First Participant Enrolled in Phase 4 Clinical Trial Testing Acthar Gel for Severe Keratitis

First Participant Enrolled in Phase 4 Clinical Trial Testing Acthar Gel for Severe Keratitis

The first participant has been enrolled in a Phase 4 clinical trial testing Acthar Gel — a repository corticotropin injection — in people with severe keratitis, according to Mallinckrodt Pharmaceuticals, the therapy’s developer.

The trial is currently enrolling participants at two locations in California and one in Tennessee. Additional information and contacts can be found here.

Acthar Gel is a purified form of adrenocorticotropic hormone (ACTH). It is delivered via subcutaneous (under-the-skin) injection; once injected, it facilitates sustained release of ACTH over time. That ACTH stimulates the adrenal glands to produce hormones such as cortisol and aldosterone, which can have a variety of effects on the body. Relevant to keratitis, these effects can include reducing inflammation.

The U.S. Food and Drug Administration (FDA) has approved Acthar Gel for 19 different indications, among which are severe inflammation of the eye, including keratitis. It also is approved for use in multiple sclerosis, sarcoidosis, and juvenile arthritis, among other diseases.

The new clinical trial (NCT04169061) aims to better understand which people with keratitis are most likely to benefit from Acthar Gel treatment, particularly for individuals who have had lackluster responses to other therapies.

The trial intends to enroll 30 people with severe keratitis who have undergone previous treatments that were either ineffective or not well-tolerated. Participants will receive subcutaneous injections of 80 units of Acthar Gel twice a week for 12 weeks, followed by a four-week-long period during which lower doses will be given to wean participants off the medication.

The outcome will be measured via change in the Impact of Dry Eye on Everyday Life (IDEEL) scale after the 12-week treatment period. This scale evaluates quality of life, treatment satisfaction, and symptom-related bother in individuals with mild-to-severe dry eye.

“We believe this exploratory evaluation of patients whose severe keratitis persists — after the use of one or more standard treatments — can potentially help physicians better understand which individuals may benefit from the drug as a treatment alternative,” said Tunde Otulana, MD, the chief medical officer of Mallinckrodt.

Eugene McLaurin, MD, a fellow at the American Academy of Ophthalmology and the American College of Surgeons, added that the results of this trial “may potentially provide data to further support Acthar Gel as a treatment option in appropriate keratitis patients.”

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