A Study to Evaluate the Safety and Effectiveness of Ustekinumab or Golimumab Administered Subcutaneously (SC) in Patients With Sarcoidosis

Ustekinumab is approved for dosing in patients with psoriasis and golimumab is approved for
dosing in patients with rheumatoid arthritis, psoriatic arthritis and ankylosing
spondylitis. This study will use either drug in patients with chronic sarcoidosis.
Ustekinumab and golimumab are being tested to see if they may be useful in treating chronic
sarcoidosis. This study will compare the effects (both good and bad) of ustekinumab and
golimumab to those of placebo. The purpose of this study is to evaluate the safety and
effectiveness of ustekinumab and golimumab (administered as individual treatments) in
patients with chronic sarcoidosis with lung and/or skin involvement who still have symptoms
even though receiving current therapy. About 180 patients will take part in the study.
While in this study, patients may not take part in any other medical research studies.
Ustekinumab and golimumab are not approved by the national health authorities for treatment
of chronic sarcoidosis; therefore, they can only be used in a research setting to treat this
condition. The screening phase of the study, where the doctor will determine if a patient
is eligible for the study, will last 1 to 4 weeks. Patients are put into 1 of 3 groups and
each group will get a different treatment. The results of the golimumab group and the
ustekinumab group are compared to placebo. Patients will either receive ustekinumab,
golimumab or placebo. Placebo looks like ustekinumab and golimumab and is given in the same
way, by injection, but contains no active drug. Patients will receive study agent until Week
24 and will continue to be followed through Week 44 for assessment of safety and any other
effects after discontinuation of therapy. The patient will continue to take all sarcoidosis
medication(s) at current, stable dose for the first part of the study. If the patient
remained on a stable steroid dose from Week 0 through Week 16 of the study, the study doctor
will begin to taper (lower) the steroid dose. The steroid taper will continue through to the
end of the Week 28 visit. The patient will continue to take their other sarcoidosis
medication(s) at the same dose for the rest of the study. An independent Data Monitoring
Committee will be responsible for reviewing the safety data for the study. Patients will be
in the study for about 48 weeks. The end of the study is defined as the last visit of the
last patient. A site-specific substudy is being implemented to collect serum and lung
samples from patients who are currently enrolled in this study. A separate protocol is being
implemented to collect lung fluid and serum samples from normal, healthy subjects to be used
as comparators for similar samples obtained in the 1275148SCD2001 substudy. Patients will be
randomly assigned to 1 of 3 treatment groups: ustekinumab (180 mg at Week 0, followed by 90
mg at Weeks 8, 16, and 24 with placebo at Weeks 4, 12, and 20), golimumab (200 mg at Week 0,
followed by 100 mg at Weeks 4, 8, 12, 16, 20, and 24) or placebo (at Weeks 0, 4, 8, 12, 16,
20, and 24) administered by SC injection.