NCT00946699

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

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Mar 2010

Longer than P75 for phase_1

Geographic Reach
3 countries

14 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 23, 2009

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 27, 2009

Completed
7 months until next milestone

Study Start

First participant enrolled

March 1, 2010

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2012

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2014

Completed
Last Updated

November 13, 2014

Status Verified

November 1, 2014

Enrollment Period

2 years

First QC Date

July 23, 2009

Last Update Submit

November 11, 2014

Conditions

Scleroderma

Outcome Measures

Primary Outcomes (1)

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

    Day 85

Secondary Outcomes (1)

  • 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

Study Arms (6)

1

EXPERIMENTAL

MEDI-551

Biological: MEDI-551

2

EXPERIMENTAL

MEDI-551

Biological: Placebo

3

EXPERIMENTAL

MEWDI-551

Biological: MEDI-551

4

EXPERIMENTAL

MEDI-551

Biological: MEDI-551

5

EXPERIMENTAL

MEDI-551

Biological: MEDI-551

6

PLACEBO COMPARATOR

Placebo

Other: Placebo

Interventions

MEDI-551BIOLOGICAL

0.1 mg/kg

1
PlaceboBIOLOGICAL

0.3 mg/kg

2

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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
  • +45 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (14)

Research Site

Loma Linda, California, United States

Location

Research Site

Redwood City, California, United States

Location

Research Site

Farmington, Connecticut, United States

Location

Research Site

Shreveport, Louisiana, United States

Location

Research Site

Worcester, Massachusetts, United States

Location

Research Site

Ann Arbor, Michigan, United States

Location

Research Site

New Brunswick, New Jersey, United States

Location

Research Site

Great Neck, New York, United States

Location

Research Site

Durham, North Carolina, United States

Location

Research Site

Cleveland, Ohio, United States

Location

Research Site

Duncansville, Pennsylvania, United States

Location

Research Site

Dallas, Texas, United States

Location

Research Site

Winnipeg, Manitoba, Canada

Location

Research Site

London, United Kingdom

Location

Related Publications (1)

  • Schiopu E, Chatterjee S, Hsu V, Flor A, Cimbora D, Patra K, Yao W, Li J, Streicher K, McKeever K, White B, Katz E, Drappa J, Sweeny S, Herbst R. Safety and tolerability of an anti-CD19 monoclonal antibody, MEDI-551, in subjects with systemic sclerosis: a phase I, randomized, placebo-controlled, escalating single-dose study. Arthritis Res Ther. 2016 Jun 7;18(1):131. doi: 10.1186/s13075-016-1021-2.

    PMID: 27267753DERIVED

MeSH Terms

Conditions

Scleroderma, Diffuse

Interventions

inebilizumab

Condition Hierarchy (Ancestors)

Scleroderma, SystemicConnective Tissue DiseasesSkin and Connective Tissue DiseasesSkin Diseases

Study Officials

  • Medical Monitor

    MedImmune LLC

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 23, 2009

First Posted

July 27, 2009

Study Start

March 1, 2010

Primary Completion

March 1, 2012

Study Completion

March 1, 2014

Last Updated

November 13, 2014

Record last verified: 2014-11

Locations

CA(1)GB(1)US(12)