Phase 2
N=32
A Phase 2a, Randomized, Placebo Controlled, Study to Evaluate the Safety and Efficacy of AMG 557/MEDI5872 in Primary Sjögren's Syndrome
Primary Sjögren's Syndrome
Bottom Line
View on ClinicalTrials.gov: NCT02334306 ↗Enrolled (actual)
32
Serious AEs
2.1%
Results posted
Mar 2019
Primary outcome: Primary: Change From Baseline in European League Against Rheumatism Sjogren's Syndrome Disease Activity Index (ESSDAI) Score at Day 99 — -2.3; -3.8 Scores on a scale — p=0.262
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- AMG 557/MEDI5872 (Biological); Placebo (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- MedImmune LLC
- Primary completion
- Jan 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in European League Against Rheumatism Sjogren's Syndrome Disease Activity Index (ESSDAI) Score at Day 99 |
-2.3; -3.8 | 0.262 |
| SECONDARY Ratio to Baseline in Peripheral Blood Biomarkers at Day 99 |
0.70; 0.65; 0.94; 0.62 | 0.820 |
| SECONDARY Ratio to Baseline in Minor Salivary Gland Tissue Biomarkers at Day 99 |
1.32; 1.15; 1.76; 0.75; 1.06; 1.07 | 0.440 |
| SECONDARY Ratio to Baseline in Focus Score at Day 99 |
0.79; 0.96 | — |
| SECONDARY Change From Baseline in European League Against Rheumatism Sjogren's Syndrome Patient Reported Index (ESSPRI) Score at Day 99 |
-1.0; -0.6 | 0.574 |
| SECONDARY Percentage of ESSDAI Responders at Day 99 |
18.8; 43.8; 18.8; 43.8 | 0.252 |
| SECONDARY Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs) |
14; 29; 0; 1 | — |
| SECONDARY Number of Participants With Adverse Events of Special Interest (AESIs) |
1; 6 | — |
Summary
A Phase 2a study to evaluate the efficacy and safety of AMG 557/MEDI5872 in Primary Sjögren's Syndrome
Eligibility Criteria
Inclusion Criteria
- Age 18 through 75 years at the time of signing the ICF.
- Fulfill American-European Consensus Group (AECG) criteria for pSS
- ESSDAI score ≥ 6.
- Positive anti-SS-A and/or anti-SS-B autoantibodies and at least IgG > 13 g/L or RF level > upper limit of normal (ULN) or positive test for cryoglobulins
- Willingness to undergo protocol-required minor salivary gland biopsies.
- Negative TB test during screening
- Immunization up to date as determined by local standard of care.
Exclusion Criteria
- Previous treatment with AMG 557/MEDI5872.
- Evidence of signs or symptoms of a viral, bacterial, or fungal infection within 2 weeks (14 days) prior to randomization (Day 1) according to the assessment of the investigator; any infection requiring IV antibiotic or antiviral treatment within 8 weeks of randomization (Day 1); history of herpes zoster within 3 months prior to randomization (Day 1).
- Evidence of significant renal insufficiency
- Positive test at screening for hepatitis B, hepatitis C, or human immunodeficiency virus (HIV) antibody.
- Prior administration of any of the following:
- Belimumab in the past 6 months prior to randomization (Day 1);
- Rituximab in the past 12 months or CD19+ B cells 10 mg/day oral prednisone (or equivalent); Any change or initiation of new dose within 4 weeks prior to signing the ICF through randomization (Day 1); Intramuscular, IV, or intra-articular corticosteroids within 4 weeks prior to signing the ICF through randomization (Day 1); Any change or initiation of new dose of topical corticosteroids within 2 weeks prior to signing the ICF through randomization (Day 1);
- Antimalarials: any increase or initiation of new dose of antimalarials (eg, chloroquine, hydroxychloroquine, quinacrine) within 12 weeks prior to signing the ICF through randomization (Day 1).
- Methotrexate: > 20 mg/week methotrexate; Any change or initiation of new dose of methotrexate within 4 weeks prior to signing the ICF through randomization (Day 1); Any change in route of administration.
- Any increase or initiation of new dose of regularly scheduled nonsteroidal anti inflammatory drugs (NSAIDs) within 2 weeks prior to signing the ICF through randomization (Day 1).
- Cevimeline or pilocarpine and cyclosporine eye drops (Restasis): any increase or initiation of new doses within 2 weeks prior to signing the ICF through randomization (Day 1).
Data sourced from ClinicalTrials.gov (NCT02334306). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.