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
3 other identifiers
interventional
173
9 countries
53
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Nov 2009
53 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 6, 2009
CompletedFirst Posted
Study publicly available on registry
August 10, 2009
CompletedStudy Start
First participant enrolled
November 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2012
CompletedResults Posted
Study results publicly available
July 17, 2014
CompletedJuly 17, 2014
June 1, 2014
2.5 years
August 6, 2009
June 18, 2014
June 18, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change From Baseline in Percent-predicted Forced Vital Capacity (FVC) at Week 16
Forced vital capacity (FVC) is a standard pulmonary function test used to quantify respiratory muscle weakness . FVC was the volume of air that can forcibly be blown out after full inspiration in the upright position, measured in liters. Predicted forced vital capacity is based on a formula using sex, age and height of a person, and is an estimate of healthy lung capacity. Percent of predicted FVC = (observed value)/(predicted value) \* 100%. Change was calculated as the value at Week 16 minus the baseline value.
Baseline (Day 1) and Week 16
Secondary Outcomes (4)
Change From Baseline in 6-minute Walk Distance at Week 28
Baseline (Day 1) and Week 28
Change From Baseline in the St. George's Respiratory Questionnaire (SGRQ) Total Score at Week 28
Baseline (Day 1) and Week 28
Percentage of Responders With a Score of Less Than or Equal to 1 on Skin Physician's Global Assessment (SPGA) Scale
Week 28
Change From Baseline in Percent-predicted Forced Vital Capacity (FVC) at Week 28
Baseline (Day 1) and Week 28
Study Arms (3)
Placebo
PLACEBO COMPARATORMatching Placebo will be administered subcutaneously (injected under the skin by way of a needle) every 4 weeks up to Week 24.
Golimumab
EXPERIMENTALGolimumab 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
EXPERIMENTALUstekinumab 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.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Centocor, Inc.lead
Study Sites (53)
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Birmingham, Alabama, United States
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Los Angeles, California, United States
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Denver, Colorado, United States
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New Haven, Connecticut, United States
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Chicago, Illinois, United States
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Baltimore, Maryland, United States
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Ann Arbor, Michigan, United States
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Detroit, Michigan, United States
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St Louis, Missouri, United States
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Lebanon, New Hampshire, United States
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New York, New York, United States
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Chapel Hill, North Carolina, United States
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Charlotte, North Carolina, United States
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Greenville, North Carolina, United States
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Cincinnati, Ohio, United States
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Cleveland, Ohio, United States
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Columbus, Ohio, United States
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Philadelphia, Pennsylvania, United States
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Pittsburgh, Pennsylvania, United States
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Charleston, South Carolina, United States
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Spartanburg, South Carolina, United States
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Memphis, Tennessee, United States
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Dallas, Texas, United States
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Colchester, Vermont, United States
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Brussels, Belgium
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Leuven, Belgium
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Liège, Belgium
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Aarhus, Denmark
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Arhus C, Denmark
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Hellerup, Denmark
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København NV, Denmark
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Bobigny, France
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Lille, France
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Marseille, France
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Montpellier, France
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Paris, France
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Bad Berka, Germany
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Berlin, Germany
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Essen, Germany
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Freiburg im Breisgau, Germany
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Hanover, Germany
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München, Germany
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Amsterdam-Zuidoost, Netherlands
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Rotterdam, Netherlands
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Sittard, Netherlands
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Oslo, Norway
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Trondheim, Norway
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Bucharest, Romania
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Bristol, United Kingdom
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London, United Kingdom
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Portsmouth, United Kingdom
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Sheffield, United Kingdom
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Southampton, United Kingdom
Related Publications (3)
Judson MA, Mack M, Beaumont JL, Watt R, Barnathan ES, Victorson DE. Validation and important differences for the Sarcoidosis Assessment Tool. A new patient-reported outcome measure. Am J Respir Crit Care Med. 2015 Apr 1;191(7):786-95. doi: 10.1164/rccm.201410-1785OC.
PMID: 25594886DERIVEDCrommelin HA, Vorselaars AD, van Moorsel CH, Korenromp IH, Deneer VH, Grutters JC. Anti-TNF therapeutics for the treatment of sarcoidosis. Immunotherapy. 2014;6(10):1127-43. doi: 10.2217/imt.14.65.
PMID: 25428650DERIVEDJudson MA, Baughman RP, Costabel U, Drent M, Gibson KF, Raghu G, Shigemitsu H, Barney JB, Culver DA, Hamzeh NY, Wijsenbeek MS, Albera C, Huizar I, Agarwal P, Brodmerkel C, Watt R, Barnathan ES. Safety and efficacy of ustekinumab or golimumab in patients with chronic sarcoidosis. Eur Respir J. 2014 Nov;44(5):1296-307. doi: 10.1183/09031936.00000914. Epub 2014 Jul 17.
PMID: 25034562DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Senior Director
- Organization
- Johnson & Johnson Pharmaceutical Research & Development
Study Officials
- STUDY DIRECTOR
Centocor, Inc. Clinical Trial
Centocor, Inc.
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- GT60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 6, 2009
First Posted
August 10, 2009
Study Start
November 1, 2009
Primary Completion
May 1, 2012
Study Completion
August 1, 2012
Last Updated
July 17, 2014
Results First Posted
July 17, 2014
Record last verified: 2014-06