A Study to Evaluate the Safety and Effectiveness of Ustekinumab or Golimumab Administered Subcutaneously (SC) in Patients with Sarcoidosis
- Conditions
- Chronic sarcoidosisMedDRA version: 14.0Level: PTClassification code 10039486Term: SarcoidosisSystem Organ Class: 10021428 - Immune system disordersTherapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
- Registration Number
- EUCTR2009-010714-30-DK
- Lead Sponsor
- Janssen Biologics B.V.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 180
- 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 thesemedications for >=4 weeks before screening
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 11
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 11
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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method