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
1 other identifier
interventional
36
1 country
9
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_4
Started Nov 2019
Shorter than P25 for phase_4
9 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 13, 2019
CompletedFirst Submitted
Initial submission to the registry
November 14, 2019
CompletedFirst Posted
Study publicly available on registry
November 19, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 9, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
December 7, 2020
CompletedResults Posted
Study results publicly available
August 18, 2021
CompletedAugust 18, 2021
July 1, 2021
12 months
November 14, 2019
July 7, 2021
July 27, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (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]
A 12-point score reduction on the 100-point symptom bother module indicates a clinically important reduction of bothersome dry eye symptoms.
Week 12
Study Arms (1)
All participants
EXPERIMENTALParticipants 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.
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Mallinckrodtlead
Study Sites (9)
Cornea and Cataract Consultants of Arizona
Phoenix, Arizona, 85032, United States
Global Research Management, Inc.
Glendale, California, 91204, United States
Eye Research Foundation
Newport Beach, California, 92663, United States
Eye Care Institute
Louisville, Kentucky, 40206, United States
Andover Eye Associates
Raynham, Massachusetts, 02767, United States
Vita Eye Clinic
Shelby, North Carolina, 28150, United States
Scott & Christie and Associates, PC
Cranberry Township, Pennsylvania, 06066, United States
Total Eye Care, P.A.
Memphis, Tennessee, 38119, United States
Advancing Vision Research, LLC
Nashville, Tennessee, 37205, United States
Related Publications (1)
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.
PMID: 34669183DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Medical Information Call Center
- Organization
- Mallinckrodt
Study Officials
- STUDY DIRECTOR
Global Clinical Leader
Mallinckrodt
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 14, 2019
First Posted
November 19, 2019
Study Start
November 13, 2019
Primary Completion
November 9, 2020
Study Completion
December 7, 2020
Last Updated
August 18, 2021
Results First Posted
August 18, 2021
Record last verified: 2021-07
Data Sharing
- IPD Sharing
- Will not share
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.