Trial Outcomes & Findings for Impact of Acthar on Everyday Life of Participants With Severe Keratitis (NCT NCT04169061)

Last Updated: 2021-08-18

Results Overview

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

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

36 participants

Primary outcome timeframe

Week 12

Results posted on

2021-08-18

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

Participant milestones
Measure	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.
Overall Study STARTED	36
Overall Study Safety Population	36
Overall Study Modified Intent to Treat (mITT) Population	34
Overall Study COMPLETED	31
Overall Study NOT COMPLETED	5

Reasons for withdrawal
Measure	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.
Overall Study Adverse Event	2
Overall Study Death	1
Overall Study Withdrawal by Subject	1
Overall Study Protocol Violation	1

Impact of Acthar on Everyday Life of Participants With Severe Keratitis

Baseline characteristics by cohort
Measure	All Participants n=36 Participants Participants receive Acthar Gel administered by a shot under the skin (subcutaneous injection) per study regimen
Age, Continuous	63.6 years STANDARD_DEVIATION 10.17 • n=5 Participants
Sex: Female, Male Female	26 Participants n=5 Participants
Sex: Female, Male Male	10 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	34 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	7 Participants n=5 Participants
Race (NIH/OMB) White	29 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	36 participants n=5 Participants

Timeframe: Week 12

Population: Participants with non-missing baseline data

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

Outcome measures
Measure	All Participants n=34 Participants Participants receive Acthar Gel administered by a shot under the skin (subcutaneous injection) per study regimen
Number of Participants Who Improved on the Impact of Dry Eye on Everyday Life (IDEEL) Scale [Using the Symptom Bother Module at Week 12]	17 Participants

Serious events: 1 serious events

Other events: 2 other events

Deaths: 1 deaths

Serious adverse events
Measure	All Participants n=36 participants at risk Participants receive Acthar Gel administered by a shot under the skin (subcutaneous injection) per study regimen
Injury, poisoning and procedural complications Intentional overdose	2.8% 1/36 • Number of events 1 • While participating in the trial (up to 22 weeks) 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.

Other adverse events
Measure	All Participants n=36 participants at risk Participants receive Acthar Gel administered by a shot under the skin (subcutaneous injection) per study regimen
Vascular disorders Hypertension	5.6% 2/36 • Number of events 2 • While participating in the trial (up to 22 weeks) 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.

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