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New treatment option for Autoimmune Diseases
Official title Use of Acthar Gel Single-Dose Pre-Filled SelfJectTM Injector in Patients With Moderate-Severe Keratitis and Autoimmune Disease
ClinicalTrials.gov ID: NCT06964269
What this study is testing
What is Acthar Gel 80 UNT/ML Injectable Solution?
Acthar Gel 80 UNT/ML Injectable Solution is an investigational medicine, given as an once-weekly injection under the skin, being studied as a potential treatment for autoimmune diseases.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Single-site, open label pilot study of 20 autoimmune patients diagnosed with dry eye demonstrating via the proparacaine challenge some peripheral corneal pain component. At least 16 patients will receive and complete 12 weeks of 80 units of Acthar Gel to be injected subcutaneously twice weekly via Acthar Gel single-dose pre-filled SelfJectTM injector (SelfJect) to assess the effects on subjective sensation of ocular pain, conjunctival and corneal staining, in vivo assessments of corneal nerves as measured by confocal imaging, VAS scales of common neuropathic pain symptoms and comfort of SelfJect will be assessed.
- Phase 4: studies an already-approved treatment
- Time commitment: about 3 years
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 85. Healthy volunteers may be eligible.
You may be able to join if
- Subject can read, understand, sign and informed consent.
- Provision of signed and dated informed consent form and HIPPA authorization.
- Stated willingness to comply with all study procedures and availability
- for the duration of the study
- Male or female aged 18-85 years.
You likely can't join if
- 1\. Have a known hypersensitivity or contraindication to the investigational product or their components.
- 2\. Unwilling to participate in study activities or report for study visits. 3. Current pregnancy or lactation per self-report. Patients who are...
- 4\. Use of antihistamines, mast cell stabilizers, or prescription eye drops within 24 hours prior to screening and for the study, unless the dose has...
- 5\. Current use of cenegermin, topical nerve growth factor or platelet rich plasma or use within the past 30 days.
- 6\. Treatment with another investigational drug or other intervention within 30 days of screening.
- 7\. Have serious or severe disease or uncontrolled medical condition that in the judgement of the investigator could confound study assessments...
See the full eligibility criteria
- Subject can read, understand, sign and informed consent.
- Provision of signed and dated informed consent form and HIPPA authorization.
- Stated willingness to comply with all study procedures and availability
- for the duration of the study
- Male or female aged 18-85 years.
- Normal eyelid anatomy
- Patients diagnosed with dry eye for at least 6 months prior to enrollment.
- Patients with Symptom Bother score at Baseline of 50.6 or greater.
- Patients with a diagnosis of any autoimmune disease.
- Patients with one or more corneal neuroma as seen on baseline confocal microscopy.
- Patients with partial or total relief of corneal pain with one drop of proparacaine over 15 minutes post-instillation.
- No prior use of Acthar Gel SelfJect or otherwise for any indication.
- 1\. Have a known hypersensitivity or contraindication to the investigational product or their components.
- 2\. Unwilling to participate in study activities or report for study visits. 3. Current pregnancy or lactation per self-report. Patients who are unwilling to use an effective method of birth control while participating...
- 4\. Use of antihistamines, mast cell stabilizers, or prescription eye drops within 24 hours prior to screening and for the study, unless the dose has been stable for 14 days.
- 5\. Current use of cenegermin, topical nerve growth factor or platelet rich plasma or use within the past 30 days.
- 6\. Treatment with another investigational drug or other intervention within 30 days of screening.
- 7\. Have serious or severe disease or uncontrolled medical condition that in the judgement of the investigator could confound study assessments, limit compliance, or pose safety risks.
- 8\. Systemic medications known to cause dry eye should not be used including antimuscarinics, antihistamines, vitamin A analogs, antianxiety agents, and others unless stable for at least 30 days.
The study team makes the final eligibility decision.
Where it's taking place
- Nashville, Tennessee, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 3 years per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 85 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Nashville, Tennessee, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.