Trial · NCT02039687
Study of Efficacy of ARA 290 on Corneal Nerve Fiber Density and Neuropathic Symptoms of Subjects With Sarcoidosis
NCT02039687, Phase 2, Completed, Araim Pharmaceuticals, Inc.; results first posted 2017-01-18
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Study of Efficacy of ARA 290 on Corneal Nerve Fiber Density and Neuropathic Symptoms of Subjects With Sarcoidosis. Trials, record NCT02039687. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02039687
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study of Efficacy of ARA 290 on Corneal Nerve Fiber Density and Neuropathic Symptoms of Subjects With Sarcoidosis
- NCT number
- NCT02039687
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 64 participants, actual
- Lead sponsor
- Araim Pharmaceuticals, Inc.
- Conditions
- Neuropathy of Sarcoidosis
- Interventions
- ARA 290, Placebo
- First posted
- 2014-01-20
- Last updated
- 2017-04-18
- Results first posted
- 2017-01-18
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in Corneal Nerve Fiber Area | 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. |
| Secondary | Change in the 6 Minute Walk Test | Baseline and 28 days | Measurement of the distance a patient can walk in 6 minutes |
| Secondary | Change in Intra-epidermal Nerve Fiber Density (IENFD) | Baseline and 28 days | Measurement of small fiber density in skin biopsies. Density is reduced in sarcoidosis patients, an indication of neuropathy. |
| Secondary | Change in the Scores of the SFNSL, BPI, NPSI, and FAS Questionnaires | 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.. |
| Secondary | Frequency of Adverse Events, Serious Adverse Events, and Laboratory Parameters | Continuous reporting from baseline through 16 weeks | Patients reporting at least one treatment emergent adverse event (TEAE) or serious TEAE |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change in Corneal Nerve Fiber Area | Baseline and 28 days | µm^2 | MEAN | |
| SECONDARY | Change in the 6 Minute Walk Test | Baseline and 28 days | meters | MEAN | |
| SECONDARY | Change in Intra-epidermal Nerve Fiber Density (IENFD) | Baseline and 28 days | fibers/mm | MEAN | |
| SECONDARY | Change in the Scores of the SFNSL, BPI, NPSI, and FAS Questionnaires | Baseline to 28 days | Questionnaires incomplete for some subjects | units on a scale | MEAN |
| SECONDARY | Frequency of Adverse Events, Serious Adverse Events, and Laboratory Parameters | Continuous reporting from baseline through 16 weeks | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group40
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change in Corneal Nerve Fiber Area | 1 mg Per Day ARA 290 | -64.3 | Standard Deviation 759.9 | µm^2 | |
| Change in Corneal Nerve Fiber Area | 4 mg Per Day ARA 290 | 533.8 | Standard Deviation 1110.02 | µm^2 | |
| Change in Corneal Nerve Fiber Area | 8 mg Per Day ARA 290 | 203.8 | Standard Deviation 641.2 | µm^2 | |
| Change in Corneal Nerve Fiber Area | Placebo | -170.0 | Standard Deviation 633.0 | µm^2 | |
| Change in the 6 Minute Walk Test | 1 mg Per Day ARA 290 | 19.3 | Standard Deviation 79.27 | meters | |
| Change in the 6 Minute Walk Test | 4 mg Per Day ARA 290 | 17.7 | Standard Deviation 40.29 | meters | |
| Change in the 6 Minute Walk Test | 8 mg Per Day ARA 290 | 18.2 | Standard Deviation 47.9 | meters | |
| Change in the 6 Minute Walk Test | Placebo | 1.2 | Standard Deviation 38.56 | meters | |
| Change in Intra-epidermal Nerve Fiber Density (IENFD) | 1 mg Per Day ARA 290 | 0.5 | Standard Deviation 1.58 | fibers/mm | |
| Change in Intra-epidermal Nerve Fiber Density (IENFD) | 4 mg Per Day ARA 290 | 0.4 | Standard Deviation 2.28 | fibers/mm |
1 to 10 of 40Source ClinicalTrials.gov
See all 40 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | 1 mg Per Day ARA 290 | 16 | |
| Overall Study | STARTED | 4 mg Per Day ARA 290 | 16 | |
| Overall Study | STARTED | 8 mg Per Day ARA 290 | 16 | |
| Overall Study | STARTED | Placebo | 16 | |
| Overall Study | COMPLETED | 1 mg Per Day ARA 290 | 16 | |
| Overall Study | COMPLETED | 4 mg Per Day ARA 290 | 15 | |
| Overall Study | COMPLETED | 8 mg Per Day ARA 290 | 13 | |
| Overall Study | COMPLETED | Placebo | 16 | |
| Overall Study | NOT COMPLETED | 1 mg Per Day ARA 290 | 0 | |
| Overall Study | NOT COMPLETED | 4 mg Per Day ARA 290 | 1 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events452
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Diarrhoea | Gastrointestinal disorders | 1 mg Per Day ARA 290 | 2 | 16 | 2 |
| other | Diarrhoea | Gastrointestinal disorders | 4 mg Per Day ARA 290 | 1 | 16 | 1 |
| other | Diarrhoea | Gastrointestinal disorders | 8 mg Per Day ARA 290 | 2 | 14 | 2 |
| other | Diarrhoea | Gastrointestinal disorders | Placebo | 2 | 16 | 2 |
| other | Nausea | Gastrointestinal disorders | 1 mg Per Day ARA 290 | 2 | 16 | 2 |
| other | Nausea | Gastrointestinal disorders | 4 mg Per Day ARA 290 | 2 | 16 | 2 |
| other | Nausea | Gastrointestinal disorders | 8 mg Per Day ARA 290 | 1 | 14 | 1 |
| other | Nausea | Gastrointestinal disorders | Placebo | 0 | 16 | 0 |
| other | Abdominal Pain | Gastrointestinal disorders | 1 mg Per Day ARA 290 | 1 | 16 | 1 |
| other | Abdominal Pain | Gastrointestinal disorders | 4 mg Per Day ARA 290 | 1 | 16 | 1 |
1 to 10 of 452Source ClinicalTrials.gov
See all 452 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | 1 mg Per Day ARA 290 | ||
| Total, all-cause mortality | 4 mg Per Day ARA 290 | ||
| Total, all-cause mortality | 8 mg Per Day ARA 290 | ||
| Total, all-cause mortality | Placebo | ||
| Total, other adverse events | 1 mg Per Day ARA 290 | 14 | 16 |
| Total, other adverse events | 4 mg Per Day ARA 290 | 11 | 16 |
| Total, other adverse events | 8 mg Per Day ARA 290 | 12 | 14 |
| Total, other adverse events | Placebo | 12 | 16 |
| Total, serious adverse events | 1 mg Per Day ARA 290 | 2 | 16 |
| Total, serious adverse events | 4 mg Per Day ARA 290 | 0 | 16 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02039687
GET https://conductscience.org/api/trials/v1/NCT02039687/results?page=2