DERMATOMYOSITIS OR POLYMYOSITISPhase 1NCT00533091
A Study to Evaluate Safety of Multi-Dose MEDI-545 in Adult Patients With Dermatomyositis or Polymyositis
A Phase 1 study testing MEDI-545 in people with DERMATOMYOSITIS OR POLYMYOSITIS, run by MedImmune LLC at 14 sites in United States.
Trial summary
The primary objective of the study is to evaluate the safety and tolerability of multiple IV doses of MEDI-545 in adult patients with myositis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- DERMATOMYOSITIS OR POLYMYOSITIS
- What is being tested?
- MEDI-545
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 51 participants
- Where
- 14 sitesUnited States
- Study dates
- Apr 2008to Oct 2010
- 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 adults at least 18 years of age at the time of randomization;
- Written informed consent obtained from the patient or the patient's legal representative prior to receipt of any study medication or beginning study procedures;
- Probable or definite PM or DM according to the Bohan and Peter criteria (Bohan, 1975);
- For patients with PM, documentation of a muscle biopsy result that is consistent with the diagnosis of PM;
- All patients including those with DM must meet at least two of the following criteria:
- Strength in MMT greater ≥ 80/150 but ≤ 125/150 using the MMT-8 muscle group testing;
Show all 16Show fewer
- Patient Global Activity Assessment by visual analog scale (VAS)≥ 2.0 cm on a 10 cm scale, which is included as part of CLINHAQ;
- Physician Global Activity Assessment by VAS ≥ 2.0 cm on a 10 cm scale, which is included as part of MDAAT;
- CLINHAQ disability index ≥ 0.25;
- Global extramuscular activity assessment ≥ 1.0 cm on a 10-cm VAS scale (this measure is the physician's composite evaluation and is based on assessments of activity scores on the constitutional, cutaneous, skeletal, gastrointestinal, pulmonary and cardiovascular scales of the MDAAT;
- Subjects with PM must have an elevation of serum CK or aldolase at a minimum level of 1.3 x upper limit of normal (ULN) or serum CK or aldolase at least 2-fold higher than the patient's own lowest value since diagnosis;
- Subjects with DM must have either an elevated CK or aldolase as above (per inclusion criterion #6) or other laboratory evidence of active myositis. This could include either abnormal signal on skeletal muscle MRI suggestive of inflammation or an electromyogram demonstrated muscle membrane irritability (e.g., fibrillation potentials, positive sharp waves, complex repetitive discharges) and short duration, small amplitude, polyphasic motor unit action potentials;
- For patients randomized to Dose Cohorts 1.2, 3A and 4: median fold overexpression of the top 25 type I IFN inducible genes of four-fold or greater in whole blood at the time of screening; For patients randomized to dose cohort 3B: low or negative expression of type I IFN-inducible genes;
- Sexually active women, unless surgically sterile (including tubal ligation) or at least 2 years postmenopausal, 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 screening through end of study. Cessation of birth control after this point should be discussed with a responsible physician. Sexually active males, unless surgically sterile, must likewise practice two effective methods of birth control (condom with spermicide or abstinence) and must use such precautions from Study Day 0 through end of study;
- Ability to complete the study period, including follow-up period, of up to 350 days; and
- Willing to forego other forms of experimental treatment during the study.
Who cannot join
- Receipt of MEDI-545 in any previous clinical study or prior randomization into the trial;
- History of allergy or reaction to any component of the study drug formulation;
- Inclusion body myositis, cancer-associated myositis, myositis associated with another connective tissue disease, environmentally-associated myositis, or drug-related myopathy;
- A history of or a family history of noninflammatory myopathy, scapular winging, atrophy, or hypertrophy of the calf muscles;
- Receiving prednisone > 35 mg/day (or an equivalent dose of another corticosteroid) within 14 days before Study Day 0;
- Receiving the following dosages of medications within 28 days before Study Day 0: hydroxychloroquine > 600 mg/day, mycophenolate mofetil > 3 g/day, methotrexate > 25 mg/week, azathioprine > 3 mg/kg/day, or any dose of cyclophosphamide, cyclosporine, or thalidomide;
Show all 28Show fewer
- Have received fluctuating doses of antimalarials, mycophenolate mofetil, methotrexate, leflunomide, or azathioprine within 28 days before Study Day 0 or fluctuating doses of corticosteroids within 14 days before Study Day 0;
- Have received leflunomide > 20 mg/day in the 6 months prior to Study Day 0;
- Treatment with any investigational drug therapy within 28 days before Study Day 0 or biologic therapies (eg, rituximab) within 30 days or 5 half-lives of the biologic agent, whichever is longer, before Study Day 0;
- In the investigator's opinion, evidence of clinically significant active infection, including ongoing, chronic infection, within 28 days before Study Day 0;
- A history of severe viral infection as judged by the investigators, including severe infections of either CMV or the herpes family such as disseminated herpes, herpes encephalitis, ophthalmic herpes;
- Herpes zoster ≤ 3 months prior to Study Day 0;
- Evidence of infection with hepatitis B or C virus or 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 Study Day 0;
- Pregnancy (sexually active women, unless surgically sterile or at least 2 years post-menopausal, must have a negative serum pregnancy test at screening and a negative urine pregnancy test prior to study drug administration on Study Day 0);
- Breastfeeding or lactating women;
- History of alcohol or drug abuse < 1 year prior to Study Day 0;
- History of cancer, except for basal cell carcinoma or carcinoma in situ of the cervix treated with apparent success with curative therapy more than 1 year prior to Study Day 0;
- History of active tuberculous infection;
- History of latent tuberculous infection or newly positive TB skin test (reaction defined as ≥ 10 mm in diameter if not on systemic immunosuppressive medication or ≥ 5 mm if on systemic immunosuppressive medication) without completion of an appropriate course of treatment or ongoing prophylactic therapy;
- A history of coagulation disorders that in the opinion of the investigator would contraindicate skin or muscle biopsies;
- Elective surgery planned from the time of screening through Study Day 196;
- At screening blood tests (must be within 28days before Study Day 0) any of the following:
- Serum 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 DM or PM), any finding upon physical examination, or any laboratory abnormality, that, in the opinion of the investigator or medical monitor, may compromise the safety of the patient 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.
Trial locations and contacts
14 sites in 1 country.
14 sites in 1 country
United States14 sites
Research Site
Baltimore, Maryland, 21224
Research Site
Boston, Massachusetts, 02115
Research Site
Cumberland, Maryland, 21502
Research Site
Duncansville, Pennsylvania, 16635
Research Site
Evansville, Indiana, 47714
Research Site
Fort Lauderdale, Florida, 33334
Research Site
Kansas City, Kansas, 66160
Research Site
Lake Success, New York, 11042
Research Site
Lebanon, New Hampshire, 03756
Research Site
Miami, Florida, 33136
Research Site
Portland, Oregon, 97239
Research Site
Scottsdale, Arizona, 85258
Research Site
Stanford, California, 94305
Research Site
Whittier, California, 90606
About this study
Official title: A Phase 1B, Randomized, Double-blind, Placebo-Controlled, Multicenter Study to Evaluate Safety of Multiple-Dose, Intravenously Administered MEDI-545, A Fully Human Anti Interferon-Alpha Monoclonal Antibody, In Adult Patients With Dermatomyositis or Polymyositis
The primary objective of the study is to evaluate the safety and tolerability of multiple IV doses of MEDI-545 in adult patients with myositis.
Read the detailed description
The primary objective of the study is to evaluate the safety and tolerability of multiple intravenous (IV) doses of MEDI-545 in adult patients with dermatomyositis (DM) or polymyositis (PM).
- Conditions
- DERMATOMYOSITIS OR POLYMYOSITIS
- Being tested
- MEDI-545, Placebo
- Medical subject headings
- Dermatomyositis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MEDI-545Biological
MEDI-545 is supplied as a sterile liquid containing 0.75 mL of MEDI-545 solution at a concentration of 100 mg/mL in a 3 mL single-use glass vial.
Dosage, frequency and duration: MEDI-545 (0.3, 1.0, 3.0, or 10.0 mg/kg) will be administered via infusion over at least 60 minutes every 2 weeks for 26 weeks.
PlaceboOther
Dosage form: Placebo is supplied as a sterile liquid containing a 0.75 mL solution in a 3 mL single-use vial.
Dosage, frequency and duration: Placebo (0.3, 1.0, 3.0, or 10.0 mg/kg) will be administered via infusion over at least 60 minutes every 2 weeks for 12 weeks.
Thereafter, subjects will receive MEDI-545, at the dose specified in the dose cohort they are assigned, every 2 weeks for an additional 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | MEDI-545 Receives: Biological: MEDI-545 |
| 2 | Other | Placebo Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary endpoints of the study are safety and tolerability of multiple intravenous (IV) doses of MEDI-545 in adult patients with Dermatomyositis or Polymyositis, assessed primarily by summarizing AEs assessing changes in viral cultures and titers.
Measured: 12 months
Secondary outcomes (2)
The secondary endpoints of the study are the PK and IM of multiple IV doses of MEDI-545.
Measured: 12 months
The third endpoint of the study are the evaluations of disease activities.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2007 (estimated)
- Study startApr 2008
- Primary completionAug 2010
- Study completionOct 2010
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 DERMATOMYOSITIS OR POLYMYOSITISStudies 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- MedImmune LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Dominique Ethgen, M.D., Study director, MedImmune LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00533091
- Sponsor's protocol ID
- MI-CP151
- Status last verified
- May 2012
- First submitted
- 20 Sep 2007
- Last updated
- 28 May 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Higgs BW, Zhu W, Morehouse C, White WI, Brohawn P, Guo X, Rebelatto M, Le C, Amato A, Fiorentino D, Greenberg SA, Drappa J, Richman L, Greth W, Jallal B, Yao Y. A phase 1b clinical trial evaluating sifalimumab, an anti-IFN-alpha monoclonal antibody, shows target neutralisation of a type I IFN signature in blood of dermatomyositis and polymyositis patients. Ann Rheum Dis. 2014 Jan;73(1):256-62. doi: 10.1136/annrheumdis-2012-202794. Epub 2013 Feb 23.
PubMed 23434567
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1B, Randomized, Double-blind, Placebo-Controlled, Multicenter Study to Evaluate Safety of Multiple-Dose, Intravenously Administered MEDI-545, A Fully Human Anti Interferon-Alpha Monoclonal Antibody, In Adult Patients With Dermatomyositis or Polymyositis
- ClinicalTrials.gov ID
- NCT00533091
- Acronym / sponsor ID
- MI-CP151
- Conditions
- DERMATOMYOSITIS OR POLYMYOSITIS
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- MedImmune LLCIndustry (pharma, biotech, devices)
- Study start
- Apr 2008
- Primary completion
- Aug 2010 (actual)
- Study completion
- Oct 2010 (actual)
- First posted
- 21 Sep 2007 (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.
The primary objective of the study is to evaluate the safety and tolerability of multiple IV doses of MEDI-545 in adult patients with myositis.
Detailed description
The primary objective of the study is to evaluate the safety and tolerability of multiple intravenous (IV) doses of MEDI-545 in adult patients with dermatomyositis (DM) or polymyositis (PM).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Biological: MEDI-545MEDI-545 |
| 2 | Other | Other: PlaceboPlacebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Male or female adults at least 18 years of age at the time of randomization;
- Written informed consent obtained from the patient or the patient's legal representative prior to receipt of any study medication or beginning study procedures;
- Probable or definite PM or DM according to the Bohan and Peter criteria (Bohan, 1975);
- For patients with PM, documentation of a muscle biopsy result that is consistent with the diagnosis of PM;
- All patients including those with DM must meet at least two of the following criteria:
Key exclusion criteria (28 listed)
- Receipt of MEDI-545 in any previous clinical study or prior randomization into the trial;
- History of allergy or reaction to any component of the study drug formulation;
- Inclusion body myositis, cancer-associated myositis, myositis associated with another connective tissue disease, environmentally-associated myositis, or drug-related myopathy;
- A history of or a family history of noninflammatory myopathy, scapular winging, atrophy, or hypertrophy of the calf muscles;
- Receiving prednisone > 35 mg/day (or an equivalent dose of another corticosteroid) within 14 days before Study Day 0;
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-545MEDI-545 is supplied as a sterile liquid containing 0.75 mL of MEDI-545 solution at a concentration of 100 mg/mL in a 3 mL single-use glass vial. Dosage, frequency and duration: MEDI-545 (0.3, 1.0, 3.0, or 10.0 mg/kg) will be administered via infusion over at least 60 minutes every 2 weeks for 26 weeks. | Biological | 1 |
| PlaceboDosage form: Placebo is supplied as a sterile liquid containing a 0.75 mL solution in a 3 mL single-use vial. Dosage, frequency and duration: Placebo (0.3, 1.0, 3.0, or 10.0 mg/kg) will be administered via infusion over at least 60 minutes every 2 weeks for 12 weeks. Thereafter, subjects will receive MEDI-545, at the dose specified in the dose cohort they are assigned, every 2 weeks for an additional 12 weeks. | Other | 2 |
Primary outcome
The primary endpoints of the study are safety and tolerability of multiple intravenous (IV) doses of MEDI-545 in adult patients with Dermatomyositis or Polymyositis, assessed primarily by summarizing AEs assessing changes in viral cultures and titers.
Time frame: 12 months
2 secondary outcomes
The secondary endpoints of the study are the PK and IM of multiple IV doses of MEDI-545.
Time frame: 12 months
The third endpoint of the study are the evaluations of disease activities.
Time frame: 12 months
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 28 May 2012.
- Derived from this study: PubMed 23434567Higgs BW, Zhu W, Morehouse C, White WI, Brohawn P, Guo X, Rebelatto M, Le C, Amato A, Fiorentino D, Greenberg SA, Drappa J, Richman L, Greth W, Jallal B, Yao Y. A phase 1b clinical trial evaluating sifalimumab, an anti-IFN-alpha monoclonal antibody, shows target neutralisation of a type I IFN signature in blood of dermatomyositis and polymyositis patients. Ann Rheum Dis. 2014 Jan;73(1):256-62. doi: 10.1136/annrheumdis-2012-202794. Epub 2013 Feb 23.
Related trials for DERMATOMYOSITIS OR POLYMYOSITIS
RecruitingPhase 2
FAST for DM - Fatty Acid Supplementation Trial (FAST) for Dermatomyositis (DM)
Dermatomyositis (DM), Juvenile Dermatomyositis (JDM)
Active, not recruitingPhase 2
A Study to Evaluate Safety and Efficacy of Empasiprubart in Adults With Dermatomyositis
Dermatomyositis, Myositis
RecruitingObservational study
Natural History of Inflammatory Muscle Diseases
Inflammation In Skeletal Muscle
RecruitingPhase 1
A Study to Investigate the Safety and Preliminary Efficacy of ALLO-329, an Allogeneic CAR T-cell Therapy, in Adults With Autoimmune Disease
Systemic Lupus Erythematosus (With and Without Nephritis), Idiopathic Inflammatory Myopathy
RecruitingPhase 2
Topical Ruxolitinib Cream for Refractory Cutaneous Dermatomyositis
Dermatomyositis
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.
Dominique Ethgen, M.D. study director
MedImmune LLC
14 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-545 in people with DERMATOMYOSITIS OR POLYMYOSITIS, run by MedImmune LLC at 14 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 16 inclusion and 28 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 28 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 14 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 primary endpoints of the study are safety and tolerability of multiple intravenous (IV) doses of MEDI-545 in adult patients with Dermatomyositis or Polymyositis, assessed primarily by summarizing AEs assessing changes in viral cultures and titers. (time frame: 12 months). 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 NCT00533091, 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 28 May 2012.