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Use of Acthar Gel Single-Dose Pre-Filled SelfJectTM Injector in Patients With Moderate-Severe Keratitis and Autoimmune Disease
Plain-language guide to NCT06964269: phase 4 interventional trial of ACTH (Corticotropin), 20 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT06964269
- Phase
- phase 4
- Status
- recruiting participants
- Start
- 2025-02-11
- Completion (planned or actual)
- 2028-02-28
- Participants
- 20 (estimated)
- Design
- na, open label (everyone knows who gets what), treatment
- Conditions studied
- Autoimmune Diseases; Dry Eye; Neurotrophic Keratitis
- Results posted
- not yet
What This Study Did, in Plain Language
What Was Tested
In this phase 4 trial, researchers set out to test ACTH (Corticotropin).
It had 1 arm (groups): 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.
The registry classes the interventions as drug.
Who Took Part
The registry lists 20 planned participants were the target.
It was open to people of any sex aged from 18 years up to 85 years.
Healthy volunteers could join, not only people with the condition.
Examples of who could 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.
The full record lists 12 inclusion and 1 exclusion criteria; among the exclusions: 1\. have a known hypersensitivity or contraindication to the investigational product or their components.
How the Study Was Run
The set-up was single-group and open-label.
Nothing was hidden in this open-label ACTH (Corticotropin) study: the participants and staff both knew the treatment.
Everyone received the same intervention, so there was no separate comparison group inside the trial.
It started in 2025-02-11 with completion listed for 2028-02-28.
It ran at 1 site in United States.
Its stated primary purpose is treatment.
What Was Measured
The main thing measured (primary outcome): Visual Analog scale for injection comfort (time frame: 3 years). Visual Analog scale for burning (time frame: 3 years). Visual Analog scale for Stinging (time frame: 3 years).
What This Means in Plain Language
Put simply, this is a phase 4 trial of ACTH (Corticotropin) in 20 people.
Its size is small, so on its own it can only give an early look.
It is still recruiting; no results are posted to the registry yet, so nothing here describes outcomes.
More context: the ACTH (Corticotropin) compound page, all human trials.
Our Notes on the Compound
ACTH (Corticotropin): The 39-amino-acid pituitary hormone that drives cortisol production; given as repository corticotropin (Acthar Gel).
Related Pages
Source: ClinicalTrials.gov record. This explanation is written by PeptideWhiz from the public record. For research and education only. Not medical advice; no dosing information is given.