A Phase 1, Randomized, Double-blind, Placebo-controlled Study of the Safety and Tolerability of MEDI-551 in Scleroderma

MedImmune LLC1 site in 1 country50 target enrollmentMarch 2010

ConditionsScleroderma

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Scleroderma
Sponsor: MedImmune LLC
Enrollment: 50
Locations: 1
Primary Endpoint: The safety and tolerability of MEDI-551 will be assessed primarily by summarizing treatment-emergent AEs and SAEs.
Status: Completed
Last Updated: 11 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

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

Detailed Description

To evaluate the safety and tolerability of escalating single IV doses of MEDI-551 in adult subjects with scleroderma who have at least moderate skin thickening in an area suitable for repeat biopsy.

Registry

clinicaltrials.gov

Start Date

March 2010

End Date

March 2014

Last Updated

11 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

MedImmune LLC

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•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)

Exclusion Criteria

•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

Outcomes

Primary Outcomes

The safety and tolerability of MEDI-551 will be assessed primarily by summarizing treatment-emergent AEs and SAEs.

Time Frame: Day 85

Secondary Outcomes

The secondary endpoints of the study are to assess the PK, IM, and PD of single IV doses of MEDI-551 in adult subjects with scleroderma. Pharmacodynamics will be assessed by numbers of B cells in blood and skin.(Day 85)