We will need about 36 participants for this study.

Volunteers might be able to participate if:

• they have bad noninfectious keratitis
• early treatments failed or were not well tolerated

Participants will be in the study for about 22 weeks:

• 4 weeks for tests to see if the study might be good for them
• 12 weeks of treatment with Acthar gel
• 4 weeks to wean off Acthar gel and follow-up with the doctor

Inclusion Criteria:

• Has severe or recalcitrant keratitis
• Did not respond to, or tolerate, treatment with topical cyclosporine, Lifitegrast, or any immunosuppressant to treat keratitis
• If able to reproduce, agrees to use 2 forms of effective contraception with a partner of the opposite sex for the duration of the study (through Visit 6)
• Has normal eyelids, and protocol-defined physical and medical eye attributes
• Agrees to avoid wearing contact lenses during the trial

Exclusion Criteria:

• Is pregnant or breast-feeding
• Is defined as vulnerable, or is employed by, or related to anyone involved in the study
• Has a medical condition or history that might, per protocol or in the opinion of the investigator, compromise the participant's safety or study analysis

Discussion of statistical endpoints and analysis are included in manuscripts. Summary aggregate (basic) results (including adverse events information) and the study protocol are made available on clinicaltrials.gov (NCT04169061) when required by regulation. Individual de-identified patient data will not be disclosed. Requests for additional information should be directed to the company at medinfo@mnk.com.

Safety Analysis Population

While participating in the trial (up to 22 weeks)

All serious adverse events that occurred during the trial are reported, regardless of dosing status. Non-serious treatment-emergent adverse events are included if 5% or more participants had that same event.

Participants may have more than one event per system organ class and preferred term.

At each level of subject summarization, a participant is counted once if the participant had one or more events.