Autoimmune DiseasesPhase 4MNKNCT06964269
Use of Acthar Gel Single-Dose Pre-Filled SelfJectTM Injector in Patients With Moderate-Severe Keratitis and Autoimmune Disease
A Phase 4 study testing Acthar Gel 80 UNT/ML Injectable Solution in people with Autoimmune Diseases and Dry Eye, run by Toyos Clinic at 1 site in United States.
Trial summary
Single-site, open label pilot study of 20 autoimmune patients diagnosed with dry eye demonstrating via the proparacaine challenge some peripheral corneal pain component. At least 16 patients will receive and complete 12 weeks of 80 units of Acthar Gel to be injected subcutaneously twice weekly via Acthar Gel… Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Autoimmune Diseases, Dry Eye, Neurotrophic Keratitis
- What is being tested?
- Acthar Gel 80 UNT/ML Injectable Solution
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Feb 2025to 28 Feb 2028
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
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 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subject can read, understand, sign and informed consent.
- Provision of signed and dated informed consent form and HIPPA authorization.
- Stated willingness to comply with all study procedures and availability
- for the duration of the study
- Male or female aged 18-85 years.
- Normal eyelid anatomy
Show all 12Show fewer
- Patients diagnosed with dry eye for at least 6 months prior to enrollment.
- Patients with Symptom Bother score at Baseline of 50.6 or greater.
- Patients with a diagnosis of any autoimmune disease.
- Patients with one or more corneal neuroma as seen on baseline confocal microscopy.
- Patients with partial or total relief of corneal pain with one drop of proparacaine over 15 minutes post-instillation.
- No prior use of Acthar Gel SelfJect or otherwise for any indication.
Who cannot join
- 1. Have a known hypersensitivity or contraindication to the investigational product or their components.
- 2. Unwilling to participate in study activities or report for study visits. 3. Current pregnancy or lactation per self-report. Patients who are unwilling to use an effective method of birth control while participating in the study and for four weeks after the last dose of study drug is administered.
- 4. Use of antihistamines, mast cell stabilizers, or prescription eye drops within 24 hours prior to screening and for the study, unless the dose has been stable for 14 days.
- 5. Current use of cenegermin, topical nerve growth factor or platelet rich plasma or use within the past 30 days.
- 6. Treatment with another investigational drug or other intervention within 30 days of screening.
- 7. Have serious or severe disease or uncontrolled medical condition that in the judgement of the investigator could confound study assessments, limit compliance, or pose safety risks.
- 8. Systemic medications known to cause dry eye should not be used including antimuscarinics, antihistamines, vitamin A analogs, antianxiety agents, and others unless stable for at least 30 days.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Toyos Clinic
Nashville, Tennessee, 37215
Marcella Garza, 6153274015, mgarza@toyosclinic.com
Melissa toyos, MD
About this study
Official title: A Phase 4 Pilot Study With Extension to Assess the Use of Acthar Gel Single-Dose Pre-Filled SelfJectTM Injector in Patients With Moderate-Severe Keratitis and Autoimmune Disease and the Effect on Corneal Nerves and Neuropathic Corneal Pain
Single-site, open label pilot study of 20 autoimmune patients diagnosed with dry eye demonstrating via the proparacaine challenge some peripheral corneal pain component. At least 16 patients will receive and complete 12 weeks of 80 units of Acthar Gel to be injected subcutaneously twice weekly via Acthar Gel single-dose pre-filled SelfJectTM injector (SelfJect) to assess the effects on subjective sensation of ocular pain, conjunctival and corneal staining, in vivo assessments of corneal nerves as measured by confocal imaging, VAS scales of common neuropathic pain symptoms and comfort of SelfJect will be assessed.
Read the detailed description
The primary objective of the study is to demonstrate the on-label use of Acthar Gel with SelfJect for improvement of symptoms in non-infectious keratitis related to systemic autoimmune disease and the improvement of the appearance and function of corneal nerves as visualized by confocal microscopy and demonstrated by Cochet-Bonnet) and to assess the improvement of common neuropathic corneal pain symptoms caused by dysfunctional nerves due to various autoimmune
inflammatory disease. This study will also follow patients for up to 3 years after 12 weeks of administration of Acthar Gel 80 units twice weekly to assess changes from end of treatment to end of study in visual acuity, corneal and conjunctival staining
- Conditions
- Autoimmune Diseases, Dry Eye, Neurotrophic Keratitis
- Being tested
- Acthar Gel 80 UNT/ML Injectable Solution
- Keywords
- Dry eye, Autoimmune, Neurotropic Keratitis
- Medical subject headings
- Autoimmune Diseases, Dry Eye Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acthar Gel 80 UNT/ML Injectable SolutionDrug
Study intervention is twice weekly injections of Acthar Gel via single-dose pre-filled SelfJect injector for 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| One study arm of approximately 20 active receiving and completing active, open-label interventions. | Active comparator | One study arm of approximately 20 active receiving and completing active, open-label interventions. Receives: Drug: Acthar Gel 80 UNT/ML Injectable Solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analog scale for injection comfort
To assess the severity of injection comfort in the eyes. scale ranges from 0(none) - 100(severe)
Measured: 3 years
Visual Analog scale for burning
To assess the severity of burning in the eyes. scale ranges from 0(none) - 100(severe)
Measured: 3 years
Visual Analog scale for Stinging
To assess the severity of stinging in the eyes. scale ranges from 0(none) - 100(severe)
Measured: 3 years
Visual Analog scale for Light sensitivity
To assess the severity of light sensitivity in the eyes. scale ranges from 0(none) - 100(severe)
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2025
- Study start11 Feb 2025
- Primary completion28 Feb 2028 (estimated)
- Study completion28 Feb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autoimmune DiseasesStudies 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
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Toyos Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06964269
- Sponsor's protocol ID
- MNK-MT-2024
- Acronym
- MNK
- Status last verified
- May 2025
- First submitted
- 7 Apr 2025
- Last updated
- 11 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 4 Pilot Study With Extension to Assess the Use of Acthar Gel Single-Dose Pre-Filled SelfJectTM Injector in Patients With Moderate-Severe Keratitis and Autoimmune Disease and the Effect on Corneal Nerves and Neuropathic Corneal Pain
- ClinicalTrials.gov ID
- NCT06964269
- Acronym / sponsor ID
- MNK / MNK-MT-2024
- Conditions
- Autoimmune Diseases, Dry Eye, Neurotrophic Keratitis
- Keywords
- Dry eye, Autoimmune, Neurotropic Keratitis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Toyos ClinicUniversity, hospital or other
- Study start
- 11 Feb 2025 (actual)
- Primary completion
- 28 Feb 2028 (estimated)
- Study completion
- 28 Feb 2028 (estimated)
- First posted
- 9 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Single-site, open label pilot study of 20 autoimmune patients diagnosed with dry eye demonstrating via the proparacaine challenge some peripheral corneal pain component. At least 16 patients will receive and complete 12 weeks of 80 units of Acthar Gel to be injected subcutaneously twice weekly via Acthar Gel single-dose pre-filled SelfJectTM injector (SelfJect) to assess the effects on subjective sensation of ocular pain, conjunctival and corneal staining, in vivo assessments of corneal nerves as measured by confocal imaging, VAS scales of common neuropathic pain symptoms and comfort of SelfJect will be assessed.
Detailed description
The primary objective of the study is to demonstrate the on-label use of Acthar Gel with SelfJect for improvement of symptoms in non-infectious keratitis related to systemic autoimmune disease and the improvement of the appearance and function of corneal nerves as visualized by confocal microscopy and demonstrated by Cochet-Bonnet) and to assess the improvement of common neuropathic corneal pain symptoms caused by dysfunctional nerves due to various autoimmune
inflammatory disease. This study will also follow patients for up to 3 years after 12 weeks of administration of Acthar Gel 80 units twice weekly to assess changes from end of treatment to end of study in visual acuity, corneal and conjunctival staining
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| One study arm of approximately 20 active receiving and completing active, open-label interventions. | Active comparator | Drug: Acthar Gel 80 UNT/ML Injectable SolutionOne study arm of approximately 20 active receiving and completing active, open-label interventions. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Subject can read, understand, sign and informed consent.
- Provision of signed and dated informed consent form and HIPPA authorization.
- Stated willingness to comply with all study procedures and availability
- for the duration of the study
- Male or female aged 18-85 years.
Key exclusion criteria (7 listed)
- 1. Have a known hypersensitivity or contraindication to the investigational product or their components.
- 2. Unwilling to participate in study activities or report for study visits. 3. Current pregnancy or lactation per self-report. Patients who are unwilling to use an effective method of birth control while participating in the study and for four weeks after the last dose of study drug is administered.
- 4. Use of antihistamines, mast cell stabilizers, or prescription eye drops within 24 hours prior to screening and for the study, unless the dose has been stable for 14 days.
- 5. Current use of cenegermin, topical nerve growth factor or platelet rich plasma or use within the past 30 days.
- 6. Treatment with another investigational drug or other intervention within 30 days of screening.
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 |
|---|---|---|
| Acthar Gel 80 UNT/ML Injectable SolutionStudy intervention is twice weekly injections of Acthar Gel via single-dose pre-filled SelfJect injector for 12 weeks. | Drug | One study arm of approximately 20 active receiving and completing active, open-label interventions. |
Primary outcome
Visual Analog scale for injection comfort
Time frame: 3 years
To assess the severity of injection comfort in the eyes. scale ranges from 0(none) - 100(severe)
Visual Analog scale for burning
Time frame: 3 years
To assess the severity of burning in the eyes. scale ranges from 0(none) - 100(severe)
Visual Analog scale for Stinging
Time frame: 3 years
To assess the severity of stinging in the eyes. scale ranges from 0(none) - 100(severe)
Visual Analog scale for Light sensitivity
Time frame: 3 years
To assess the severity of light sensitivity in the eyes. scale ranges from 0(none) - 100(severe)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2025.
- Individual participant dataSharing planned: Undecided
Related trials for Autoimmune Diseases
RecruitingPhase 2
Study of PTC844 in Participants With Active Rheumatoid Arthritis
Rheumatoid Arthritis
RecruitingPhase 3
Study to Assess the Efficacy, Pharmacokinetics, Safety and Tolerability of Atrasentan in Pediatric Patients With Primary IgAN
Berger Disease, Bergers Disease
RecruitingPhase 2
Metformin as an add-on or Monotherapy in Treatment of Aging People With Multiple Sclerosis (MS)
Multiple Sclerosis
RecruitingObservational study
Pain Phenotypes in Individuals With Multiple Sclerosis
Multiple Sclerosis, Chronic Pain
Not yet recruitingPhase 1
An Ascending Dose Study of DKB903 in Participants With Rheumatoid Arthritis (RA) and Participants With Systemic Lupus Erythematosus (SLE)
Rheumatoid Arthritis and Systemic Lupus Erythematosus
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.
1 site 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 Gel 80 UNT/ML Injectable Solution in people with Autoimmune Diseases and Dry Eye, run by Toyos Clinic at 1 site 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 12 inclusion and 7 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: looking for participants now, as of the sponsor's last update on 11 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Harley cheney Study Coordinator, Study Coordinator (+616153274015, hcheney@toyosclinic.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analog scale for injection comfort (time frame: 3 years). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 May 2025.