Impact of Acthar on Everyday Life of Participants With Severe Keratitis

Mallinckrodt

Status and phase: Completed; Phase 4

Conditions: Keratitis

Treatments: Drug: Acthar

Study type: Interventional

Funder types: Industry

Identifiers

NCT04169061

MNK14084113

Details and patient eligibility

About

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

Enrollment: 36 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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36 participants in 1 patient group

All participants

Experimental group

Description:

Participants receive: * a shot of Acthar (80 units) under the skin twice a week for 12 weeks * a shot of Acthar (40 units) twice a week for 2 weeks * a shot of Acthar (40 units) once a week for 2 more weeks At each visit they will have medical tests and answer questions about their symptoms.

Treatment:

Drug: Acthar