ACTHAR Therapy for Central Nervous System Sarcoidosis

• Status: Withdrawn
• Trial end date: 2020-11-02
• Target enrollment: 0
• Participant gender: All

Summary

There is a need for a more reliable, expeditious therapy that can be used as an alternative to glucocorticoids in severe Central Nervous System (CNS) sarcoidosis. This study aims to provide evidence for effectiveness of ACTHAR gel in CNS sarcoidosis, and provide information about its safety and tolerability

• Phase: Phase 4
• 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 (American Thoracic Society/European Thoracic Society/World Association for Sarcoidosis and Other Granulomatous Disorders)

• Stable baseline immunosuppressive medications

• Moderate to severe disease as defined by at least one of the following criteria:

• Cranial nerve palsy

• Neurologic deficits related to intraparenchymal brain, spinal cord and/or cauda equina involvement

• Dural or leptomeningeal involvement of brain and/or spinal cord

• Hydrocephalus

• Seizures

Exclusion Criteria:

• Diagnosis of any underlying neurologic disorder that would potentially confound interpretation of the study results

• Significant change in corticosteroid dose within the past 4 weeks, or other immunosuppressive medication within the past 6 months

• Evidence of current serious infection, or a history of chronic or recurring infections.

• Contraindication to high-dose corticosteroids (e.g. uncontrolled blood sugar).

• Allergies to pig-derived proteins

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

• History of malignancy.