Status and phase
Conditions
Treatments
About
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
Full 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.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
Exclusion criteria
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:
Change in standing daily dosage of the following within 21 days before randomization into the study:
At screening blood tests (within 21 days prior to randomization into the study), any of the following:
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:
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
Primary purpose
Allocation
Interventional model
Masking
50 participants in 6 patient groups, including a placebo group
Loading...
Data sourced from clinicaltrials.gov
Clinical trials
Research sites
Resources
Legal