Impact of Acthar on Everyday Life of Participants With Severe Keratitis

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

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 DiseaseIntervention/TreatmentPhase
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

ArmIntervention/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

    SiteCityStateCountryPostal Code
    1Cornea and Cataract Consultants of ArizonaPhoenixArizonaUnited States85032
    2Global Research Management, Inc.GlendaleCaliforniaUnited States91204
    3Eye Research FoundationNewport BeachCaliforniaUnited States92663
    4Eye Care InstituteLouisvilleKentuckyUnited States40206
    5Andover Eye AssociatesRaynhamMassachusettsUnited States02767
    6Vita Eye ClinicShelbyNorth CarolinaUnited States28150
    7Scott & Christie and Associates, PCCranberry TownshipPennsylvaniaUnited States06066
    8Total Eye Care, P.A.MemphisTennesseeUnited States38119
    9Advancing Vision Research, LLCNashvilleTennesseeUnited States37205

    Sponsors and Collaborators

    • Mallinckrodt

    Investigators

    • Study Director: Global Clinical Leader, Mallinckrodt

    Study Documents (Full-Text)

    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
    Additional relevant MeSH terms:

    Study Results

    Participant Flow

    Recruitment DetailsThirty-six participants were enrolled at 8 locations in the United States
    Pre-assignment Detail
    Arm/Group TitleAll Participants
    Arm/Group DescriptionParticipants 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
    STARTED36
    Safety Population36
    Modified Intent to Treat (mITT) Population34
    COMPLETED31
    NOT COMPLETED5

    Baseline Characteristics

    Arm/Group TitleAll Participants
    Arm/Group DescriptionParticipants receive Acthar Gel administered by a shot under the skin (subcutaneous injection) per study regimen
    Overall Participants36
    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
    TitleNumber of Participants Who Improved on the Impact of Dry Eye on Everyday Life (IDEEL) Scale [Using the Symptom Bother Module at Week 12]
    DescriptionA 12-point score reduction on the 100-point symptom bother module indicates a clinically important reduction of bothersome dry eye symptoms.
    Time FrameWeek 12

    Outcome Measure Data

    Analysis Population Description
    Participants with non-missing baseline data
    Arm/Group TitleAll Participants
    Arm/Group DescriptionParticipants receive Acthar Gel administered by a shot under the skin (subcutaneous injection) per study regimen
    Measure Participants34
    Count of Participants [Participants]
    17
    47.2%

    Adverse Events

    Time FrameWhile 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 TitleAll Participants
    Arm/Group DescriptionParticipants receive Acthar Gel administered by a shot under the skin (subcutaneous injection) per study regimen
    All Cause Mortality
    All Participants
    Affected / at Risk (%)# Events
    Total1/36 (2.8%)
    Serious Adverse Events
    All Participants
    Affected / at Risk (%)# Events
    Total1/36 (2.8%)
    Injury, poisoning and procedural complications
    Intentional overdose1/36 (2.8%) 1
    Other (Not Including Serious) Adverse Events
    All Participants
    Affected / at Risk (%)# Events
    Total2/36 (5.6%)
    Vascular disorders
    Hypertension2/36 (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.

    Results Point of Contact

    Name/TitleMedical Information Call Center
    OrganizationMallinckrodt
    Phone800-844-2830
    EmailMedInfo@mnk.com
    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