CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 55 enrolled
Drug / intervention
Acthar Gel +1 moredrug
Likely dose
Acthar Gel 80 unitsfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03320070
NCT03320070Phase 4Completed
CompareCT.gov

A Multicenter, Randomized, Double Blind, Placebo Controlled Exploratory Study to Assess the Efficacy and Safety of Acthar Gel in Subjects With Pulmonary Sarcoidosis

Mallinckrodt·interventional·Posted Oct 25, 2017·Updated Feb 27, 2023

In Brief

A Phase 4 clinical trial evaluating Acthar Gel and Placebo for Sarcoidosis, Pulmonary. Completed, enrolled 55 participants across 29 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSarcoidosis, Pulmonary
CountriesUnited States
Collaborators--

Timeline

Phase 4CompletedFinished
201820192020202120222023202420252026
First PostedOct 25, 2017
Enrollment StartFeb 21, 2018
Primary CompletionNov 15, 2021
TodayJul 2, 2026
Enrollment to primary: 3.7 yearsPosted 8.7 years ago

Interventions

Acthar Geldrug

Acthar Gel for subcutaneous (SC) injection (80 units per 1 mL)

Placebodrug

Placebo gel for SC injection