Phase 4
Completed N=55
Acthar Gel in Participants With Pulmonary Sarcoidosis
Sarcoidosis, Pulmonary
Source: ClinicalTrials.gov NCT03320070 ↗
Enrolled (actual)
55
Serious AEs
12.8%
Results posted
Feb 2023
Primary outcomePrimary: DBT: Number of Participants in Each Category of Assessment Based on Forced Vital Capacity (FVC), a Pulmonary Function Test Parameter at Week 24 — 10; 7; 12; 12 Participants — p=0.5076
◆ Published Evidence
Emerging
16citations · ~5 / year
Results From a Phase 4, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of Repository Corticotropin Injection for the Treatment of Pulmonary Sarcoidosis.
Summary
The purpose of this study is to find out if Acthar Gel is safe and effective to treat pulmonary sarcoidosis.
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.
All participants who complete the 24-week treatment period will be eligible to receive Acthar Gel for 24 more weeks, even if they were originally in the placebo group.
Linked Publications
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Results From a Phase 4, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of Repository Corticotropin Injection for the Treatment of Pulmonary Sarcoidosis.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY DBT: Number of Participants in Each Category of Assessment Based on Forced Vital Capacity (FVC), a Pulmonary Function Test Parameter at Week 24 |
10; 7; 12; 12; 1; 3 | 0.5076 |
| PRIMARY OLE: Number of Participants in Each Category of Assessment Based on FVC, a Pulmonary Function Test Parameter at Week 48 |
2; 6; 13; 11; 1; 3 | — |
| PRIMARY 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 |
5; 4; 11; 11; 7; 7 | 1.0000 |
| PRIMARY OLE: Number of Participants in Each Category of Assessment Based on the DLCO, a Pulmonary Function Test Parameter at Week 48 |
9; 6; 3; 6; 4; 8 | — |
| PRIMARY DBT: Number of Participants in Each Category of Assessment Based on High Resolution Computer Tomography (HRCT) at Week 24 |
2; 1; 22; 18; 0; 4 | 0.0848 |
| PRIMARY OLE: Number of Participants in Each Category of Assessment Based on HRCT at Week 48 |
1; 6; 13; 13; 1; 2 | — |
| PRIMARY DBT: Number of Participants in Each Category of Assessment Based on the King's Sarcoidosis Questionnaire (KSQ) (General Health), a Quality of Life Parameter at Week 24 |
11; 7; 3; 8; 10; 9 | 0.2005 |
| PRIMARY OLE: Number of Participants in Each Category of Assessment Based on the KSQ (General Health), a Quality of Life Parameter at Week 48 |
8; 8; 2; 5; 6; 9 | — |
| PRIMARY DBT: Number of Participants in Each Category of Assessment Based on the Fatigue Assessment Score (FAS), a Quality of Life Parameter at Week 24 |
6; 6; 12; 11; 6; 7 | 0.9416 |
| PRIMARY OLE: Number of Participants in Each Category of Assessment Based on FAS, a Quality of Life Parameter at Week 48 |
7; 4; 5; 13; 4; 5 | — |
| PRIMARY DBT: Number of Participants in Each Category of Assessment Based on Corticosteroid Taper Score in Participants Receiving Each Dose of Prednisone at Week 24 |
17; 21; 8; 4; 0; 0 | 0.1853 |
| PRIMARY OLE: Number of Participants in Each Category of Assessment Based on Corticosteroid Taper Score in Participants Receiving Each Dose of Prednisone at Week 48 |
15; 19; 5; 5; 0; 0 | — |
Eligibility Criteria
Inclusion Criteria
- Has biopsy-confirmed sarcoidosis meeting American Thoracic Society criteria ≥ 1 year at screening (Visit 1)
- Has protocol-defined symptomatic pulmonary disease
- Has been receiving a stable prednisone dose between 5 mg and 40 mg (or equivalent) for pulmonary sarcoidosis, for at least 4 weeks before screening, or a stable dose of another disease-modifying anti-sarcoidosis drug for at least 3 months before screening
- Has lung function within protocol-defined parameters
Exclusion Criteria
- Has at least a 10% change in forced vital capacity (FVC) on spirometry between Visits 1 and 2
- 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
Data sourced from ClinicalTrials.gov (NCT03320070) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.