Change in Corneal Nerve Fiber Area
| Group | Value (µm^2) | Spread |
|---|---|---|
| 1 mg Per Day ARA 290 | -64.3 | 759.9 |
| 4 mg Per Day ARA 290 | 533.8 | 1110.02 |
| 8 mg Per Day ARA 290 | 203.8 | 641.2 |
| Placebo | -170.0 | 633.0 |
Trial · Interventional
CompletedPhase 2Results postedRegistry dataUnited States, Netherlands
1 trial · 1 completed · 1 with posted results
Study of Efficacy of ARA 290 on Corneal Nerve Fiber Density and Neuropathic Symptoms of Subjects With Sarcoidosis
NCT02039687Jan 2014 to Feb 2015
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
The purpose of this study is to determine whether ARA 290, a new class of compound, is effective in the treatment of the neuropathic symptoms of sarcoidosis. Brief interaction of ARA 290 with the innate repair receptor results in anti-apoptotic and anti-inflammatory activities in myriad of cells, tissues and organs throughout the body to activate repair mechanisms and accelerate healing, including the nerve damage that can be associated with sarcoidosis. 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. In addition to monitoring the safety of the treatment, the symptoms of the subjects will be assessed with several questionnaires, function tests, and measurement of nerve fibers in their cornea and skin (via a non-invasive test and a biopsy, respectively). The total participation time for each patient will be 16 weeks.
Experimental
1 mg per day ARA 290
1 mg ARA 290 administered subcutaneously for 28 consecutive days
Experimental
4 mg per day ARA 290
4 mg ARA 290 administered subcutaneously for 28 consecutive days
Experimental
8 mg per day ARA 290
8 mg ARA 290 administered subcutaneously for 28 consecutive days
Placebo comparator
placebo
1 mL placebo administered subcutaneously for 28 consecutive days
Outcomes the sponsor listed as primary.
Change in Corneal Nerve Fiber Area
Time frame · Baseline and 28 days
Measurement of corneal nerve fiber area is a non-invasive procedure performed at baseline and at the end of dosing and at 12 weeks follow-up. The nerve fiber area in sarcoidosis patients is reduced compared to normal humans, a measurement of small fiber loss.
Change in the 6 Minute Walk Test
Time frame · Baseline and 28 days
Measurement of the distance a patient can walk in 6 minutes
Change in Intra-epidermal Nerve Fiber Density (IENFD)
Time frame · Baseline and 28 days
Measurement of small fiber density in skin biopsies. Density is reduced in sarcoidosis patients, an indication of neuropathy.
Change in the Scores of the SFNSL, BPI, NPSI, and FAS Questionnaires
Time frame · Baseline to 28 days
Change in mean score from baseline to Day 28 is recorded for each outcome. Brief Pain Inventory (BPI), Pain Severity - scale of 0 (no pain) to 10 (worst pain imaginable) in 4 time frames, averaged. BPI, Pain Interference - scale of 0 (does not interfere) to 10 (completely interferes) how pain interferes with 7 lifestyle parameters, averaged. Small Fiber Neuropathy Screening List (SFNSL) - scale of 0 to 84 (higher score indicates greater neuropathy), sum of 21 questions. Neuropathic Pain Symptom Inventory (NPSI) - scale of 0 (least pain) to 10 (most pain) in 10 questions, summed. Total score range from 0 to 100. Fatigue Assessment Scale (FAS) - scale of 1 (never) to 5 (always) in 10 questions related to fatigue, summed. Total score range from 0 to 50, with 0 being the best possible score and 50 the worst..
Frequency of Adverse Events, Serious Adverse Events, and Laboratory Parameters
Time frame · Continuous reporting from baseline through 16 weeks
Patients reporting at least one treatment emergent adverse event (TEAE) or serious TEAE
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
| Group | Value (µm^2) | Spread |
|---|---|---|
| 1 mg Per Day ARA 290 | -64.3 | 759.9 |
| 4 mg Per Day ARA 290 | 533.8 | 1110.02 |
| 8 mg Per Day ARA 290 | 203.8 | 641.2 |
| Placebo | -170.0 | 633.0 |
| Group | Value (meters) | Spread |
|---|---|---|
| 1 mg Per Day ARA 290 | 19.3 | 79.27 |
| 4 mg Per Day ARA 290 | 17.7 | 40.29 |
| 8 mg Per Day ARA 290 | 18.2 | 47.9 |
| Placebo | 1.2 | 38.56 |
| Group | Value (fibers/mm) | Spread |
|---|---|---|
| 1 mg Per Day ARA 290 | 0.5 | 1.58 |
| 4 mg Per Day ARA 290 | 0.4 | 2.28 |
| 8 mg Per Day ARA 290 | -0.3 | 1.81 |
| Placebo | 0.8 | 1.13 |
| Group | Value (units on a scale) | Spread |
|---|---|---|
| 1 mg Per Day ARA 290 | -0.594 | 1.6680 |
| 4 mg Per Day ARA 290 | -1.167 | 1.6894 |
| 8 mg Per Day ARA 290 | -1.115 | 1.7067 |
| Placebo | -0.922 | 1.4429 |
| Group | Value (Participants) |
|---|---|
| 1 mg Per Day ARA 290 | 14 |
| 4 mg Per Day ARA 290 | 11 |
| 8 mg Per Day ARA 290 | 12 |
| Placebo | 12 |
| Group | Deaths | Serious events | Other events |
|---|---|---|---|
| 1 mg Per Day ARA 2901 mg ARA 290 administered subcutaneously for 28 consecutive days ARA 290: A small peptide that activates the innate repair receptor to induce anti-inflammatory and tissue repair mechanisms. | – | 2 / 16 | 14 / 16 |
| 4 mg Per Day ARA 2904 mg ARA 290 administered subcutaneously for 28 consecutive days ARA 290: A small peptide that activates the innate repair receptor to induce anti-inflammatory and tissue repair mechanisms. | – | 0 / 16 | 11 / 16 |
| 8 mg Per Day ARA 2908 mg ARA 290 administered subcutaneously for 28 consecutive days ARA 290: A small peptide that activates the innate repair receptor to induce anti-inflammatory and tissue repair mechanisms. | – | 1 / 14 | 12 / 14 |
| Placebo1 mL placebo administered subcutaneously for 28 consecutive days Placebo: Formulation buffer | – | 0 / 16 | 12 / 16 |
Each cell reads participants affected / participants at risk, as the registry posted them.
Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works
Studies that cite this trial.
No study cites this trial.
Who could join, as posted.
PepBank is a research reference. Talk to a doctor before you use any peptide.
In PepBank now:147 peptides, 6 blends and 13 other compounds97,577 study results from 17,383 studies8,473 clinical trialsUpdated