A Study Of The Safety And Tolerability Of JNJ-55920839, Either As A Single Ascending Dose In Healthy Individuals Or As Multiple Doses For Patients Who Have Mild To Moderate Systemic Lupus Erythematosus
Overview
Tab Title Description
Study type
InterventionalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Rochester, Minnesota: 16-005510
NCT ID: NCT02609789
Sponsor Protocol Number: 55920839SLE1001
About this study
The purpose of this study is to assess the safety and tolerability of JNJ-55920839 either as a single ascending intravenous (IV) dose administration in healthy participants or multiple IV dose administrations in patients with mild to moderate Systemic Lupus Erythematosus.
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
Inclusion Criteria
- Healthy Participants
- Must be willing/able to adhere to the study visit schedule and other requirements, prohibitions, and restrictions specified in this protocol
- Must have a body weight in the range of 50 to 90 kilogram (kg) inclusive, and have a body mass index (BMI) of 18 to 30 kilogram per square meters kg/m^2 inclusive, at screening
- Must be healthy on the basis of physical examination, medical history, vital signs, and 12-lead electrocardiogram (ECG) performed at screening
- Must be recorded in the participant's source documents and initialed by the investigator
- Must be healthy on the basis of clinical laboratory tests performed at screening
- Females must not be of childbearing potential, such as
- Postmenopausal
- > 45 years of age with amenorrhea for at least 12 months
- Any age with amenorrhea for at least 6 months and a serum follicle stimulating hormone (FSH) level >40 international units per liters (IU/L) or mIU/mL)
- Permanently sterilized
- Bilateral tubal occlusion which includes tubal ligation procedures as consistent with local regulations
- Hysterectomy
- Bilateral salpingectomy
- Bilateral oophorectomy
- Otherwise incapable of pregnancy
- A woman must agree not to donate eggs (ova, oocytes) for the purposes of assisted reproduction during the study and for 4 months (≥ 5 half-lives) after receiving last dose of study agent
- A man who is sexually active with a woman of childbearing potential and has not had a vasectomy
- Must agree to use a barrier method of birth control , either
- Condom with spermicidal foam/gel/film/cream/suppository
- Partner with occlusive cap, diaphragm or cervical/vault caps with spermicidal foam/gel/film/cream/suppository
- All men must also not donate sperm during the study and for 4 months (≥ 5 half-lives) after receiving the last dose of study agent
- Participants with Systemic Lupus Erythematosus
- Must be willing/able to adhere to the study visit schedule and other requirements, prohibitions, and restrictions specified in this protocol
- Must have a body weight in the range of 40 to 100 kg inclusive
- Must have a BMI of 18 to 30 kilograms per square meters (kg/m^2) inclusive at screening
- Must meet Systemic Lupus International Collaborating Clinics (SLICC) criteria for diagnosis of lupus
Exclusion Criteria
- Healthy Participants
- Currently has or has had a history of any clinically significant medical illness or medical disorders the investigator considers significant, including but not limited to
- Neuromuscular disorder
- Hematological disease
- Immune deficiency states
- Respiratory disease
- Cardiovascular disease (including poor peripheral venous access)
- Hepatic or gastrointestinal (GI) disease
- Neurological or psychiatric disease
- Ophthalmological disorders
- Neoplastic disease
- Renal or urinary tract diseases
- Dermatological disease
- Careful consideration should be given to past or current signs and symptoms of severe, progressive, or uncontrolled
- Hepatic disease
- Hematological disease
- Gastrointestinal disease
- Endocrine disease
- Pulmonary disease
- Cardiac disease
- Neurologic/ cerebral disease
- Psychiatric disease
- Has a condition that might confound assessments including major surgery, substance abuse or acute illness
- Is a woman of childbearing potential, is pregnant, breast-feeding, or planning to become pregnant while enrolled in this study or within 4 months (≥5 half-lives) after the last dose of study agent
- Participants with Systemic Lupus Erythematosus
- History or suspected occurrence of drug-induced SLE
- Has active Central nervous system (CNS) lupus or history of severe CNS lupus including but not limited to
- Seizures
- Psychosis
- Transverse myelitis
- CNS vasculitis
- Optic neuritis
- Currently has or has had a history of any clinically significant medical illness or medical disorder the investigator considers significant, including but not limited to
- Neuromuscular disorder
- Hematological disease
- Immune deficiency states
- Respiratory disease
- Cardiovascular disease, including poor peripheral venous access
- Hepatic or gastrointestinal (GI) disease
- Neurological or psychiatric disease
- Ophthalmological disorders
- Neoplastic disease
- Renal or urinary tract diseases
- Dermatological disease
- Careful consideration should be given to past or current signs and symptoms of severe, progressive, or uncontrolled
- Hepatic Disease
- Hematological Disease
- Gastrointestinal Disease
- Endocrine Disease
- Pulmonary Disease
- Cardiac Disease
- Neurologic/ cerebral Disease
- Psychiatric disease
- Has had major surgery requiring general anesthesia within 4 months before screening, and will not have fully recovered from surgery
- Has surgery planned within 4 weeks prior to study agent administration, or during the expected study participation time, or within 4 months (≥5 half-lives) after the last dose of study agent administration
- Has laboratory findings or biopsy results consistent with severe lupus nephritis
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
| Mayo Clinic Location |
Status |
|
Rochester, Minn.
Mayo Clinic principal investigator |
Closed for enrollment |
|
More information
Publications
Publications are currently not available