Acthar Gel for Chronic Pulmonary Sarcoidosis (ACPS)

• Register: ClinicalTrials.gov
• Last refreshed on: 14 December 2015
• Main ID: NCT02188017
• Date of registration: 24/04/2014
• Prospective Registration: Yes
• Primary sponsor: University of Cincinnati
• Public title: Acthar Gel for Chronic Pulmonary Sarcoidosis (ACPS) ACPS
• Scientific title: ACTHAR Gel for Chronic Pulmonary Sarcoidosis (ACPS)
• Date of first enrolment: June 2014
• Target sample size: 20
• Recruitment status: Recruiting
• URL: https://clinicaltrials.gov/show/NCT02188017
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
• Phase: Phase 4

Countries of recruitment

United States

Contacts

• Name: Robert P Baughman, MD

• Name: Felicia Thompson

• Name: Robert P Baughman, MD
• Affiliation: University of Cincinnati

Key inclusion & exclusion criteria

Inclusion Criteria:

- Patient with biopsy confirmed sarcoidosis meeting American Thoracic Society criteria
23

- Patient on >5 mg prednisone for pulmonary indications

- FVC <85% predicted

- Prednisone dose not reduced in prior 3 months

- Deterioration of pulmonary disease over the past year

- Decrease in FVC >5%

- Age: 18 through 90 (i.e., candidates must have had their 18th birthday, but not had
their 91st birthday).

Exclusion Criteria:

adrenal insufficiency (Addison's disease)

- Scleroderma

- a fungal infection

- herpes infection of the eyes

- osteoporosis

- a stomach ulcer

- congestive heart failure

- high blood pressure

- recent surgery

- if you are allergic to pork proteins

- Do not receive a smallpox vaccine or any "live" vaccine while you are using
corticotropin.

- Patients receiving anti-Tumor Necrosis Factor antibody (e.g. infliximab, adalimumab)
in prior six months

- Uncontrolled diabetes, hypertension, or other contra-indication to increased dosage
of glucocorticoids

- Patients requiring therapy for pulmonary hypertension

- Females of childbearing potential who are known to be pregnant and/or lactating or
who have a positive urine pregnancy test on screening.

- Current participation in another research drug treatment protocol (patient cannot
start another experimental agent until after 90 days)

- Any other condition that the investigator feels would pose a significant hazard to
the patient if Acthar Gel therapy is initiated.



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

Health Condition(s) or Problem(s) studied

Sarcoidosis

Pulmonary Sarcoidosis

Intervention(s)

Drug: Acthar gel

Primary Outcome(s)

Steroid toxicity [Time Frame: 24 weeks]

Secondary Outcome(s)

Forced Vital Capacity (FVC) [Time Frame: 24 weeks]

PET scan [Time Frame: 24 weeks]

Sarcoidosis Health Questionnaire [Time Frame: 24 weeks]

Chest x-ray [Time Frame: 24 weeks]

Secondary ID(s)

ACPS

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Mallinckrodt