Back to resultsImpact of Acthar on Everyday Life of Participants With Severe Keratitis
Primary Purpose
Keratitis
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Acthar
Sponsored by
About this trial
This is an interventional treatment trial for Keratitis focused on measuring Severe or recalcitrant keratitis
Eligibility 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
Sites / Locations
- Cornea and Cataract Consultants of Arizona
- Global Research Management, Inc.
- Eye Research Foundation
- Eye Care Institute
- Andover Eye Associates
- Vita Eye Clinic
- Scott & Christie and Associates, PC
- Total Eye Care, P.A.
- Advancing Vision Research, LLC
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
All participants
Arm Description
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04169061
Brief Title
Impact of Acthar on Everyday Life of Participants With Severe Keratitis
Official Title
A Multicenter, Open-label Study to Assess the Efficacy and Safety of Acthar® Gel in Subjects With Severe Keratitis
Study Type
Interventional
2. Study Status
Record Verification Date
July 2021
Overall Recruitment Status
Completed
Study Start Date
November 13, 2019 (Actual)
Primary Completion Date
November 9, 2020 (Actual)
Study Completion Date
December 7, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mallinckrodt
4. Oversight
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
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Keratitis
Keywords
Severe or recalcitrant keratitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
36 (Actual)
8. Arms, Groups, and Interventions
Arm Title
All participants
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Acthar
Other Intervention Name(s)
Acthar Gel
Intervention Description
Acthar gel for subcutaneous injection
Primary Outcome Measure Information:
Title
Number of Participants Who Improved on the Impact of Dry Eye on Everyday Life (IDEEL) Scale [Using the Symptom Bother Module at Week 12]
Description
A 12-point score reduction on the 100-point symptom bother module indicates a clinically important reduction of bothersome dry eye symptoms.
Time Frame
Week 12
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Global Clinical Leader
Organizational Affiliation
Mallinckrodt
Official's Role
Study Director
Facility Information:
Facility Name
Cornea and Cataract Consultants of Arizona
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85032
Country
United States
Facility Name
Global Research Management, Inc.
City
Glendale
State/Province
California
ZIP/Postal Code
91204
Country
United States
Facility Name
Eye Research Foundation
City
Newport Beach
State/Province
California
ZIP/Postal Code
92663
Country
United States
Facility Name
Eye Care Institute
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40206
Country
United States
Facility Name
Andover Eye Associates
City
Raynham
State/Province
Massachusetts
ZIP/Postal Code
02767
Country
United States
Facility Name
Vita Eye Clinic
City
Shelby
State/Province
North Carolina
ZIP/Postal Code
28150
Country
United States
Facility Name
Scott & Christie and Associates, PC
City
Cranberry Township
State/Province
Pennsylvania
ZIP/Postal Code
06066
Country
United States
Facility Name
Total Eye Care, P.A.
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38119
Country
United States
Facility Name
Advancing Vision Research, LLC
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37205
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing 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.
Citations:
PubMed Identifier
34669183
Citation
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.
Results Reference
derived
Learn more about this trial
Impact of Acthar on Everyday Life of Participants With Severe Keratitis
We'll reach out to this number within 24 hrs