chronic pain in sarcoidosis patients Sarcoid neuropathy
Conditions
Interventions
Subcutaneous injection ARA 290 (1 mg, 4 mg, or 8 mg) or placebo daily during 28
days
Sponsors
ARAIM Pharmaceuticals
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: The subjects will have to present the following criteria: Established diagnosis of sarcoidosis with both of the following two criteria: 1) Score of 4 or greater on Brief Pain Inventory *average pain* questions (BPI; 0 (least discomfort)-10 (worst discomfort)) 2) Discomfort defined as distal pain/discomfort plus one of the following: 1) dysesthesia, 2) burning/painful feet worsening at night, or 3) intolerance of sheets or clothes touching the legs or feet AND either of the following two criteria 1) Corneal nerve fiber density reduced compared to normal (i.e., greater than 1 standard deviation less than the mean of a normative population) 2) A previous skin biopsy (obtained within the prior 2 years) showing a reduced intraepidermal nerve fiber density ((i.e., greater than 1 standard deviation less than the mean of a normal age and gender relevant population);In addition, subjects must: * Be able to read and understand the written consent form, complete study-related procedures, and communicate with the study staff * Be willing to comply with study restrictions * Be willing to check in with the study center via the telephone * Between 18 and 70 years of age (inclusive) * Body Mass Index (BMI)
Exclusion criteria
Exclusion criteria: The subjects should not present any of the following criteria: * Medical history of clinically relevant physical and mental health condition other than conditions related to sarcoidosis, as judged by the investigator * Clinically relevant abnormal laboratory results, vital signs, or physical findings other than conditions related to sarcoidosis or could interfere with conduct of 6-minute walk assessment (as judged by the investigator) * Other medical conditions known to be associated with small nerve fiber loss, except for diabetes in good control (as judged by the investigator) Known clinically relevant abnormalities in ECG (as judged by the investigator) * Illicit drug abuse or excessive alcohol consumption (as judged by the investigator) * History of serious malignancy within the last 5 years other than a basal cell or squamous cell carcinoma that has been removed * History of severe allergies, or has had an anaphylactic reaction or significant intolerability to prescription or non-prescription drugs or food (as judged by the investigator) * Anti-TNF therapy or other biological anti-inflammatory agents administered within the 6 months prior to screening. * Use of erythropoiesis stimulating agents within the two months prior to screening or during the trial * 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 in the calendar year preceding study enrollment * Inadequate venous accessibility as judged by clinicians (physician or nurse) * Inability or unwillingness to self-administer ARA 290 via subcutaneous injections (or not have access to home health care for assistance in administration) * If female, pregnant or breast-feeding * Any other condition that in the opinion of the investigator would complicate or compromise the study, or the well-being of the subject
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To study the effect on cornea nerve fiber density. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary objectives are to assess: 1) The effect of different doses of ARA 290 on Intraepidermal Nerve Fiber Density (IENFD) of the ankle 2) the effect of different doses of ARA 290 on neuropathic symptoms in subjects with sarcoidosis 3) the effects of ARA 290 on general health and well-being, and 6 minute walk test, . 4) the safety of different doses ARA 290 administered subcutaneously (SC) daily for 28 days Exploratory objectives are to assess: 1) the effects of ARA 290 quantitative sensory testing, and on cardiac autonomic function (heart rate variability; R-R and QT intervals) | — |
Countries
Netherlands
Outcome results
None listed