Acthar Gel in Participants With Pulmonary Sarcoidosis

What Was Tested

The trial (phase 4) is built around ACTH (Corticotropin).

Participants will be randomly assigned (like flipping a coin) to receive a shot under their skin of Acthar Gel or a matching placebo gel that has no drug in it.

They will receive their assigned shot twice a week for 24 weeks.

It had two arms (groups): Acthar Gel in DBT Then Acthar Gel in OLE (experimental) and Placebo in DBT Then Acthar Gel in OLE (experimental).

The registry classes the interventions as drug.

Who Took Part

The registry lists 55 actual participants took part.

It was open to people of any sex aged from 18 years up to 90 years.

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

Examples of who could join: Has biopsy-confirmed sarcoidosis meeting American Thoracic Society criteria ≥ 1 year at screening (Visit 1). Has protocol-defined symptomatic pulmonary disease. Has lung function within protocol-defined parameters.

The full record lists 4 inclusion and 4 exclusion criteria; among the exclusions: has pulmonary arterial hypertension requiring treatment; has been treated with antitumor necrosis factor-α antibody within the past 3 months; has any pulmonary condition that requires treatment, therefore impeding corticosteroid tapering.

How the Study Was Run

The set-up was randomized, parallel-group and double-blind.

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.

Groups ran in parallel: each of the participants stayed in one arm throughout.

As a double-blind ACTH (Corticotropin) study, the assignments were hidden from both participants and investigators until the end.

Those kept unaware of assignments: participant and investigator.

It started in 2018-02-21 with completion listed for 2021-11-15.

It ran at 29 sites in United States (29).

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: DBT: Number of Participants in Each Category of Assessment Based on Forced Vital Capacity (FVC), a Pulmonary Function Test Parameter at Week 24 (time frame: Week 24). OLE: Number of Participants in Each Category of Assessment Based on FVC, a Pulmonary Function Test Parameter at Week 48 (time frame: Week 48). DBT: Number of Participants in Each Category of Assessment Based on the Diffusing Capacity of the Lungs for Carbon Monoxide (DLCO), a Pulmonary Function Test Parameter at Week 24 (time frame: Week 24).

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of ACTH (Corticotropin) in 55 people.

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.