Clinical Trials Logo
  1. Home
  2. Systemic Lupus Erythematosus
  3. NCT02194400
  4. Details
NCT02194400 Clinical Trial

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

Systemic Lupus Erythematosus Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02194400
Other study ID # 132-02
Secondary ID
Status Completed
Phase Phase 1
First received July 16, 2014
Last updated December 8, 2015
Start date July 2014
Est. completion date November 2015

Study information
Verified date December 2015
Source Resolve Therapeutics
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 32
Est. completion date November 2015
Est. primary completion date November 2015
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 70 Years
Eligibility Inclusion Criteria:

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

Exclusion Criteria:

- Other biologic drugs

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
United States Clinical Research of West Florida Clearwater Florida
United States Metroplex Clinical Research Dallas Texas
United States Altoona Center for Clinical Research Duncansville Pennsylvania
United States West Michigan Rheumatology Grand Rapids Michigan

Sponsors (1)
Lead Sponsor Collaborator
Resolve Therapeutics

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 30 days No
See also
  Status Clinical Trial Phase
Terminated NCT03843125 - A Study of Baricitinib in Participants With Systemic Lupus Erythematosus (SLE) Phase 3
Recruiting NCT05698173 - Systemic Lupus Erythematosus and Accelerated Aging N/A
Active, not recruiting NCT01649765 - Pediatric Lupus Trial of Belimumab Plus Background Standard Therapy Phase 2
Recruiting NCT05704153 - Modelling and Control of Non-invasive Vagus Nerve Stimulation for Autoimmune Diseases (1A) N/A
Completed NCT05048238 - Evaluation of Tofacitinib in Prevention of Photosensitivity in Lupus Phase 1
Recruiting NCT06056778 - The Prevalence Evaluation of Systemic Lupus Erythematosus in Russian Patients With Reproductive Issues (PRISMA)
Completed NCT04358302 - Individual Patient Exposure and Response in Pediatric Lupus N/A
Completed NCT03802578 - The Impact of Exercise on Hand Function, Daily Activities Performance and Quality of Life of SLE' Patients N/A
Completed NCT02554019 - Proof-of-Concept Study With BT063 in Subjects With Systemic Lupus Erythematosus Phase 2
Recruiting NCT04835883 - Exploring the Efficacy and Safety of CS20AT04 (Allogenic Bone Marrow-Derived Stem Cell) in Systemic Lupus Erythematosus Patients Phase 2
Terminated NCT02665364 - Phase IIb Study of IFN-K in Systemic Lupus Erythematosus Phase 2
Completed NCT00278538 - Cyclophosphamide and Rabbit Antithymocyte Globulin (rATG)/Rituximab in Patients With Systemic Lupus Erythematosus Phase 2
Completed NCT00069342 - Health Beliefs and Health Behaviors Among Minorities With Rheumatic Diseases
Completed NCT03252587 - An Investigational Study to Evaluate BMS-986165 in Participants With Systemic Lupus Erythematosus Phase 2
Terminated NCT02066311 - Nelfinavir in Systemic Lupus Erythematosus Phase 2
Recruiting NCT01892748 - Cholecalciferol Supplementation on Disease Activity, Fatigue and Bone Mass on Juvenile Systemic Lupus Erythematosus. N/A
Terminated NCT01689025 - An Investigation of Safety and Tolerability of NNC0114-0006 in Subjects With Systemic Lupus Erythematosus (SLE) Phase 1
Completed NCT01475149 - Effect of HCQ on AnxA5 Resistance Assay in Antiphospholipid (aPL) Positive Patients With and Without Systemic Lupus Erythematosus (SLE) N/A
Unknown status NCT01712529 - Physical Exercise, Endothelial Function and Progenitor Endothelial Cells in Systemic Lupus Erythematosus Patients N/A
Completed NCT00962832 - A Study to Evaluate the Efficacy and Safety of Rontalizumab in Patients With Moderately to Severely Active Systemic Lupus Erythematosus Phase 2

External Links