Viewing Study NCT03427151


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Study NCT ID: NCT03427151
Status: COMPLETED
Last Update Posted: 2019-04-11
First Post: 2017-12-08
Is NOT Gene Therapy: False
Has Adverse Events: False

Brief Title: Study of Repeated Administration of a 200-mcg Dose of IPP-201101 Plus Standard of Care in Patients With Systemic Lupus Erythematosus
Sponsor: ImmuPharma
Organization:

Study Overview

Official Title: An Open-label Study of the Safety and Tolerability of Repeated Administration of a 200-mcg Dose of IPP-201101 Plus Standard of Care in Patients With Systemic Lupus Erythematosus
Status: COMPLETED
Status Verified Date: 2019-04
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: IP-006
Brief 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.
Detailed Description: None

Study Oversight

Has Oversight DMC: True
Is a FDA Regulated Drug?: True
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: