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A 52-Week, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study to Evaluate the Efficacy and Safety of a 200-mcg Dose of IPP-201101 Plus Standard of Care in Patients With Systemic Lupus Erythematosus

NCT02504645 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 202

Last updated 2019-04-11

Study results available
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Summary

This current Phase 3 study will evaluate the efficacy and safety of administration of subcutaneous (sc) IPP-201101 in patients with active SLE.

Conditions

  • Lupus Erythematosus, Systemic

Interventions

DRUG

IPP-201101

DRUG

Placebo

OTHER

Standard of Care

Sponsors & Collaborators

  • ImmuPharma

    lead INDUSTRY

Principal Investigators

  • Daniel WALLACE · Wallace Rheumatic Studies Center LLC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-03-31
Primary Completion
2018-01-31
Completion
2018-01-31

Countries

  • United States
  • Czechia
  • France
  • Germany
  • Hungary
  • Mauritius
  • Poland
  • Puerto Rico

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02504645 on ClinicalTrials.gov