Pilot Study to Assess the Efficacy and Safety of H.P. Acthar® Gel in Subjects With Pulmonary Sarcoidosis

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Pilot Study to Assess the Efficacy and Safety of H.P. Acthar® Gel in Subjects With Pulmonary Sarcoidosis

Study Purpose

The purpose of this study is to evaluate the efficacy and safety of H.P. Acthar® Gel (Acthar) in the treatment of pulmonary sarcoidosis.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years - 90 Years
Gender	All

More Inclusion & Exclusion Criteria

Inclusion Criteria:

- Subject with biopsy confirmed sarcoidosis meeting American Thoracic Society criteria ≥ 1 year at screening (Visit 1).

- Symptomatic pulmonary disease defined as any one of the following criteria for pulmonary function test (PFT); imaging; steroid dose; or symptoms: 1.

Decrease ≥ 5% absolute change of % predicted in the best available FVC within the past 2 years. 2. Decrease ≥ 5% absolute change of % predicted in the best available DLCO within the past 2 years. 3. Radiographic progression in chest imaging on side by side comparison within the past 2 years. 4. Progression of pulmonary sarcoidosis necessitating increase in antisarcoidosis therapy in the past 2 years. 5. Dyspnea with Medical Research Council Scale of ≥ 1 at screening (Visit 1).

- Subject receiving ≥ 5 mg and ≤ 40 mg prednisone (or equivalent) for pulmonary sarcoidosis.

- Stable prednisone dose ≥ 4 weeks prior to screening (Visit 1).

- Subjects treated with any disease modifying antisarcoidosis drugs (eg, methotrexate) must be on stable dose for ≥ 3 months prior to screening (Visit 1).

- Forced vital capacity (FVC) ≥ 45% ≤ 95% predicted.

- Diffusing capacity of the lung for carbon monoxide (DLCO) ≥ 30%.

Exclusion Criteria:

- Any difference >10% in FVC on spirometry between the determination at screening (Visit 1) and the determination at Visit 2.

- Pulmonary arterial hypertension requiring or receiving treatment.

- Extra pulmonary involvement that per the Investigator's evaluation requires treatment that would impede corticosteroid tapering for pulmonary involvement.

- Treatment with antitumor necrosis factor-α antibody (eg, infliximab, adalimumab) in prior 3 months.

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT03320070
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	Phase 4
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Mallinckrodt
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Study Director
Principal Investigator Affiliation	Mallinckrodt
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Industry
Overall Status	Recruiting
Countries	United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Sarcoidosis, Pulmonary

Additional Details

This is a Phase 4, multicenter, randomized, double-blind, placebo-controlled pilot study evaluating the efficacy and safety of Acthar gel in the treatment of pulmonary sarcoidosis. All subjects who meet eligibility criteria will be randomly assigned to receive either 1 mL (80 U) of Acthar or 1 mL of a matching placebo subcutaneously (SC) 2 x/week. Subjects will be assigned to treatment in a 1:1 ratio with up to 50 subjects per arm for a total of up to 100 subjects. Subjects who complete the 24 week randomized, double-blind, placebo-controlled treatment period will be eligible to continue in an optional 24 week open label extension.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Tyler, Texas

Status

Recruiting

Address

University of Texas Health Science Center at Tyler

Tyler, Texas, 75708

Site Contact

Clinical Trial Finder

Pilot Study to Assess the Efficacy and Safety of H.P. Acthar® Gel in Subjects With Pulmonary Sarcoidosis

Study Purpose

Recruitment Criteria

Inclusion Criteria:

Exclusion Criteria:

Trial Details

Contact a Trial Team