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

Sponsored by:	Centocor, Inc.
Information provided by:	Centocor, Inc.
ClinicalTrials.gov Identifier:	NCT00955279

Purpose

The experimental drug ustekinumab is being studied in 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. 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 sarcoidosis. The study will be conducted at approximately 40 sites globally. Patients can remain on usual, accepted treatment for sarcoid while enrolled in the study. Patients receiving corticosteroids at the beginning of the study will be required to begin tapering at Week 16 of the study. Participating in other experimental studies or taking other experimental medications while participating in this study will not be allowed.

Condition	Intervention	Phase
Sarcoidosis	Drug: Placebo Drug: golimumab Drug: ustekinumab	Phase II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study
Official Title:	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

Resource links provided by NLM:

MedlinePlus related topics: Sarcoidosis

Drug Information available for: Golimumab Ustekinumab

U.S. FDA Resources

Further study details as provided by Centocor, Inc.:

Primary Outcome Measures:

The primary endpoint is the change from baseline in percent-predicted Forced Vital Capacity (measure of lung volume at maximum rate of exhalation) at Week 16 in the primary population. [ Time Frame: Week 16. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Change from baseline in 6 minute walk distance at Week 28 in the primary population [ Time Frame: Week 28 ] [ Designated as safety issue: No ]
Change from baseline in St. George's Respiratory Questionnaire total score at Week 28 in the primary population [ Time Frame: Week 28 ] [ Designated as safety issue: No ]
Proportion of Skin Physician Global Assessment responders at Week 28 in the secondary population [ Time Frame: Week 28 ] [ Designated as safety issue: No ]
Change from baseline in percent-predicted Forced Vital Capacity at Week 28 in the primary population. [ Time Frame: Week 28. ] [ Designated as safety issue: No ]

Estimated Enrollment:	180
Estimated Study Completion Date:	October 2011
Estimated Primary Completion Date:	July 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
001: Placebo Comparator	Drug: Placebo Placebo at Weeks 0, 4, 8, 12, 16, 20, and 24
002: Experimental	Drug: ustekinumab 180 mg at Wk 0, 90 mg at Wks 8, 16, and 24
003: Experimental	Drug: golimumab 200 mg at Wk 0, 100 mg at Wks 4, 8, 12, 16, 20, and 24

Detailed Description:

Ustekinumab and golimumab are two experimental drugs that 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. 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.

Eligibility

Ages Eligible for Study:	18 Years to 85 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00955279

Contacts

Contact: This study is not yet recruiting patients. Please check back for future recruiting sites, or email

info1@veritasmedicine.com

Sponsors and Collaborators

Centocor, Inc.

Investigators

Study Director:

Centocor, Inc. Clinical Trial

Centocor, Inc.

More Information

No publications provided

Responsible Party:	Centocor ( Director, Clinical Research )
Study ID Numbers:	CR016405, 1275148SCD2001, 2009-010714-30, CR016405
Study First Received:	August 6, 2009
Last Updated:	August 27, 2009
ClinicalTrials.gov Identifier:	NCT00955279 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Centocor, Inc.:

Ustekinumab
CNTO 1275
Stelara
Golimumab
CNTO 148

Simponi
Sarcoidosis
Sarcoid
Pulmonary Sarcoidosis
Skin Sarcoidosis

Study placed in the following topic categories:

Lymphatic Diseases
Sarcoidosis
Lymphoproliferative Disorders
Sarcoidosis, Pulmonary

Additional relevant MeSH terms:

Lymphatic Diseases
Sarcoidosis
Lymphoproliferative Disorders

ClinicalTrials.gov processed this record on September 11, 2009