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

• Status: Completed
• Trial end date: 2012-08-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Centocor, Inc.
• Treatments: Antibodies, Monoclonal; Golimumab; Ustekinumab

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