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

• ClinicalTrials.gov Identifier: NCT02194400
• Recruitment Status: Completed
• First Posted: July 18, 2014
• Last Update Posted: December 9, 2015
• Sponsor: Resolve Therapeutics
• Information provided by (Responsible Party): Resolve Therapeutics

Tracking Information

• First Submitted Date: July 16, 2014
• First Posted Date: July 18, 2014
• Last Update Posted Date: December 9, 2015
• Study Start Date: July 2014
• Actual Primary Completion Date: November 2015 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: December 8, 2015): Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 [ Time Frame: 30 days ]
• Original Primary Outcome Measures (submitted: July 17, 2014): Circulating RNA-Containing Immune Complexes [ Time Frame: 30 days ]
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Dose Escalation Study of RSLV-132 in Subjects With Systemic Lupus Erythematosus
• 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
• 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.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 1
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment
• Condition: Systemic Lupus Erythematosus

Intervention

Biological: RSLV-132

0.3 - 10.0 mg/kg RSLV-132 weekly for 4 weeks

Study Arms

• Placebo Comparator: Placebo
  Saline infusion
  Intervention: Biological: RSLV-132
• Experimental: RSLV-132
  0.3 - 10 mg/kg experimental drug
  Intervention: Biological: RSLV-132

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: July 17, 2014): 32
• Original Estimated Enrollment: Same as current
• Actual Study Completion Date: November 2015
• Actual Primary Completion Date: November 2015 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

• Other biologic drugs

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 70 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT02194400
• Other Study ID Numbers: 132-02
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Resolve Therapeutics
• Original Responsible Party: Same as current
• Current Study Sponsor: Resolve Therapeutics
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Study Chair: James Posada, Ph.D.; Resolve Therapeutics

• PRS Account: Resolve Therapeutics
• Verification Date: December 2015