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Treatment of CNS Sarcoidosis With H.P. Acthar Gel

NCT02298491 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 4

Last updated 2026-04-17

Study results available
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Summary

The purpose of this study is to see if treatment with H.P. Acthar® Gel will result in the improvement and long-term stabilization of clinical and radiographic abnormalities that occur in patients with CNS sarcoidosis. In addition, it will also look at whether treatment will be also associated with improvement in measures of quality of life. The treatment of CNS sarcoidosis involves the use of either corticosteroids such as prednisone or potent immunosuppressive agents such as methotrexate, both which can induce severe long term side effects. The adverse effects of steroids may be avoided by treatment with adrenocorticotropic hormone (ACTH), which is available for patient use as H.P. Acthar® Gel. The efficacies of H.P. Acthar® Gel in the treatment of CNS sarcoidosis and the impact on quality of life have not been previously studied. In addition, little is known regarding the expression of immune markers in CNS sarcoidosis and the association of such markers with disease activity and response to treatment.

Conditions

  • CNS Sarcoidosis

Interventions

DRUG

H.P. Acthar Gel

80 IU subcutaneously daily for 10 days then followed by 80 IU subcutaneously three times per week through Month 12

Sponsors & Collaborators

  • Mallinckrodt

    collaborator INDUSTRY

  • University of Maryland, Baltimore

    lead OTHER

Principal Investigators

  • Horea Rus · University of Maryland, Baltimore

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-05-31
Primary Completion
2020-11-30
Completion
2020-11-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02298491 on ClinicalTrials.gov