Impact of Acthar on Everyday Life of Participants With Severe Keratitis

NCT04169061 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2021-08-18

Study results available
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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

Conditions

  • Keratitis

Interventions

DRUG

Acthar

Acthar gel for subcutaneous injection

Sponsors & Collaborators

  • Mallinckrodt

    lead INDUSTRY

Principal Investigators

  • Global Clinical Leader · Mallinckrodt

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-11-13
Primary Completion
2020-11-09
Completion
2020-12-07
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04169061 on ClinicalTrials.gov