A Phase 4 interventional study of Acthar in Keratitis, sponsored by Mallinckrodt. Completed at 9 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-08-18.
Sponsored by Mallinckrodt · Phase 4, Interventional, and Treatment
We will need about 36 participants for this study.
Volunteers might be able to participate if:
Participants will be in the study for about 22 weeks:
108 studies on the registry are indexed under Keratitis; 19 are open to participants now.
This study's enrollment of 36 is close to the median of 40 across 70 interventional studies indexed under Keratitis.
Browse Keratitis studies →Mallinckrodt is the lead sponsor of 87 studies on the registry; none are open to participants now.
Of its 15 completed or terminated interventional studies of FDA-regulated products, 15 (100%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
Also known as: Acthar Gel
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.
Time frame: Week 12
Thirty-six participants were enrolled at 8 locations in the United States
| Milestone | All Participants |
|---|---|
| Started | 36 |
| Safety population | 36 |
| Modified intent to treat (mitt) population | 34 |
| Completed | 31 |
| Not completed | 5 |
| Withdrew: Adverse event | 2 |
| Withdrew: Death | 1 |
| Withdrew: Withdrawal by subject | 1 |
| Withdrew: Protocol violation | 1 |
A 12-point score reduction on the 100-point symptom bother module indicates a clinically important reduction of bothersome dry eye symptoms.
| Participants | All Participants |
|---|---|
| Number of Participants Who Improved on the Impact of Dry Eye on Everyday Life (IDEEL) Scale [Using the Symptom Bother Module at Week 12] | 17 |
Collected over While participating in the trial (up to 22 weeks). Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| All Participants | 1/36 (2.8%) | 1/36 (2.8%) | 2/36 (5.6%) |
| Event | All Participants |
|---|---|
| Intentional overdoseInjury, poisoning and procedural complications | 1/36 |
| Event | All Participants |
|---|---|
| HypertensionVascular disorders | 2/36 |
Safety Analysis Population
| Age, Continuous(years) | All Participants |
|---|---|
| Mean | 63.6 ± 10.17 |
| Sex: Female, Male(Participants) | All Participants |
|---|---|
| Female | 26 |
| Male | 10 |
| Ethnicity (NIH/OMB)(Participants) | All Participants |
|---|---|
| Hispanic or Latino | 2 |
| Not Hispanic or Latino | 34 |
| Unknown or Not Reported | 0 |
| Race (NIH/OMB)(Participants) | All Participants |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 7 |
| White | 29 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
| Region of Enrollment(participants) | All Participants |
|---|---|
| United States | 36 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: 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.
This study is completed, as verified in Jul 2021. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Adrenocorticotropic Hormone