sarcoidosis small fiber neuropathy pain eye exams skin biopsy
Conditions
Interventions
Ara290 subcutuaneous during 28 days. Measurements will be done before and after this treatment. The control group will receive placebo, which exist of a saline solution subcutuaneously.
Sponsors
Leiden University Medical Center
Eligibility
Inclusion criteria
Inclusion criteria: 1. Age of 18 to 65 years (inclusive); 2. Body Mass Index (BMI) between 18 and 30 kg/m2 (inclusive) and body weight between 50 kg and 90 kg (inclusive); 3. Patient is able to read and understand the written consent form, complete study-related procedures, and communicate with the study staff; 4. Patient is willing to comply with study restrictions; 5. Diagnosis of sarcoidosis, as determined by the investigator; 6. Symptoms at screening AND at first dosing visit consistent with small fiber neuropathy with a spontaneous pain level ("Pain Now") of great than or equal to 5 and small fiber neuropathy screening list score (SFNSL; (6)) > 22, or pain 37; 7. Pain defined as distal pain plus one of the following: A. Dysparesthesias; B. Burning/painful feet worsening at night; C. Intolerance of sheets or clothes touching the legs or feet.
Exclusion criteria
Exclusion criteria: 1. Clinically relevant abnormal history of physical and mental health, as determined by medical history taking and physical examinations obtained during the screening visit and/or prior to the administration of the initial dose of the study drug (as judged by the investigator); 2. A semi recumbent systolic blood pressure of >150 mmHg and/or diastolic blood pressure of > 90 mmHg at screening; 3. History of alcoholism or substance abuse within three years prior to screening; 4. Positive pregnancy test; 5. Male patients habitually using more than 21 units of alcohol per week and female patients using more than 14 units of alcohol per week; 6. Male patient is unable/unwilling to use a medically acceptable method of contraception throughout the entire study period. Female patient is not using oral contraceptives, or is not post-menopausal (last menstrual period > 2 years ago and FSH > 25 IU/L), or surgically sterilized; 7. patient has a history of severe allergies, or has had an anaphylactic reaction or significant intolerability to prescription or non-prescription drugs or food; 8. Patient that received a vaccination or immunization within the last month; 9. Participation in an investigational drug trial in the 3 months prior to administration of the initial dose of study drug or more than 4 times per year; 10. Patient has undergone major surgery within three months prior to screening; 11. Donation or loss of blood (> 500 mL) within 3 months prior to screening; 12. Inadequate venous accessibility as judged by clinicians (physician or nurse); 13. Inability or unwillingness to self-administer ARA 290 via subcutaneous injections; 14. Quantitative sensory testing not consistent with small fiber neuropathy; 15. Any other condition that in the opinion of the investigator would complicate or compromise the study, or the well being of the patient.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Change in epidermal nerve fiber density; 2. Change in cutaneous sensitivity; 3. Change in visual test, OCT, oximap and/or CCM (eye department). | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Change in the small fiber neuropathy score; 2. Change in Brief Pain Inventory; 3. Change in 6 minut walking test. | — |
Contacts
Public ContactL.R. Heij
Afdeling Anesthesiologie, LUMC, P5
Outcome results
None listed