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Monoclonal Antibodies

Open-Label Sarilumab (pre-randomization) for Sarcoidosis

Phase 2
Waitlist Available
Led By Mark Genovese, MD
Research Sponsored by Stanford University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 16 to week 28
Awards & highlights

Study Summary

This trial will test if sarilumab is an effective and safe treatment for patients with sarcoidosis that is not responding to steroids.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 16 to week 28
This trial's timeline: 3 weeks for screening, Varies for treatment, and week 16 to week 28 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of Participants Without Sarcoidosis Flare (Flare-Free Survival)
Secondary outcome measures
Change From Baseline in Erythrocyte Sedimentation Rate (ESR)
Change From Baseline in Extrapulmonary Physician Organ Severity Tool (ePOST) Scale Score
Change From Baseline in FACIT-F Score (Fatigue Scale)
+15 more

Side effects data

From 2016 Phase 3 trial • 217 Patients • NCT02057250
13%
Upper respiratory tract infection
6%
Neutropenia
6%
Sinusitis
5%
Alanine aminotransferase increased
5%
Urinary tract infection
4%
Injection site erythema
4%
Accidental overdose
4%
Bronchitis
3%
Injection site pruritus
2%
Thrombocytopenia
2%
Nasopharyngitis
2%
Contusion
1%
Arthralgia
1%
Anaemia
1%
Lumbar spinal stenosis
1%
Leukopenia
1%
Coronary artery occlusion
1%
Wolff-Parkinson-White syndrome
1%
Transient ischaemic attack
1%
Vertebrobasilar insufficiency
1%
Chronic obstructive pulmonary disease
1%
Small intestinal obstruction
1%
Nephrolithiasis
1%
Cataract
1%
Thrombophlebitis superficial
1%
Vomiting
1%
Endometrial hyperplasia
1%
Traumatic arthritis
1%
Hypertension
1%
Pneumonia
1%
Pancreatic carcinoma metastatic
1%
Osteoarthritis
1%
Rheumatoid lung
1%
Pharyngitis
1%
Femoral neck fracture
100%
80%
60%
40%
20%
0%
Study treatment Arm
Sarilumab 150 mg by PFS (Extension Phase)
Sarilumab 150 mg by AID (AID Assessment Phase)
Sarilumab 150 mg by PFS (AID Assessment Phase)
Sarilumab 200 mg by PFS (AID Assessment Phase)
Sarilumab 200 mg by AID (AID Assessment Phase)

Trial Design

3Treatment groups
Experimental Treatment
Placebo Group
Group I: Open-Label Sarilumab (pre-randomization)Experimental Treatment1 Intervention
On entering the study, all participants receive open-label sarilumab every two weeks for 16 weeks.
Group II: Double-Blind Sarilumab (post-randomization)Experimental Treatment1 Intervention
After completing the open-label period, participants are randomized in blinded fashion to receive sarilumab every two weeks for 12 weeks.
Group III: Double-Blind Placebo (post-randomization)Placebo Group1 Intervention
After completing the open-label period, participants are randomized in blinded fashion to receive placebo every two weeks for 12 weeks.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Sarilumab
2020
Completed Phase 3
~5980

Find a Location

Who is running the clinical trial?

Stanford UniversityLead Sponsor
2,383 Previous Clinical Trials
17,333,874 Total Patients Enrolled
3 Trials studying Sarcoidosis
55 Patients Enrolled for Sarcoidosis
Mark Genovese, MDPrincipal InvestigatorStanford University
3 Previous Clinical Trials
47 Total Patients Enrolled
Matthew Baker, MDPrincipal InvestigatorStanford University

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are geriatric patients being accepted into this particular clinical trial?

"To be eligible for this study, potential participants must fall between the ages of 18-80. There are 37 other similar studies for patients outside of that age range."

Answered by AI

Are there other ongoing research projects that use Sarilumab 200 MG/1.14 ML Subcutaneous Solution [KEVZARA]_#1?

"As of now, there are 7 ongoing clinical trials for Sarilumab 200 MG/1.14 ML Subcutaneous Solution [KEVZARA]#1 . Out of these 7 studies, 2 are currently in Phase 3. It's worth mentioning that the majority of research sites for Sarilumab 200 MG/1.14 ML Subcutaneous Solution [KEVZARA]#1 are located in Omaha, Nebraska; though, there are a total of 465 research facilities running trials for this medication across the United States."

Answered by AI

Are participants being enrolled in this research project at present?

"No, this research is not looking for participants at the moment. The posting on clinicaltrials.gov dates back to September 3rd, 2019 and was edited as recently as January 12th, 2022. Even though this study isn't enrolling right now, there are 40 other active trials that patients can sign up for."

Answered by AI

How many participants will be included in this research project?

"This specific trial is no longer recruiting patients, however there are 33 other studies currently looking for participants that have sarcoidosis. Additionally, there is a study called Sarilumab 200 MG/1.14 ML Subcutaneous Solution [KEVZARA]_#1 that is actively recruiting patients."

Answered by AI

What are the short-term and long-term effects of Sarilumab on patients?

"This Sarilumab 200 MG/1.14 ML Subcutaneous Solution [KEVZARA]_#1 clinical trial is a Phase 2, meaning that while there is some evidence backing the safety of the medication, none supports its efficacy. We rated it a 2."

Answered by AI

Who meets the requirements to take part in this research?

"This study is looking for 15 patients that have been diagnosed with sarcoidosis and are between 18-80 years old. In addition to this age requirement, participants must also: Be currently taking a glucocorticoid medication like prednisone, have required this type of treatment for at least 28 days prior to the start of the study, and take the equivalent dose of prednisone daily for 14 days before baseline., Have involvement in any stage II or III pulmonary sarcoidosis, lymph node, liver, kidney, spleen, bone soft tissue,, skin or eye manifestations of the disease., Be currently taking a DMARD"

Answered by AI

Who else is applying?

What state do they live in?
Georgia
How old are they?
18 - 65
What site did they apply to?
Stanford University
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
Sarilumab in Patients With Glucocorticoid-Dependent Sarcoidosis
Matthew C. Baker 2019. "Sarilumab in Patients With Glucocorticoid-Dependent Sarcoidosis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04008069.
~3 spots leftby Apr 2025
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