Impact of Acthar on Everyday Life of Participants With Severe Keratitis

• Sponsor: Mallinckrodt (Industry)
• Overall Status: Completed
• CT.gov ID: NCT04169061
• Collaborator: (none)
• Enrollment: 36
• Locations: 9
• Arm: 1
• Actual Duration (Months): 12.8
• Patients Per Site: 4
• Patients Per Site Per Month: 0.3

Study Details

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

Condition or Disease	Intervention/Treatment	Phase
Keratitis	Drug: Acthar	Phase 4

Study Design

• Study Type: Interventional
• 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: Nov 13, 2019
• Actual Primary Completion Date: Nov 9, 2020
• Actual Study Completion Date: Dec 7, 2020

Arms and Interventions

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

Outcome Measures

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] [Week 12]

   A 12-point score reduction on the 100-point symptom bother module indicates a clinically important reduction of bothersome dry eye symptoms.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Cornea and Cataract Consultants of Arizona	Phoenix	Arizona	United States	85032
2	Global Research Management, Inc.	Glendale	California	United States	91204
3	Eye Research Foundation	Newport Beach	California	United States	92663
4	Eye Care Institute	Louisville	Kentucky	United States	40206
5	Andover Eye Associates	Raynham	Massachusetts	United States	02767
6	Vita Eye Clinic	Shelby	North Carolina	United States	28150
7	Scott & Christie and Associates, PC	Cranberry Township	Pennsylvania	United States	06066
8	Total Eye Care, P.A.	Memphis	Tennessee	United States	38119
9	Advancing Vision Research, LLC	Nashville	Tennessee	United States	37205

Sponsors and Collaborators

• Mallinckrodt

Investigators

• Study Director: Global Clinical Leader, Mallinckrodt

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Sep 11, 2019

More Information

Publications

None provided.

• Responsible Party: Mallinckrodt
• ClinicalTrials.gov Identifier: NCT04169061
• Other Study ID Numbers: MNK14084113
• First Posted: Nov 19, 2019
• Last Update Posted: Aug 18, 2021
• Last Verified: Jul 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• 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: Keratitis; Adrenocorticotropic Hormone

Study Results

Participant Flow

Recruitment Details	Thirty-six participants were enrolled at 8 locations in the United States

Arm/Group Title	All Participants
Arm/Group 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.
Period Title: Overall Study
STARTED	36
Safety Population	36
Modified Intent to Treat (mITT) Population	34
COMPLETED	31
NOT COMPLETED	5

Baseline Characteristics

Arm/Group Title	All Participants
Arm/Group Description	Participants receive Acthar Gel administered by a shot under the skin (subcutaneous injection) per study regimen
Overall Participants	36
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	63.6 (10.17)
Sex: Female, Male (Count of Participants)
Female	26 72.2%
Male	10 27.8%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	2 5.6%
Not Hispanic or Latino	34 94.4%
Unknown or Not Reported	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%
Asian	0 0%
Native Hawaiian or Other Pacific Islander	0 0%
Black or African American	7 19.4%
White	29 80.6%
More than one race	0 0%
Unknown or Not Reported	0 0%
Region of Enrollment (participants) [Number]
United States	36 100%

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

Participants with non-missing baseline data

Arm/Group Title	All Participants
Arm/Group Description	Participants receive Acthar Gel administered by a shot under the skin (subcutaneous injection) per study regimen
Measure Participants	34
Count of Participants [Participants]	17 47.2%

Adverse Events

Time Frame	While participating in the trial (up to 22 weeks)
Adverse Event Reporting Description	All serious adverse events that occurred during the trial are reported, regardless of dosing status. Non-serious treatment-emergent adverse events are included if 5% or more participants had that same event. Participants may have more than one event per system organ class and preferred term. At each level of subject summarization, a participant is counted once if the participant had one or more events.
Arm/Group Title	All Participants
Arm/Group Description	Participants receive Acthar Gel administered by a shot under the skin (subcutaneous injection) per study regimen
All Cause Mortality
	All Participants
	Affected / at Risk (%)	# Events
Total	1/36 (2.8%)
Serious Adverse Events
	All Participants
	Affected / at Risk (%)	# Events
Total	1/36 (2.8%)
Injury, poisoning and procedural complications
Intentional overdose	1/36 (2.8%)	1
Other (Not Including Serious) Adverse Events
	All Participants
	Affected / at Risk (%)	# Events
Total	2/36 (5.6%)
Vascular disorders
Hypertension	2/36 (5.6%)	2

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.