Impact of Acthar on Everyday Life of Participants With Severe Keratitis

A Multicenter, Open-label Study to Assess the Efficacy and Safety of Acthar® Gel in Subjects With Severe Keratitis

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

Study Overview

• Status: Completed
• Conditions: Keratitis
• Intervention / Treatment: Drug: Acthar

• Study Type: Interventional
• Enrollment (Actual): 36
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Phoenix, Arizona, United States, 85032
      • Cornea and Cataract Consultants of Arizona
  • California
    • Glendale, California, United States, 91204
      • Global Research Management, Inc.
    • Newport Beach, California, United States, 92663
      • Eye Research Foundation
  • Kentucky
    • Louisville, Kentucky, United States, 40206
      • Eye Care Institute
  • Massachusetts
    • Raynham, Massachusetts, United States, 02767
      • Andover Eye Associates
  • North Carolina
    • Shelby, North Carolina, United States, 28150
      • Vita Eye Clinic
  • Pennsylvania
    • Cranberry Township, Pennsylvania, United States, 06066
      • Scott & Christie and Associates, PC
  • Tennessee
    • Memphis, Tennessee, United States, 38119
      • Total Eye Care, P.A.
    • Nashville, Tennessee, United States, 37205
      • Advancing Vision Research, LLC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: All participants; 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.	Drug: Acthar; Acthar gel for subcutaneous injection; Other Names: Acthar Gel

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants Who Improved on the Impact of Dry Eye on Everyday Life (IDEEL) Scale [Using the Symptom Bother Module at Week 12]	A 12-point score reduction on the 100-point symptom bother module indicates a clinically important reduction of bothersome dry eye symptoms.	Week 12

Collaborators and Investigators

• Sponsor: Mallinckrodt

Publications and helpful links

General Publications

• Wirta D, McLaurin E, Ousler G, Liu J, Kacmaz RO, Grieco J. Repository Corticotropin Injection (Acthar(R) Gel) for Refractory Severe Noninfectious Keratitis: Efficacy and Safety from a Phase 4, Multicenter, Open-Label Study. Ophthalmol Ther. 2021 Dec;10(4):1077-1092. doi: 10.1007/s40123-021-00400-y. Epub 2021 Oct 20.

Study record dates

Study Major Dates

• Study Start (ACTUAL): November 13, 2019
• Primary Completion (ACTUAL): November 9, 2020
• Study Completion (ACTUAL): December 7, 2020

Study Registration Dates

• First Submitted: November 14, 2019
• First Submitted That Met QC Criteria: November 18, 2019
• First Posted (ACTUAL): November 19, 2019

Study Record Updates

• Last Update Posted (ACTUAL): August 18, 2021
• Last Update Submitted That Met QC Criteria: July 27, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Keywords: Severe or recalcitrant keratitis
• Additional Relevant MeSH Terms: Eye Diseases; Corneal Diseases; Keratitis; Physiological Effects of Drugs; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Adrenocorticotropic Hormone
• Other Study ID Numbers: MNK14084113

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Discussion of statistical endpoints and analysis are included in manuscripts. Summary aggregate (basic) results (including adverse events information) and the study protocol are made available on clinicaltrials.gov (NCT04169061) when required by regulation. Individual de-identified patient data will not be disclosed. Requests for additional information should be directed to the company at medinfo@mnk.com.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No