NCT06964269

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

A Phase 4 Pilot Study With Extension to Assess the Use of Acthar Gel Single-Dose Pre-Filled SelfJectTM Injector in Patients With Moderate-Severe Keratitis and Autoimmune Disease and the Effect on Corneal Nerves and Neuropathic Corneal Pain

• Status: Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Toyos Clinic · Academic / Other
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Accepted

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.

Detailed description

The primary objective of the study is to demonstrate the on-label use of Acthar Gel with SelfJect for improvement of symptoms in non-infectious keratitis related to systemic autoimmune disease and the improvement of the appearance and function of corneal nerves as visualized by confocal microscopy and demonstrated by Cochet-Bonnet) and to assess the improvement of common neuropathic corneal pain symptoms caused by dysfunctional nerves due to various autoimmune inflammatory disease. This study will also follow patients for up to 3 years after 12 weeks of administration of Acthar Gel 80 units twice weekly to assess changes from end of treatment to end of study in visual acuity, corneal and conjunctival staining

Conditions

• Autoimmune Diseases
• Dry Eye
• Neurotrophic Keratitis

Interventions

Type	Name	Description
DRUG	Acthar Gel 80 UNT/ML Injectable Solution	Study intervention is twice weekly injections of Acthar Gel via single-dose pre-filled SelfJect injector for 12 weeks.

Timeline

• Start date: 2025-02-11
• Primary completion: 2028-02-28
• Completion: 2028-02-28
• First posted: 2025-05-09
• Last updated: 2025-05-11

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study