Ocular Sarcoidosis Open Label Trial of ACTHAR Gel

• Status: Recruiting
• Trial end date: 2022-12-01
• Target enrollment: 0
• Participant gender: All

Summary

Treatment with ACTHAR Gel will result in a reduction of ocular inflammation in patients with active ocular sarcoidosis that requires systemic immunosuppressant therapy (hypothesis)

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: The Cleveland Clinic
• Collaborator: Mallinckrodt
• Treatments: Adrenocorticotropic Hormone

Criteria

Inclusion Criteria:

• Patient with sarcoidosis as defined by ATS/ERS/WASOG guidelines (American Thoracic Society/European Respiratory Society /World Association of Sarcoidosis and Other Granulomatous Diseases)

• Any posterior, intermediate or panuveitis of sufficient severity to warrant therapy, in the opinion of the treating physician --OR-- Anterior uveitis requiring 4 or more daily applications of topical corticosteroids to maintain control of inflammation, or uncontrolled with topical therapy

• Persistent disease activity (active uveitis) at the time of screening

Exclusion Criteria:

• Other cause for ocular inflammation

• Uncontrolled diabetes, hypertension, or other contra-indication to increased dosage of glucocorticoids

• Recent (less than 4 weeks) intra-ocular or intra-orbital steroid injection

• Escalation of immunosuppressive medications between screening and initiation of the study medication

• Severe extra-ocular sarcoidosis likely to require additional therapy (in the opinion of the investigator)

• Administration of an investigational medication for sarcoidosis within 3 months, or 5 half-lives, whichever is longer

• Have a history of any opportunistic infection within 6 months prior to screening

• Have any history of malignancy, except fully resected cutaneous squamous cell cancer or cutaneous basal cell cancer, or cervical carcinoma in-situ with a minimum of 5 years period without recurrence

• Severe other organ disease felt to be likely to lead to death within the next six months

• Unable to follow the study protocol, including the requisite travel and follow-up ocular testing

• Women of childbearing potential must be using adequate birth control measures (abstinence, hormonal contraceptives, intrauterine device, barrier method with spermicide, or surgical sterilization) and must agree to continue such precautions, and not become pregnant or plan a pregnancy for 6 months after receiving their last treatment with study agent. Women of childbearing potential must test negative on a serum pregnancy test at screening.

• Breastfeeding women are excluded from participation