AzTrials
AzTrials

SclerodermaPhase 1NCT00946699

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

A Phase 1 study testing MEDI-551 in people with Scleroderma, run by MedImmune LLC at 14 sites in 3 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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 Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Scleroderma
What is being tested?
MEDI-551
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
50 participants
Where
14 sitesin 3 countries
Study dates
Mar 2010to Mar 2014
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 9Show fewer
  • 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)

Who cannot join

  • 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
Show all 60Show fewer
  • 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
  • Systemic corticosteroids
  • At screening blood tests (within 21 days prior to randomization into the study), any of the following:
  • Aspartate aminotransferase (AST) > 1.5 × upper limit of the normal range (ULN)unless due to documented myositis
  • Alanine aminotransferase (ALT) > 1.5 × ULN unless due to documented myositis
  • Total bilirubin > ULN, unless because of known Gilbert's disease - Total immunoglobin <500 mg/dl
  • Creatinine > 2.5 mg/dL
  • Neutrophils < 1,500/mm3
  • Platelet count < 75,000/mm3
  • Hemoglobin (Hgb) < 8 g/dL
  • Hemoglobin A1c (HbA1c) > 8% at screening (diabetic subjects only)
  • Positive serum βHCG (pregnancy test)
  • Lactating woman
  • Herpes zoster infection within 3 months before randomization
  • A history of severe viral infection as judged by the investigator, including severe infections of either cytomegalovirus or the herpes family such as disseminated herpes, herpes encephalitis, ophthalmic herpes
  • At screening, positive tests for active hepatitis A, hepatitis B surface antigen (HbsAg), Hepatitis B core antibody (HbcAb) or hepatitis C serology, or human immunodeficiency virus-1 or -2 (HIV-1/2). False positive tests are not included.
  • Deep space/tissue infection (eg, fasciitis, abscess, osteomyelitis, or infected joint replacements) within 1 year before randomization into the study
  • Any opportunistic infection or serious infection (in the opinion of the investigator) within 6 months prior to screening
  • Any of the following within 21 days before randomization into the study:
  • Clinically significant active infection, including ongoing, chronic infection
  • Any infection requiring hospitalization or treatment with IV anti-infectives
  • Completion of a course of oral anti-infectives within 14 days before randomization into the study
  • Any acute illness or evidence of clinically significant active infection, such as fever ≥ 38.0 degrees C (≥ 100.5 degrees F) at screening or at Day 1
  • 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. Evaluation and treatment will be according to the local standard of care and may consist of history and physical examinations, and/or chest X ray, and/or TB test (eg. purified protein derivative) testing, with the standard of care as determined by local guidelines
  • History of primary immunodeficiency or underlying condition that predisposes the subject to infection (eg, splenectomy)
  • Receipt of any live or attenuated vaccine within 21 days before randomization into the study or anticipated to be given within 5 half-lives of the last dose of investigational product administration, half-life is estimated to be approximately 15 days. Therefore, receipt of live attenuated vaccine should be avoided for 75 days post dose of investigational product
  • Medically indicated adult immunizations that are not current (eg, pneumococcal vaccine)
  • Current evidence of alcohol, drug or chemical abuse, or a recent history of such abuse < 1 year prior to randomization into the study
  • History of cancer except basal cell carcinoma treated with apparent success with curative therapy ≥ 1 year prior to randomization into the study
  • Major surgery within 8 weeks before randomization into the study or elective surgery planned from screening through the Early Discontinuation Visit/End of Study (Day 85, single-dose cohorts)
  • History of any disease, evidence of any current disease (other than scleroderma), any finding upon physical examination, chest x-ray, or any laboratory abnormality that, in the opinion of the investigator or medical monitor, may compromise the safety of the subject in the study or confound the analysis of the study
  • Any institutionalized individual
  • Employees of the clinical study site or any other individuals involved with the conduct of the study, or immediate family members of such individuals
  • Concurrent enrollment in another clinical study with the exception of observational or interventional studies that do not involve therapeutic strategies or invasive diagnostic tests
  • Concurrent enrollment in another clinical study with an investigational product administered within 4 weeks prior to Day 1 or within 5 half-lives of the investigational product, whichever is longer
  • Known sensitivity to acetaminophen/paracetamol, diphenhydramine, and methylprednisolone or equivalent glucocorticoid

Trial locations and contacts

14 sites in 3 countries.

14 sites in 3 countries

United States12 sites

  • Research Site

    Ann Arbor, Michigan

  • Research Site

    Cleveland, Ohio

  • Research Site

    Dallas, Texas

  • Research Site

    Duncansville, Pennsylvania

  • Research Site

    Durham, North Carolina

  • Research Site

    Farmington, Connecticut

  • Research Site

    Great Neck, New York

  • Research Site

    Loma Linda, California

  • Research Site

    New Brunswick, New Jersey

  • Research Site

    Redwood City, California

  • Research Site

    Shreveport, Louisiana

  • Research Site

    Worcester, Massachusetts

Other trials in United States

Canada1 site

  • Research Site

    Winnipeg, Manitoba

Other trials in Canada

United Kingdom1 site

  • Research Site

    London

Other trials in United Kingdom

About this study

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

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

Read the 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.

Conditions
Scleroderma
Being tested
MEDI-551, Placebo
Medical subject headings
Scleroderma, Diffuse

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MEDI-551Biological

    0.1 mg/kg

  • PlaceboBiological

    0.3 mg/kg

  • MEDI-551Biological

    1.0 mg/kg

  • MEDI-551Biological

    3.0 mg/kg

  • MEDI-551Biological

    10.0 mg/kg

  • PlaceboOther

    Placebo

Study groups in NCT00946699
Study groupRoleWhat they receive
1ExperimentalMEDI-551
Receives: Biological: MEDI-551
2ExperimentalMEDI-551
Receives: Biological: Placebo
3ExperimentalMEWDI-551
Receives: Biological: MEDI-551
4ExperimentalMEDI-551
Receives: Biological: MEDI-551
5ExperimentalMEDI-551
Receives: Biological: MEDI-551
6Placebo comparatorPlacebo
Receives: Other: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: Day 85

Secondary outcomes (1)

  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.

    Measured: Day 85

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Jul 2009 (estimated)
  2. Study startMar 2010
  3. Primary completionMar 2012
  4. Study completionMar 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Single group
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
50 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00946699
Sponsor's protocol ID
MI-CP200
Status last verified
Nov 2014
First submitted
23 Jul 2009
Last updated
13 Nov 2014
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 27267753

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing MEDI-551 in people with Scleroderma, run by MedImmune LLC at 14 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 60 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Nov 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 14 sites in United States, Canada, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The safety and tolerability of MEDI-551 will be assessed primarily by summarizing treatment-emergent AEs and SAEs. (time frame: Day 85). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00946699, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Nov 2014.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in