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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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21 December 2015 |
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Main ID: |
NCT02194400 |
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Date of registration:
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16/07/2014 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Dose Escalation Study of RSLV-132 in Subjects With Systemic Lupus Erythematosus
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Scientific title:
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A Double-Blind, Placebo-Controlled Dose Escalation Study of the Administration of Multiple Intravenous Doses of RSLV-132 in Subjects With Systemic Lupus Erythematosus |
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Date of first enrolment:
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July 2014 |
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Target sample size:
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32 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02194400 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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Phase:
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Phase 1
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Countries of recruitment
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United States
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Contacts
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Name:
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James Posada, Ph.D. |
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Address:
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Telephone:
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Email:
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Affiliation:
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Resolve Therapeutics |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Stable SLE with no anticipated change in medications for the next 60 days
Exclusion Criteria:
- Other biologic drugs
Age minimum:
18 Years
Age maximum:
70 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Systemic Lupus Erythematosus
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Intervention(s)
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Biological: RSLV-132
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Primary Outcome(s)
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Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
[Time Frame: 30 days]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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