A Multicenter, Open-label Study to Assess the Efficacy and Safety of Acthar® Gel in Subjects With Severe Keratitis
Impact of Acthar on Dry Eye in Everyday Life of Participants With Severe Keratitis
Sponsors
Source
Mallinckrodt
Oversight Info
Has Dmc
No
Is Fda Regulated Drug
Yes
Is Fda Regulated Device
No
Is Us Export
No
Brief Summary
We will need about 36 participants for this study.
Volunteers might be able to participate if:
- they have bad noninfectious keratitis (swelling in their eyes)
- early treatments failed or were not well accepted
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
- 4 weeks of follow-up with the doctor
Overall Status
Recruiting
Start Date
2019-09-30
Completion Date
2020-06-01
Primary Completion Date
2020-06-01
Phase
Phase 4
Study Type
Interventional
Primary Outcome
Measure |
Time Frame |
|
Responder scores on the IDEEL questionnaire |
within 88 days |
Enrollment
36
Condition
Intervention
Intervention Type
Drug
Intervention Name
Description
Acthar gel for subcutaneous injection
Arm Group Label
All participants
Other Name
Acthar Gel
Eligibility
Criteria
Inclusion Criteria:
- Has severe or recalcitrant keratitis
- Did not respond to, or tolerate, treatment with topical cyclosporine 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
Gender
All
Minimum Age
18 Years
Maximum Age
N/A
Healthy Volunteers
No
Overall Official
Last Name |
Role |
Affiliation |
|
Global Clinical Leader |
Study Director |
Mallinckrodt |
Overall Contact
Location
Facility |
Status |
|
Total Eye Care, P.A. Memphis Tennessee 38119 United States |
Recruiting |
Location Countries
Country
United States
Verification Date
2019-11-01
Lastchanged Date
N/A
Firstreceived Date
N/A
Responsible Party
Responsible Party Type
Sponsor
Keyword
Has Expanded Access
No
Condition Browse
Number Of Arms
1
Intervention Browse
Mesh Term
Adrenocorticotropic Hormone
Arm Group
Arm Group Label
All participants
Arm Group Type
Experimental
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.
They will be checked at the clinic four weeks after their last shot.
Firstreceived Results Date
N/A
Patient Data
Sharing Ipd
No
Firstreceived Results Disposition Date
N/A
Study Design Info
Intervention Model
Single Group Assignment
Primary Purpose
Treatment
Masking
None (Open Label)
Study First Submitted
November 14, 2019
Study First Submitted Qc
November 18, 2019
Study First Posted
November 19, 2019
Last Update Submitted
November 18, 2019
Last Update Submitted Qc
November 18, 2019
Last Update Posted
November 19, 2019
ClinicalTrials.gov processed this data on December 11, 2019
Conditions
Conditions usually refer to a disease, disorder, syndrome, illness, or injury. In ClinicalTrials.gov,
conditions include any health issue worth studying, such as lifespan, quality of life, health risks, etc.
Interventions
Interventions refer to the drug, vaccine, procedure, device, or other potential treatment being studied.
Interventions can also include less intrusive possibilities such as surveys, education, and interviews.
Study Phase
Most clinical trials are designated as phase 1, 2, 3, or 4, based on the type of questions
that study is seeking to answer:
In Phase 1 (Phase I) clinical trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
In Phase 2 (Phase II) clinical trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.
In Phase 3 (Phase III) clinical trials, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
In Phase 4 (Phase IV) clinical trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.
These phases are defined by the Food and Drug Administration in the Code of Federal Regulations.
In Phase 1 (Phase I) clinical trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
In Phase 2 (Phase II) clinical trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.
In Phase 3 (Phase III) clinical trials, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
In Phase 4 (Phase IV) clinical trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.
These phases are defined by the Food and Drug Administration in the Code of Federal Regulations.