KeratitisPhase 4NCT04169061

Impact of Acthar on Everyday Life of Participants With Severe Keratitis

A Phase 4 study testing Acthar in people with Keratitis, run by Mallinckrodt at 9 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial 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… Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Keratitis
What is being tested?: Acthar
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 36 participants
Where: 9 sitesUnited States
Study dates: 13 Nov 2019to 7 Dec 2020
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

9 sites in 1 country.

City, postcode or hospital

9 sites in 1 country

United States9 sites

Scott & Christie and Associates, PC
Cranberry Township, Pennsylvania, 06066
Global Research Management, Inc.
Glendale, California, 91204
Eye Care Institute
Louisville, Kentucky, 40206
Total Eye Care, P.A.
Memphis, Tennessee, 38119
Advancing Vision Research, LLC
Nashville, Tennessee, 37205
Eye Research Foundation
Newport Beach, California, 92663
Cornea and Cataract Consultants of Arizona
Phoenix, Arizona, 85032
Andover Eye Associates
Raynham, Massachusetts, 02767
Vita Eye Clinic
Shelby, North Carolina, 28150

Other trials in United States

About this study

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

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
Being tested: Acthar
Keywords: Severe or recalcitrant keratitis
Medical subject headings: Keratitis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

ActharDrug
Also called Acthar Gel
Acthar gel for subcutaneous injection

Study groups in NCT04169061
Study group	Role	What they receive
All participants	Experimental	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. Receives: Drug: Acthar

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Participants Who Improved on the Impact of Dry Eye on Everyday Life (IDEEL) Scale [Using the Symptom Bother Module at Week 12]
A 12-point score reduction on the 100-point symptom bother module indicates a clinically important reduction of bothersome dry eye symptoms.
Measured: Week 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

13 Nov 20197 Dec 2020

First posted19 Nov 2019
Study start13 Nov 2019
Primary completion9 Nov 2020
Study completion7 Dec 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for KeratitisStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 36 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04169061
Sponsor's protocol ID: MNK14084113
Status last verified: Jul 2021
First submitted: 14 Nov 2019
Last updated: 18 Aug 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No: Discussion of statistical endpoints and analysis are included in manuscripts. Summary aggregate (basic) results (including adverse events information) and the study protocol are made available on clinicaltrials.gov (NCT04169061) when required by regulation. Individual de-identified patient data will not be disclosed. Requests for additional information should be directed to the company at medinfo@mnk.com.

Publications

Wirta D, McLaurin E, Ousler G, Liu J, Kacmaz RO, Grieco J. Repository Corticotropin Injection (Acthar(R) Gel) for Refractory Severe Noninfectious Keratitis: Efficacy and Safety from a Phase 4, Multicenter, Open-Label Study. Ophthalmol Ther. 2021 Dec;10(4):1077-1092. doi: 10.1007/s40123-021-00400-y. Epub 2021 Oct 20.
PubMed 34669183

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 1/2
A Phase 1/2, Single-Dose, Multicenter, Dose Escalation, Clinical Trial to Evaluate the Safety and Efficacy of MR-146: An Open-Label Part 1 in Participants With Stage 1 or 2 Neurotrophic Keratopathy and a Double-Masked Part 2 in Participants With Stage 2 Neurotrophic Keratopathy
Neurotrophic Keratopathy
RecruitingObservational study
Validation of Interleukins and Other Cytokines Together With OCT Imaging for Rapid Infectious Keratitis Assessment
Keratitis Bacterial, Keratitis Fungal
RecruitingPhase 2
Efficacy of Locally Delivered Allogeneic Mesenchymal Stromal Cells
Corneal Ulcer
Not yet recruitingPhase 2
Trial to Evaluate the Efficacy And Safety of IVIEW-1201 In the Treatment of Fungal Keratitis
Fungal Keratitis
Not yet recruitingPhase 1
A Clinical Study to Evaluate the Safety and Effectiveness of MSCohi-O Lens in the Treatment of Immune-related Ocular Surface Diseases.
Keratitis, Autoimmunity

All Keratitis trials

Study at a glance

From the registry record, last updated by the sponsor on 18 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Multicenter, Open-label Study to Assess the Efficacy and Safety of Acthar® Gel in Subjects With Severe Keratitis
ClinicalTrials.gov ID: NCT04169061
Acronym / sponsor ID: MNK14084113
Conditions: Keratitis
Keywords: Severe or recalcitrant keratitis
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 36 participants (actual)
Lead sponsor: MallinckrodtIndustry (pharma, biotech, devices)
Study start: 13 Nov 2019 (actual)
Primary completion: 9 Nov 2020 (actual)
Study completion: 7 Dec 2020 (actual)
First posted: 19 Nov 2019 (actual)
Results: Posted 18 Aug 2021

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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 design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
All participants	Experimental	Drug: ActharParticipants 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.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

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

Key exclusion criteria (3 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
ActharAlso: Acthar GelActhar gel for subcutaneous injection	Drug	All participants

Primary outcome

Number of Participants Who Improved on the Impact of Dry Eye on Everyday Life (IDEEL) Scale [Using the Symptom Bother Module at Week 12]
Time frame: Week 12
A 12-point score reduction on the 100-point symptom bother module indicates a clinically important reduction of bothersome dry eye symptoms.

Results and safety

Results posted to the registry on 18 Aug 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
All Participants	36	31

Primary outcome: Number of Participants Who Improved on the Impact of Dry Eye on Everyday Life (IDEEL) Scale [Using the Symptom Bother Module at Week 12]

Time frame: Week 12. Count of participants. Unit: Participants

Measure	All Participants n = 34
Value	17

Population analysed: Participants with non-missing baseline data

Adverse events

Time frame: While participating in the trial (up to 22 weeks). Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
All Participants	1 of 36 (2.8%)	2 of 36 (5.6%)	1 of 36

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 34669183Wirta D, McLaurin E, Ousler G, Liu J, Kacmaz RO, Grieco J. Repository Corticotropin Injection (Acthar(R) Gel) for Refractory Severe Noninfectious Keratitis: Efficacy and Safety from a Phase 4, Multicenter, Open-Label Study. Ophthalmol Ther. 2021 Dec;10(4):1077-1092. doi: 10.1007/s40123-021-00400-y. Epub 2021 Oct 20.
Individual participant dataSharing planned: No. Discussion of statistical endpoints and analysis are included in manuscripts. Summary aggregate (basic) results (including adverse events information) and the study protocol are made available on clinicaltrials.gov (NCT04169061) when required by regulation. Individual de-identified patient data will not be disclosed. Requests for additional information should be directed to the company at medinfo@mnk.com.

Related trials for Keratitis

RecruitingPhase 1/2
A Phase 1/2, Single-Dose, Multicenter, Dose Escalation, Clinical Trial to Evaluate the Safety and Efficacy of MR-146: An Open-Label Part 1 in Participants With Stage 1 or 2 Neurotrophic Keratopathy and a Double-Masked Part 2 in Participants With Stage 2 Neurotrophic Keratopathy
Neurotrophic Keratopathy
RecruitingObservational study
Validation of Interleukins and Other Cytokines Together With OCT Imaging for Rapid Infectious Keratitis Assessment
Keratitis Bacterial, Keratitis Fungal
RecruitingPhase 2
Efficacy of Locally Delivered Allogeneic Mesenchymal Stromal Cells
Corneal Ulcer
Not yet recruitingPhase 2
Trial to Evaluate the Efficacy And Safety of IVIEW-1201 In the Treatment of Fungal Keratitis
Fungal Keratitis
Not yet recruitingPhase 1
A Clinical Study to Evaluate the Safety and Effectiveness of MSCohi-O Lens in the Treatment of Immune-related Ocular Surface Diseases.
Keratitis, Autoimmunity

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Global Clinical Leader study director

Mallinckrodt

9 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Acthar in people with Keratitis, run by Mallinckrodt at 9 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 9 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 18 Aug 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants Who Improved on the Impact of Dry Eye on Everyday Life (IDEEL) Scale [Using the Symptom Bother Module at Week 12] (time frame: Week 12). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04169061, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Aug 2021.