A Study to Evaluate Safety and Tolerability of Multiple Doses of MEDI-546 in Adult Subjects With Scleroderma

NCT00930683 | Completed Phase 1

• 1 other identifier: MI-CP180
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 11

Brief Summary

To evaluate the safety and tolerability of a multiple-dosed drug (MEDI-546) in adults with scleroderma.

Conditions

Scleroderma

Outcome Measures

Primary Outcomes (1)

• The safety and tolerability of MEDI-546 will be assessed primarily by summarizing treatment-emergent AEs and SAEs.

  Study Day 84 for single-dose; Study Day 105 for multi-dose

Secondary Outcomes (1)

• The secondary endpoints of the study are to assess the PK, IM, and PD of single and multiple IV doses of MEDI-546 in adult subjects with scleroderma.

  Study Day 84 for single-dose; Study Day 105 for multi-dose

Study Arms (9)

1

OTHER

MEDI-546

Drug: MEDI-546

2

OTHER

MEDI-546

Drug: MEDI-546

3

OTHER

MEDI-546

Drug: MEDI-546

4

OTHER

MEDI-546

Drug: MEDI-546

5

OTHER

MEDI-546

Drug: MEDI-546

6

OTHER

MEDI-546

Drug: MEDI-546

7

OTHER

MEDI-546

Drug: MEDI-546

8

OTHER

MEDI-546

Drug: MEDI-546

9

OTHER

MEDI-546

Drug: MEDI-546

Interventions

MEDI-546 DRUG

0.1 mg/kg MEDI-546 as a single IV dose

1

Eligibility Criteria

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

You may qualify if:

• Male or female subjects ≥ 18 years of age at the time of the first dose of MEDI-546;
• Written informed consent and HIPAA authorization (applies to covered entities in the US only) obtained from the subject or subject's legal representative;
• 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 modified Rodnan Total Skin Score \[mRTSS\]) in at least one area suitable for repeat biopsy, such as arms, legs, or trunk;
• Women, unless surgically sterile (including tubal ligation) or at least 2 years post-menopausal, must use an effective method of avoiding pregnancy (including oral, injectable, transdermal, or implanted contraceptives, intrauterine device, diaphragm with spermicide, cervical cap, abstinence, and sterile sexual partner) in addition to the use of condoms (male or female condoms with spermicide) from signing of the informed consent through the end of the study. Cessation of birth control after this point should be discussed with a responsible physician. Men, unless surgically sterile, must likewise practice 2 effective methods of birth control (condom with spermicide or abstinence) and must use such precautions from Study Day 0 through the end of the study;
• Ability to complete the study period, including follow-up period through a maximum of Study Day 105; and
• Willing to forego other forms of experimental treatment during study.

You may not qualify if:

• History of allergy or reaction to any component of the MEDI-546 formulation;
• Forced vital capacity (FVC) \< 60% 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;
• Have received the following medications within 28 days before entry:
• Cyclophosphamide at any dose
• Systemic cyclosporine at any dose
• Thalidomide at any dose
• Hydroxychloroquine \> 600 mg/day
• Mycophenolate mofetil \> 3 g/day
• Methotrexate \> 25 mg/week
• Azathioprine \> 3 mg/kg/day;
• Have received leflunomide \> 20 mg/day within 6 months before entry;
• Have received fluctuating doses of the following within 28 days before entry:
• Antimalarials
• Mycophenolate mofetil
• Methotrexate

Sponsors & Collaborators

• MedImmune LLC: lead

Study Sites (11)

Research Site

Los Angeles, California, 90095, United States

Location

Boston University

Boston, Massachusetts, 02118, United States

Location

Research Site

Ann Arbor, Michigan, 48106, United States

Location

Research Site

New Brunswick, New Jersey, 08903, United States

Location

Research Site

Lake Success, New York, 11042, United States

Location

Research Site

Toledo, Ohio, 43614, United States

Location

Metroplex Clinical Research Center

Dallas, Texas, 75231, United States

Location

Research Site

Houston, Texas, 77030, United States

Location

University of Utah Medical Center

Salt Lake City, Utah, 84132, United States

Location

Research Site

Salt Lake City, Utah, United States

Location

Research Site

Seattle, Washington, 98101, United States

Location

Related Publications (1)

• Goldberg A, Geppert T, Schiopu E, Frech T, Hsu V, Simms RW, Peng SL, Yao Y, Elgeioushi N, Chang L, Wang B, Yoo S. Dose-escalation of human anti-interferon-alpha receptor monoclonal antibody MEDI-546 in subjects with systemic sclerosis: a phase 1, multicenter, open label study. Arthritis Res Ther. 2014 Feb 24;16(1):R57. doi: 10.1186/ar4492.

  PMID: 24559157 DERIVED

MeSH Terms

Conditions

Scleroderma, Diffuse

Interventions

anifrolumab

Condition Hierarchy (Ancestors)

Scleroderma, Systemic; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Skin Diseases

Study Officials

• Stephen Yoo, M.D.

  MedImmune LLC

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 29, 2009
• First Posted: June 30, 2009
• Study Start: September 1, 2009
• Primary Completion: May 1, 2010
• Study Completion: July 1, 2011
• Last Updated: May 8, 2012

Record last verified: 2012-05

Locations

US (11)