Trial · NCT02334306
A Phase 2a, Randomized, Placebo Controlled, Study to Evaluate the Safety and Efficacy of AMG 557/MEDI5872 in Primary Sjögren's Syndrome
NCT02334306, Phase 2, Completed, MedImmune LLC; results first posted 2019-03-19
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Phase 2a, Randomized, Placebo Controlled, Study to Evaluate the Safety and Efficacy of AMG 557/MEDI5872 in Primary Sjögren's Syndrome. Trials, record NCT02334306. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02334306
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Phase 2a, Randomized, Placebo Controlled, Study to Evaluate the Safety and Efficacy of AMG 557/MEDI5872 in Primary Sjögren's Syndrome
- NCT number
- NCT02334306
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 32 participants, actual
- Lead sponsor
- MedImmune LLC
- Conditions
- Primary Sjögren's Syndrome
- Interventions
- AMG 557/MEDI5872, Placebo
- First posted
- 2015-01-08
- Last updated
- 2019-03-19
- Results first posted
- 2019-03-19
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline in European League Against Rheumatism Sjogren's Syndrome Disease Activity Index (ESSDAI) Score at Day 99 | Baseline (Day 1 predose) and Day 99 | The European League Against Rheumatism Sjogren's Syndrome Disease Activity Index (ESSDAI) is a clinical index that measures Sjogren's syndrome disease activity. A physician scores the disease activity level of 12 organ-specific domains (constitutional, lymphadenopathy, articular, muscular, cutaneous, glandular, pulmonary, renal, peripheral nervous system, central nervous system, hematological, and biological). Each domain is assessed for activity level in 3 or 4 levels (i.e., no, low, moderate, high) according to their severity (no disease activity equals to 0 and for high disease activity the domain score equals 3 or 4). Each domain is assigned a weight between 1 and 6, and the domain score is multiplied by the domain weight. Overall score is calculated as sum of all individual weighted domain scores (ranges from 0 (best) to 123 (worst activity). A higher score indicates worsening of the disease. Adjusted mean change and standard error are presented. |
| Secondary | Ratio to Baseline in Peripheral Blood Biomarkers at Day 99 | Baseline (Day 1 predose) and Day 99 | The peripheral blood biomarkers included total plasma cell levels (including plasma blast levels) and T follicular helper (TFH) cells. Adjusted geometric mean ratio to baseline and standard error (log) are presented. |
| Secondary | Ratio to Baseline in Minor Salivary Gland Tissue Biomarkers at Day 99 | Baseline (Day 1 predose) and Day 99 | The minor salivary gland biopsy biomarkers included total plasma cell levels, CD4/ inducible T-cell costimulator (ICOS) TFH cells, and PD-1/ICOS TFH cells. Adjusted geometric mean ratio to baseline and standard error (log) are presented. |
| Secondary | Ratio to Baseline in Focus Score at Day 99 | Baseline (Day 1 predose) and Day 99 | The focus score is a semi-quantitative assessment of focal lymphocytic sialoadenitis, which is defined as the presence of \>= 1 dense aggregate of 50 or more lymphocytes in a 4 mm2 area. Higher numbers are associated with more inflammation. |
| Secondary | Change From Baseline in European League Against Rheumatism Sjogren's Syndrome Patient Reported Index (ESSPRI) Score at Day 99 | Baseline (Day 1 predose) and Day 99 | The European League Against Rheumatism Sjogren's Syndrome Patient Reported Index (ESSPRI) is a patient-reported, subjective symptom index for primary Sjögren's syndrome. It consists of three questions covering the cardinal symptoms of Sjögren's syndrome: dryness, fatigue and pain (articular and/or muscular). Each domain scored on scale of 0-10 (0 =no symptom at all and 10 = worst symptom imaginable), and an overall score is calculated as the mean of the three individual domains where all domains carry the same weight. Adjusted mean change and standard error are presented. |
| Secondary | Percentage of ESSDAI Responders at Day 99 | Baseline (Day 1 predose) and Day 99 | The ESSDAI is a clinical index that measures Sjogren's syndrome disease activity. A physician scores the disease activity level of 12 organ-specific domains (constitutional, lymphadenopathy, articular, muscular, cutaneous, glandular, pulmonary, renal, peripheral nervous system, central nervous system, hematological, and biological). Each domain is assessed for activity level in 3 or 4 levels (no, low, moderate, high) according to their severity (0=no disease activity and ¾ = high disease activity of the domain). Each domain is assigned a weight between 1 and 6, and the domain score is multiplied by the domain weight. Overall score is calculated as sum of all individual weighted domain scores (ranges from 0 \[best\] to 123 \[worst activity\]). Participants are considered to be an ESSDAI\[x\] responder as they achieved a reduction of x points or more in ESSDAI score, did not prematurely discontinue the study drug, and did not receive prohibited concomitant medications. |
| Secondary | Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs) | Placebo arm: Day 1 (postdose) through Day 99 (predose); Any MEDI5872 210 mg arm: Day 1 (postdose) through Day 296 for MEDI5872 210 mg arm, and Day 99 (postdose) through Day 296 for participants who received placebo at double-blind period | An adverse event (AE) is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An serious adverse event (SAE) is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent AEs were collected from Day 1 (postdose) until Day 99 for 'Placebo' arm and Day 296 for 'Any MEDI5872 210 mg' arm that were absent before treatment or that worsened relative to pre-treatment state. |
| Secondary | Number of Participants With Adverse Events of Special Interest (AESIs) | Placebo arm: Day 1 (postdose) through Day 99 (predose); Any MEDI5872 210 mg arm: Day 1 (postdose) through Day 296 for MEDI5872 210 mg arm, and Day 99 (postdose) through Day 296 for participants who received placebo at double-blind period | An AESI (serious or non-serious) was one of scientific and medical interest specific to understanding of study drug and may have required close monitoring and rapid communication by investigator to the sponsor. The AESIs for this study were hepatic function abnormality meeting the definition of Hy's law, new or reactivated tuberculosis infection, malignancy, and hypersensitivity and anaphylactic reactions. Treatment-emergent AESIs were collected from Day 1 (postdose) until Day 99 for 'Placebo' arm and Day 296 for 'Any MEDI5872 210 mg' arm. |
Source ClinicalTrials.gov
Outcomes8
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Baseline in European League Against Rheumatism Sjogren's Syndrome Disease Activity Index (ESSDAI) Score at Day 99 | Baseline (Day 1 predose) and Day 99 | Intent-to-treat (ITT) population included all randomized and treated participants, grouped according to assigned treatment. The Overall Number of Participants Analyzed denotes the number of participants evaluated for this outcome measure. | Scores on a scale | MEAN |
| SECONDARY | Ratio to Baseline in Peripheral Blood Biomarkers at Day 99 | Baseline (Day 1 predose) and Day 99 | The ITT population included all randomized and treated participants, grouped according to assigned treatment. | Ratio | GEOMETRIC_MEAN |
| SECONDARY | Ratio to Baseline in Minor Salivary Gland Tissue Biomarkers at Day 99 | Baseline (Day 1 predose) and Day 99 | The ITT population included all randomized and treated participants, grouped according to assigned treatment. | Ratio | GEOMETRIC_MEAN |
| SECONDARY | Ratio to Baseline in Focus Score at Day 99 | Baseline (Day 1 predose) and Day 99 | The ITT population included all randomized and treated participants, grouped according to assigned treatment. The Overall Number of Participants Analyzed denotes the number of participants evaluated for this outcome measure. | Ratio | MEAN |
| SECONDARY | Change From Baseline in European League Against Rheumatism Sjogren's Syndrome Patient Reported Index (ESSPRI) Score at Day 99 | Baseline (Day 1 predose) and Day 99 | The ITT population included all randomized and treated participants, grouped according to assigned treatment. | Scores on a scale | MEAN |
| SECONDARY | Percentage of ESSDAI Responders at Day 99 | Baseline (Day 1 predose) and Day 99 | The ITT population included all randomized and treated participants, grouped according to assigned treatment. | Percentage of participants | NUMBER |
| SECONDARY | Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs) | Placebo arm: Day 1 (postdose) through Day 99 (predose); Any MEDI5872 210 mg arm: Day 1 (postdose) through Day 296 for MEDI5872 210 mg arm, and Day 99 (postdose) through Day 296 for participants who received placebo at double-blind period | Placebo: As-treated population (participants grouped per actual treatment received).~Any MEDI5872 210 mg: Any MEDI5872 population (participants received at least 1 dose of MEDI5872 either in double-blind and/or open-label). 1 participant from 'Placebo' discontinued treatment before Day 99 and didn't receive MEDI5872 dose in open-label period. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Adverse Events of Special Interest (AESIs) | Placebo arm: Day 1 (postdose) through Day 99 (predose); Any MEDI5872 210 mg arm: Day 1 (postdose) through Day 296 for MEDI5872 210 mg arm, and Day 99 (postdose) through Day 296 for participants who received placebo at double-blind period | Placebo: As-treated population (participants grouped per actual treatment received).~Any MEDI5872 210 mg: Any MEDI5872 population (participants received at least 1 dose of MEDI5872 either in double-blind and/or open-label). 1 participant from 'Placebo' discontinued treatment before Day 99 and didn't receive MEDI5872 dose in open-label period. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group26
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change From Baseline in European League Against Rheumatism Sjogren's Syndrome Disease Activity Index (ESSDAI) Score at Day 99 | Placebo | -2.3 | Standard Error 0.8 | Scores on a scale | |
| Change From Baseline in European League Against Rheumatism Sjogren's Syndrome Disease Activity Index (ESSDAI) Score at Day 99 | MEDI5872 210 mg | -3.8 | Standard Error 0.9 | Scores on a scale | |
| Ratio to Baseline in Peripheral Blood Biomarkers at Day 99 | Placebo | Plasma Cell Levels | 0.70 | Standard Error 0.24 | Ratio |
| Ratio to Baseline in Peripheral Blood Biomarkers at Day 99 | MEDI5872 210 mg | Plasma Cell Levels | 0.65 | Standard Error 0.24 | Ratio |
| Ratio to Baseline in Peripheral Blood Biomarkers at Day 99 | Placebo | TFH Cells | 0.94 | Standard Error 0.27 | Ratio |
| Ratio to Baseline in Peripheral Blood Biomarkers at Day 99 | MEDI5872 210 mg | TFH Cells | 0.62 | Standard Error 0.27 | Ratio |
| Ratio to Baseline in Minor Salivary Gland Tissue Biomarkers at Day 99 | Placebo | Total Plasma Cells | 1.32 | Standard Error 0.13 | Ratio |
| Ratio to Baseline in Minor Salivary Gland Tissue Biomarkers at Day 99 | MEDI5872 210 mg | Total Plasma Cells | 1.15 | Standard Error 0.11 | Ratio |
| Ratio to Baseline in Minor Salivary Gland Tissue Biomarkers at Day 99 | Placebo | CD4/ICOS TFH Cells | 1.76 | Standard Error 0.21 | Ratio |
| Ratio to Baseline in Minor Salivary Gland Tissue Biomarkers at Day 99 | MEDI5872 210 mg | CD4/ICOS TFH Cells | 0.75 | Standard Error 0.18 | Ratio |
1 to 10 of 26Source ClinicalTrials.gov
See all 26 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Double-blind Period | STARTED | Placebo/MEDI5872 210 mg | 16 | |
| Double-blind Period | STARTED | MEDI5872 210 mg/MEDI5872 210 mg | 16 | |
| Double-blind Period | COMPLETED | Placebo/MEDI5872 210 mg | 15 | |
| Double-blind Period | COMPLETED | MEDI5872 210 mg/MEDI5872 210 mg | 14 | |
| Double-blind Period | NOT COMPLETED | Placebo/MEDI5872 210 mg | 1 | |
| Double-blind Period | NOT COMPLETED | MEDI5872 210 mg/MEDI5872 210 mg | 2 | |
| Open-label Period | STARTED | Placebo/MEDI5872 210 mg | 15 | |
| Open-label Period | STARTED | MEDI5872 210 mg/MEDI5872 210 mg | 14 | |
| Open-label Period | COMPLETED | Placebo/MEDI5872 210 mg | 15 | |
| Open-label Period | COMPLETED | MEDI5872 210 mg/MEDI5872 210 mg | 14 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events266
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 | Anaemia | Blood and lymphatic system disorders | Placebo | 1 | 16 | 1 |
| other | Anaemia | Blood and lymphatic system disorders | Any MEDI5872 210 mg | 0 | 31 | 0 |
| other | Lymphopenia | Blood and lymphatic system disorders | Placebo | 0 | 16 | 0 |
| other | Lymphopenia | Blood and lymphatic system disorders | Any MEDI5872 210 mg | 1 | 31 | 1 |
| other | Palpitations | Cardiac disorders | Placebo | 0 | 16 | 0 |
| other | Palpitations | Cardiac disorders | Any MEDI5872 210 mg | 2 | 31 | 4 |
| other | Vertigo | Ear and labyrinth disorders | Placebo | 0 | 16 | 0 |
| other | Vertigo | Ear and labyrinth disorders | Any MEDI5872 210 mg | 1 | 31 | 1 |
| other | Vision blurred | Eye disorders | Placebo | 0 | 16 | 0 |
| other | Vision blurred | Eye disorders | Any MEDI5872 210 mg | 1 | 31 | 1 |
1 to 10 of 266Source ClinicalTrials.gov
See all 266 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo | 0 | 16 |
| Total, all-cause mortality | Any MEDI5872 210 mg | 0 | 31 |
| Total, other adverse events | Placebo | 14 | 16 |
| Total, other adverse events | Any MEDI5872 210 mg | 29 | 31 |
| Total, serious adverse events | Placebo | 0 | 16 |
| Total, serious adverse events | Any MEDI5872 210 mg | 1 | 31 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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 comparisons3
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Any MEDI5872 210 mg vs Placebo: Number of Participants With Adverse Events of Special Interest (AESIs) | Trial comparisons |
| Any MEDI5872 210 mg vs Placebo: deaths from any cause | Trial comparisons |
| Any MEDI5872 210 mg vs Placebo: serious adverse events | 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/NCT02334306
GET https://conductscience.org/api/trials/v1/NCT02334306/results?page=2