||||||||
---|---|---|---|---|---|---|---|---|---|
First Submitted Date ICMJE | June 25, 2019 | ||||||||
First Posted Date ICMJE | July 5, 2019 | ||||||||
Last Update Posted Date | October 22, 2020 | ||||||||
Actual Study Start Date ICMJE | September 3, 2019 | ||||||||
Estimated Primary Completion Date | July 2025 (Final data collection date for primary outcome measure) | ||||||||
Current Primary Outcome Measures ICMJE |
flare-free survival of sarilumab-treated patients compared to placebo-treated controls [ Time Frame: 2 weeks ] Patients will be considered to have flared if they receive rescue medication including increased glucocorticoids, or if they discontinue the study treatment in order to start a different therapy.
|
||||||||
Original Primary Outcome Measures ICMJE | Same as current | ||||||||
Change History | |||||||||
Current Secondary Outcome Measures ICMJE |
|
||||||||
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 | Sarilumab in Patients With Glucocorticoid-Dependent Sarcoidosis | ||||||||
Official Title ICMJE | A Phase II, Single-Site, Double-Blind, Placebo-Controlled Randomized Withdrawal Study Assessing the Efficacy and Safety of Sarilumab in Patients With Glucocorticoid-Dependent Sarcoidosis | ||||||||
Brief Summary | The purpose of this study is to compare the effectiveness and the safety of sarilumab in patients with glucocorticoid-dependent sarcoidosis. | ||||||||
Detailed Description | The purpose of this study is to compare the effectivness and the safety of sarilumab in patients with glucocorticoid-dependent sarcoidosis. To demonstrate that sarilumab treatment will be effective for inducing and maintaining glucocorticoid-free remission in male or female patients with biopsy proven active, glucocorticoid-dependent sarcoidosis affecting the lungs, lymph nodes, liver, kidneys, spleen, bone, soft tissues, skin, and/or eyes. | ||||||||
Study Type ICMJE | Interventional | ||||||||
Study Phase ICMJE | Phase 2 | ||||||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Intervention Model Description: All subjects will all receive sarilumab 200 mg subcutaneously every two weeks for the first 16 weeks of the study. At Week 16, those patients who were able to successfully taper off of prednisone will then be assigned randomly to receive either sarilumab 200 mg subcutaneously every two weeks (study drug) or placebo subcutaneously for an additional 12 weeks. Masking: Triple (Participant, Care Provider, Investigator)Masking Description: study doctor and personnel will not know whether you are assigned to the sarilumab group or the placebo group after Week 16. Primary Purpose: Treatment
|
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Condition ICMJE | Sarcoidosis | ||||||||
Intervention ICMJE |
|
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Study Arms ICMJE |
|
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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 |
15 | ||||||||
Original Estimated Enrollment ICMJE | Same as current | ||||||||
Estimated Study Completion Date ICMJE | July 2027 | ||||||||
Estimated Primary Completion Date | July 2025 (Final data collection date for primary outcome measure) | ||||||||
Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
|
||||||||
Sex/Gender ICMJE |
|
||||||||
Ages ICMJE | 18 Years to 80 Years (Adult, Older Adult) | ||||||||
Accepts Healthy Volunteers ICMJE | No | ||||||||
Contacts ICMJE |
|
||||||||
Listed Location Countries ICMJE | United States | ||||||||
Removed Location Countries | |||||||||
Administrative Information | |||||||||
NCT Number ICMJE | NCT04008069 | ||||||||
Other Study ID Numbers ICMJE | 48375 | ||||||||
Has Data Monitoring Committee | No | ||||||||
U.S. FDA-regulated Product |
|
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IPD Sharing Statement ICMJE | Not Provided | ||||||||
Responsible Party | Matthew C. Baker, Stanford University | ||||||||
Study Sponsor ICMJE | Stanford University | ||||||||
Collaborators ICMJE | Not Provided | ||||||||
Investigators ICMJE |
|
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PRS Account | Stanford University | ||||||||
Verification Date | October 2020 | ||||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |