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NCT03320070 · ClinicalTrials.gov registry record · Phase 4
Acthar Gel in Participants With Pulmonary Sarcoidosis
A Phase 4 study, sponsored by Mallinckrodt.
- Completed
- Registry status
- Phase 4
- Development phase
- 55
- Enrollment target
NCT03320070: Completed Phase 4 study, sponsored by Mallinckrodt.
NCT03320070 is a Phase 4 study that has completed, run by Mallinckrodt. The registered enrollment target is 55 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (89% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03320070, a Phase 4 study, has completed, sponsored by Mallinckrodt.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 55 participants
- Enrollment target
Study 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.
Primary Outcome
Forced vital capacity (FVC) is a pulmonary function test parameter that indicates the amount of air that can be forcibly exhaled from the lungs after taking the deepest breath possible. It's measured by spirometry, which is a common breathing test to check lung function. Based on the absolute change of percent predicted, FVC was evaluated to determine if the condition is: * Improved (+1) \[≥ 5% absolute change\] * Unchanged (0) \[\>- 5% to \< 5% absolute change\], or * Worse (-1) \[≤ -5% absolu
Interventions
- DRUG Placebo
- DRUG Acthar Gel
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 55 participants |
| Start Date | 2018-02-21 |
| Est. Completion | 2021-11-15 |
| Phase | Phase 4 |
What the finished NCT03320070 record still lists
NCT03320070 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 55 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (89% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT03320070 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03320070 about?
NCT03320070 is a clinical study titled "Acthar Gel in Participants With Pulmonary Sarcoidosis". 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 assig...
What is the current status of trial NCT03320070?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 55 participants. The study started on 2018-02-21. Estimated completion is 2021-11-15.
What interventions are being tested in trial NCT03320070?
The interventions under investigation include: Placebo (DRUG), Acthar Gel (DRUG).
Who is sponsoring clinical trial NCT03320070?
This trial is sponsored by Mallinckrodt, which has 69 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03320070's enrollment target sits among peer trials
55 1218th of 2000 higher than 778 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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