Safety and efficacy of ARA 290 in sarcoidosis patients with symptoms of small fiber neuropathy: a randomized, double-blind pilot study.

Heij L, Niesters M, Swartjes M, Hoitsma E, Drent M, Dunne A, Grutters JC, Vogels O, Brines M, Cerami A, Dahan A

Molecular medicine (Cambridge, Mass.)15 Nov 2012Cited by 74 (Europe PMC)

PMID23168581PMCIDPMC3563705DOI10.2119/molmed.2012.00332PepBankPUB-23168581

Summary

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.

CC BYText from Europe PMC. Highlighted sentences are the source of results.

Results from this study7

7 results from studies that gave the peptide. 7 results from people.

01HumanRandomized controlled trialSafety outcome
In patients with sarcoidosis and small fiber neuropathy symptoms, clinical and laboratory assessments raised no safety concerns with ARA‑290.
In plain wordsIn people with sarcoidosis and nerve symptoms, tests and checks raised no safety concerns with ARA‑290 in this small study.
Peptide
Cibinetide (ARA-290)
Outcome
No significant changeSafety (clinical and laboratory assessments)
Study
n = 22
Comparator
Placebo
Outcome group
Adverse events · Whole body
Studied dose
2 mg three times weekly · intravenous · 4 weeksAs given in this study (human).
Source sentences
Summary
No safety concerns were raised by clinical or laboratory assessments.
1 context sentence(design, population, supporting numbers)
Summary · context
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.
Show in the study text Report a problemFND-2316858101
02HumanRandomized controlled trialEfficacy outcome
In patients with sarcoidosis, ARA‑290 significantly improved the small fiber neuropathy screening list score at week 4 compared with placebo.
In plain wordsIn people with sarcoidosis and nerve symptoms, ARA‑290 improved a nerve symptom score at week 4 more than placebo did.
Peptide
Cibinetide (ARA-290)
Outcome
DecreaseSFNSL score change at week 4
Study
n = 22
Comparator
Placebo
Outcome group
Pain · Nervous system and cognition
Studied dose
2 mg three times weekly · intravenous · 4 weeksAs given in this study (human).
Measurements
SFNSL score change
−11.5 points
ARA 290
SFNSL score change
−2.9 points
Placebo
Source sentences
Summary
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]).
1 context sentence(design, population, supporting numbers)
Summary · context
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.
Show in the study text Report a problemFND-2316858102
03HumanRandomized controlled trialEfficacy outcome
In patients with sarcoidosis, mean BPI scores improved significantly but equivalently in the ARA‑290 and placebo groups, so the improvement was not specific to ARA‑290.
In plain wordsIn people with sarcoidosis and nerve symptoms, pain scores improved about equally with ARA‑290 and with placebo.
Peptide
Cibinetide (ARA-290)
Outcome
No significant changeBrief Pain Inventory (BPI) score
Study
n = 22
Comparator
Placebo
Outcome group
Pain · Nervous system and cognition
Studied dose
2 mg three times weekly · intravenous · 4 weeksAs given in this study (human).
Source sentences
Summary
The mean BPI and FAS scores improved significantly but equivalently in both patient groups.
1 context sentence(design, population, supporting numbers)
Summary · context
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.
Show in the study text Report a problemFND-2316858105
04HumanRandomized controlled trialEfficacy outcome
In patients with sarcoidosis, mean FAS scores improved significantly but equivalently in the ARA‑290 and placebo groups, so the improvement was not specific to ARA‑290.
In plain wordsIn people with sarcoidosis and nerve symptoms, tiredness scores improved about equally with ARA‑290 and with placebo.
Peptide
Cibinetide (ARA-290)
Outcome
No significant changeFatigue Assessment Scale (FAS) score
Study
n = 22
Comparator
Placebo
Outcome group
Exercise and physical function · Whole body
Studied dose
2 mg three times weekly · intravenous · 4 weeksAs given in this study (human).
Source sentences
Summary
The mean BPI and FAS scores improved significantly but equivalently in both patient groups.
1 context sentence(design, population, supporting numbers)
Summary · context
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.
Show in the study text Report a problemFND-2316858106
05HumanRandomized controlled trialEfficacy outcome
In patients with sarcoidosis, no change was observed in the Inventory of Depressive Symptomatology after ARA‑290.
In plain wordsIn people with sarcoidosis and nerve symptoms, depression symptom scores did not change with ARA‑290.
Peptide
Cibinetide (ARA-290)
Outcome
No significant changeDepressive symptoms (IDS)
Study
n = 22
Outcome group
Anxiety and mood · Mental health and mood
Studied dose
2 mg three times weekly · intravenous · 4 weeksAs given in this study (human).
Source sentences
Summary
No change was observed in the IDS.
1 context sentence(design, population, supporting numbers)
Summary · context
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.
Show in the study text Report a problemFND-2316858107
06HumanRandomized controlled trialEfficacy outcome
In patients with sarcoidosis, the ARA‑290 group showed a significant change from baseline in the pain dimension of the SF-36.
In plain wordsIn people with sarcoidosis and nerve symptoms, the ARA‑290 group had a clear change from baseline in a pain quality-of-life score.
Peptide
Cibinetide (ARA-290)
Outcome
Direction not reportedSF-36 pain dimension change from baseline
Study
n = 12
Comparator
Baseline
Outcome group
Pain · Nervous system and cognition
Studied dose
2 mg three times weekly · intravenous · 4 weeksAs given in this study (human).
Measurements
SF-36 pain dimension change
−23.4 points
ARA 290
Source sentences
Summary
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).
1 context sentence(design, population, supporting numbers)
Summary · context
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.
Show in the study text Report a problemFND-2316858103
07HumanRandomized controlled trialEfficacy outcome
In patients with sarcoidosis, the ARA‑290 group showed a significant change from baseline in the physical functioning dimension of the SF-36.
In plain wordsIn people with sarcoidosis and nerve symptoms, the ARA‑290 group had a clear change from baseline in a physical function quality-of-life score.
Peptide
Cibinetide (ARA-290)
Outcome
Direction not reportedSF-36 physical functioning dimension change from baseline
Study
n = 12
Comparator
Baseline
Outcome group
Exercise and physical function · Nervous system and cognition
Studied dose
2 mg three times weekly · intravenous · 4 weeksAs given in this study (human).
Measurements
SF-36 physical functioning change
−14.6 points
ARA 290
Source sentences
Summary
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).
1 context sentence(design, population, supporting numbers)
Summary · context
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.
Show in the study text Report a problemFND-2316858104

AI wrote and checked these results. AI can make mistakes, so check important results against the source.

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Version 2Current
9 Oct 2026, 19:08 UTC
Study results updated
Version 1
9 Oct 2026, 03:13 UTC
First added · source update from Europe PMC

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