Acthar Gel for Chronic Pulmonary Sarcoidosis (ACPS)

What Was Tested

In this phase 4 trial, researchers set out to test ACTH (Corticotropin).

Patients will be observed for 24 weeks of treatment.

It had two arms (groups): one (active comparator) and one (active comparator).

The registry classes the interventions as drug.

More on the Plan

A total of 20 chronic pulmonary sarcoidosis patients will be recruited at eight clinical sites across the United States.

At the end of total 24 weeks of treatment, they will undergo repeat evaluation including pulmonary function, CT, and PET scanning.

Who Took Part

20 planned participants were the target.

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: Patient with biopsy confirmed sarcoidosis meeting American Thoracic Society criteria 23. Deterioration of pulmonary disease over the past year. Age: 18 through 90 (i.e., candidates must have had their 18th birthday, but not had their 91st birthday).

The full record lists 7 inclusion and 16 exclusion criteria; among the exclusions: a fungal infection; herpes infection of the eyes; a stomach ulcer.

How the Study Was Run

Design: randomized, parallel-group and triple-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.

Neither the participants nor the staff measuring them knew who was on ACTH (Corticotropin), so expectations could not easily colour the readings.

Those kept unaware of assignments: participant, care provider and investigator.

It started in 2014-06 with completion listed for 2016-12.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Steroid toxicity (time frame: 24 weeks).

It also tracked 4 secondary outcomes, for example Forced Vital Capacity (FVC), Chest x-ray, PET scan and Sarcoidosis Health Questionnaire.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of ACTH (Corticotropin) in 20 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.