Study of Efficacy of ARA 290 on Corneal Nerve Fiber Density and Neuropathic Symptoms of Subjects With Sarcoidosis

What Was Tested

The trial (phase 2) is built around ARA-290.

In this study, subjects with sarcoidosis and symptoms of small fiber neuropathy will administered ARA 290 or placebo by subcutaneous injection daily for 28 days.

It had four arms (groups): one (experimental), one (experimental), one (experimental) and placebo (placebo comparator).

The registry classes the interventions as drug and other.

More on the Plan

Up to 64 subjects with sarcoidosis and symptoms of small fiber neuropathy were planned to be enrolled in the study.

Subjects determined to be eligible at the screening visit were asked to return to the study site for the start of the treatment period (Visit 1, study day 1) within 28 days of screening.

Subjects who were not able to return for Visit 1 within 28 days of the screening visit could be rescreened.

The study drug (ARA 290 or placebo) was to be administered daily for 28 days via SC injection.

Who Took Part

The registry lists 64 actual participants took part.

It was open to people of any sex aged from 18 years up to 70 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Score of 4 or greater on Brief Pain Inventory "pain now" or "average pain" questions (BPI; 0 (least discomfort)-10 (worst discomfort)). 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. 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.

The full record lists 12 inclusion and 14 exclusion criteria; among the exclusions: 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 of the skin that has been removed.

How the Study Was Run

Design: randomized, parallel-group and quadruple-blind.

The participants were allocated by chance, so the ARA-290 group and the comparison group should start out alike.

The ARA-290 group and the comparison group ran side by side rather than switching.

Blinding on both sides kept the participants and researchers unaware of who received ARA-290.

Those kept unaware of assignments: participant, care provider, investigator and outcomes assessor.

It started in 2014-01 with completion listed for 2015-01.

It ran at 2 sites in United States (1) and Netherlands (1).

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Change in Corneal Nerve Fiber Area (time frame: Baseline and 28 days).

It also tracked 4 secondary outcomes, for example Change in the 6 Minute Walk Test, Change in Intra-epidermal Nerve Fiber Density (IENFD), Change in the Scores of the SFNSL, BPI, NPSI, and FAS Questionnaires and Frequency of Adverse Events, Serious Adverse Events, and Laboratory Parameters.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of ARA-290 in 64 people.

The trial is marked completed; results are posted on the registry, and this page does not restate them.

More context: the ARA-290 compound page, all human trials.