Study summary · research use only
Safety and efficacy of ARA 290 in sarcoidosis patients with symptoms of small fiber neuropathy: a randomized, double-blind pilot study
Plain-language summary
Paraphrased from the published abstract below — not a verdict on whether anything works.
This double-blind, placebo-controlled pilot trial in human patients with sarcoidosis and symptoms of small fiber neuropathy (SFN) tested ARA 290, a peptide designed to activate the innate repair receptor, given three times weekly by intravenous dosing (2 mg) versus placebo for 4 wks in 22 patients (12 ARA 290, 10 placebo). Endpoints assessed included pain intensity, SFNSL score, SF-36, IDS, and FAS. The authors reported no adverse clinical or laboratory findings, and a significant (p < 0.05) improvement at wk 4 in SFNSL score with ARA 290 versus placebo (Δ -11.5 ± 3.04 vs Δ -2.9 ± 3.34), plus significant changes in the SF-36 pain and physical functioning dimensions; BPI and FAS scores improved similarly in both groups and IDS was unchanged.
Abstract
ARA 290 (a peptide designed to activate the innate repair receptor that arrests injury and initiates cytoprotection, antiinflammation and healing) reduces allodynia in preclinical neuropathy models. We studied the safety and efficacy of ARA 290 to reduce symptoms of small fiber neuropathy (SFN) in patients with sarcoidosis. A total of 22 patients diagnosed with sarcoidosis and symptoms of SFN were enrolled in a double-blind, placebo-controlled exploratory trial consisting of three times weekly intravenous dosing of ARA 290 (2 mg; n = 12) or placebo (n = 10) for 4 wks. Inclusion criteria were a diagnosis of neuropathy and a spontaneous pain score of ≥5 (Brief Pain Inventory [BPI]). Endpoints assessed were changes in pain intensity and the small fiber neuropathy screening list (SFNSL) score, quality of life (SF-36), depressive symptoms (Inventory of Depressive Symptomatology [IDS]) and fatigue (Fatigue Assessment Scale [FAS]). No safety concerns were raised by clinical or laboratory assessments. The ARA 290 group showed significant (p < 0.05) improvement at wk 4 in SFNSL score compared with placebo (Δ -11.5 ± 3.04 versus Δ -2.9 ± 3.34 [standard error of the mean]). Additionally, the ARA 290 group showed a significant change from baseline in the pain and physical functioning dimensions of the SF-36 (Δ -23.4 ± 5.5 and Δ -14.6 ± 3.9, respectively). The mean BPI and FAS scores improved significantly but equivalently in both patient groups. No change was observed in the IDS. ARA 290 appears to be safe in patients with sarcoidosis and can reduce neuropathic symptoms.
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