A Clinical Study to Evaluate the Potential Role of ACTH Gel in Patients With Scleritis

What Was Tested

The trial (phase 2) is built around ACTH (Corticotropin).

ATLAS study is a clinical trial to evaluate the potential role of subcutaneous adrenocorticotropic hormone (ACTH) gel in the management of non-infectious scleritis.

It had two arms (groups): Twice Weekly Treatment Arm (experimental) and Thrice Weekly Treatment Arm (experimental).

The registry classes the interventions as drug.

More on the Plan

ATLAS study will be conducted at up to 6 clinical sites in USA.

The ATLAS Study aims to evaluate the potential role of subcutaneous adrenocorticotropic hormone (ACTH) gel, in the management of non-infectious anterior scleritis.

Anterior scleritis may manifest as necrotizing or non-necrotizing.

Non-necrotizing, noninfectious scleritis is the most prevalent form.

Who Took Part

The registry lists 30 planned participants were the target.

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: Adults, age ≥ 18 years;. Able to give informed consent and attend all study visits;. Have diagnosis of non-necrotizing scleritis determined by the Investigator to be non-infectious;. Have active scleirits, defined as:. Are receiving no other treatment; or,.

The full record lists 27 inclusion and 46 exclusion criteria; among the exclusions: diabetic retinopathy: proliferative diabetic retinopathy (pdr) or non-proliferative diabetic retinopathy (npdr) that compromise the vision; age-related macular degeneration;; myopic degeneration with active subfoveal choroidal neovascularization.

How the Study Was Run

The set-up was randomized, parallel-group and open-label.

Because people in this ACTH (Corticotropin) study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

The ACTH (Corticotropin) group and the comparison group ran side by side rather than switching.

Everyone knew when ACTH (Corticotropin) was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

It started in 2019-01-01 with completion listed for 2024-12-08.

It ran at 3 sites in United States (3).

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Change in grade of pain on an 11-point pain intensity numerical rating scale (NRS) (time frame: At the primary end point (week 16) and at the end of follow-up period (week 52) or at time of rescue). Change in degree of inflammation, based on the standardized scleritis grading scale (time frame: At the primary end point (week 16) and at the end of follow-up period (week 52) or at time of rescue).

It also tracked 7 secondary outcomes, for example Best corrected visual acuity outcome, Vascular leakage outcome, Retinal thickness outcome, Scleral thickness outcome and Response to therapy with/without systemic corticosteroids.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of ACTH (Corticotropin) in 30 people.

Its size is small, so on its own it can only give an early look.

Its status is unknown; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the ACTH (Corticotropin) compound page, all human trials.