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Dose Escalation Study of RSLV-132 in Subjects With Systemic Lupus Erythematosus

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02194400
Recruitment Status : Completed
First Posted : July 18, 2014
Last Update Posted : December 9, 2015
Sponsor:
Information provided by (Responsible Party):
Resolve Therapeutics

Study Description
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Brief Summary:
A one month multi-dose study will evaluate the safety and tolerability of 3 intravenous infusions of RSLV-132 in subjects with inactive to mild SLE.

Condition or disease Intervention/treatment Phase
Systemic Lupus Erythematosus Biological: RSLV-132 Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 32 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Double-Blind, Placebo-Controlled Dose Escalation Study of the Administration of Multiple Intravenous Doses of RSLV-132 in Subjects With Systemic Lupus Erythematosus
Study Start Date : July 2014
Actual Primary Completion Date : November 2015
Actual Study Completion Date : November 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lupus

Arms and Interventions
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Arm Intervention/treatment
Placebo Comparator: Placebo
Saline infusion
 Biological: RSLV-132
0.3 - 10.0 mg/kg RSLV-132 weekly for 4 weeks
Experimental: RSLV-132
0.3 - 10 mg/kg experimental drug
 Biological: RSLV-132
0.3 - 10.0 mg/kg RSLV-132 weekly for 4 weeks


Outcome Measures
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Primary Outcome Measures :
  1. Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 [ Time Frame: 30 days ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Stable SLE with no anticipated change in medications for the next 60 days

Exclusion Criteria:

  • Other biologic drugs
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02194400


Locations
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United States, Florida
Clinical Research of West Florida
Clearwater, Florida, United States, 33765
United States, Michigan
West Michigan Rheumatology
Grand Rapids, Michigan, United States, 49546
United States, Pennsylvania
Altoona Center for Clinical Research
Duncansville, Pennsylvania, United States, 16635
United States, Texas
Metroplex Clinical Research
Dallas, Texas, United States, 75231
Sponsors and Collaborators
Resolve Therapeutics
Investigators
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Study Chair: James Posada, Ph.D. Resolve Therapeutics
More Information
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Additional Information:

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Responsible Party: Resolve Therapeutics
ClinicalTrials.gov Identifier: NCT02194400    
Other Study ID Numbers: 132-02
First Posted: July 18, 2014    Key Record Dates
Last Update Posted: December 9, 2015
Last Verified: December 2015
Keywords provided by Resolve Therapeutics:
RSLV-132
Systemic Lupus Erythematosus
Lupus
SLE
Resolve
Additional relevant MeSH terms:
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Lupus Erythematosus, Systemic
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases