Trial · NCT04008069
Sarilumab in Patients With Glucocorticoid-Dependent Sarcoidosis
NCT04008069, Phase 2, Completed, Stanford University; results first posted 2023-10-05
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Sarilumab in Patients With Glucocorticoid-Dependent Sarcoidosis. Trials, record NCT04008069. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04008069
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Sarilumab in Patients With Glucocorticoid-Dependent Sarcoidosis
- NCT number
- NCT04008069
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 16 participants, actual
- Lead sponsor
- Stanford University
- Conditions
- Sarcoidosis
- Interventions
- Sarilumab, Placebo
- First posted
- 2019-07-05
- Last updated
- 2023-10-05
- Results first posted
- 2023-10-05
Source ClinicalTrials.gov
Registered outcomes19
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants Without Sarcoidosis Flare (Flare-Free Survival) | Week 16 to Week 28 | The primary outcome was flare-free survival of sarilumab-treated patients compared to placebo-treated controls. 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. |
| Secondary | Change From Baseline in Forced Vital Capacity (FVC) Percent Predicted | Baseline and week 16 | FVC is a pulmonary function test, and is defined as the volume of air that can forcibly be blown out after taking a full breath. FVC% predicted is defined as FVC% of the patient divided by the average FVC% in the population for any person of similar age, sex and body composition. |
| Secondary | Change From Baseline in Hemoglobin-corrected Diffusing Capacity for Carbon Monoxide (DLCO) Percent Predicted | Baseline, and week 16 | DLCO is a pulmonary function test, and measures the partial pressure difference between inspired and expired carbon monoxide. DLCO% predicted is defined as DLCO% of the patient divided by the average DLCO% in the population for any person of similar age, sex and body composition. |
| Secondary | Change in Pulmonary Function (FEV1) Percent Predicted | Baseline and week 16 | FEV1 percent predicted is a normalized value of FEV1 calculated using the Knudson equation and based upon participant age, gender, and height. |
| Secondary | Change From Baseline in Extrapulmonary Physician Organ Severity Tool (ePOST) Scale Score | Baseline, week 16, and week 28 | Physician and patient assessments assessed using the extrapulmonary physician organ severity tool (ePOST). Score Description: 0: Not affected 1. Slight 2. Mild 3. Moderate 4. Moderate to severe 5. Severe 6. Very Severe 17 organ domains were rated and summed to create a total score (range 0-102, higher scores correspond with more severity). |
| Secondary | Change From Baseline in Physician Disease Activity Visual Analogue Scale (VAS) | Baseline, week 16, and week 28 | Physician rates patient's disease on a 100 mm VAS. Score range: 0 to 100, higher scores correspond to worse disease state. |
| Secondary | Change From Baseline in Patient Disease Activity Visual Analogue Scale (VAS) | Baseline, week 16, and week 28 | Patient rates their disease on a 100 mm VAS. Score range: 0 to 100, higher scores correspond to worse disease state. |
| Secondary | Change From Baseline in FACIT-F Score (Fatigue Scale) | Baseline, week 16, and week 28 | FACIT-F score Total score range: 0-52, lower scores correspond with more fatigue. |
| Secondary | Number of Tender and Swollen Joints Per 68/66 Joint Evaluation | Baseline, week 16, and week 28 | The 66/68 Joint Count evaluates 68 joints for tenderness and pain with movement and 66 joints for swelling (hip joints can be evaluated for tenderness only, not for swelling. Joint evaluation score: 0: Absent 1: Present 9: Not applicable |
| Secondary | Sarcoidosis Activity and Severity Index for Cutaneous Sarcoidosis | Baseline, week 16, and week 28 | Sarcoidosis Activity and Severity Index evaluates 7 parameters on a 0 to 4 scale, summed for an overall scale score of 0 to 28 (higher values indicate higher activity/severity). |
1 to 10 of 19Source ClinicalTrials.gov
See all 19 registered outcomesOutcomes19
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants Without Sarcoidosis Flare (Flare-Free Survival) | Week 16 to Week 28 | Assessed in participants in the randomized-withdrawal period | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Change From Baseline in Forced Vital Capacity (FVC) Percent Predicted | Baseline and week 16 | Participants with available data at each respective time point are included in the analysis | FVC % predicted | MEAN |
| SECONDARY | Change From Baseline in Hemoglobin-corrected Diffusing Capacity for Carbon Monoxide (DLCO) Percent Predicted | Baseline, and week 16 | Participants with available data at each respective time point are included in the analysis | DLCO % predicted | MEAN |
| SECONDARY | Change in Pulmonary Function (FEV1) Percent Predicted | Baseline and week 16 | Data were collected during the open-label portion of the study only | FEV1 % predicted | MEAN |
| SECONDARY | Change From Baseline in Extrapulmonary Physician Organ Severity Tool (ePOST) Scale Score | Baseline, week 16, and week 28 | Participants with available data at each respective time point are included in the analysis | score on a scale | MEAN |
| SECONDARY | Change From Baseline in Physician Disease Activity Visual Analogue Scale (VAS) | Baseline, week 16, and week 28 | Participants with available data at each respective time point are included in the analysis | units on a scale (mm) | MEAN |
| SECONDARY | Change From Baseline in Patient Disease Activity Visual Analogue Scale (VAS) | Baseline, week 16, and week 28 | Participants with available data at each respective time point are included in the analysis | units on a scale (mm) | MEAN |
| SECONDARY | Change From Baseline in FACIT-F Score (Fatigue Scale) | Baseline, week 16, and week 28 | Participants with available data at each respective time point are included in the analysis. | score on a scale | MEAN |
| SECONDARY | Number of Tender and Swollen Joints Per 68/66 Joint Evaluation | Baseline, week 16, and week 28 | Participants who presented with inflammatory arthritis and with available data at each respective time point are included in the analysis. | joints | NUMBER |
| SECONDARY | Sarcoidosis Activity and Severity Index for Cutaneous Sarcoidosis | Baseline, week 16, and week 28 | Participants who presented with cutaneous sarcoidosis and with available data at each respective time point. | score on a scale | MEAN |
1 to 10 of 19Source ClinicalTrials.gov
See all 19 outcomesResults by group131
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants Without Sarcoidosis Flare (Flare-Free Survival) | Double-Blind Sarilumab (Post-randomization) | 2 | Participants | ||
| Number of Participants Without Sarcoidosis Flare (Flare-Free Survival) | Double-Blind Placebo (Post-randomization) | 7 | Participants | ||
| Change From Baseline in Forced Vital Capacity (FVC) Percent Predicted | Open-Label Sarilumab (Pre-randomization) | Baseline | 92.1 | Standard Deviation 19.8 | FVC % predicted |
| Change From Baseline in Forced Vital Capacity (FVC) Percent Predicted | Double-Blind Sarilumab (Post-randomization) | Baseline | 113 | Standard Deviation 14.9 | FVC % predicted |
| Change From Baseline in Forced Vital Capacity (FVC) Percent Predicted | Double-Blind Placebo (Post-randomization) | Baseline | 95.9 | Standard Deviation 17.3 | FVC % predicted |
| Change From Baseline in Forced Vital Capacity (FVC) Percent Predicted | Open-Label Sarilumab (Pre-randomization) | Change at week 16 | -2.69 | Standard Deviation 4.89 | FVC % predicted |
| Change From Baseline in Forced Vital Capacity (FVC) Percent Predicted | Double-Blind Sarilumab (Post-randomization) | Change at week 16 | -11.0 | Standard Deviation NA | FVC % predicted |
| Change From Baseline in Forced Vital Capacity (FVC) Percent Predicted | Double-Blind Placebo (Post-randomization) | Change at week 16 | -1.38 | Standard Deviation 4.78 | FVC % predicted |
| Change From Baseline in Hemoglobin-corrected Diffusing Capacity for Carbon Monoxide (DLCO) Percent Predicted | Open-Label Sarilumab (Pre-randomization) | Baseline | 92.6 | Standard Deviation 21.4 | DLCO % predicted |
| Change From Baseline in Hemoglobin-corrected Diffusing Capacity for Carbon Monoxide (DLCO) Percent Predicted | Double-Blind Sarilumab (Post-randomization) | Baseline | 90 | Standard Deviation NA | DLCO % predicted |
1 to 10 of 131Source ClinicalTrials.gov
See all 131 results by groupParticipant flow24
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Open-Label Period | STARTED | Open-Label Sarilumab (Pre-randomization) | 15 | |
| Open-Label Period | STARTED | Double-Blind Sarilumab (Post-randomization) | 0 | |
| Open-Label Period | STARTED | Double-Blind Placebo (Post-randomization) | 0 | |
| Open-Label Period | Completed Treatment up to Week 16 | Open-Label Sarilumab (Pre-randomization) | 10 | |
| Open-Label Period | Completed Treatment up to Week 16 | Double-Blind Sarilumab (Post-randomization) | 0 | |
| Open-Label Period | Completed Treatment up to Week 16 | Double-Blind Placebo (Post-randomization) | 0 | |
| Open-Label Period | COMPLETED | Open-Label Sarilumab (Pre-randomization) | 10 | |
| Open-Label Period | COMPLETED | Double-Blind Sarilumab (Post-randomization) | 0 | |
| Open-Label Period | COMPLETED | Double-Blind Placebo (Post-randomization) | 0 | |
| Open-Label Period | NOT COMPLETED | Open-Label Sarilumab (Pre-randomization) | 5 |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 participant flowAdverse events63
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Transaminitis | Investigations | Open-Label Sarilumab (Pre-randomization) | 2 | 15 | |
| other | Transaminitis | Investigations | Double-Blind Sarilumab (Post-randomization) | 0 | 2 | |
| other | Transaminitis | Investigations | Double-Blind Placebo (Post-randomization) | 2 | 8 | |
| other | Neutropenia | Blood and lymphatic system disorders | Open-Label Sarilumab (Pre-randomization) | 1 | 15 | |
| other | Neutropenia | Blood and lymphatic system disorders | Double-Blind Sarilumab (Post-randomization) | 0 | 2 | |
| other | Neutropenia | Blood and lymphatic system disorders | Double-Blind Placebo (Post-randomization) | 0 | 8 | |
| other | Prolonged neutropenia | Blood and lymphatic system disorders | Open-Label Sarilumab (Pre-randomization) | 0 | 15 | |
| other | Prolonged neutropenia | Blood and lymphatic system disorders | Double-Blind Sarilumab (Post-randomization) | 1 | 2 | |
| other | Prolonged neutropenia | Blood and lymphatic system disorders | Double-Blind Placebo (Post-randomization) | 0 | 8 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Open-Label Sarilumab (Pre-randomization) | 1 | 15 |
1 to 10 of 63Source ClinicalTrials.gov
See all 63 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Open-Label Sarilumab (Pre-randomization) | 0 | 15 |
| Total, all-cause mortality | Double-Blind Sarilumab (Post-randomization) | 0 | 2 |
| Total, all-cause mortality | Double-Blind Placebo (Post-randomization) | 0 | 8 |
| Total, other adverse events | Open-Label Sarilumab (Pre-randomization) | 9 | 15 |
| Total, other adverse events | Double-Blind Sarilumab (Post-randomization) | 1 | 2 |
| Total, other adverse events | Double-Blind Placebo (Post-randomization) | 5 | 8 |
| Total, serious adverse events | Open-Label Sarilumab (Pre-randomization) | 1 | 15 |
| Total, serious adverse events | Double-Blind Sarilumab (Post-randomization) | 0 | 2 |
| Total, serious adverse events | Double-Blind Placebo (Post-randomization) | 0 | 8 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 37471590 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Double-Blind Sarilumab (Post-randomization) vs Double-Blind Placebo (Post-randomization): Number of Participants Without Sarcoidosis Flare (Flare-Free Survival) |
Source Trial comparisons
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT04008069
GET https://conductscience.org/api/trials/v1/NCT04008069/results?page=2