SclerodermaPhase 1MEDI-546NCT00930683
A Study to Evaluate Safety and Tolerability of Multiple Doses of MEDI-546 in Adult Subjects With Scleroderma
A Phase 1 study testing MEDI-546 in people with Scleroderma, run by MedImmune LLC at 11 sites in United States.
Trial summary
To evaluate the safety and tolerability of a multiple-dosed drug (MEDI-546) in adults 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-546
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 11 sitesUnited States
- Study dates
- Sep 2009to Jul 2011
- 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 ≥ 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.
Who cannot join
- 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
Show all 43Show fewer
- 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
- Leflunomide
- Azathioprine;
- Have received prednisone > 20 mg/day or in fluctuating doses within 14 days before entry;
- Have received fluctuating doses of nonsteroidal anti-inflammatory drugs (NSAIDs) within 14 days before entry;
- Treatment with any investigational drug therapy within 28 days before entry into the study, B cell-depleting therapies within 12 months before entry, or biologic therapies within 30 days or 5 half-lives of the biologic agent, whichever is longer, before entry into the study;
- In the investigator's opinion, evidence of clinically significant active infection, including ongoing, chronic infection, within 28 days before entry;
- A history of severe viral infection as judged by the investigators, including severe infections of either cytomegalovirus (CMV) or the herpes family such as disseminated herpes, herpes encephalitis, ophthalmic herpes;
- Herpes zoster infection within 3 months before entry;
- Evidence of infection with hepatitis B or C virus, or human immunodeficiency virus (HIV)-1 or HIV-2, or active infection with hepatitis A, as determined by results of testing at screening;
- Vaccination with live attenuated viruses within 28 days before entry;
- Pregnancy (women, unless surgically sterile or at least 2 years post-menopausal, must have a negative serum pregnancy test within 28 days before receiving MEDI-546 and a negative urine pregnancy test on days of MEDI-546 administration before receiving MEDI-546);
- Breastfeeding or lactating women;
- History of primary immunodeficiency;
- History of alcohol or drug abuse < 1 year prior to entry;
- History of cancer except basal cell carcinoma or in situ carcinoma of the cervix treated with apparent success with curative therapy > 1 year prior to entry;
- History of active tuberculosis (TB) infection or latent TB infection without completion of an appropriate course of treatment;
- Newly positive TB skin test (defined as a reaction ≥ 10 mm in diameter if not on systemic immunosuppressive medication or ≥ 5 mm if on systemic immunosuppressive medication) without concomitant prophylactic therapy;
- Elective surgery planned from the time of signing of the informed consent through end of study;
- At screening blood tests (within 28 days before entry), any of the following:
- Aspartate aminotransferase (AST) > 2.5 x upper limit of the normal range (ULN), unless due to Myositis
- Alanine aminotransferase (ALT) > 2.5 x ULN
- Creatinine > 4.0 mg/dL
- Creatinine > 4.0 mg/dL
- Neutrophils < 1,500/mm3
- Platelet count < 50,000/mm3;
- 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; or
- Any employee of the research site who is involved with the conduct of the study.
- History of vasculitis.
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
United States11 sites
Research Site
Ann Arbor, Michigan, 48106
Boston University
Boston, Massachusetts, 02118
Metroplex Clinical Research Center
Dallas, Texas, 75231
Research Site
Houston, Texas, 77030
Research Site
Lake Success, New York, 11042
Research Site
Los Angeles, California, 90095
Research Site
New Brunswick, New Jersey, 08903
University of Utah Medical Center
Salt Lake City, Utah, 84132
Research Site
Salt Lake City, Utah
Research Site
Seattle, Washington, 98101
Research Site
Toledo, Ohio, 43614
About this study
Official title: A Phase 1 Multicenter, Open-label Study to Evaluate the Safety and Tolerability of Single and Multiple Intravenous Doses of MEDI-546, a Fully Human Monoclonal Antibody Directed Against Subunit 1 of the Type I Interferon Receptor, in Adult Subjects With Scleroderma
To evaluate the safety and tolerability of a multiple-dosed drug (MEDI-546) in adults with scleroderma.
Read the detailed description
The primary objective of this study is to evaluate the safety and tolerability of single and multiple IV doses of MEDI-546 in adult subjects with scleroderma who have skin thickening in an area suitable for repeat biopsy.
- Conditions
- Scleroderma
- Being tested
- MEDI-546
- 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-546Drug
0.1 mg/kg MEDI-546 as a single IV dose
MEDI-546Drug
0.3 mg/kg MEDI-546 as a single IV dose
MEDI-546Drug
1.0 mg/kg MEDI-546 as a single IV dose
MEDI-546Drug
3.0 mg/kg MEDI-546 as a single IV dose
MEDI-546Drug
10.0 mg/kg MEDI-546 as a single IV dose
MEDI-546Drug
0.3 mg/kg MEDI-546 as a weekly IV dose x 4 doses
MEDI-546Drug
1.0 mg/kg MEDI-546 as a weekly IV dose x 4 doses
MEDI-546Drug
5.0 mg/kg MEDI-546 as a weekly IV dose x 4 doses
MEDI-546Drug
20.0 mg/kg MEDI-546 as a single IV dose
| Study group | Role | What they receive |
|---|---|---|
| 1 | Other | MEDI-546 Receives: Drug: MEDI-546 |
| 2 | Other | MEDI-546 Receives: Drug: MEDI-546 |
| 3 | Other | MEDI-546 Receives: Drug: MEDI-546 |
| 4 | Other | MEDI-546 Receives: Drug: MEDI-546 |
| 5 | Other | MEDI-546 Receives: Drug: MEDI-546 |
| 6 | Other | MEDI-546 Receives: Drug: MEDI-546 |
| 7 | Other | MEDI-546 Receives: Drug: MEDI-546 |
| 8 | Other | MEDI-546 Receives: Drug: MEDI-546 |
| 9 | Other | MEDI-546 Receives: Drug: MEDI-546 |
What is being measured
The primary outcome is the main question the study is designed to answer.
The safety and tolerability of MEDI-546 will be assessed primarily by summarizing treatment-emergent AEs and SAEs.
Measured: 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.
Measured: Study Day 84 for single-dose; Study Day 105 for multi-dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2009 (estimated)
- Study startSep 2009
- Primary completionMay 2010
- Study completionJul 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SclerodermaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- None (open label)
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- MedImmune LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Stephen Yoo, M.D., Study director, MedImmune LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00930683
- Sponsor's protocol ID
- MI-CP180
- Acronym
- MEDI-546
- Status last verified
- May 2012
- First submitted
- 29 Jun 2009
- Last updated
- 8 May 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 24559157
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Multicenter, Open-label Study to Evaluate the Safety and Tolerability of Single and Multiple Intravenous Doses of MEDI-546, a Fully Human Monoclonal Antibody Directed Against Subunit 1 of the Type I Interferon Receptor, in Adult Subjects With Scleroderma
- ClinicalTrials.gov ID
- NCT00930683
- Acronym / sponsor ID
- MEDI-546 / MI-CP180
- Conditions
- Scleroderma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- MedImmune LLCIndustry (pharma, biotech, devices)
- Study start
- Sep 2009
- Primary completion
- May 2010 (actual)
- Study completion
- Jul 2011 (actual)
- First posted
- 30 Jun 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To evaluate the safety and tolerability of a multiple-dosed drug (MEDI-546) in adults with scleroderma.
Detailed description
The primary objective of this study is to evaluate the safety and tolerability of single and multiple IV doses of MEDI-546 in adult subjects with scleroderma who have skin thickening in an area suitable for repeat biopsy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 9
| Arm | Type | Receives |
|---|---|---|
| 1 | Other | Drug: MEDI-546MEDI-546 |
| 2 | Other | Drug: MEDI-546MEDI-546 |
| 3 | Other | Drug: MEDI-546MEDI-546 |
| 4 | Other | Drug: MEDI-546MEDI-546 |
| 5 | Other | Drug: MEDI-546MEDI-546 |
| 6 | Other | Drug: MEDI-546MEDI-546 |
| 7 | Other | Drug: MEDI-546MEDI-546 |
| 8 | Other | Drug: MEDI-546MEDI-546 |
| 9 | Other | Drug: MEDI-546MEDI-546 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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;
Key exclusion criteria (43 listed)
- 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:
- Have received leflunomide > 20 mg/day within 6 months before entry;
- Have received fluctuating doses of the following within 28 days before entry:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MEDI-5460.1 mg/kg MEDI-546 as a single IV dose | Drug | 1 |
| MEDI-5460.3 mg/kg MEDI-546 as a single IV dose | Drug | 2 |
| MEDI-5461.0 mg/kg MEDI-546 as a single IV dose | Drug | 3 |
| MEDI-5463.0 mg/kg MEDI-546 as a single IV dose | Drug | 4 |
| MEDI-54610.0 mg/kg MEDI-546 as a single IV dose | Drug | 5 |
| MEDI-5460.3 mg/kg MEDI-546 as a weekly IV dose x 4 doses | Drug | 6 |
| MEDI-5461.0 mg/kg MEDI-546 as a weekly IV dose x 4 doses | Drug | 7 |
| MEDI-5465.0 mg/kg MEDI-546 as a weekly IV dose x 4 doses | Drug | 8 |
| MEDI-54620.0 mg/kg MEDI-546 as a single IV dose | Drug | 9 |
Primary outcome
The safety and tolerability of MEDI-546 will be assessed primarily by summarizing treatment-emergent AEs and SAEs.
Time frame: Study Day 84 for single-dose; Study Day 105 for multi-dose
1 secondary outcome
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.
Time frame: Study Day 84 for single-dose; Study Day 105 for multi-dose
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2012.
- Derived from this study: PubMed 24559157Goldberg 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.
Related trials for Scleroderma
Active, not recruiting
Patient Reported Outcomes With UVA-1 Therapy for Treatment of Sclerosing Skin Diseases
Scleroderma, Systemic, Morphea
Not yet recruitingPhase 1
A Phase 1 Study of QLS2416 Injection in Participants With Autoimmune Diseases
Systemic Lupus Erythematosus, Rheumatoid Arthritis (RA)
RecruitingPhase 1/2
A Phase 1/2 Study of NKX019 in Subjects With Immune-Mediated Diseases (Ntrust-2)
Systemic Sclerosis, Idiopathic Inflammatory Myopathies
Active, not recruitingObservational study
Cross-cultural Adaptation and Validation of the Localised Scleroderma Quality of Life Instrument (LoSQI) in Juvenile Localised Scleroderma (JLS)
Scleroderma
Recruiting
Tissue Modeling in Systemic Sclerosis Using Induced Pluripotent Stem Cells (iPSCs)
Systemic Sclerosis (SSc)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stephen Yoo, M.D. study director
MedImmune LLC
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing MEDI-546 in people with Scleroderma, run by MedImmune LLC at 11 sites in United States.
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 7 inclusion and 43 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 8 May 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in United States. 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. 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-546 will be assessed primarily by summarizing treatment-emergent AEs and SAEs. (time frame: Study Day 84 for single-dose; Study Day 105 for multi-dose). 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 NCT00930683, 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 8 May 2012.