Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 17 of 22163 for:    Placebo AND subjects

A Phase 2a of RSLV-132 in Subjects With Systemic Lupus Erythematosus (SLE)

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02660944
Recruitment Status : Recruiting
First Posted : January 21, 2016
Last Update Posted : June 4, 2018
Sponsor:
Information provided by (Responsible Party):
Resolve Therapeutics

Brief Summary:
This study evaluates the impact of 13 bi-weekly intravenous infusions of RSLV-132 on the cutaneous manifestations in subjects with systemic lupus erythematosus.

Condition or disease Intervention/treatment Phase
Systemic Lupus Erythematosus Drug: RSLV-132 Drug: Placebo Phase 2

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 2a, Double-blind, Placebo-Controlled Study of RSLV-132 in Subjects With Systemic Lupus Erythematosus (SLE)
Study Start Date : January 2016
Estimated Primary Completion Date : April 2019
Estimated Study Completion Date : September 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lupus

Arm Intervention/treatment
Experimental: RSLV-132
10 mg/kg RSLV-132
Drug: RSLV-132
RNase-Fc fusion protein

Placebo Comparator: Placebo
Saline placebo
Drug: Placebo
Saline placebo




Primary Outcome Measures :
  1. Proportion of RSLV-132 treated subjects with cutaneous lupus erythematosus disease area and severity index (CLASI) improvement compared to placebo. [ Time Frame: 24 weeks ]

Secondary Outcome Measures :
  1. Proportion of RSLV-132 treated subjects with steroid reduction as compared to placebo. [ Time Frame: 24 weeks ]
  2. Proportion of RSLV-132 treated subjects with improvement in FACIT-fatigue index as compared to placebo. [ Time Frame: 24 weeks ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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

Inclusion Criteria:

  • CLASI score greater than or equal to 10 at Baseline
  • Positive for one or more RNA autoantibodies

Exclusion Criteria:

  1. severe, active central nervous system (CNS) involvement at Screening;
  2. severe renal involvement at Screening (urine protein/creatinine ratio of >200 mg/mmol, or an estimated creatinine clearance of <30 mL/min);
  3. use of cyclophosphamide within 3 months of the Baseline visit;
  4. use of rituximab within 6 months of the Baseline visit;
  5. use of belimumab within 3 months of the Baseline visit;
  6. use of background medications within 1 month of Baseline in excess of: i. mycophenolate mofetil > 3 g/day; ii. azathioprine > 200 mg/day; iii. methotrexate > 25 mg/day; iv. hydroxychloroquine > 400 mg/day; v. prednisone (or equivalent) > 15 mg/day;
  7. use of an intravenous steroid "pulse" within 2 months of Baseline;
  8. use of an intramuscular steroid injection within 1 month of Baseline;
  9. change in SLE medications within 1 month of Baseline;
  10. the presence of a clinically significant infection in the judgement of the Investigator within seven days prior to the receipt of the first dose of study drug;
  11. positive viral load test for hepatitis B, C, or HIV at Screening;
  12. participation in another clinical trial with receipt of an investigational product within 3 months or 5 half- lives, of last administration (whichever is longer) from Baseline;
  13. positive pregnancy test at Screening or at Baseline;
  14. female subjects currently breast feeding at Baseline;
  15. inability or unwillingness to comply with protocol-specified procedures which, in the opinion of the Investigator, would make the subject unsuitable for study participation.

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): NCT02660944


Contacts
Layout table for location contacts
Contact: James Posada, Ph.D. 208 727 7010 jp@resolvebio.com

Locations
Layout table for location information
United States, California
TriWest Research Associates Recruiting
El Cajon, California, United States, 92020
Contact: Diana Banales         
University of California San Diego Recruiting
La Jolla, California, United States, 92093
Contact: Millicent Abanilla         
Valerius Research Center Recruiting
Los Alamitos, California, United States, 90720
Contact: Michelle Pratt         
Wallace Rheumatic Study Center Recruiting
Los Angeles, California, United States, 90048
Contact: Erin Avila         
United States, Colorado
University of Colorado Recruiting
Aurora, Colorado, United States, 80045
Contact: Ruth Grosskreuz         
United States, Florida
Clinical Research of West Florida Recruiting
Clearwater, Florida, United States, 33765
Contact: Bernadette Melendez         
Center for Rheumatology, Immunology and Arthritis Recruiting
Fort Lauderdale, Florida, United States, 33309
Contact: Diana Paz         
Alper Research Recruiting
Naples, Florida, United States, 34102
Contact: Cheryl Banks         
United States, New York
Northwell Health/ Division of Rheumatology Recruiting
Great Neck, New York, United States, 11042
Contact: Michelle Kong-Rosario         
Feinstein Institute for Medical Research Recruiting
Manhasset, New York, United States, 11030
Contact: Sanita Kandasami         
United States, North Carolina
DJL Clinical Research Recruiting
Charlotte, North Carolina, United States, 28210
Contact: Emily Box, MD         
United States, Ohio
Cleveland Clinic Recruiting
Cleveland, Ohio, United States, 44195
Contact: Lori Strozniak         
United States, Pennsylvania
Temple University Recruiting
Philadelphia, Pennsylvania, United States, 19140
Contact: Lynne Kohler         
United States, Tennessee
Vanderbilt University Recruiting
Nashville, Tennessee, United States, 37232
Contact: Meena Golchha         
United States, Texas
Metroplex Clinical Research Center Recruiting
Dallas, Texas, United States, 75231
Contact: Paul Hernandez         
Accurate Clinical Research Recruiting
Sugar Land, Texas, United States, 77479
Contact: Anallansy Leiva-Brito         
Sponsors and Collaborators
Resolve Therapeutics
Investigators
Layout table for investigator information
Study Chair: James Posada, Ph.D. Resolve Therapeutics

Layout table for additonal information
Responsible Party: Resolve Therapeutics
ClinicalTrials.gov Identifier: NCT02660944     History of Changes
Other Study ID Numbers: 132-03
First Posted: January 21, 2016    Key Record Dates
Last Update Posted: June 4, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Layout table for MeSH terms
Lupus Erythematosus, Systemic
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Immunoglobulin G
Immunologic Factors
Physiological Effects of Drugs