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

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT02039687
• Date of registration: 16/01/2014
• Prospective Registration: No
• Primary sponsor: Araim Pharmaceuticals, Inc.
• Public title: Study of Efficacy of ARA 290 on Corneal Nerve Fiber Density and Neuropathic Symptoms of Subjects With Sarcoidosis
• Scientific title: A Double Blind, Placebo Controlled Phase 2 Dose Ranging Study of the Effects of ARA 290 on Corneal Nerve Fiber Density and Neuropathic Symptoms of Subjects With Sarcoidosis
• Date of first enrolment: January 2014
• Target sample size: 64
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02039687
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 2

Countries of recruitment

Netherlands, United States

Contacts

• Name: Micheal Brines, MD, PhD
• Affiliation: Araim Pharmaceuticals, Inc.

Key inclusion & exclusion criteria

Inclusion Criteria:

• Established diagnosis of sarcoidosis with both of the following two criteria:

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

2. 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

AND either of the following two criteria

1. Corneal nerve fiber density reduced compared to normal (i.e., greater than 1 standard
deviation less than the mean of a normative population)

2. A previous skin biopsy (obtained within the prior 2 years) showing a reduced
intraepidermal nerve fiber density ((i.e., greater than 1 standard deviation less than
the mean of a normal age and gender relevant population)

In addition, subjects must:

- 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

- Between 18 and 70 years of age (inclusive)

- Body Mass Index (BMI) < 40 kg/m2 (inclusive)

- If female of childbearing potential, a negative urine pregnancy test at screening and
acceptable contraception will be maintained during the screening and dosing period and
1 month beyond. Acceptable contraception consists of hormonal methods such as oral,
implantable, injectable, or transdermal contraceptives for a minimum of 1 full cycle
(based on the subject's usual menstrual cycle period) before study entry, intrauterine
device (IUD), or double barrier method (condoms, sponge, diaphragm, or vaginal ring
with spermicidal jellies or cream).

- Able to complete self-administered questionnaires (RAND-36, SFNSL, BPI, FAS, NPSI)

- Refrigerator and freezer at home for storage of study medication.

Exclusion Criteria:

- Clinically relevant abnormal history of physical and mental health other than
conditions related to sarcoidosis, as determined by medical history taking (as judged
by the investigator)

- Clinically relevant abnormal laboratory results, vital signs, or physical findings
other than conditions related to sarcoidosis or could interfere with conduct of
6-minute walk assessment (as judged by the investigator)

- Other medical conditions known to be associated with small nerve fiber loss, except
for diabetes in good control (as judged by the investigator)

- 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

- History of severe allergies, or has had an anaphylactic reaction or significant
intolerability to prescription or non-prescription drugs or food (as judged by the
investigator)

- Anti-TNF therapy, other biological anti-inflammatory agents, or immunoglobulins
administered within the 3 months prior to screening.

- Use of erythropoiesis stimulating agents within the two months prior to screening or
during the trial

- Participation in an investigational drug trial in the 3 months prior to administration
of the initial dose of study drug or more than 4 times in the calendar year preceding
study enrollment

- Inadequate venous accessibility as judged by clinicians (physician or nurse)

- Inability or unwillingness to self-administer ARA 290 via subcutaneous injections (or
not have access to home health care for assistance in administration)

- If female, pregnant or breast-feeding

- Any other condition that in the opinion of the investigator would complicate or
compromise the study, or the well-being of the subject



Age minimum: 18 Years
Age maximum: 70 Years
Gender: All

Health Condition(s) or Problem(s) studied

Neuropathy of Sarcoidosis

Intervention(s)

Other: Placebo

Drug: ARA 290

Primary Outcome(s)

Change in Corneal Nerve Fiber Area [Time Frame: Baseline and 28 days]

Secondary Outcome(s)

Change in the Scores of the SFNSL, BPI, NPSI, and FAS Questionnaires [Time Frame: Baseline to 28 days]

Change in the 6 Minute Walk Test [Time Frame: Baseline and 28 days]

Frequency of Adverse Events, Serious Adverse Events, and Laboratory Parameters [Time Frame: Continuous reporting from baseline through 16 weeks]

Change in Intra-epidermal Nerve Fiber Density (IENFD) [Time Frame: Baseline and 28 days]

Secondary ID(s)

APCP-112

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 18/01/2017
• URL: https://clinicaltrials.gov/ct2/show/results/NCT02039687