A Study to Evaluate the Safety and Effectiveness of Ustekinumab or Golimumab Administered Subcutaneously (SC) in Patients With Sarcoidosis
Condition: Sarcoidosis
MeSH terms: Sarcoidosis
Study type: Interventional
Phase: Phase 2

Summary: 
      This study tests the safety and effectiveness of ustekinumab or golimumab compared to placebo
      (placebo looks like the drugs being studied, but has no active ingredients). The purpose of
      this research study is to determine if ustekinumab or golimumab is safe and to determine its
      effects (good and bad) on patients with chronic sarcoidosis with pulmonary and/or skin
      involvement. Patients with pulmonary involvement constitute the primary population for
      analysis, and patients with skin involvement constitute the secondary population; a patient
      may be in both populations. The study will be conducted at approximately 40 sites globally.
    

Detailed description: 
      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.
    

Intervention name(s): Placebo; Golimumab; Ustekinumab
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Matching Placebo will be administered subcutaneously (injected under the skin by way of a needle) every 4 weeks up to Week 24.; Golimumab will be administered subcutaneously at a dose of 200 milligram (mg) at Week 0 and thereafter at a dose of 100 mg every 4 weeks up to Week 24.; Ustekinumab will be administered subcutaneously at a dose of 180 mg at Week 0 and thereafter at a dose of 90 mg at Week 8, 16 and 24 and matching Placebo was administered subcutaneously at Week 4, 12 and 20.
Intervention MeSH terms: Golimumab; Ustekinumab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Ustekinumab; CNTO 1275; Stelara; Golimumab; CNTO 148; Simponi; Sarcoidosis; Sarcoid; Pulmonary Sarcoidosis; Skin Sarcoidosis