Ocular Sarcoidosis Open Label Trial of ACTHAR Gel

NCT02725177 | Completed Results

• 1 other identifier: Ocular Sarcoidosis 15-1072
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

Brief 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)

Conditions

Ocular Sarcoidosis; Panuveitis; Anterior Uveitis

Keywords

Ocular Sarcoidosis

Outcome Measures

Primary Outcomes (1)

• Percentage of Patients With Clinically Significant Improvement in Visual Acuity

  The primary outcome was percentage of patients meeting at least one of the following variables 1) improved visual acuity, 2) resolution of intraocular inflammation, 3) ability to taper ocular or oral steroids by at least 50% or 4) reduction of cystoid macular edema, with no worsening of any single one and no need for additional sarcoidosis therapies at 24 weeks .

  Measured at 24 weeks

Secondary Outcomes (3)

• Percentage of Patients With Clinically Significant Improvement in the Resolution-intraocular Inflammation

  Measured at 24 weeks

• Proportion of Patients Experiencing a Tapering of Ocular/Oral Steroids by at Least 50%

  Measured at 24 weeks

• Proportion of Patients With a Clinically Significant Reduction-cystoid Macular Edema

  Measured at 24 weeks

Study Arms (1)

H.P. Achtar Gel 80 U

EXPERIMENTAL

H.P. Acthar Gel (repository corticotropin) Injection, 80 U daily for 10 days, then 80 U twice weekly for up to a total of 24 weeks on therapy.

Drug: Repository Corticotropin Injection; Drug: Repository Corticotropin Injection -Treatment Extension

Interventions

Repository Corticotropin Injection DRUG

Treatment with ACTHAR Gel for 24 weeks * Initial treatment with 80 units daily for ten days (induction phase) * Maintenance treatment with 80 units twice weekly (maintenance phase)

Also known as: H.P. Acthar Gel, ACTH Gel, ACTH

H.P. Achtar Gel 80 U

Repository Corticotropin Injection -Treatment Extension DRUG

24 open label extension permitted in subjects who respond to treatment

Also known as: H.P. Acthar Gel, ACTH Gel, ACTH

H.P. Achtar Gel 80 U

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The Cleveland Clinic: lead
• Mallinckrodt: collaborator

Study Sites (1)

Cleveland Clinical Foundation

Cleveland, Ohio, 44145, United States

Location

MeSH Terms

Conditions

Panuveitis; Uveitis, Anterior

Interventions

Adrenocorticotropic Hormone

Condition Hierarchy (Ancestors)

Uveitis; Uveal Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Melanocortins; Pro-Opiomelanocortin; Hypothalamic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Pituitary Hormones, Anterior; Pituitary Hormones; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Nerve Tissue Proteins; Proteins

Results Point of Contact

• Title: Daniel Culver, DO
• Organization: Cleveland Clinic Foundation

culverd@ccf.org

216-444-6508

Study Officials

• Daniel A Culver, DO

  The Cleveland Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 11, 2016
• First Posted: March 31, 2016
• Study Start: July 1, 2016
• Primary Completion: December 1, 2021
• Study Completion: March 1, 2022
• Last Updated: November 14, 2023
• Results First Posted: February 15, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)