A Study to Evaluate the Long-Term Safety of MEDI-545 in Adult Participants with Systemic Lupus Erythematosus or Myositis

Study identifier:MI-CP212

ClinicalTrials.gov identifier:NCT00979654

EudraCT identifier:N/A

CTIS identifier:N/A

Study Complete

Official Title

A Phase 2 Open-label Study to Evaluate the Long-term Safety of Sifalimumab in Adult Subjects with Systemic Lupus Erythematosus or Myositis

Medical condition

Systemic Lupus Erythematosus

Phase

Phase 2

Healthy volunteers

Study drug

Sifalimumab

Sex

All

Actual Enrollment

118

Study type

Interventional

Age

18 Years - 99 Years

Date

Study Start Date: 01 Aug 2010

Primary Completion Date: 01 Mar 2015

Study Completion Date: 01 Mar 2015

Study design

Allocation: N/A
Endpoint Classification: Safety
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Verification:

Verified 01 Aug 2016 by MedImmune, LLC

Collaborators

PPD

Inclusion and exclusion criteria

Inclusion Criteria

- Age 18 years or older at the time of screening.
- Written informed consent and any locally required authorization [example, Health Insurance Portability and Accountability Act (HIPAA) in the United States of America (USA), European Union (EU) Data Privacy Directive in the EU] obtained from the participant/legal representative prior to performing any protocol-related procedures, including Screening evaluations.
- Female participants of childbearing potential who are sexually active must use must use 2 effective methods of avoiding pregnancy from Screening, and must agree to continue using such precautions for 26 weeks after the final dose of investigational product.
- Males, unless surgically sterile, must use 2 effective methods of birth control with a female partner and must agree to continue using such contraceptive precautions from Screening until 26 weeks after the final dose of investigational product. If female, unless cervix has been surgically removed, have had a Pap smear with no evidence of malignancy within 6 months of baseline (defined as Day 1).
- Must have qualified for and received investigational product (sifalimumab or placebo) and completed the treatment period plus follow-up (through Day 266 for participants from MI-CP151 and MI-CP152 or through Day 168 for participants from MI-CP179) in one of the following sifalimumab clinical studies: MI-CP151, MI-CP152, or MI‑CP179, ability to complete the study period through the final visit, willing to forego other forms of experimental drug treatment during the study.

Exclusion Criteria

- Discontinued investigational product (sifalimumab) for safety reasons from any previous sifalimumab clinical study.
- For participants with systemic lupus erythematosus (SLE): Active severe or unstable neuropsychiatric SLE, that in the opinion of the investigator, would make the participant unsuitable for the study or unable to fully understand the informed consent, Active severe or unstable renal disease that in the opinion of the investigator would make the participant unsuitable for this study
- For participants with dermatomyositis (DM) or polymyositis (PM): Inclusion body myositis, cancer-associated myositis, myositis associated with another connective tissue disease, environmentally-associated myositis, or drug-related myopathy, a history of or a family history of non-inflammatory myopathy, scapular winging, atrophy, or hypertrophy of the calf muscles, Active Hepatitis A, confirmed positive tests for hepatitis B surface antigen (HbsAg) and hepatitis B core antibody (HbcAb) or hepatitis C serology. Isolated HbcAb positivity will be explored with additional reflex testing to determine eligibility.
- Evidence of active tuberculosis (TB), either treated or untreated, or latent TB without completion of an appropriate course of treatment or appropriate ongoing prophylactic treatment, history of severe viral infection, such as disseminated herpes, herpes encephalitis, or ophthalmic herpes.
- Any of the following medications within 6 months before entry into the study: Leflunomide greater than (>) 20 milligram/day, Cyclophosphamide (or any other alkylating agent).
- Any of the following medications within 28 days before entry into the study: Prednisone or equivalent > 30 mg/day or > 0.5 mg/kg, whichever is the lesser amount, Cyclosporine at any dose, Thalidomide at any dose, Interferon alpha 2b, Hydroxychloroquine > 600 mg/day, Mycophenolate mofetil > 3 gram/day, Methotrexate > 25 mg/week, Azathioprine > 3 mg/kilogram (kg)/day, Combination of leflunomide and methotrexate
- Nonstable doses of one or more of the following medications within 28 days before entry into the study: Hydroxychloroquine, Mycophenolate mofetil, Methotrexate, Azathioprine
- At Screening blood tests (within 28 days before entry into the study), any of the following: Total bilirubin > upper limit of normal (ULN), Neutrophil count < 1,500/microliter (mcl) (or < 1.5 × 109/L), Platelet count < 60,000/microliter (mcl) (or < 60 × 109/L), Hemoglobin (Hgb) < 7 gram per decilitre (g/dL) (or < 70 g/L).

No locations available

Arms	Assigned Interventions
Experimental: Sifalimumab (MEDI-545) 500 or 600 milligram (mg) All participants will receive intravenous (IV) sifalimumab as fixed dose of 500 mg every 2 weeks (Q2W) on Day 1, Week 2, and Week 4, then every 4 weeks (Q4W) thereafter for a total of 156 weeks. The initial fixed dose of 500 mg is increased to 600 mg with subsequent protocol amendment.	Drug: Sifalimumab All participants will receive intravenous (IV) sifalimumab as fixed dose of 500 mg every 2 weeks (Q2W) on Day 1, Week 2, and Week 4, then every 4 weeks (Q4W) thereafter for a total of 156 weeks. The initial fixed dose of 500 mg is increased to 600 mg with subsequent protocol amendment.

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Trial Results Summaries
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Contacts

Contact

AstraZeneca Clinical Study Information Center

1-877-240-9479

[email protected]

Investigators

Principal Investigator

Jerry Green

MedImmune