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Impact of Acthar on Everyday Life of Participants With Severe Keratitis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04169061
Recruitment Status : Completed
First Posted : November 19, 2019
Results First Posted : August 18, 2021
Last Update Posted : August 18, 2021
Sponsor:
Information provided by (Responsible Party):
Mallinckrodt

Brief Summary:

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

Condition or disease Intervention/treatment Phase
Keratitis Drug: Acthar Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 36 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Multicenter, Open-label Study to Assess the Efficacy and Safety of Acthar® Gel in Subjects With Severe Keratitis
Actual Study Start Date : November 13, 2019
Actual Primary Completion Date : November 9, 2020
Actual Study Completion Date : December 7, 2020

Resource links provided by the National Library of Medicine


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 Name: Acthar Gel




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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04169061


Locations
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United States, Arizona
Cornea and Cataract Consultants of Arizona
Phoenix, Arizona, United States, 85032
United States, California
Global Research Management, Inc.
Glendale, California, United States, 91204
Eye Research Foundation
Newport Beach, California, United States, 92663
United States, Kentucky
Eye Care Institute
Louisville, Kentucky, United States, 40206
United States, Massachusetts
Andover Eye Associates
Raynham, Massachusetts, United States, 02767
United States, North Carolina
Vita Eye Clinic
Shelby, North Carolina, United States, 28150
United States, Pennsylvania
Scott & Christie and Associates, PC
Cranberry Township, Pennsylvania, United States, 06066
United States, Tennessee
Total Eye Care, P.A.
Memphis, Tennessee, United States, 38119
Advancing Vision Research, LLC
Nashville, Tennessee, United States, 37205
Sponsors and Collaborators
Mallinckrodt
Investigators
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Study Director: Global Clinical Leader Mallinckrodt
  Study Documents (Full-Text)

Documents provided by Mallinckrodt:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Mallinckrodt
ClinicalTrials.gov Identifier: NCT04169061    
Other Study ID Numbers: MNK14084113
First Posted: November 19, 2019    Key Record Dates
Results First Posted: August 18, 2021
Last Update Posted: August 18, 2021
Last Verified: July 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
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.

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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
Keywords provided by Mallinckrodt:
Severe or recalcitrant keratitis
Additional relevant MeSH terms:
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Keratitis
Corneal Diseases
Eye Diseases
Adrenocorticotropic Hormone
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs