Acthar Gel in Participants With Pulmonary Sarcoidosis

• Register: ClinicalTrials.gov
• Last refreshed on: 6 March 2023
• Main ID: NCT03320070
• Date of registration: 20/10/2017
• Prospective Registration: Yes
• Primary sponsor: Mallinckrodt
• Public title: Acthar Gel in Participants With Pulmonary Sarcoidosis PULSAR
• Scientific title: A Multicenter, Randomized, Double Blind, Placebo Controlled Exploratory Study to Assess the Efficacy and Safety of Acthar Gel in Subjects With Pulmonary Sarcoidosis
• Date of first enrolment: February 21, 2018
• Target sample size: 55
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT03320070
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator).
• Phase: Phase 4

Countries of recruitment

United States

Contacts

• Name: Clinical Team Leader
• Affiliation: Mallinckrodt

Key inclusion & exclusion 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-a antibody within the past 3 months

- Has any pulmonary condition that requires treatment, therefore impeding corticosteroid
tapering



Age minimum: 18 Years
Age maximum: 90 Years
Gender: All

Health Condition(s) or Problem(s) studied

Sarcoidosis, Pulmonary

Intervention(s)

Drug: Acthar Gel

Drug: Placebo

Primary Outcome(s)

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 [Time Frame: Week 24]

OLE: Number of Participants in Each Category of Assessment Based on the DLCO, a Pulmonary Function Test Parameter at Week 48 [Time Frame: Week 48]

OLE: Number of Participants in Each Category of Assessment Based on the KSQ (General Health), a Quality of Life Parameter at Week 48 [Time Frame: Week 48]

DBT: Number of Participants in Each Category of Assessment Based on High Resolution Computer Tomography (HRCT) at Week 24 [Time Frame: Week 24]

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 [Time Frame: Week 24]

OLE: Number of Participants in Each Category of Assessment Based on Corticosteroid Taper Score in Participants Receiving Each Dose of Prednisone at Week 48 [Time Frame: Week 48]

DBT: Number of Participants in Each Category of Assessment Based on Corticosteroid Taper Score in Participants Receiving Each Dose of Prednisone at Week 24 [Time Frame: Week 24]

DBT: Number of Participants in Each Category of Assessment Based on Forced Vital Capacity (FVC), a Pulmonary Function Test Parameter at Week 24 [Time Frame: Week 24]

OLE: Number of Participants in Each Category of Assessment Based on FVC, a Pulmonary Function Test Parameter at Week 48 [Time Frame: Week 48]

DBT: Number of Participants in Each Category of Assessment Based on the Fatigue Assessment Score (FAS), a Quality of Life Parameter at Week 24 [Time Frame: Week 24]

OLE: Number of Participants in Each Category of Assessment Based on FAS, a Quality of Life Parameter at Week 48 [Time Frame: Week 48]

OLE: Number of Participants in Each Category of Assessment Based on HRCT at Week 48 [Time Frame: Week 48]

Secondary ID(s)

MNK14344100

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 27/02/2023
• URL: https://clinicaltrials.gov/ct2/show/results/NCT03320070