A Phase 2a, Randomized, Placebo Controlled, Study to Evaluate the Safety and Efficacy of AMG 557/MEDI5872 in Primary Sjögren's Syndrome

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02334306
• Date of registration: 12/12/2014
• Prospective Registration: Yes
• Primary sponsor: MedImmune LLC
• Public title: A Phase 2a, Randomized, Placebo Controlled, Study to Evaluate the Safety and Efficacy of AMG 557/MEDI5872 in Primary Sjögren's Syndrome
• Scientific title: A Phase 2a, Randomized, Placebo Controlled, Proof of Mechanism Study to Evaluate the Safety and Efficacy of AMG 557/MEDI5872 in Subjects With Primary Sjögren's Syndrome
• Date of first enrolment: June 8, 2015
• Target sample size: 32
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02334306
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Triple (Participant, Investigator, Outcomes Assessor).
• Phase: Phase 2

Countries of recruitment

France, Sweden, United Kingdom, United States

Contacts

• Name: Maria Dall'Era, MD
• Affiliation: University of California, San Francisco

• Name: Ghaith Noaiseh, MD
• Affiliation: University of Pittsburgh

Key inclusion & exclusion 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:

1. Belimumab in the past 6 months prior to randomization (Day 1);

2. Rituximab in the past 12 months or CD19+ B cells < 5/µL if rituximab treatment
was more than 12 months prior to randomization (Day 1);

3. Abatacept in the past 6 months prior to randomization (Day 1);

4. Tumor necrosis factor inhibitors (adalimumab, certolizumab, etanercept,
golimumab, infliximab) in the past 3 months prior to randomization (Day 1);

5. Tocilizumab in the past 3 months prior to randomization (Day 1);

6. Cyclophosphamide (or any other alkylating agent) in the past 6 months prior to
randomization (Day 1); cyclosporine (except for eye drops), tacrolimus,
sirolimus, mycophenolate mofetil, azathioprine, or leflunomide in the past 3
months prior to randomization (Day 1).

- Receiving any of the following:

1. Corticosteroids: > 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);

2. 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).

3. 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.

4. 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).

5. 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).



Age minimum: 18 Years
Age maximum: 75 Years
Gender: All

Health Condition(s) or Problem(s) studied

Primary Sjögren's Syndrome

Intervention(s)

Other: Placebo

Biological: AMG 557/MEDI5872

Primary Outcome(s)

Change From Baseline in European League Against Rheumatism Sjogren's Syndrome Disease Activity Index (ESSDAI) Score at Day 99 [Time Frame: Baseline (Day 1 predose) and Day 99]

Secondary Outcome(s)

Number of Participants With Adverse Events of Special Interest (AESIs) [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]

Ratio to Baseline in Minor Salivary Gland Tissue Biomarkers at Day 99 [Time Frame: Baseline (Day 1 predose) and Day 99]

Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs) [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]

Ratio to Baseline in Focus Score at Day 99 [Time Frame: Baseline (Day 1 predose) and Day 99]

Ratio to Baseline in Peripheral Blood Biomarkers at Day 99 [Time Frame: Baseline (Day 1 predose) and Day 99]

Change From Baseline in European League Against Rheumatism Sjogren's Syndrome Patient Reported Index (ESSPRI) Score at Day 99 [Time Frame: Baseline (Day 1 predose) and Day 99]

Percentage of ESSDAI Responders at Day 99 [Time Frame: Baseline (Day 1 predose) and Day 99]

Secondary ID(s)

D5181C00001

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Amgen

Results

• Results available: Yes
• Date Posted: 19/03/2019
• URL: https://clinicaltrials.gov/ct2/show/results/NCT02334306