NCT00955279

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

A Phase 2, Multicenter, Randomized, Double-Blind, Parallel-group, Placebo-controlled Study Evaluating the Safety and Efficacy of Treatment With Ustekinumab or Golimumab in Subjects With Chronic Sarcoidosis

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 173 (actual)
• Sponsor: Centocor, Inc. · Industry
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Sarcoidosis

Interventions

Type	Name	Description
DRUG	Placebo	Matching Placebo will be administered subcutaneously (injected under the skin by way of a needle) every 4 weeks up to Week 24.
DRUG	Golimumab	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.
DRUG	Ustekinumab	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.

Timeline

• Start date: 2009-11-01
• Primary completion: 2012-05-01
• Completion: 2012-08-01
• First posted: 2009-08-10
• Last updated: 2014-07-17
• Results posted: 2014-07-17

Locations

53 sites across 9 countries: United States, Belgium, Denmark, France, Germany, Netherlands, Norway, Romania, United Kingdom