CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 36 enrolled
Drug / intervention
Acthardrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04169061
NCT04169061Phase 4Completed

A Multicenter, Open-label Study to Assess the Efficacy and Safety of Acthar® Gel in Subjects With Severe Keratitis

Mallinckrodt·interventional·Posted Nov 19, 2019·Updated Aug 18, 2021

In Brief

A Phase 4 clinical trial evaluating Acthar for Keratitis. Completed, enrolled 36 participants across 9 sites.

Detailed 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

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsKeratitis
CountriesUnited States
Collaborators--

Timeline

Phase 4CompletedFinished
2020202120222023202420252026
First PostedNov 19, 2019
Enrollment StartNov 13, 2019
Primary CompletionNov 9, 2020
Study CompletionDec 7, 2020
TodayJul 2, 2026
Enrollment to primary: 12 monthsPosted 6.6 years ago

Interventions

Acthardrug

Acthar gel for subcutaneous injection