Print

Purpose

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.

Condition

Eligibility

Eligible Ages
Between 18 Years and 90 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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

Study Design

Phase
Phase 4
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Double (Participant, Investigator)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Acthar Gel in DBT Then Acthar Gel in OLE 		Participants received Acthar Gel as a 1 milliliter (mL) injection under the skin, twice weekly, for 24 weeks in the double-blind treatment (DBT) phase. Participants, who chose to continue into the optional OLE phase, then received Acthar Gel as a 1 mL injection under the skin, twice weekly, for another 24 weeks in the optional open-label extension (OLE) phase.
  • Drug: Acthar Gel
    Acthar Gel for subcutaneous (SC) injection (80 units per 1 mL)
    Other names:
    • H.P. Acthar Gel
    • Repository Corticotropin Injection
Experimental
Placebo in DBT Then Acthar Gel in OLE 		Participants received Acthar Gel matching placebo as a 1 mL injection under the skin, twice weekly, for 24 weeks in the DBT phase. Participants, who chose to continue into the optional OLE phase, then received Acthar Gel as a 1 mL injection under the skin, twice weekly, for another 24 weeks in the optional OLE phase.
  • Drug: Acthar Gel
    Acthar Gel for subcutaneous (SC) injection (80 units per 1 mL)
    Other names:
    • H.P. Acthar Gel
    • Repository Corticotropin Injection
  • Drug: Placebo
    Placebo gel for SC injection
    Other names:
    • Matching Placebo

More Details

Status
Completed
Sponsor
Mallinckrodt

Study Contact

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.