Phase 4
N=55
Acthar Gel in Participants With Pulmonary Sarcoidosis
Sarcoidosis, Pulmonary
Bottom Line
View on ClinicalTrials.gov: NCT03320070 ↗Enrolled (actual)
55
Serious AEs
12.8%
Results posted
Feb 2023
Primary outcome: 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 Participants — p=0.5076
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Acthar Gel (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Mallinckrodt
- Primary completion
- Nov 2021
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 | — |
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.
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). 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.