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Study of Repeated Administration of a 200-mcg Dose of IPP-201101 Plus Standard of Care in Patients With Systemic Lupus Erythematosus

NCT03427151 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 62

Last updated 2019-04-11

No results posted yet for this study

Summary

this study extension objective is to evaluate the safety and tolerability of a 200-mcg dose every 4 weeks for 24 weeks of IPP-201101 in patients with active systemic lupus erythematosus (SLE) who had participated in the main study IP-005.

Conditions

  • Lupus Erythematosus, Systemic

Interventions

DRUG

IPP-201101

200 mcg of IPP-201101 will be administered subcutaneously every 4 weeks for 24 weeks.

Sponsors & Collaborators

  • ImmuPharma

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-02-27
Primary Completion
2019-02-05
Completion
2019-02-05
FDA Drug
Yes

Countries

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

Study Locations

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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 NCT03427151 on ClinicalTrials.gov