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

NCT00979654 | Completed Phase 2 Results

• 1 other identifier: MI-CP212
• Study Type: interventional
• Target: 118
• Locations: 4 countries
• Sites: 28

Brief Summary

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.

Conditions

Systemic Lupus Erythematosus

Keywords

Sifalimumab; MEDI-545

Outcome Measures

Primary Outcomes (1)

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

  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.

  From start of study drug administration until week 182

Secondary Outcomes (8)

• Maximum Observed Serum Concentration (Cmax) for Sifalimumab

  Pre-infusion and End of Infusion on Day 1

• Time to Reach Maximum Observed Plasma Concentration (Tmax) of Sifalimumab

  Pre-infusion and End of Infusion on Day 1

• Time to Last Quantifiable Plasma Concentration (Tlast) of Sifalimumab

  Pre-infusion and End of Infusion on Day 1

• Minimum Observed Serum Concentration (Ctrough) of Sifalimumab

  Pre-infusion and End of Infusion on Day 1

• Area Under the Serum Concentration-time Curve Over the Dosing Interval (AUCtau) of Sifalimumab

  Pre-infusion and End of Infusion on Day 1

Study Arms (1)

Sifalimumab (MEDI-545) 500 or 600 milligram (mg)

EXPERIMENTAL

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

Interventions

Sifalimumab DRUG

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.

Sifalimumab (MEDI-545) 500 or 600 milligram (mg)

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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
• 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).

Sponsors & Collaborators

• MedImmune LLC: lead
• PPD Development, LP: collaborator

Study Sites (28)

Research Site

Anniston, Alabama, United States

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Scottsdale, Arizona, United States

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San Leandro, California, United States

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Upland, California, United States

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Colorado Springs, Colorado, United States

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Fort Lauderdale, Florida, United States

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Ocala, Florida, United States

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Tampa, Florida, United States

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Baltimore, Maryland, United States

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Cumberland, Maryland, United States

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Boston, Massachusetts, United States

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Ann Arbor, Michigan, United States

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Lansing, Michigan, United States

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Lake Success, New York, United States

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Manhasset, New York, United States

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New York, New York, United States

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Charlotte, North Carolina, United States

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Cincinnati, Ohio, United States

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Oklahoma City, Oklahoma, United States

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Portland, Oregon, United States

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Duncansville, Pennsylvania, United States

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Columbia, South Carolina, United States

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Dallas, Texas, United States

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Houston, Texas, United States

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Curitiba, Brazil

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São Paulo, Brazil

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Winnipeg, Manitoba, Canada

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Santiago, Chile

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MeSH Terms

Conditions

Lupus Erythematosus, Systemic

Interventions

sifalimumab

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Limitations and Caveats

A business decision was made to discontinue the development of sifalimumab in favor of another type 1 interferon (IFN) inhibitor.

Results Point of Contact

• Title: Jerry Green
• Organization: MedImmune, LLC

rtpsafety@ppdi.com

1-888-483-7729

Study Officials

• Jerry Green

  MedImmune LLC

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 17, 2009
• First Posted: September 18, 2009
• Study Start: August 1, 2010
• Primary Completion: March 1, 2015
• Study Completion: March 1, 2015
• Last Updated: October 27, 2016
• Results First Posted: August 23, 2016

Record last verified: 2016-08

Locations

CA (1); CL (1); BR (2); US (24)