Study of H.P. ACTHAR Subcutaneous Gelatin (Gel)(Highly Purified Gel Injection) in Uveitis Patients

What Was Tested

This registered phase 4 trial tested ACTH (Corticotropin).

The inflammation usually causes pain, redness, photophobia and blurred vision.

This inflammation, is typically treated with regional or systemic therapy.

It had 1 arm (groups): H.P. Acthar Subcutaneous Gel Injection (other).

The registry classes the interventions as drug.

More on the Plan

H.P Acthar Gel stimulate the adrenal cortex to secrete cortisol.

Acthar gel is also reported to bind to melanocortin receptors.

Specifically melanocortins down regulate Tumor Necrosis Factor (TNF) alpha, Interleukin (IL) -2, Interferon gamma and T-cell proliferation and upregulates IL-10 and regulatory T cells.

Acthar is an approved treatment for ocular inflammatory disease.

Who Took Part

Enrollment: 6 actual participants took part.

It was open to people of any sex aged from 18 years with no upper age limit.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Subject has the ability to understand and sign the informed consent document. Subject is 18 years of age or older. Subject can be male or female. Subject has negative Purified Protein Derivative (Tuberculosis skin test) or quantiferon TB Gold Test (blood test for TB) testing done in 3 months. Subject has active ocular inflammation in at least one eye.

The full record lists 9 inclusion and 10 exclusion criteria; among the exclusions: subject has any ocular infection; subject has any systemic infection; participant has documented immunocompromised or immune-incompetent state.

How the Study Was Run

Design: single-group and open-label.

Being open-label, the ACTH (Corticotropin) study did not mask who received what.

Everyone received the same intervention, so there was no separate comparison group inside the trial.

It started in 2016-06-30 with completion listed for 2016-12-07.

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 phase 4 trial of ACTH (Corticotropin) in 6 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.