Results From a Phase 4, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of Repository Corticotropin Injection for the Treatment of Pulmonary Sarcoidosis.

Mirsaeidi M, Baughman RP, Sahoo D, Tarau E

Pulmonary therapy19 Apr 2023Cited by 15 (Europe PMC)

PMID37072607PMCIDPMC10113127DOI10.1007/s41030-023-00222-2PepBankPUB-37072607

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Summary

The text of this summary is not shown here, because the article license does not allow reuse. Read it at the source (opens in a new tab)

Text rights: CC BY-NC. Results still quote short attributed sentences.

Results from this study6

6 results from studies that gave the peptide. 6 results from people.

01HumanRandomized controlled trialEfficacy outcome
In pulmonary sarcoidosis, mean STS improvement at week 24 was 1.4 with Acthar versus 0.7 with placebo.
In plain wordsIn pulmonary sarcoidosis, the treatment score improved more with Acthar than placebo at week 24, but the study had no statistical analysis.
Peptide
ACTH (corticotropin)
Outcome
IncreaseSarcoidosis treatment score at week 24
Study
n = 55
Comparator
Placebo
Outcome group
Disease activity · Respiratory
Studied dose
80 U twice weekly · subcutaneous · 24 weeksAs given in this study (human).
Measurements
STS
1.4 score
Acthar week 24
STS
0.7 score
placebo week 24
Source sentences
Summary
Mean STS at week 24 showed greater improvement with RCI (1.4) compared with placebo (0.7).
2 context sentences(design, population, supporting numbers)
Summary · context
In this multicenter, randomized, placebo-controlled trial, subjects received subcutaneous RCI (80 U) twice weekly or matching placebo through 24 weeks in a double-blind treatment phase, followed by an optional 24-week open-label extension.
Summary · context
The study was terminated early due to low enrollment caused by the COVID-19 pandemic, thereby precluding statistical analysis.
Report a problemFND-3707260701
02HumanRandomized controlled trialEfficacy outcome
In pulmonary sarcoidosis, more Acthar recipients discontinued glucocorticoids at week 24 than placebo recipients.
In plain wordsIn pulmonary sarcoidosis, more patients stopped glucocorticoids with Acthar than with placebo at week 24, but the study had no statistical analysis.
Peptide
ACTH (corticotropin)
Outcome
IncreaseGlucocorticoid discontinuation at week 24
Study
n = 55
Comparator
Placebo
Outcome group
Glucocorticoid use · Respiratory
Studied dose
80 U twice weekly · subcutaneous · 24 weeksAs given in this study (human).
Source sentences
Summary
More subjects in the RCI group discontinued glucocorticoids at week 24 compared to the placebo group.
2 context sentences(design, population, supporting numbers)
Summary · context
In this multicenter, randomized, placebo-controlled trial, subjects received subcutaneous RCI (80 U) twice weekly or matching placebo through 24 weeks in a double-blind treatment phase, followed by an optional 24-week open-label extension.
Summary · context
The study was terminated early due to low enrollment caused by the COVID-19 pandemic, thereby precluding statistical analysis.
Report a problemFND-3707260703
03HumanRandomized controlled trialEfficacy outcome
In pulmonary sarcoidosis, other efficacy endpoints showed trends favoring Acthar over placebo.
In plain wordsIn pulmonary sarcoidosis, other efficacy results showed trends favoring Acthar over placebo.
Peptide
ACTH (corticotropin)
Outcome
Direction not reportedOther efficacy endpoints
Study
n: not reported in source
Comparator
Placebo
Outcome group
Disease activity · Respiratory
Studied dose
80 U twice weekly · subcutaneous · 24 weeksAs given in this study (human).
Source sentences
Summary
Similar trends in favor of RCI over placebo were observed with the other efficacy endpoints.
2 context sentences(design, population, supporting numbers)
Summary · context
In this multicenter, randomized, placebo-controlled trial, subjects received subcutaneous RCI (80 U) twice weekly or matching placebo through 24 weeks in a double-blind treatment phase, followed by an optional 24-week open-label extension.
Summary · context
The study was terminated early due to low enrollment caused by the COVID-19 pandemic, thereby precluding statistical analysis.
Report a problemFND-3707260705
04HumanNon-randomized trialEfficacy outcome
In pulmonary sarcoidosis, week 48 STS was 1.8 with continued Acthar versus 0.9 after switching from placebo.
In plain wordsIn pulmonary sarcoidosis, continued Acthar had a higher treatment score than switching from placebo at week 48.
Peptide
ACTH (corticotropin)
Outcome
IncreaseSarcoidosis treatment score at week 48
Study
n: not reported in source
Comparator
Switched from placebo to RCI
Outcome group
Disease activity · Respiratory
Studied dose
80 U twice weekly · subcutaneous · 48 weeksAs given in this study (human).
Measurements
STS
1.8 score
week 48, remained on RCI
STS
0.9 score
week 48, switched from placebo to RCI
Source sentences
Summary
At week 48, those who remained on RCI had an STS of 1.8 compared with 0.9 in those who switched from placebo to RCI.
2 context sentences(design, population, supporting numbers)
Summary · context
In this multicenter, randomized, placebo-controlled trial, subjects received subcutaneous RCI (80 U) twice weekly or matching placebo through 24 weeks in a double-blind treatment phase, followed by an optional 24-week open-label extension.
Summary · context
The study was terminated early due to low enrollment caused by the COVID-19 pandemic, thereby precluding statistical analysis.
Report a problemFND-3707260702
05HumanNon-randomized trialEfficacy outcome
In pulmonary sarcoidosis, glucocorticoid discontinuation was comparable with continued Acthar and switching from placebo at week 48.
In plain wordsIn pulmonary sarcoidosis, steroid discontinuation was comparable with continued Acthar and switching from placebo at week 48.
Peptide
ACTH (corticotropin)
Outcome
No significant changeGlucocorticoid discontinuation at week 48
Study
n: not reported in source
Comparator
Switched from placebo to RCI
Outcome group
Glucocorticoid use · Respiratory
Studied dose
80 U twice weekly · subcutaneous · 48 weeksAs given in this study (human).
Source sentences
Summary
Glucocorticoid discontinuation was comparable at week 48 for those who switched from placebo to RCI and those who continued RCI.
2 context sentences(design, population, supporting numbers)
Summary · context
In this multicenter, randomized, placebo-controlled trial, subjects received subcutaneous RCI (80 U) twice weekly or matching placebo through 24 weeks in a double-blind treatment phase, followed by an optional 24-week open-label extension.
Summary · context
The study was terminated early due to low enrollment caused by the COVID-19 pandemic, thereby precluding statistical analysis.
Report a problemFND-3707260704
06HumanNon-randomized trialSafety outcome
In pulmonary sarcoidosis, no new or unexpected safety signals were identified with Acthar.
In plain wordsIn pulmonary sarcoidosis, investigators identified no new or unexpected safety signals with Acthar.
Peptide
ACTH (corticotropin)
Outcome
Not applicableNew or unexpected safety signals
Study
n: not reported in source
Outcome group
Adverse events · Whole body
Studied dose
80 U twice weekly · subcutaneousAs given in this study (human).
Source sentences
Summary
No new or unexpected safety signals were identified.
2 context sentences(design, population, supporting numbers)
Summary · context
In this multicenter, randomized, placebo-controlled trial, subjects received subcutaneous RCI (80 U) twice weekly or matching placebo through 24 weeks in a double-blind treatment phase, followed by an optional 24-week open-label extension.
Summary · context
The study was terminated early due to low enrollment caused by the COVID-19 pandemic, thereby precluding statistical analysis.
Report a problemFND-3707260706

AI wrote and checked these results. AI can make mistakes, so check important results against the source.

Registered trials1

Trials this study reports on, or that list this study as a reference. Registry data from ClinicalTrials.gov.

1 trial · 1 completed · 1 with posted results · source ClinicalTrials.gov (opens in a new tab)

CompletedPhase 4Results postedNCT03320070

Acthar Gel in Participants With Pulmonary Sarcoidosis

Mallinckrodtn = 5521 Feb 2018 to 15 Nov 2021

Sarcoidosis, Pulmonary

Trial page ClinicalTrials.govUpdated 27 Feb 2023

Version history

PepBank keeps every version of the data on this study. Status changes from Retraction Watch, Europe PMC and Crossref are listed with their source.

Version 2Current
28 Oct 2026, 02:03 UTC
Study results updated
Version 1
27 Oct 2026, 16:35 UTC
First added · source update from Europe PMC

Subjects

Terms as the source lists them.

Publication types

Keywords

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