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

This study has been completed.
Sponsor:
Collaborator:
PPD
Information provided by (Responsible Party):
MedImmune LLC
ClinicalTrials.gov Identifier:
NCT00979654
First received: September 17, 2009
Last updated: July 12, 2016
Last verified: July 2016
  Purpose
The objective of this study is to assess the safety and tolerability of sifalimumab in adult participants with active systemic lupus erythematosus (SLE) or active dermatomyositis (DM) or polymyositis (PM) who participated in the following clinical studies: MI-CP151, MI-CP152, or MI-CP179.

Condition Intervention Phase
Systemic Lupus Erythematosus
Drug: Sifalimumab
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by MedImmune LLC:

Primary Outcome Measures:
  • Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs) [ Time Frame: From start of study drug administration until week 182 ] [ Designated as safety issue: Yes ]
    An adverse event (AE) was any untoward medical occurrence attributed to study drug in a participant who received investigational product. A serious adverse event (SAE) was 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 were events between administration of investigational product and 30 days after the last dose of study drug that were absent before treatment or that worsened relative to pre-treatment state.


Secondary Outcome Measures:
  • Maximum Observed Serum Concentration (Cmax) for Sifalimumab [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
    The Cmax is the maximum observed plasma concentration of sifalimumab.

  • Time to Reach Maximum Observed Plasma Concentration (Tmax) of Sifalimumab [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
    The Tmax is the time to reach maximum observed plasma concentration of sifalimumab.

  • Time to Last Quantifiable Plasma Concentration (Tlast) of Sifalimumab [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
    The Tlast is the time to last quantifiable plasma concentration (Tlast) of sifalimumab.

  • Minimum Observed Serum Concentration (Ctrough) of Sifalimumab [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
    The Ctrough is the minimum observed serum concentration of sifalimumab.

  • Area Under the Serum Concentration-time Curve Over the Dosing Interval (AUCtau) of Sifalimumab [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
    The AUCtau is the area under the serum concentration-time curve over the dosing interval of sifalimumab.

  • Minimum Observed Serum Concentration at Steady State (Ctrough,ss) of Sifalimumab [ Time Frame: Day 168 ] [ Designated as safety issue: No ]
    The Ctrough is the minimum observed serum concentration at steady state of sifalimumab.

  • Accumulation Index for Minimum Observed Serum Concentration (Ctrough) of Sifalimumab [ Time Frame: Day 168 ] [ Designated as safety issue: No ]
    The Ctrough is the minimum observed serum concentration of sifalimumab.

  • Number of Participants With Positive Anti-Drug Antibody [ Time Frame: Day 1 and Week 12, 24, 52, 104, 156 and 168 ] [ Designated as safety issue: No ]
    Participants tested for immunogenicity to Sifalimumab (MEDI-545) from Day 1 to the end of study.


Enrollment: 118
Study Start Date: August 2010
Study Completion Date: March 2015
Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
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.

Detailed Description:
The primary objective of this study is to evaluate the long-term safety and tolerability of multiple intravenous (IV) doses of sifalimumab in adult participants with active SLE or DM or PM who were previously treated with investigational product (sifalimumab or placebo) in one of the following sifalimumab clinical studies: MI-CP151, MI-CP152, or MI-CP179.
  Eligibility

Ages Eligible for Study:   18 Years to 99 Years   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00979654

  Show 29 Study Locations
Sponsors and Collaborators
MedImmune LLC
PPD
Investigators
Study Director: Jerry Green MedImmune LLC
  More Information

Additional Information:
Responsible Party: MedImmune LLC
ClinicalTrials.gov Identifier: NCT00979654     History of Changes
Other Study ID Numbers: MI-CP212 
Study First Received: September 17, 2009
Results First Received: July 12, 2016
Last Updated: July 12, 2016
Health Authority: United States: Food and Drug Administration

Keywords provided by MedImmune LLC:
Sifalimumab
MEDI-545

Additional relevant MeSH terms:
Lupus Erythematosus, Systemic
Myositis
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Muscular Diseases
Musculoskeletal Diseases
Neuromuscular Diseases
Nervous System Diseases
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 30, 2016