A Study to Evaluate the Safety and Effectiveness of Ustekinumab or Golimumab Administered Subcutaneously (SC) in Patients With Sarcoidosis
Condition: Sarcoidosis
MeSH terms: Sarcoidosis
Intervention: Placebo; Golimumab; Ustekinumab
Intervention description: 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
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 173.0
Sex: All
Minimum age: 18 Years
Maximum age: 85 Years
Healthy volunteers: No
Keywords: Ustekinumab; CNTO 1275; Stelara; Golimumab; CNTO 148; Simponi; Sarcoidosis; Sarcoid; Pulmonary Sarcoidosis; Skin Sarcoidosis

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.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients must have sarcoidosis with onset date of >=2 years prior to screening with at
             least 1 of the following: a. pulmonary sarcoidosis defined as 1) a diagnosis of
             sarcoidosis with evidence of lung parenchymal disease (Stage II, III or IV on chest
             radiograph), and 2) an FVC of >=45% and <=80% of predicted normal value at screening,
             and 3) an MRC dyspnea score of >2 at screening, and 4) a 6 minute walk distance
             between 100 to 550 meters at screening, and 5) <=15% absolute change in
             percent-predicted FVC at baseline relative to screening AND/OR b. skin sarcoidosis
             defined as 1) active chronic skin lesions for >=3 months either on face or elsewhere
             on body that have not resolved on current systemic and/or local therapy, and 2) have
             either: a single lesion of >=2 cm in longest dimension or multiple (3 or more) lesions
             with at least 1 lesion having a longest dimension of >=1 cm, and 3) have an SPGA score
             >=2 at screening

          -  have been receiving treatment with oral corticosteroids and/or 1 or more
             immunomodulators for >=3-month period immediately prior to screening

          -  on a stable dose of these medications for >=4 weeks before screening

        Exclusion Criteria:

          -  Have a diagnosis of other significant respiratory disorder other than sarcoidosis that
             would complicate the evaluation of response to treatment

          -  Have a smoking history of >=20 pack years

          -  Have used an investigational drug within 1 month prior to screening or within 5
             half-lives of the investigational agent, whichever is longer

          -  have received previous administration of a treatment with any other therapeutic agent
             targeted at reducing TNFalpha within 6 months or 5 half-lives of the agent, whichever
             is longer, prior to screening

          -  Patients who have previously received biologic anti-TNFalpha agents outside of the
             above period are allowed to enter the study

          -  Have previously used cyclophosphamide

          -  Have previously used or received local therapy (including local injections) within 3
             months before the screening visit or used or received treatment with prescription
             topical creams within 1 month before the screening visit for treatment of sarcoidosis
             skin lesions

          -  Have used any therapeutic agent targeted at reducing IL-12 and/or IL-23, including but
             not limited to, ustekinumab and briakinumab within 6 months or 5 half-lives of the
             agent, whichever is longer, prior to the screening visit

          -  have received natalizumab or agents that deplete or modulate the activity of B cells
             or T cells within 12 months of screening, or, if after receiving these agents,
             evidence is available at screening of persistent depletion of the targeted lymphocyte
             population

          -  have used any antibody (monoclonal or polyclonal) or antibody-based agents <= 6 months
             or within 5 half-lives of the biologic prior to the screening visit, whichever is
             longer