A Study of the Efficacy and Safety of MEDI-546 in Systemic Lupus Erythematosus

• Register: ClinicalTrials.gov
• Last refreshed on: 19 October 2017
• Main ID: NCT01438489
• Date of registration: 09/09/2011
• Prospective Registration: Yes
• Primary sponsor: MedImmune LLC
• Public title: A Study of the Efficacy and Safety of MEDI-546 in Systemic Lupus Erythematosus
• Scientific title: A Phase 2, Randomized Study to Evaluate the Efficacy and Safety of MEDI-546 in Subjects With Systemic Lupus Erythematosus
• Date of first enrolment: January 2012
• Target sample size: 626
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT01438489
• Study type: Interventional
• Phase: Phase 2

Countries of recruitment

Brazil, Bulgaria, Colombia, Czech Republic, Hong Kong, Hungary, India, Korea, Republic of, Mexico, Peru, Poland, Romania, Taiwan, Ukraine, United States

Contacts

• Name: Warren Greth, MD
• Affiliation: MedImmune LLC

Key inclusion & exclusion criteria

Inclusion Criteria:

- Fulfills at least 4 of the 11 American College of Rheumatology (ACR) criteria for
systemic lupus erythematosus (SLE) including a positive antinuclear antibody (ANA)
greater than or equal to 1:80 or elevated anti-double-stranded DNA or anti-Smith
antibody at screening

- Pediatric or adult SLE with chronic disease activity for greater than or equal to 24
weeks

- Weight greater than or equal to 40 kg

- Currently receiving stable dose of oral prednisone (or equivalent) less than or equal
to 40 mg/day and/or antimalarials/immunosuppressives

- Active moderate to severe SLE disease based on SLE disease activity score (SLEDAI) and
British Isles Lupus Assessment Group Index (BILAG) and Physicians Global Assessment

- No evidence of cervical malignancy on Pap smear within 2 years of randomization

- Female participants must be willing to avoid pregnancy

- Negative tuberculosis (TB) test or newly positive TB test due to latent TB for which
treatment must be initiated at or before randomization.

Exclusion Criteria:

- Active severe SLE-driven renal disease or unstable renal disease prior to screening

- Active severe or unstable neuropsychiatric SLE

- Clinically significant active infection including ongoing and chronic infections

- History of human immunodeficiency virus (HIV)

- Confirmed Positive tests for hepatitis B or positive test for hepatitis C

- History of severe herpes infection such as herpes encephalitis, ophthalmic herpes,
disseminated herpes

- Live or attenuated vaccine within 4 weeks prior to screening

- Participants with significant hematologic abnormalities.



Age minimum: 18 Years
Age maximum: 65 Years
Gender: All

Health Condition(s) or Problem(s) studied

Systemic Lupus Erythematosus

Intervention(s)

Biological: Anifrolumab 1000 mg

Biological: Anifrolumab 300 mg

Other: Placebo

Primary Outcome(s)

Percentage of Type I Interferon (IFN) Test High Participants Achieving an Systemic Lupus Erythematosus Responder Index (SRI) (4) Response With Oral Corticosteroids (OCS) Tapering at Day 169 [Time Frame: Day 169]

Percentage of Participants Achieving an Systemic Lupus Erythematosus (SLE) Responder Index [SRI (4)] Response With Oral Corticosteroids (OCS) Tapering at Day 169 [Time Frame: Day 169]

Secondary Outcome(s)

Maximum Observed Plasma Concentration (Cmax) of Anifrolumab at Day 1, 169 and 337 [Time Frame: Pre-infusion and 15 minutes post-infusion on Day 1, 169 and 337]

Number of Participants With Vital Signs Abnormalities Reported as Treatment-Emergent Adverse Events (TEAEs) [Time Frame: Day 1 (Baseline) to Day 422 (End of Study)]

Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Adverse Events of Special Interest (AESIs) and Treatment-Emergent Serious Adverse Events (TESAEs) [Time Frame: Day 1 (Baseline) to Day 422 (End of Study)]

Percentage of Participants on Oral Corticosteroids (OCS) >=10 mg/Day of Prednisone or Equivalent at Baseline Who Were Able to Taper to Less Than or Equal to (<=) 7.5 mg/Day at Day 365 [Time Frame: Day 365]

Percentage of SLE Participants With Positive Anti-drug Antibody (ADA) [Time Frame: Days 1, 85, 141, 169, 253, 337 (Treatment Phase), 365, 396, and 422 (Follow-up Period)]

Accumulation Ratio of Trough Concentration (Ctrough,AR) of Anifrolumab at Day 169 and 365 [Time Frame: Pre-infusion and 15 minutes post-infusion on Day 169 and 365]

Neutralization Ratio of 21-Gene Type I Interferon (IFN) Signature for Participants With Positive Baseline Pharmacodynamic (PD) Gene Signature [Time Frame: Days 29, 85, 141, 169, 253, 337 (treatment phase), on Days 365, 396, and 422 (follow up period)]

Accumulation Ratio of Maximum Observed Plasma Concentration (Cmax,AR) of Anifrolumab [Time Frame: Pre-infusion and 15 minutes post-infusion on Day 169 and 337]

Trough Concentration (Ctrough) of Anifrolumab at Day 29, 169 and 365 [Time Frame: Pre-infusion and 15 minutes post-infusion on Day 29, 169 and 365]

Number of Participants With Clinically Significant Laboratory Abnormalities in Investigations Reported as Treatment-Emergent Adverse Events [Time Frame: Day 1 (Baseline) to Day 422 (End of Study)]

Number of Participants With Electrocardiogram (ECG) Abnormalities Reported as Treatment-Emergent Adverse Events (TEAEs) [Time Frame: Day 1 (Baseline) to Day 422 (End of Study)]

Percentage of Participants Achieving an Systemic Lupus Erythematosus (SLE) Responder Index [SRI (4)] Response With Oral Corticosteroids (OCS) Tapering at Day 365 [Time Frame: Day 365]

Secondary ID(s)

CD-IA-MEDI-546-1013

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 15/08/2016
• URL: https://clinicaltrials.gov/ct2/show/results/NCT01438489