Acthar Gel in Participants With Pulmonary Sarcoidosis (PULSAR)

Mallinckrodt

Status and phase: Completed; Phase 4

Conditions: Sarcoidosis, Pulmonary

Treatments: Drug: Acthar Gel; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT03320070

MNK14344100

Details and patient eligibility

About

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.

Enrollment: 55 patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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55 participants in 2 patient groups

Acthar Gel in DBT Then Acthar Gel in OLE

Experimental group

Description:

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.

Treatment:

Drug: Acthar Gel

Placebo in DBT Then Acthar Gel in OLE

Experimental group

Description:

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.

Treatment:

Drug: Placebo

Drug: Acthar Gel