| City: |
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Colchester |
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State:
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VT |
| Zip Code: |
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| Conditions: |
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Sarcoidosis |
| Purpose: |
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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.
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| Study summary: |
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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. |
| Criteria: |
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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 |
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| Study is available at: |
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Colchester, VT
United States
Primary Contact:
Use link at the bottom of the page to see if you qualify for an enrolling site (see list). If you still have questions:
Email: info1@veritasmedicine.com |
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If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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March 23, 2011 |
Modifications to
this listing: |
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Only selected fields are shown, please use the link
above to view all information about this clinical trial. |
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