Use of Acthar Gel Single-Dose Pre-Filled SelfJectTM Injector in Patients With Moderate-Severe Keratitis and Autoimmune Disease

NCT06964269 | Recruiting Phase 4 FDA Drug

• 1 other identifier: MNK-MT-2024
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Autoimmune Diseases; Dry Eye; Neurotrophic Keratitis

Keywords

Dry eye; Autoimmune; Neurotropic Keratitis

Outcome Measures

Primary Outcomes (4)

• Visual Analog scale for injection comfort

  To assess the severity of injection comfort in the eyes. scale ranges from 0(none) - 100(severe)

  3 years

• Visual Analog scale for burning

  To assess the severity of burning in the eyes. scale ranges from 0(none) - 100(severe)

  3 years

• Visual Analog scale for Stinging

  To assess the severity of stinging in the eyes. scale ranges from 0(none) - 100(severe)

  3 years

• Visual Analog scale for Light sensitivity

  To assess the severity of light sensitivity in the eyes. scale ranges from 0(none) - 100(severe)

  3 years

Study Arms (1)

One study arm of approximately 20 active receiving and completing active, open-label interventions.

ACTIVE COMPARATOR

One study arm of approximately 20 active receiving and completing active, open-label interventions.

Drug: Acthar Gel 80 UNT/ML Injectable Solution

Interventions

Acthar Gel 80 UNT/ML Injectable Solution DRUG

Study intervention is twice weekly injections of Acthar Gel via single-dose pre-filled SelfJect injector for 12 weeks.

One study arm of approximately 20 active receiving and completing active, open-label interventions.

Eligibility Criteria

• Age: 18 Years - 85 Years
• Gender Eligibility Details: 18-85
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify 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.
• 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.

You may not qualify if:

• \. Have a known hypersensitivity or contraindication to the investigational product or their components.
• \. 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 in the study and for four weeks after the last dose of study drug is administered.
• \. 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.
• \. Current use of cenegermin, topical nerve growth factor or platelet rich plasma or use within the past 30 days.
• \. Treatment with another investigational drug or other intervention within 30 days of screening.
• \. 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.
• \. 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.

Sponsors & Collaborators

• Toyos Clinic: lead

Study Sites (1)

Toyos Clinic

Nashville, Tennessee, 37215, United States

RECRUITING

MeSH Terms

Conditions

Autoimmune Diseases; Dry Eye Syndromes

Condition Hierarchy (Ancestors)

Immune System Diseases; Lacrimal Apparatus Diseases; Eye Diseases

Central Study Contacts

Harley cheney Study Coordinator, Study Coordinator

CONTACT

+616153274015; hcheney@toyosclinic.com

Melissa Toyos, MD, MD

CONTACT

6153274015; mtoyos@toyosclinic.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 7, 2025
• First Posted: May 9, 2025
• Study Start: February 11, 2025
• Primary Completion (Estimated): February 28, 2028
• Study Completion (Estimated): February 28, 2028
• Last Updated: May 11, 2025

Record last verified: 2025-05

Locations

US (1)