Adults 18 to 75, any sex, with Primary Sjögren's Syndrome. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Change From Baseline in European League Against Rheumatism Sjogren's Syndrome Disease Activity Index (ESSDAI) Score at Day 99Primary· 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
Group
Value
95% CI
Placebo
-2.3
± 0.8
MEDI5872 210 mg
-3.8
± 0.9
Ratio to Baseline in Peripheral Blood Biomarkers at Day 99Secondary· 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.
Plasma Cell Levels
Group
Value
95% CI
Placebo
0.70
± 0.24
MEDI5872 210 mg
0.65
± 0.24
TFH Cells
Group
Value
95% CI
Placebo
0.94
± 0.27
MEDI5872 210 mg
0.62
± 0.27
Ratio to Baseline in Minor Salivary Gland Tissue Biomarkers at Day 99Secondary· 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.
Total Plasma Cells
Group
Value
95% CI
Placebo
1.32
± 0.13
MEDI5872 210 mg
1.15
± 0.11
CD4/ICOS TFH Cells
Group
Value
95% CI
Placebo
1.76
± 0.21
MEDI5872 210 mg
0.75
± 0.18
PD-1/ICOS TFH Cells
Group
Value
95% CI
Placebo
1.06
± 0.19
MEDI5872 210 mg
1.07
± 0.16
Ratio to Baseline in Focus Score at Day 99Secondary· 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.
Group
Value
95% CI
Placebo
0.79
± 0.53
MEDI5872 210 mg
0.96
± 0.50
Change From Baseline in European League Against Rheumatism Sjogren's Syndrome Patient Reported Index (ESSPRI) Score at Day 99Secondary· 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.
Group
Value
95% CI
Placebo
-1.0
± 0.5
MEDI5872 210 mg
-0.6
± 0.5
Percentage of ESSDAI Responders at Day 99Secondary· 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 multipli
ESSDAI [3]
Group
Value
95% CI
Placebo
18.8
MEDI5872 210 mg
43.8
ESSDAI [4]
Group
Value
95% CI
Placebo
18.8
MEDI5872 210 mg
43.8
Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs)Secondary· 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
Any TEAEs
Group
Value
95% CI
Placebo
14
Any MEDI5872 210 mg
29
Any TESAEs
Group
Value
95% CI
Placebo
0
Any MEDI5872 210 mg
1
Number of Participants With Adverse Events of Special Interest (AESIs)Secondary· 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.
Group
Value
95% CI
Placebo
1
Any MEDI5872 210 mg
6
Adverse events — posted to ClinicalTrials.gov
Time frame: 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 1 participant from 'Placebo' arm discontinued treatment before Day 99, didn't receive MEDI5872 dose and entered in safety follow-up period..
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Placebo
Serious: 0/16 (0%)
Deaths: 0/16
Any MEDI5872 210 mg
Serious: 1/31 (3%)
Deaths: 0/31
Serious adverse events (1 terms)
Reaction
System
Placebo
Any MEDI5872 210 mg
Small intestine polyp
Gastrointestinal disorders
—
—
Other adverse events (132 terms — click to expand)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by MedImmune LLC
Last refreshed: 19 March 2019
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02334306.