A Study of the Safety and Tolerability of MEDI-551 in Scleroderma

Completed · Phase 1 · Has a placebo group

Conditions studied: Scleroderma

In brief

The primary objective of this study is to evaluate the safety and tolerability of intravenously administered MEDI-551 over escalating single doses in adult subjects with Scleroderma

Key facts

Study ID

NCT00946699

Run by

MedImmune LLC

People needed

50

Starts

2010-03-01

Expected to finish

2014-03-01

Last updated by the study team

2014-11-13

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Male or female subjects
• Age ≥ 18 years of age at the time of screening
• Written informed consent and HIPAA authorization (applies to covered entities in the USA only) obtained from the subject/legal representative prior to performing any protocol-related procedures, including screening evaluations
• Must fulfill the American Rheumatism Association (American College of Rheumatology) preliminary classification criteria for systemic sclerosis
• Has at least moderate skin thickening (score of at least 2 by mRTSS) in at least one area suitable for repeat biopsy, such as on the arms, legs, or trunk
• Females of childbearing potential, unless surgically sterile (ie, bilateral tubal ligation, bilateral oophorectomy, or complete hysterectomy), has sterile male partner, is at least 2 years post menopause, or practices abstinence, must use 2 effective methods of avoiding pregnancy (including oral, transdermal, or implanted contraceptives, intrauterine device, female condom with spermicide, diaphragm with spermicide, cervical cap, or use of a condom with spermicide by the sexual partner), from screening, and must agree to continue using such precautions through the Early Discontinuation Visit/End of Study (Day 85, single-dose cohorts); cessation of birth control should not occur until 5 half-lives post-cessation of MEDI-551, 5 half-lives is estimated to be 75 days
• Men, 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 Day 1 through the Early Discontinuation Visit/End of Study (Day 85, single-dose cohorts) and for 5 half-lives post-cessation of MEDI-551, 5 half-lives is estimated to be 75 days
• Ability to complete the study period, including follow-up period through Day 85
• Willingness to forego other forms of experimental treatment during the study (Day 1 through the Early Discontinuation Visit/End of Study - Day 85, single-dose cohorts)

You may not qualify if…

• History of allergic reactions to any component of the investigational product
• History of coagulation disorders that in the opinion of the investigator would contraindicate skin biopsies
• Has a body weight ≥ 120 kg or < 40 kg
• Has B-cell count in peripheral blood < 50% lower limit of normal (LLN) at screening
• Forced vital capacity (FVC) < 55% predicted, diffusing capacity for carbon monoxide (DLCO) < 40% predicted, pulmonary hypertension requiring treatment with endothelin receptor antagonists or prostacyclin analogues
• Scleroderma renal crisis within the last year, or medically significant malabsorption
• Receipt of any B-cell-depleting biologic therapies at any time, such as rituximab
• Receipt of leflunomide > 20 mg/day within 6 months prior to randomization into the study
• Receipt of the following concomitant medications within 21 days prior to randomization into the study:
• Prednisone > 30 mg/day or > 0.5 mg/kg
• Cyclophosphamide
• Systemic cyclosporine
• Thalidomide
• Hydroxychloroquine > 600 mg/day
• Mycophenolate mofetil > 3 g/day
• Methotrexate > 25 mg/week
• Azathioprine > 3 mg/kg/day
• Concomitant methotrexate and leflunomide
• Any investigational drug therapy or non-B-cell-depleting biologic therapy (or within 5 half-lives of ingestion, whichever is longer)
• Change in standing daily dosage of the following within 21 days before randomization into the study:
• Antimalarials
• Mycophenolate mofetil
• Methotrexate
• Leflunomide
• Azathioprine

Where it is running

• Research Site — Loma Linda, California, United States
• Research Site — Redwood City, California, United States
• Research Site — Farmington, Connecticut, United States
• Research Site — Shreveport, Louisiana, United States
• Research Site — Worcester, Massachusetts, United States
• Research Site — Ann Arbor, Michigan, United States
• Research Site — New Brunswick, New Jersey, United States
• Research Site — Great Neck, New York, United States
• Research Site — Durham, North Carolina, United States
• Research Site — Cleveland, Ohio, United States
• Research Site — Duncansville, Pennsylvania, United States
• Research Site — Dallas, Texas, United States
• Research Site — Winnipeg, Manitoba, Canada
• Research Site — London, United Kingdom

Full record on ClinicalTrials.gov

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