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Ocular Sarcoidosis Open Label Trial of ACTHAR Gel
Plain-language guide to NCT02725177: not phased interventional trial of ACTH (Corticotropin), 9 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT02725177
- Phase
- not phased
- Status
- completed
- Start
- 2016-07
- Completion (planned or actual)
- 2021-12
- Participants
- 9 (actual)
- Design
- na, open label (everyone knows who gets what), treatment
- Conditions studied
- Ocular Sarcoidosis; Panuveitis; Anterior Uveitis
- Results posted
- yes
What This Study Did, in Plain Language
What Was Tested
This registered not phased trial tested ACTH (Corticotropin).
The registry classes the interventions as drug.
More on the Plan
As a result, it is not uncommon that treating physicians must choose between excessive glucocorticoid toxicity versus poor control of ocular inflammation.
Ongoing ocular inflammation, in turn, leads to eventual visual loss and occasionally blindness.
There is a need for a more reliable, expeditious therapy that can be used as an alternative to glucocorticoids in sarcoidosis uveitis.
Adrenocorticotropic hormone, through activation of melanocortin receptors on leukocytes, can dampen immune responses through non-glucocorticoid dependent mechanisms.
Who Took Part
The registry lists 9 actual participants took part.
It was open to people of any sex aged from 18 years up to 99 years.
Healthy volunteers were not accepted; participants needed the condition being studied.
Examples of who could join: Patient with sarcoidosis as defined by ATS/ERS/WASOG guidelines (American Thoracic Society/European Respiratory Society /World Association of Sarcoidosis and Other Granulomatous Diseases). Persistent disease activity (active uveitis) at the time of screening.
The full record lists 3 inclusion and 12 exclusion criteria; among the exclusions: other cause for ocular inflammation; recent (less than 4 weeks) intra-ocular or intra-orbital steroid injection; escalation of immunosuppressive medications between screening and initiation of the study medication.
How the Study Was Run
Design: 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 2016-07 with completion listed for 2021-12.
It ran at 1 site in United States.
Its stated primary purpose is treatment.
What This Means in Plain Language
Put simply, this is a not phased trial of ACTH (Corticotropin) in 9 people.
Its size is small, so on its own it can only give an early look.
The trial is marked completed; results are posted on the registry, and this page does not restate them.
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.